U.S. BRAND NAMES — Orencia®
PHARMACOLOGIC CATEGORY
Antirheumatic, Disease Modifying
DOSING: ADULTS — Rheumatoid arthritis: I.V.: Dosing is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose, and every 4 weeks thereafter:
<60 kg: 500 mg
60-100 kg: 750 mg
>100 kg: 1000 mg
DOSING: PEDIATRIC — JIA: I.V.:
(For additional information see "Abatacept: Pediatric drug information")
Children ≥ 6 years and <75 kg: 10 mg/kg, repeat dose at 2 and 4 weeks after initial infusion, and every 4 weeks thereafter
Children ≥ 6 years and >75 kg: Note: Dosage is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose and every 4 weeks thereafter:
75-100 kg: 750 mg
>100 kg: 1000 mg
DOSING: ELDERLY — Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.
DOSING: ADJUSTMENT FOR TOXICITY — Withhold therapy for patients with serious infections.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [preservative free]:
Orencia®: 250 mg [contains maltose]
DOSAGE FORMS: CONCISE
Injection, powder for reconstitution [preservative free]:
Orencia®: 250 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Infuse over 30 minutes. Administer through a 0.2-1.2 micron low protein-binding filter
COMPATIBILITY — Stable in NS.
USE
Treatment of moderately- to severely-active adult rheumatoid arthritis (RA); may be used as monotherapy or in combination with other DMARDs
Treatment of moderately- to severely-active juvenile idiopathic arthritis (JIA); may be used as monotherapy or in combination with methotrexate
Note: Abatacept should not be used in combination with anakinra or TNF-blocking agents
ADVERSE REACTIONS SIGNIFICANT — Note: Percentages not always reported; COPD patients experienced a higher frequency of COPD-related adverse reactions (COPD exacerbation, cough, dyspnea, pneumonia, rhonchi)
>10%:
Central nervous system: Headache (≤ 18%)
Gastrointestinal: Nausea
Respiratory: Nasopharyngitis (12%), upper respiratory tract infection
Miscellaneous: Infection (adults 54%; children 36%), antibody formation (2% to 41%)
1% to 10%:
Cardiovascular: Hypertension (7%)
Central nervous system: Dizziness (9%), fever
Dermatologic: Rash (4%)
Gastrointestinal: Dyspepsia (6%), abdominal pain, diarrhea
Genitourinary: Urinary tract infection (6%)
Neuromuscular & skeletal: Back pain (7%), limb pain (3%)
Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, sinusitis
Miscellaneous: Infusion-related reactions (2% to 9%), herpes simplex, influenza
<1% (Limited to important or life-threatening): Acute lymphocytic leukemia, anaphylaxis, anaphylactoid reactions, cellulitis, COPD exacerbation, disease flare, diverticulitis, dyspnea, flushing, hypersensitivity, hypotension, joint wear, lung cancer, lymphoma; malignancies (including bile duct, bladder, breast, cervical, melanoma, myelodysplastic syndrome, prostate, renal, skin, thyroid and uterine); ovarian cyst, pruritus, pyelonephritis, rhonchi, urticaria, varicella infection, wheezing
CONTRAINDICATIONS — There are no contraindications listed within the FDA-approved labeling.
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Rare cases of hypersensitivity, anaphylaxis, or anaphylactoid reactions have been reported; medication for the treatment of hypersensitivity reactions should be available for immediate use. Infections: Caution should be exercised when considering the use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Malignancy: Use may affect defenses against malignancies (via T cell inhibition); impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma and lung cancer has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.
Disease-related concerns: COPD: Use caution with chronic obstructive pulmonary disease (COPD), higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.
Concurrent drug therapy issues: Anakinra: The manufacturer does not recommend concurrent use with anakinra. TNF-blocking agents: Adult patients receiving therapy in combination with TNF-blocking agents had higher rates of infections (including serious infections) than patients on TNF-blocking agents alone. Concurrent use with TNF-blocking agents is not recommended. Monitor for signs and symptoms of infection when transitioning from TNF-blocking agents to abatacept.
Special populations: Elderly: Use with caution, higher incidences of infection and malignancy were observed in the elderly. Pediatrics: Not FDA approved for use in children <6 years of age. Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy. Treat patients testing positive according to standard therapy prior to initiating abatacept.
Dosage form specific issues: Maltose: May contain maltose, which may result in falsely-elevated serum glucose readings on the day of infusion.
Other warnings/precautions: Hepatitis screening: Patients should be screened for viral hepatitis prior to use; antirheumatic therapy may cause reactivation of hepatitis B. Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently or within 3 months of discontinuation of therapy; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
DRUG INTERACTIONS
Anti-TNF Agents: May enhance the adverse/toxic effect of Abatacept. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
ETHANOL / NUTRITION / HERB INTERACTIONS — Herb/Nutraceutical: Avoid echinacea (has immunostimulant properties; consider therapy modifications).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Due to the potential risk for development of autoimmune disease in the fetus, use during pregnancy only if clearly needed. A pregnancy registry has been established to monitor outcomes of women exposed to abatacept during pregnancy (1-877-311-8972).
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential for adverse reactions and possible effects on the developing immune system, breast-feeding is not recommended.
