U.S. BRAND NAMES — Gelfilm®; Gelfoam®
PHARMACOLOGIC CATEGORY Hemostatic Agent
DOSING: ADULTS — Hemostasis: Local: Apply packs or sponges dry or saturated with sodium chloride. When applied dry, hold in place with moderate pressure. When applied wet, squeeze to remove air bubbles. The powder is applied as a paste prepared by adding approximately 4 mL of sterile saline solution to the powder.
DOSING: PEDIATRIC — Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Film, ophthalmic (Gelfilm®): 25 mm x 50 mm (6s)
Film, topical (Gelfilm®): 100 mm x 125 mm (1s)
Powder, topical (Gelfoam®): 1 g
Sponge, dental (Gelfoam®): Size 4 (12s)
Sponge, topical (Gelfoam®): Size 50 (4s) Size 100 (6s) Size 200 (6s) Size 2 cm (1s) Size 6 cm (6s) Size 12-7 mm (12s)
DOSAGE FORMS: CONCISE Film, ophthalmic: Gelfilm®: 25 mm x 50 mm (6s)
Film, topical: Gelfilm®: 100 mm x 125 mm (1s)
Powder, topical: Gelfoam®: 1 g
Sponge, dental: Gelfoam®: Size 4 (12s)
Sponge, topical: Gelfoam®: Size 50 (4s) Size 100 (6s) Size 200 (6s) Size 2 cm (1s) Size 6 cm (6s) Size 12-7 mm (12s)
GENERIC EQUIVALENT AVAILABLE — No
USE — Adjunct to provide hemostasis in surgery; open prostatic surgery
ADVERSE REACTIONS SIGNIFICANT — 1% to 10%: Local: Infection and abscess formation
CONTRAINDICATIONS — Should not be used in closure of skin incisions since they may interfere with the healing of skin edges
WARNINGS / PRECAUTIONS — Do not sterilize by heat; do not use in the presence of infection
DRUG INTERACTIONS — No data reported
PREGNANCY RISK FACTOR — No (show table) data reported
Wednesday, January 16, 2008
Absorbable gelatin: Drug information
U.S. BRAND NAMES — Gelfilm®; Gelfoam®
PHARMACOLOGIC CATEGORY Hemostatic Agent
DOSING: ADULTS — Hemostasis: Local: Apply packs or sponges dry or saturated with sodium chloride. When applied dry, hold in place with moderate pressure. When applied wet, squeeze to remove air bubbles. The powder is applied as a paste prepared by adding approximately 4 mL of sterile saline solution to the powder.
DOSING: PEDIATRIC — Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Film, ophthalmic (Gelfilm®): 25 mm x 50 mm (6s)
Film, topical (Gelfilm®): 100 mm x 125 mm (1s)
Powder, topical (Gelfoam®): 1 g
Sponge, dental (Gelfoam®): Size 4 (12s)
Sponge, topical (Gelfoam®): Size 50 (4s) Size 100 (6s) Size 200 (6s) Size 2 cm (1s) Size 6 cm (6s) Size 12-7 mm (12s)
DOSAGE FORMS: CONCISE Film, ophthalmic: Gelfilm®: 25 mm x 50 mm (6s)
Film, topical: Gelfilm®: 100 mm x 125 mm (1s)
Powder, topical: Gelfoam®: 1 g
Sponge, dental: Gelfoam®: Size 4 (12s)
Sponge, topical: Gelfoam®: Size 50 (4s) Size 100 (6s) Size 200 (6s) Size 2 cm (1s) Size 6 cm (6s) Size 12-7 mm (12s)
GENERIC EQUIVALENT AVAILABLE — No
USE — Adjunct to provide hemostasis in surgery; open prostatic surgery
ADVERSE REACTIONS SIGNIFICANT — 1% to 10%: Local: Infection and abscess formation
CONTRAINDICATIONS — Should not be used in closure of skin incisions since they may interfere with the healing of skin edges
WARNINGS / PRECAUTIONS — Do not sterilize by heat; do not use in the presence of infection
DRUG INTERACTIONS — No data reported
PREGNANCY RISK FACTOR — No (show table) data reported
PHARMACOLOGIC CATEGORY Hemostatic Agent
DOSING: ADULTS — Hemostasis: Local: Apply packs or sponges dry or saturated with sodium chloride. When applied dry, hold in place with moderate pressure. When applied wet, squeeze to remove air bubbles. The powder is applied as a paste prepared by adding approximately 4 mL of sterile saline solution to the powder.
DOSING: PEDIATRIC — Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Film, ophthalmic (Gelfilm®): 25 mm x 50 mm (6s)
Film, topical (Gelfilm®): 100 mm x 125 mm (1s)
Powder, topical (Gelfoam®): 1 g
Sponge, dental (Gelfoam®): Size 4 (12s)
Sponge, topical (Gelfoam®): Size 50 (4s) Size 100 (6s) Size 200 (6s) Size 2 cm (1s) Size 6 cm (6s) Size 12-7 mm (12s)
DOSAGE FORMS: CONCISE Film, ophthalmic: Gelfilm®: 25 mm x 50 mm (6s)
Film, topical: Gelfilm®: 100 mm x 125 mm (1s)
Powder, topical: Gelfoam®: 1 g
Sponge, dental: Gelfoam®: Size 4 (12s)
Sponge, topical: Gelfoam®: Size 50 (4s) Size 100 (6s) Size 200 (6s) Size 2 cm (1s) Size 6 cm (6s) Size 12-7 mm (12s)
GENERIC EQUIVALENT AVAILABLE — No
USE — Adjunct to provide hemostasis in surgery; open prostatic surgery
ADVERSE REACTIONS SIGNIFICANT — 1% to 10%: Local: Infection and abscess formation
CONTRAINDICATIONS — Should not be used in closure of skin incisions since they may interfere with the healing of skin edges
WARNINGS / PRECAUTIONS — Do not sterilize by heat; do not use in the presence of infection
DRUG INTERACTIONS — No data reported
PREGNANCY RISK FACTOR — No (show table) data reported
Absorbable collagen (dental): Drug information
Copyright 1978-2006 Lexi-Comp, Inc. All rights reserved.
U.S. BRAND NAMES — CollaCote®; CollaPlug®; CollaTape®
PHARMACOLOGIC CATEGORY Hemostatic Agent
DOSING: ADULTS — Control of bleeding: Topical: A sufficiently large dressing should be selected so as to completely cover the oral wound
DOSING: PEDIATRIC — Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Wound dressing:
3/8" x 3/4"
3/4" x 1 1/2"
1" x 3"
DOSAGE FORMS: CONCISE Wound dressing: Generics: 3/8" x 3/4" 3/4" x 1 1/2" 1" x 3" Brands: CollaCote®, CollaPlug®, CollaTape®: 3/8" x 3/4" 3/4" x 1 1/2" 1" x 3"
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Hemostatic
ADVERSE REACTIONS SIGNIFICANT — No data reported.
CONTRAINDICATIONS — No data reported
WARNINGS / PRECAUTIONS — Should not be used on infected or contaminated wounds
DRUG INTERACTIONS — No data reported
LACTATION — Compatible
MECHANISM OF ACTION — The highly porous sponge structure absorbs blood and wound exudate. The collagen component causes aggregation of platelets which bind to collagen fibrils. The aggregated platelets degranulate, releasing coagulation factors that promote the formation of fibrin.
U.S. BRAND NAMES — CollaCote®; CollaPlug®; CollaTape®
PHARMACOLOGIC CATEGORY Hemostatic Agent
DOSING: ADULTS — Control of bleeding: Topical: A sufficiently large dressing should be selected so as to completely cover the oral wound
DOSING: PEDIATRIC — Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Wound dressing:
3/8" x 3/4"
3/4" x 1 1/2"
1" x 3"
DOSAGE FORMS: CONCISE Wound dressing: Generics: 3/8" x 3/4" 3/4" x 1 1/2" 1" x 3" Brands: CollaCote®, CollaPlug®, CollaTape®: 3/8" x 3/4" 3/4" x 1 1/2" 1" x 3"
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Hemostatic
ADVERSE REACTIONS SIGNIFICANT — No data reported.
CONTRAINDICATIONS — No data reported
WARNINGS / PRECAUTIONS — Should not be used on infected or contaminated wounds
DRUG INTERACTIONS — No data reported
LACTATION — Compatible
MECHANISM OF ACTION — The highly porous sponge structure absorbs blood and wound exudate. The collagen component causes aggregation of platelets which bind to collagen fibrils. The aggregated platelets degranulate, releasing coagulation factors that promote the formation of fibrin.
Absorbable collagen (dental): Drug information
Copyright 1978-2006 Lexi-Comp, Inc. All rights reserved.