PRICING — (data from drugstore.com)
Solution (reconstituted) (Orencia)
250 mg (1): $528.09
MONITORING PARAMETERS — Signs and symptoms of infection, signs and symptoms of infusion reaction; hepatitis and TB screening prior to therapy initiation
CANADIAN BRAND NAMES — Orencia®
INTERNATIONAL BRAND NAMES — Orencia (AR, CH, CN, CO, CZ, DE, DK, EE, FR, GB, IE, NO, PE, SE)
MECHANISM OF ACTION — Selective costimulation modulator; inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of rheumatoid arthritis patients.
PHARMACODYNAMICS / KINETICS
Distribution: Vss: 0.02-0.13 L/kg
Half-life elimination: 8-25 days
PATIENT INFORMATION — This drug can only be administered by infusion. Do not have any vaccinations while using this medication without consulting prescriber first. You will be more prone to infection. Avoid crowds and wash your hands frequently. Report infections (local or in your whole body) to prescriber immediately. You will need an overall health assessment prior to each treatment to ensure that you do not have an active infection. You may experience headache or dizziness (use caution when driving) or nausea (small frequent meals or sucking lozenges may help).
Showing posts with label Abatacept. Show all posts
Showing posts with label Abatacept. Show all posts
Sunday, May 16, 2010
Abatacept
U.S. BRAND NAMES — Orencia®
PHARMACOLOGIC CATEGORY
Antirheumatic, Disease Modifying
DOSING: ADULTS — Rheumatoid arthritis: I.V.: Dosing is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose, and every 4 weeks thereafter:
<60 kg: 500 mg
60-100 kg: 750 mg
>100 kg: 1000 mg
DOSING: PEDIATRIC — JIA: I.V.:
(For additional information see "Abatacept: Pediatric drug information")
Children ≥ 6 years and <75 kg: 10 mg/kg, repeat dose at 2 and 4 weeks after initial infusion, and every 4 weeks thereafter
Children ≥ 6 years and >75 kg: Note: Dosage is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose and every 4 weeks thereafter:
75-100 kg: 750 mg
>100 kg: 1000 mg
DOSING: ELDERLY — Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.
DOSING: ADJUSTMENT FOR TOXICITY — Withhold therapy for patients with serious infections.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [preservative free]:
Orencia®: 250 mg [contains maltose]
DOSAGE FORMS: CONCISE
Injection, powder for reconstitution [preservative free]:
Orencia®: 250 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Infuse over 30 minutes. Administer through a 0.2-1.2 micron low protein-binding filter
COMPATIBILITY — Stable in NS.
USE
Treatment of moderately- to severely-active adult rheumatoid arthritis (RA); may be used as monotherapy or in combination with other DMARDs
Treatment of moderately- to severely-active juvenile idiopathic arthritis (JIA); may be used as monotherapy or in combination with methotrexate
Note: Abatacept should not be used in combination with anakinra or TNF-blocking agents
ADVERSE REACTIONS SIGNIFICANT — Note: Percentages not always reported; COPD patients experienced a higher frequency of COPD-related adverse reactions (COPD exacerbation, cough, dyspnea, pneumonia, rhonchi)
>10%:
Central nervous system: Headache (≤ 18%)
Gastrointestinal: Nausea
Respiratory: Nasopharyngitis (12%), upper respiratory tract infection
Miscellaneous: Infection (adults 54%; children 36%), antibody formation (2% to 41%)
1% to 10%:
Cardiovascular: Hypertension (7%)
Central nervous system: Dizziness (9%), fever
Dermatologic: Rash (4%)
Gastrointestinal: Dyspepsia (6%), abdominal pain, diarrhea
Genitourinary: Urinary tract infection (6%)
Neuromuscular & skeletal: Back pain (7%), limb pain (3%)
Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, sinusitis
Miscellaneous: Infusion-related reactions (2% to 9%), herpes simplex, influenza
<1% (Limited to important or life-threatening): Acute lymphocytic leukemia, anaphylaxis, anaphylactoid reactions, cellulitis, COPD exacerbation, disease flare, diverticulitis, dyspnea, flushing, hypersensitivity, hypotension, joint wear, lung cancer, lymphoma; malignancies (including bile duct, bladder, breast, cervical, melanoma, myelodysplastic syndrome, prostate, renal, skin, thyroid and uterine); ovarian cyst, pruritus, pyelonephritis, rhonchi, urticaria, varicella infection, wheezing
CONTRAINDICATIONS — There are no contraindications listed within the FDA-approved labeling.
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Rare cases of hypersensitivity, anaphylaxis, or anaphylactoid reactions have been reported; medication for the treatment of hypersensitivity reactions should be available for immediate use. Infections: Caution should be exercised when considering the use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Malignancy: Use may affect defenses against malignancies (via T cell inhibition); impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma and lung cancer has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.
Disease-related concerns: COPD: Use caution with chronic obstructive pulmonary disease (COPD), higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.
Concurrent drug therapy issues: Anakinra: The manufacturer does not recommend concurrent use with anakinra. TNF-blocking agents: Adult patients receiving therapy in combination with TNF-blocking agents had higher rates of infections (including serious infections) than patients on TNF-blocking agents alone. Concurrent use with TNF-blocking agents is not recommended. Monitor for signs and symptoms of infection when transitioning from TNF-blocking agents to abatacept.
Special populations: Elderly: Use with caution, higher incidences of infection and malignancy were observed in the elderly. Pediatrics: Not FDA approved for use in children <6 years of age. Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy. Treat patients testing positive according to standard therapy prior to initiating abatacept.