U.S. BRAND NAMES — CollaCote®; CollaPlug®; CollaTape®
PHARMACOLOGIC CATEGORY Hemostatic Agent
DOSING: ADULTS — Control of bleeding: Topical: A sufficiently large dressing should be selected so as to completely cover the oral wound
DOSING: PEDIATRIC — Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Wound dressing:
3/8" x 3/4"
3/4" x 1 1/2"
1" x 3"
DOSAGE FORMS: CONCISE Wound dressing: Generics: 3/8" x 3/4" 3/4" x 1 1/2" 1" x 3" Brands: CollaCote®, CollaPlug®, CollaTape®: 3/8" x 3/4" 3/4" x 1 1/2" 1" x 3"
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Hemostatic
ADVERSE REACTIONS SIGNIFICANT — No data reported.
CONTRAINDICATIONS — No data reported
WARNINGS / PRECAUTIONS — Should not be used on infected or contaminated wounds
DRUG INTERACTIONS — No data reported
LACTATION — Compatible
MECHANISM OF ACTION — The highly porous sponge structure absorbs blood and wound exudate. The collagen component causes aggregation of platelets which bind to collagen fibrils. The aggregated platelets degranulate, releasing coagulation factors that promote the formation of fibrin.
U.S. BRAND NAMES — CollaCote®; CollaPlug®; CollaTape®
PHARMACOLOGIC CATEGORY Hemostatic Agent
DOSING: ADULTS — Control of bleeding: Topical: A sufficiently large dressing should be selected so as to completely cover the oral wound
DOSING: PEDIATRIC — Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Wound dressing:
3/8" x 3/4"
3/4" x 1 1/2"
1" x 3"
DOSAGE FORMS: CONCISE Wound dressing: Generics: 3/8" x 3/4" 3/4" x 1 1/2" 1" x 3" Brands: CollaCote®, CollaPlug®, CollaTape®: 3/8" x 3/4" 3/4" x 1 1/2" 1" x 3"
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Hemostatic
ADVERSE REACTIONS SIGNIFICANT — No data reported.
CONTRAINDICATIONS — No data reported
WARNINGS / PRECAUTIONS — Should not be used on infected or contaminated wounds
DRUG INTERACTIONS — No data reported
LACTATION — Compatible
MECHANISM OF ACTION — The highly porous sponge structure absorbs blood and wound exudate. The collagen component causes aggregation of platelets which bind to collagen fibrils. The aggregated platelets degranulate, releasing coagulation factors that promote the formation of fibrin.
Abciximab: Drug information
U.S. BRAND NAMES — ReoPro®
PHARMACOLOGIC CATEGORY Antiplatelet Agent, Glycoprotein IIb/IIIa Inhibitor
DOSING: ADULTS Prevention of restenosis (patients at high risk for abrupt closure): I.V.: 0.25 mg/kg bolus administered 10-60 minutes before the start of intervention followed by an infusion of 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours
Patients with unstable angina not responding to conventional medical therapy and with planned percutaneous coronary intervention within 24 hours: I.V.: 0.25 mg/kg intravenous bolus followed by an 18- to 24-hour intravenous infusion of 10 mcg/minute, concluding 1 hour after the percutaneous coronary intervention.
Acute MI combination regimen (unlabeled): Half-dose tenecteplase (15-25 mg based on weight), abciximab 0.25 mg/kg bolus then 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours and heparin dosing as follows: Concurrent bolus of 40 units/kg (maximum: 3000 units), then 7 units/kg/hour (maximum: 800 units/hour) as continuous infusion. Adjust to aPTT target of 50-70 seconds.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution: 2 mg/mL (5 mL)
DOSAGE FORMS: CONCISE Injection, solution: ReoPro®: 2 mg/mL (5 mL)
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Abciximab is intended for coadministration with aspirin postangioplasty and heparin infused and weight adjusted to maintain a therapeutic bleeding time (eg, ACT 300-500 seconds). Solution must be filtered prior to administration. Do not shake the vial.
Bolus dose: Aseptically withdraw the necessary amount of abciximab for the bolus dose into a syringe using a 0.2 or 5 micron low protein-binding syringe filter (or equivalent); the bolus should be administered 10-60 minutes before the procedure.
Continuous infusion: Aseptically withdraw 4.5 mL (9 mg) of abciximab for the infusion through a 0.2 or 5 micron low protein-binding syringe filter into a syringe; inject this into 250 mL of NS or D5W to make a solution with a final concentration of 35 mcg/mL. Infuse at a rate of 17 mL/hour (10 mcg/minute) for 12 hours via pump. If a syringe filter was not used when preparing the infusion, administer using an in-line 0.02 or 0.22 low protein-binding filter.