Dosage form specific issues: Maltose: May contain maltose, which may result in falsely-elevated serum glucose readings on the day of infusion.
Other warnings/precautions: Hepatitis screening: Patients should be screened for viral hepatitis prior to use; antirheumatic therapy may cause reactivation of hepatitis B. Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently or within 3 months of discontinuation of therapy; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
DRUG INTERACTIONS
Anti-TNF Agents: May enhance the adverse/toxic effect of Abatacept. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
ETHANOL / NUTRITION / HERB INTERACTIONS — Herb/Nutraceutical: Avoid echinacea (has immunostimulant properties; consider therapy modifications).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Due to the potential risk for development of autoimmune disease in the fetus, use during pregnancy only if clearly needed. A pregnancy registry has been established to monitor outcomes of women exposed to abatacept during pregnancy (1-877-311-8972).
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential for adverse reactions and possible effects on the developing immune system, breast-feeding is not recommended.
PRICING — (data from drugstore.com)
Solution (reconstituted) (Orencia)
250 mg (1): $528.09
MONITORING PARAMETERS — Signs and symptoms of infection, signs and symptoms of infusion reaction; hepatitis and TB screening prior to therapy initiation
CANADIAN BRAND NAMES — Orencia®
INTERNATIONAL BRAND NAMES — Orencia (AR, CH, CN, CO, CZ, DE, DK, EE, FR, GB, IE, NO, PE, SE)
MECHANISM OF ACTION — Selective costimulation modulator; inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of rheumatoid arthritis patients.
PHARMACODYNAMICS / KINETICS
Distribution: Vss: 0.02-0.13 L/kg
Half-life elimination: 8-25 days
PATIENT INFORMATION — This drug can only be administered by infusion. Do not have any vaccinations while using this medication without consulting prescriber first. You will be more prone to infection. Avoid crowds and wash your hands frequently. Report infections (local or in your whole body) to prescriber immediately. You will need an overall health assessment prior to each treatment to ensure that you do not have an active infection. You may experience headache or dizziness (use caution when driving) or nausea (small frequent meals or sucking lozenges may help).
PHARMACOLOGIC CATEGORY
Antirheumatic, Disease Modifying
DOSING: ADULTS — Rheumatoid arthritis: I.V.: Dosing is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose, and every 4 weeks thereafter:
<60 kg: 500 mg
60-100 kg: 750 mg
>100 kg: 1000 mg
DOSING: PEDIATRIC — JIA: I.V.:
(For additional information see "Abatacept: Pediatric drug information")
Children ≥ 6 years and <75 kg: 10 mg/kg, repeat dose at 2 and 4 weeks after initial infusion, and every 4 weeks thereafter
Children ≥ 6 years and >75 kg: Note: Dosage is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose and every 4 weeks thereafter:
75-100 kg: 750 mg
>100 kg: 1000 mg
DOSING: ELDERLY — Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.
DOSING: ADJUSTMENT FOR TOXICITY — Withhold therapy for patients with serious infections.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [preservative free]:
Orencia®: 250 mg [contains maltose]
DOSAGE FORMS: CONCISE
Injection, powder for reconstitution [preservative free]:
Orencia®: 250 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Infuse over 30 minutes. Administer through a 0.2-1.2 micron low protein-binding filter
COMPATIBILITY — Stable in NS.
USE
Treatment of moderately- to severely-active adult rheumatoid arthritis (RA); may be used as monotherapy or in combination with other DMARDs
Treatment of moderately- to severely-active juvenile idiopathic arthritis (JIA); may be used as monotherapy or in combination with methotrexate
Note: Abatacept should not be used in combination with anakinra or TNF-blocking agents
ADVERSE REACTIONS SIGNIFICANT — Note: Percentages not always reported; COPD patients experienced a higher frequency of COPD-related adverse reactions (COPD exacerbation, cough, dyspnea, pneumonia, rhonchi)
>10%:
Central nervous system: Headache (≤ 18%)
Gastrointestinal: Nausea
Respiratory: Nasopharyngitis (12%), upper respiratory tract infection
Miscellaneous: Infection (adults 54%; children 36%), antibody formation (2% to 41%)
1% to 10%:
Cardiovascular: Hypertension (7%)
Central nervous system: Dizziness (9%), fever
Dermatologic: Rash (4%)
Gastrointestinal: Dyspepsia (6%), abdominal pain, diarrhea
Genitourinary: Urinary tract infection (6%)
Neuromuscular & skeletal: Back pain (7%), limb pain (3%)
Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, sinusitis
Miscellaneous: Infusion-related reactions (2% to 9%), herpes simplex, influenza
<1% (Limited to important or life-threatening): Acute lymphocytic leukemia, anaphylaxis, anaphylactoid reactions, cellulitis, COPD exacerbation, disease flare, diverticulitis, dyspnea, flushing, hypersensitivity, hypotension, joint wear, lung cancer, lymphoma; malignancies (including bile duct, bladder, breast, cervical, melanoma, myelodysplastic syndrome, prostate, renal, skin, thyroid and uterine); ovarian cyst, pruritus, pyelonephritis, rhonchi, urticaria, varicella infection, wheezing
CONTRAINDICATIONS — There are no contraindications listed within the FDA-approved labeling.
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Rare cases of hypersensitivity, anaphylaxis, or anaphylactoid reactions have been reported; medication for the treatment of hypersensitivity reactions should be available for immediate use. Infections: Caution should be exercised when considering the use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Malignancy: Use may affect defenses against malignancies (via T cell inhibition); impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma and lung cancer has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.