COMPATIBILITY — Abciximab should be administered in a separate intravenous line. No incompatibilities have been observed with glass bottles or PVC bags.
USE — Prevention of acute cardiac ischemic complications in patients at high risk for abrupt closure of the treated coronary vessel and patients at risk of restenosis; an adjunct with heparin to prevent cardiac ischemic complications in patients with unstable angina not responding to conventional therapy when a percutaneous coronary intervention (PCI) is scheduled within 24 hours
USE - UNLABELED / INVESTIGATIONAL — Acute MI - combination regimen of abciximab (full dose), tenecteplase (half dose), and heparin (unlabeled dose)
ADVERSE REACTIONS SIGNIFICANT — As with all drugs which may affect hemostasis, bleeding is associated with abciximab. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables, including the concurrent use of multiple agents which alter hemostasis and patient susceptibility.
>10%: Cardiovascular: Hypotension (14.4%), chest pain (11.4%) Gastrointestinal: Nausea (13.6%) Hematologic: Minor bleeding (4.0% to 16.8%) Neuromuscular & skeletal: Back pain (17.6%)
1% to 10%: Cardiovascular: Bradycardia (4.5%), peripheral edema (1.6%) Central nervous system: Headache (6.45) Gastrointestinal: Vomiting (7.3%), abdominal pain (3.1%) Hematologic: Major bleeding (1.1% to 14%), thrombocytopenia: <100,000 cells/mm3 (2.5% to 5.6%); <50,000 cells/mm3 (0.4% to 1.7%) Local: Injection site pain (3.6%)
<1% (Limited to important or life-threatening): Abnormal thinking, allergic reactions/anaphylaxis (possible), AV block, bronchospasm, bullous eruption, coma, confusion, diabetes mellitus, embolism, hyperkalemia, ileus, inflammation, intracranial hemorrhage, myalgia, nodal arrhythmia, pleural effusion, pulmonary embolism, prostatitis, pruritus, stroke, urinary retention, ventricular tachycardia, xerostomia
CONTRAINDICATIONS — Hypersensitivity to abciximab, to murine proteins, or any component of the formulation; active internal hemorrhage or recent (within 6 weeks) clinically-significant GI or GU bleeding; history of cerebrovascular accident within 2 years or cerebrovascular accident with significant neurological deficit; clotting abnormalities or administration of oral anticoagulants within 7 days unless prothrombin time (PT) is 1.2 times control PT value; thrombocytopenia (<100,000 cells/µL); recent (within 6 weeks) major surgery or trauma; intracranial tumor, arteriovenous malformation, or aneurysm; severe uncontrolled hypertension; history of vasculitis; use of dextran before PTCA or intent to use dextran during PTCA; concomitant use of another parenteral GP IIb/IIIa inhibitor
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Administration may result in human antichimeric antibody formation that can cause hypersensitivity reactions (including anaphylaxis). Bleeding: The most common complication is bleeding, including retroperitoneal, pulmonary, and spontaneous GI and/or GU bleeding; watch closely for bleeding, especially the arterial access site for the cardiac catheterization. Use with extreme caution in patients with platelet counts <150,000/mm3,>70 minutes duration, or PTCA performed within 12 hours of symptom onset for acute myocardial infarction. Thrombocytopenia: Administration may result in human antichimeric antibody formation that can cause thrombocytopenia; readministration within 30 days or in patients with human antichimeric antibodies (HACA) increases the incidence and severity of thrombocytopenia.
Special populations: Elderly: Use with caution in patients >65 years of age; increased risk of bleeding. Low weight patients: Use with caution in patients weighing <75 kg; increased risk of bleeding. Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Diminished efficacy: Administration may result in human antichimeric antibody formation that can cause diminished efficacy. Sheath removal: Prior to pulling the sheath, heparin should be discontinued for 3-4 hours and ACT 175 seconds or aPTT 50 seconds. Use standard compression techniques after sheath removal. Watch the site closely afterwards for further bleeding.
DRUG INTERACTIONS Heparin and aspirin: Use with aspirin and heparin may increase bleeding over aspirin and heparin alone. However, aspirin and heparin were used concurrently in the majority of patients in the major clinical studies of abciximab.
Monoclonal antibodies: Allergic reactions may be increased in patients who have received diagnostic or therapeutic monoclonal antibodies due to the presence of HACA antibodies.
Thrombolytic agents theoretically may increase the risk of bleeding; use with caution.