Disease-related concerns: COPD: Use caution with chronic obstructive pulmonary disease (COPD), higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.
Concurrent drug therapy issues: Anakinra: The manufacturer does not recommend concurrent use with anakinra. TNF-blocking agents: Adult patients receiving therapy in combination with TNF-blocking agents had higher rates of infections (including serious infections) than patients on TNF-blocking agents alone. Concurrent use with TNF-blocking agents is not recommended. Monitor for signs and symptoms of infection when transitioning from TNF-blocking agents to abatacept.
Special populations: Elderly: Use with caution, higher incidences of infection and malignancy were observed in the elderly. Pediatrics: Not FDA approved for use in children <6 years of age. Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy. Treat patients testing positive according to standard therapy prior to initiating abatacept.
Dosage form specific issues: Maltose: May contain maltose, which may result in falsely-elevated serum glucose readings on the day of infusion.
Other warnings/precautions: Hepatitis screening: Patients should be screened for viral hepatitis prior to use; antirheumatic therapy may cause reactivation of hepatitis B. Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently or within 3 months of discontinuation of therapy; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
DRUG INTERACTIONS
Anti-TNF Agents: May enhance the adverse/toxic effect of Abatacept. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
ETHANOL / NUTRITION / HERB INTERACTIONS — Herb/Nutraceutical: Avoid echinacea (has immunostimulant properties; consider therapy modifications).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Due to the potential risk for development of autoimmune disease in the fetus, use during pregnancy only if clearly needed. A pregnancy registry has been established to monitor outcomes of women exposed to abatacept during pregnancy (1-877-311-8972).
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential for adverse reactions and possible effects on the developing immune system, breast-feeding is not recommended.
PRICING — (data from drugstore.com)
Solution (reconstituted) (Orencia)
250 mg (1): $528.09
MONITORING PARAMETERS — Signs and symptoms of infection, signs and symptoms of infusion reaction; hepatitis and TB screening prior to therapy initiation
CANADIAN BRAND NAMES — Orencia®
INTERNATIONAL BRAND NAMES — Orencia (AR, CH, CN, CO, CZ, DE, DK, EE, FR, GB, IE, NO, PE, SE)
MECHANISM OF ACTION — Selective costimulation modulator; inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of rheumatoid arthritis patients.
PHARMACODYNAMICS / KINETICS
Distribution: Vss: 0.02-0.13 L/kg
Half-life elimination: 8-25 days
PATIENT INFORMATION — This drug can only be administered by infusion. Do not have any vaccinations while using this medication without consulting prescriber first. You will be more prone to infection. Avoid crowds and wash your hands frequently. Report infections (local or in your whole body) to prescriber immediately. You will need an overall health assessment prior to each treatment to ensure that you do not have an active infection. You may experience headache or dizziness (use caution when driving) or nausea (small frequent meals or sucking lozenges may help).
Friday, February 1, 2008
Abatacept
U.S. BRAND NAMES — Orencia®
PHARMACOLOGIC CATEGORY Antirheumatic, Disease Modifying
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abatacept or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you are taking any of these medicines: Adalimumab, etanercept, or infliximab.
What is this medicine used for? This medicine is used to treat arthritis. The arthritis is usually considered moderately to severely active and may not have responded to other treatments.
How does it work? Abatacept is an arthritis-changing medicine. It reduces inflammation and helps reduce symptoms and protect joints from further harm.
How is it best taken? This medicine is given as an infusion into a vein over a period of time.
What do I do if I miss a dose? (does not apply to patients in the hospital) Call your healthcare provider for instructions.
What are the precautions when taking this medicine? Serious infections have been reported with use of this medicine. If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with healthcare provider. Be careful about taking vaccinations while you are receiving this medicine. If you have diabetes, talk with healthcare provider. You may be more likely to develop infections. If you have lung disease, talk with healthcare provider. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Tell healthcare provider if you are pregnant or plan on getting pregnant. Tell healthcare provider if you are breast-feeding.
What are some possible side effects of this medicine? Risk of infection. Avoid people with infections, colds, or flu. Headache. Feeling dizzy. Rise slowly over several minutes from sitting or lying position. Be careful climbing. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Irritation where the shot is given.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? You will need a tuberculosis test before starting this medicine. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain. Severe dizziness. Severe headache. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? This medicine will be given to you in a healthcare setting. You will not store it at home.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.
PHARMACOLOGIC CATEGORY Antirheumatic, Disease Modifying
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abatacept or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you are taking any of these medicines: Adalimumab, etanercept, or infliximab.
What is this medicine used for? This medicine is used to treat arthritis. The arthritis is usually considered moderately to severely active and may not have responded to other treatments.
How does it work? Abatacept is an arthritis-changing medicine. It reduces inflammation and helps reduce symptoms and protect joints from further harm.
How is it best taken? This medicine is given as an infusion into a vein over a period of time.
What do I do if I miss a dose? (does not apply to patients in the hospital) Call your healthcare provider for instructions.
What are the precautions when taking this medicine? Serious infections have been reported with use of this medicine. If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with healthcare provider. Be careful about taking vaccinations while you are receiving this medicine. If you have diabetes, talk with healthcare provider. You may be more likely to develop infections. If you have lung disease, talk with healthcare provider. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Tell healthcare provider if you are pregnant or plan on getting pregnant. Tell healthcare provider if you are breast-feeding.
What are some possible side effects of this medicine? Risk of infection. Avoid people with infections, colds, or flu. Headache. Feeling dizzy. Rise slowly over several minutes from sitting or lying position. Be careful climbing. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Irritation where the shot is given.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? You will need a tuberculosis test before starting this medicine. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain. Severe dizziness. Severe headache. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? This medicine will be given to you in a healthcare setting. You will not store it at home.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.
Abatacept
U.S. BRAND NAMES — Orencia®
PHARMACOLOGIC CATEGORY Antirheumatic, Disease Modifying
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abatacept or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you are taking any of these medicines: Adalimumab, etanercept, or infliximab.
What is this medicine used for? This medicine is used to treat arthritis. The arthritis is usually considered moderately to severely active and may not have responded to other treatments.
How does it work? Abatacept is an arthritis-changing medicine. It reduces inflammation and helps reduce symptoms and protect joints from further harm.
How is it best taken? This medicine is given as an infusion into a vein over a period of time.
What do I do if I miss a dose? (does not apply to patients in the hospital) Call your healthcare provider for instructions.
What are the precautions when taking this medicine? Serious infections have been reported with use of this medicine. If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with healthcare provider. Be careful about taking vaccinations while you are receiving this medicine. If you have diabetes, talk with healthcare provider. You may be more likely to develop infections. If you have lung disease, talk with healthcare provider. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Tell healthcare provider if you are pregnant or plan on getting pregnant. Tell healthcare provider if you are breast-feeding.
What are some possible side effects of this medicine? Risk of infection. Avoid people with infections, colds, or flu. Headache. Feeling dizzy. Rise slowly over several minutes from sitting or lying position. Be careful climbing. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Irritation where the shot is given.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? You will need a tuberculosis test before starting this medicine. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain. Severe dizziness. Severe headache. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? This medicine will be given to you in a healthcare setting. You will not store it at home.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.
PHARMACOLOGIC CATEGORY Antirheumatic, Disease Modifying
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abatacept or any other part of this medicine. Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved. If you are taking any of these medicines: Adalimumab, etanercept, or infliximab.
What is this medicine used for? This medicine is used to treat arthritis. The arthritis is usually considered moderately to severely active and may not have responded to other treatments.
How does it work? Abatacept is an arthritis-changing medicine. It reduces inflammation and helps reduce symptoms and protect joints from further harm.
How is it best taken? This medicine is given as an infusion into a vein over a period of time.
What do I do if I miss a dose? (does not apply to patients in the hospital) Call your healthcare provider for instructions.
What are the precautions when taking this medicine? Serious infections have been reported with use of this medicine. If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with healthcare provider. Be careful about taking vaccinations while you are receiving this medicine. If you have diabetes, talk with healthcare provider. You may be more likely to develop infections. If you have lung disease, talk with healthcare provider. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Tell healthcare provider if you are pregnant or plan on getting pregnant. Tell healthcare provider if you are breast-feeding.
What are some possible side effects of this medicine? Risk of infection. Avoid people with infections, colds, or flu. Headache. Feeling dizzy. Rise slowly over several minutes from sitting or lying position. Be careful climbing. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Irritation where the shot is given.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? You will need a tuberculosis test before starting this medicine. Follow up with healthcare provider.
REASONS TO CALL HEALTHCARE PROVIDER IMMEDIATELY If you suspect an overdose, call your local poison control center immediately or dial 911. Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat. Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain. Severe dizziness. Severe headache. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? This medicine will be given to you in a healthcare setting. You will not store it at home.
GENERAL STATEMENTS If you have a life-threatening allergy, wear allergy identification at all times. Do not share your medicine with others and do not take anyone else's medicine. Keep all medicine out of the reach of children and pets. Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant). Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.
Wednesday, January 16, 2008
Abatacept: Drug information
Copyright 1978-2006 Lexi-Comp, Inc. All rights reserved.
(For additional information see "Abatacept: Patient drug information")
U.S. BRAND NAMES — Orencia®
PHARMACOLOGIC CATEGORY Antirheumatic, Disease Modifying
DOSING: ADULTS — Rheumatoid arthritis: I.V.: Dosing is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose, and every 4 weeks thereafter: <60>100 kg: 1000 mg
DOSING: ELDERLY — Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [preservative free]: 250 mg
DOSAGE FORMS: CONCISE Injection, powder for reconstitution [preservative free]: Orencia®: 250 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Infuse over 30 minutes. Administer through a 0.2-1.2 micron low protein-binding. filter
COMPATIBILITY — Stable in NS.