Warfarin and oral anticoagulants: Risk of bleeding may be increased during concurrent therapy.
Other IIb/IIIa antagonists: Avoid concomitant use of other glycoprotein IIb/IIIa antagonists (see Contraindications).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Animal reproduction studies have not been conducted. In vitro studies have shown only small amounts of abciximab to cross the placenta. It is not known whether abciximab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
LACTATION — Excretion in breast milk unknown/use caution
MONITORING PARAMETERS — Prothrombin time, activated partial thromboplastin time (aPTT), hemoglobin, hematocrit, platelet count, fibrinogen, fibrin split products, transfusion requirements, signs of hypersensitivity reactions, guaiac stools, Hemastix® urine. Platelet count should be monitored at baseline, 2-4 hours following bolus infusion, and at 24 hours (or prior to discharge, if before 24 hours). To minimize risk of bleeding: Abciximab initiated 18-24 hours prior to PCI: Maintain aPTT between 60-85 seconds during the heparin/abciximab infusion period During PCI: Maintain ACT between 200-300 seconds Following PCI (if anticoagulation is maintained): Maintain aPTT between 50-75 seconds
Sheath removal should not occur until aPTT is 50 seconds or ACT 175 seconds.
Maintain bleeding precautions, avoid unnecessary arterial and venous punctures, use saline or heparin lock for blood drawing, assess sheath insertion site and distal pulses of affected leg every 15 minutes for the first hour and then every 1 hour for the next 6 hours. Arterial access site care is important to prevent bleeding. Care should be taken when attempting vascular access that only the anterior wall of the femoral artery is punctured, avoiding a Seldinger (through and through) technique for obtaining sheath access. Femoral vein sheath placement should be avoided unless needed. While the vascular sheath is in place, patients should be maintained on complete bedrest with the head of the bed at a 30º angle and the affected limb restrained in a straight position.
Observe patient for mental status changes, hemorrhage; assess nose and mouth mucous membranes, puncture sites for oozing, ecchymosis, and hematoma formation; and examine urine, stool, and emesis for presence of occult or frank blood; gentle care should be provided when removing dressings.
TOXICOLOGY / OVERDOSE COMPREHENSIVE — The antiplatelet effects can be quickly reversed with the administration of platelets.
CANADIAN BRAND NAMES — Reopro®
INTERNATIONAL BRAND NAMES — ReoPro (AT, AU, BE, BR, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, IE, IN, IT, KR, MX, MY, NL, NO, NZ, PE, PK, PL, SE, SG, TH, TW, ZA)
MECHANISM OF ACTION — Fab antibody fragment of the chimeric human-murine monoclonal antibody 7E3; this agent binds to platelet IIb/IIIa receptors, resulting in steric hindrance, thus inhibiting platelet aggregation
PHARMACODYNAMICS / KINETICS — Half-life elimination: ~30 minutes
Use of UpToDate is subject to the Subscription and License Agreement.
PHARMACOLOGIC CATEGORY Antiplatelet Agent, Glycoprotein IIb/IIIa Inhibitor
DOSING: ADULTS Prevention of restenosis (patients at high risk for abrupt closure): I.V.: 0.25 mg/kg bolus administered 10-60 minutes before the start of intervention followed by an infusion of 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours
Patients with unstable angina not responding to conventional medical therapy and with planned percutaneous coronary intervention within 24 hours: I.V.: 0.25 mg/kg intravenous bolus followed by an 18- to 24-hour intravenous infusion of 10 mcg/minute, concluding 1 hour after the percutaneous coronary intervention.
Acute MI combination regimen (unlabeled): Half-dose tenecteplase (15-25 mg based on weight), abciximab 0.25 mg/kg bolus then 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours and heparin dosing as follows: Concurrent bolus of 40 units/kg (maximum: 3000 units), then 7 units/kg/hour (maximum: 800 units/hour) as continuous infusion. Adjust to aPTT target of 50-70 seconds.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution: 2 mg/mL (5 mL)
DOSAGE FORMS: CONCISE Injection, solution: ReoPro®: 2 mg/mL (5 mL)
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Abciximab is intended for coadministration with aspirin postangioplasty and heparin infused and weight adjusted to maintain a therapeutic bleeding time (eg, ACT 300-500 seconds). Solution must be filtered prior to administration. Do not shake the vial.
Bolus dose: Aseptically withdraw the necessary amount of abciximab for the bolus dose into a syringe using a 0.2 or 5 micron low protein-binding syringe filter (or equivalent); the bolus should be administered 10-60 minutes before the procedure.