USE — Treatment of rheumatoid arthritis not responsive to other disease-modifying antirheumatic drugs (DMARD); may be used as monotherapy or in combination with other DMARDs (not in combination with TNF-blocking agents)
ADVERSE REACTIONS SIGNIFICANT — Note: Percentages not always reported; COPD patients experienced a higher frequency of COPD-related adverse reactions (COPD exacerbation, cough, dyspnea, pneumonia, rhonchi)
>10%: Central nervous system: Headache (18%) Gastrointestinal: Nausea Respiratory: Nasopharyngitis (12%), upper respiratory tract infection Miscellaneous: Infection
1% to 10%: Cardiovascular: Hypertension (7%) Central nervous system: Dizziness (9%) Dermatologic: Rash (4%) Gastrointestinal: Dyspepsia (6%) Genitourinary: Urinary tract infection (6%) Neuromuscular & skeletal: Back pain (7%), limb pain (3%) Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, sinusitis Miscellaneous: Infusion-related reactions (9%), herpes simplex, influenza
<1% (Limited to important or life-threatening): Anaphylaxis, anaphylactoid reactions, cellulitis, diverticulitis, dyspnea, flushing, hypersensitivity, hypotension, lung cancer, lymphoma, pruritus, pyelonephritis, urticaria, wheezing
CONTRAINDICATIONS — Hypersensitivity to abatacept or any component of the formulation; concurrent use with tumor necrosis factor (TNF) blocking agents (eg, adalimumab, etanercept, infliximab)
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: May cause hypersensitivity, anaphylaxis, or anaphylactoid reactions; medication for the treatment of hypersensitivity reactions should be available for immediate use. Infections: Caution should be exercised when considering the use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Malignancy: Use may affect defenses against malignancies; impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.
Disease-related concerns: COPD: Use caution with chronic obstructive pulmonary disease (COPD), higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.
Concurrent drug therapy issues: Anakinra: The manufacturer does not recommend concurrent use with anakinra. TNF-blocking agents: Patients receiving therapy in combination with TNF-blocking agents had higher rates of infections (including serious infections) than patients on TNF-blocking agents alone.
Special populations: Pediatrics: Safety and efficacy have not been established in children. Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy.
Other warnings/precautions: Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
DRUG INTERACTIONS TNF-blocking agents: Concurrent use with abatacept may increase risk of infections; contraindicated.
Vaccines, live: Concomitant use has not be studied; currently recommended not to administer live vaccines during or for 3 months after the completion of abatacept treatment.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Due to the potential risk for development of autoimmune disease in the fetus, use during pregnancy only if clearly needed.
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential for adverse reactions and possible effects on the developing immune system, breast-feeding is not recommended.
PRICING — (data from drugstore.com)Injection (reconstituted) (Orencia) 250 mg (1): $498.99
MONITORING PARAMETERS — Signs and symptoms of infection
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Doses up to 50 mg/kg have been tolerated. In the event of an overdose, monitor for signs and symptoms of adverse reactions; treatment should be symptom-directed and supportive.
MECHANISM OF ACTION — Selective costimulation modulator; inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of rheumatoid arthritis patients.
PHARMACODYNAMICS / KINETICS Distribution: Vss: 0.02-0.13 L/kg
Half-life elimination: 8-25 days
PATIENT INFORMATION — This drug can only be administered by infusion. Do not have any vaccinations while using this medication without consulting prescriber first. You will be more prone to infection. Avoid crowds and wash your hands frequently. Report infections (local or in your whole body) to prescriber immediately. You will need an overall health assessment prior to each treatment to ensure that you do not have an active infection. You may experience headache or dizziness (use caution when driving) or nausea (small frequent meals or sucking lozenges may help).
(For additional information see "Abatacept: Patient drug information")
(For additional information see "Abatacept: Patient drug information")
U.S. BRAND NAMES — Orencia®
PHARMACOLOGIC CATEGORY Antirheumatic, Disease Modifying
DOSING: ADULTS — Rheumatoid arthritis: I.V.: Dosing is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose, and every 4 weeks thereafter: <60>100 kg: 1000 mg
DOSING: ELDERLY — Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [preservative free]: 250 mg
DOSAGE FORMS: CONCISE Injection, powder for reconstitution [preservative free]: Orencia®: 250 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Infuse over 30 minutes. Administer through a 0.2-1.2 micron low protein-binding. filter
COMPATIBILITY — Stable in NS.
USE — Treatment of rheumatoid arthritis not responsive to other disease-modifying antirheumatic drugs (DMARD); may be used as monotherapy or in combination with other DMARDs (not in combination with TNF-blocking agents)
ADVERSE REACTIONS SIGNIFICANT — Note: Percentages not always reported; COPD patients experienced a higher frequency of COPD-related adverse reactions (COPD exacerbation, cough, dyspnea, pneumonia, rhonchi)
>10%: Central nervous system: Headache (18%) Gastrointestinal: Nausea Respiratory: Nasopharyngitis (12%), upper respiratory tract infection Miscellaneous: Infection
1% to 10%: Cardiovascular: Hypertension (7%) Central nervous system: Dizziness (9%) Dermatologic: Rash (4%) Gastrointestinal: Dyspepsia (6%) Genitourinary: Urinary tract infection (6%) Neuromuscular & skeletal: Back pain (7%), limb pain (3%) Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, sinusitis Miscellaneous: Infusion-related reactions (9%), herpes simplex, influenza
<1% (Limited to important or life-threatening): Anaphylaxis, anaphylactoid reactions, cellulitis, diverticulitis, dyspnea, flushing, hypersensitivity, hypotension, lung cancer, lymphoma, pruritus, pyelonephritis, urticaria, wheezing
CONTRAINDICATIONS — Hypersensitivity to abatacept or any component of the formulation; concurrent use with tumor necrosis factor (TNF) blocking agents (eg, adalimumab, etanercept, infliximab)
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: May cause hypersensitivity, anaphylaxis, or anaphylactoid reactions; medication for the treatment of hypersensitivity reactions should be available for immediate use. Infections: Caution should be exercised when considering the use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Malignancy: Use may affect defenses against malignancies; impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.
Disease-related concerns: COPD: Use caution with chronic obstructive pulmonary disease (COPD), higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.
Concurrent drug therapy issues: Anakinra: The manufacturer does not recommend concurrent use with anakinra. TNF-blocking agents: Patients receiving therapy in combination with TNF-blocking agents had higher rates of infections (including serious infections) than patients on TNF-blocking agents alone.
Special populations: Pediatrics: Safety and efficacy have not been established in children. Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy.
Other warnings/precautions: Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
DRUG INTERACTIONS TNF-blocking agents: Concurrent use with abatacept may increase risk of infections; contraindicated.
Vaccines, live: Concomitant use has not be studied; currently recommended not to administer live vaccines during or for 3 months after the completion of abatacept treatment.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Due to the potential risk for development of autoimmune disease in the fetus, use during pregnancy only if clearly needed.
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential for adverse reactions and possible effects on the developing immune system, breast-feeding is not recommended.
PRICING — (data from drugstore.com)Injection (reconstituted) (Orencia) 250 mg (1): $498.99
MONITORING PARAMETERS — Signs and symptoms of infection
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Doses up to 50 mg/kg have been tolerated. In the event of an overdose, monitor for signs and symptoms of adverse reactions; treatment should be symptom-directed and supportive.
MECHANISM OF ACTION — Selective costimulation modulator; inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of rheumatoid arthritis patients.
PHARMACODYNAMICS / KINETICS Distribution: Vss: 0.02-0.13 L/kg
Half-life elimination: 8-25 days
PATIENT INFORMATION — This drug can only be administered by infusion. Do not have any vaccinations while using this medication without consulting prescriber first. You will be more prone to infection. Avoid crowds and wash your hands frequently. Report infections (local or in your whole body) to prescriber immediately. You will need an overall health assessment prior to each treatment to ensure that you do not have an active infection. You may experience headache or dizziness (use caution when driving) or nausea (small frequent meals or sucking lozenges may help).
(For additional information see "Abatacept: Patient drug information")
Abatacept: Drug information
Copyright 1978-2006 Lexi-Comp, Inc. All rights reserved.
(For additional information see "Abatacept: Patient drug information")
U.S. BRAND NAMES — Orencia®
PHARMACOLOGIC CATEGORY Antirheumatic, Disease Modifying
DOSING: ADULTS — Rheumatoid arthritis: I.V.: Dosing is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose, and every 4 weeks thereafter: <60>100 kg: 1000 mg
DOSING: ELDERLY — Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [preservative free]: 250 mg
DOSAGE FORMS: CONCISE Injection, powder for reconstitution [preservative free]: Orencia®: 250 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Infuse over 30 minutes. Administer through a 0.2-1.2 micron low protein-binding. filter
COMPATIBILITY — Stable in NS.
USE — Treatment of rheumatoid arthritis not responsive to other disease-modifying antirheumatic drugs (DMARD); may be used as monotherapy or in combination with other DMARDs (not in combination with TNF-blocking agents)
ADVERSE REACTIONS SIGNIFICANT — Note: Percentages not always reported; COPD patients experienced a higher frequency of COPD-related adverse reactions (COPD exacerbation, cough, dyspnea, pneumonia, rhonchi)
>10%: Central nervous system: Headache (18%) Gastrointestinal: Nausea Respiratory: Nasopharyngitis (12%), upper respiratory tract infection Miscellaneous: Infection
1% to 10%: Cardiovascular: Hypertension (7%) Central nervous system: Dizziness (9%) Dermatologic: Rash (4%) Gastrointestinal: Dyspepsia (6%) Genitourinary: Urinary tract infection (6%) Neuromuscular & skeletal: Back pain (7%), limb pain (3%) Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, sinusitis Miscellaneous: Infusion-related reactions (9%), herpes simplex, influenza
<1% (Limited to important or life-threatening): Anaphylaxis, anaphylactoid reactions, cellulitis, diverticulitis, dyspnea, flushing, hypersensitivity, hypotension, lung cancer, lymphoma, pruritus, pyelonephritis, urticaria, wheezing
CONTRAINDICATIONS — Hypersensitivity to abatacept or any component of the formulation; concurrent use with tumor necrosis factor (TNF) blocking agents (eg, adalimumab, etanercept, infliximab)
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: May cause hypersensitivity, anaphylaxis, or anaphylactoid reactions; medication for the treatment of hypersensitivity reactions should be available for immediate use. Infections: Caution should be exercised when considering the use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Malignancy: Use may affect defenses against malignancies; impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.
Disease-related concerns: COPD: Use caution with chronic obstructive pulmonary disease (COPD), higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.
Concurrent drug therapy issues: Anakinra: The manufacturer does not recommend concurrent use with anakinra. TNF-blocking agents: Patients receiving therapy in combination with TNF-blocking agents had higher rates of infections (including serious infections) than patients on TNF-blocking agents alone.
Special populations: Pediatrics: Safety and efficacy have not been established in children. Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy.
Other warnings/precautions: Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
DRUG INTERACTIONS TNF-blocking agents: Concurrent use with abatacept may increase risk of infections; contraindicated.
Vaccines, live: Concomitant use has not be studied; currently recommended not to administer live vaccines during or for 3 months after the completion of abatacept treatment.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Due to the potential risk for development of autoimmune disease in the fetus, use during pregnancy only if clearly needed.
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential for adverse reactions and possible effects on the developing immune system, breast-feeding is not recommended.
PRICING — (data from drugstore.com)Injection (reconstituted) (Orencia) 250 mg (1): $498.99
MONITORING PARAMETERS — Signs and symptoms of infection
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Doses up to 50 mg/kg have been tolerated. In the event of an overdose, monitor for signs and symptoms of adverse reactions; treatment should be symptom-directed and supportive.
MECHANISM OF ACTION — Selective costimulation modulator; inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of rheumatoid arthritis patients.
PHARMACODYNAMICS / KINETICS Distribution: Vss: 0.02-0.13 L/kg
Half-life elimination: 8-25 days
PATIENT INFORMATION — This drug can only be administered by infusion. Do not have any vaccinations while using this medication without consulting prescriber first. You will be more prone to infection. Avoid crowds and wash your hands frequently. Report infections (local or in your whole body) to prescriber immediately. You will need an overall health assessment prior to each treatment to ensure that you do not have an active infection. You may experience headache or dizziness (use caution when driving) or nausea (small frequent meals or sucking lozenges may help).
(For additional information see "Abatacept: Patient drug information")
(For additional information see "Abatacept: Patient drug information")
U.S. BRAND NAMES — Orencia®
PHARMACOLOGIC CATEGORY Antirheumatic, Disease Modifying
DOSING: ADULTS — Rheumatoid arthritis: I.V.: Dosing is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose, and every 4 weeks thereafter: <60>100 kg: 1000 mg
DOSING: ELDERLY — Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [preservative free]: 250 mg
DOSAGE FORMS: CONCISE Injection, powder for reconstitution [preservative free]: Orencia®: 250 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Infuse over 30 minutes. Administer through a 0.2-1.2 micron low protein-binding. filter
COMPATIBILITY — Stable in NS.
USE — Treatment of rheumatoid arthritis not responsive to other disease-modifying antirheumatic drugs (DMARD); may be used as monotherapy or in combination with other DMARDs (not in combination with TNF-blocking agents)
ADVERSE REACTIONS SIGNIFICANT — Note: Percentages not always reported; COPD patients experienced a higher frequency of COPD-related adverse reactions (COPD exacerbation, cough, dyspnea, pneumonia, rhonchi)
>10%: Central nervous system: Headache (18%) Gastrointestinal: Nausea Respiratory: Nasopharyngitis (12%), upper respiratory tract infection Miscellaneous: Infection
1% to 10%: Cardiovascular: Hypertension (7%) Central nervous system: Dizziness (9%) Dermatologic: Rash (4%) Gastrointestinal: Dyspepsia (6%) Genitourinary: Urinary tract infection (6%) Neuromuscular & skeletal: Back pain (7%), limb pain (3%) Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, sinusitis Miscellaneous: Infusion-related reactions (9%), herpes simplex, influenza
<1% (Limited to important or life-threatening): Anaphylaxis, anaphylactoid reactions, cellulitis, diverticulitis, dyspnea, flushing, hypersensitivity, hypotension, lung cancer, lymphoma, pruritus, pyelonephritis, urticaria, wheezing
CONTRAINDICATIONS — Hypersensitivity to abatacept or any component of the formulation; concurrent use with tumor necrosis factor (TNF) blocking agents (eg, adalimumab, etanercept, infliximab)
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: May cause hypersensitivity, anaphylaxis, or anaphylactoid reactions; medication for the treatment of hypersensitivity reactions should be available for immediate use. Infections: Caution should be exercised when considering the use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Malignancy: Use may affect defenses against malignancies; impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.
Disease-related concerns: COPD: Use caution with chronic obstructive pulmonary disease (COPD), higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.
Concurrent drug therapy issues: Anakinra: The manufacturer does not recommend concurrent use with anakinra. TNF-blocking agents: Patients receiving therapy in combination with TNF-blocking agents had higher rates of infections (including serious infections) than patients on TNF-blocking agents alone.
Special populations: Pediatrics: Safety and efficacy have not been established in children. Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy.
Other warnings/precautions: Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
DRUG INTERACTIONS TNF-blocking agents: Concurrent use with abatacept may increase risk of infections; contraindicated.
Vaccines, live: Concomitant use has not be studied; currently recommended not to administer live vaccines during or for 3 months after the completion of abatacept treatment.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Due to the potential risk for development of autoimmune disease in the fetus, use during pregnancy only if clearly needed.
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential for adverse reactions and possible effects on the developing immune system, breast-feeding is not recommended.
PRICING — (data from drugstore.com)Injection (reconstituted) (Orencia) 250 mg (1): $498.99
MONITORING PARAMETERS — Signs and symptoms of infection
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Doses up to 50 mg/kg have been tolerated. In the event of an overdose, monitor for signs and symptoms of adverse reactions; treatment should be symptom-directed and supportive.
MECHANISM OF ACTION — Selective costimulation modulator; inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of rheumatoid arthritis patients.
PHARMACODYNAMICS / KINETICS Distribution: Vss: 0.02-0.13 L/kg
Half-life elimination: 8-25 days
PATIENT INFORMATION — This drug can only be administered by infusion. Do not have any vaccinations while using this medication without consulting prescriber first. You will be more prone to infection. Avoid crowds and wash your hands frequently. Report infections (local or in your whole body) to prescriber immediately. You will need an overall health assessment prior to each treatment to ensure that you do not have an active infection. You may experience headache or dizziness (use caution when driving) or nausea (small frequent meals or sucking lozenges may help).
(For additional information see "Abatacept: Patient drug information")
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