Continuous infusion: Aseptically withdraw 4.5 mL (9 mg) of abciximab for the infusion through a 0.2 or 5 micron low protein-binding syringe filter into a syringe; inject this into 250 mL of NS or D5W to make a solution with a final concentration of 35 mcg/mL. Infuse at a rate of 17 mL/hour (10 mcg/minute) for 12 hours via pump. If a syringe filter was not used when preparing the infusion, administer using an in-line 0.02 or 0.22 low protein-binding filter.
COMPATIBILITY — Abciximab should be administered in a separate intravenous line. No incompatibilities have been observed with glass bottles or PVC bags.
USE — Prevention of acute cardiac ischemic complications in patients at high risk for abrupt closure of the treated coronary vessel and patients at risk of restenosis; an adjunct with heparin to prevent cardiac ischemic complications in patients with unstable angina not responding to conventional therapy when a percutaneous coronary intervention (PCI) is scheduled within 24 hours
USE - UNLABELED / INVESTIGATIONAL — Acute MI - combination regimen of abciximab (full dose), tenecteplase (half dose), and heparin (unlabeled dose)
ADVERSE REACTIONS SIGNIFICANT — As with all drugs which may affect hemostasis, bleeding is associated with abciximab. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables, including the concurrent use of multiple agents which alter hemostasis and patient susceptibility.
>10%: Cardiovascular: Hypotension (14.4%), chest pain (11.4%) Gastrointestinal: Nausea (13.6%) Hematologic: Minor bleeding (4.0% to 16.8%) Neuromuscular & skeletal: Back pain (17.6%)
1% to 10%: Cardiovascular: Bradycardia (4.5%), peripheral edema (1.6%) Central nervous system: Headache (6.45) Gastrointestinal: Vomiting (7.3%), abdominal pain (3.1%) Hematologic: Major bleeding (1.1% to 14%), thrombocytopenia: <100,000 cells/mm3 (2.5% to 5.6%); <50,000 cells/mm3 (0.4% to 1.7%) Local: Injection site pain (3.6%)
<1% (Limited to important or life-threatening): Abnormal thinking, allergic reactions/anaphylaxis (possible), AV block, bronchospasm, bullous eruption, coma, confusion, diabetes mellitus, embolism, hyperkalemia, ileus, inflammation, intracranial hemorrhage, myalgia, nodal arrhythmia, pleural effusion, pulmonary embolism, prostatitis, pruritus, stroke, urinary retention, ventricular tachycardia, xerostomia
CONTRAINDICATIONS — Hypersensitivity to abciximab, to murine proteins, or any component of the formulation; active internal hemorrhage or recent (within 6 weeks) clinically-significant GI or GU bleeding; history of cerebrovascular accident within 2 years or cerebrovascular accident with significant neurological deficit; clotting abnormalities or administration of oral anticoagulants within 7 days unless prothrombin time (PT) is 1.2 times control PT value; thrombocytopenia (<100,000 cells/µL); recent (within 6 weeks) major surgery or trauma; intracranial tumor, arteriovenous malformation, or aneurysm; severe uncontrolled hypertension; history of vasculitis; use of dextran before PTCA or intent to use dextran during PTCA; concomitant use of another parenteral GP IIb/IIIa inhibitor
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Administration may result in human antichimeric antibody formation that can cause hypersensitivity reactions (including anaphylaxis). Bleeding: The most common complication is bleeding, including retroperitoneal, pulmonary, and spontaneous GI and/or GU bleeding; watch closely for bleeding, especially the arterial access site for the cardiac catheterization. Use with extreme caution in patients with platelet counts <150,000/mm3,>70 minutes duration, or PTCA performed within 12 hours of symptom onset for acute myocardial infarction. Thrombocytopenia: Administration may result in human antichimeric antibody formation that can cause thrombocytopenia; readministration within 30 days or in patients with human antichimeric antibodies (HACA) increases the incidence and severity of thrombocytopenia.
Special populations: Elderly: Use with caution in patients >65 years of age; increased risk of bleeding. Low weight patients: Use with caution in patients weighing <75 kg; increased risk of bleeding. Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Diminished efficacy: Administration may result in human antichimeric antibody formation that can cause diminished efficacy. Sheath removal: Prior to pulling the sheath, heparin should be discontinued for 3-4 hours and ACT 175 seconds or aPTT 50 seconds. Use standard compression techniques after sheath removal. Watch the site closely afterwards for further bleeding.
DRUG INTERACTIONS Heparin and aspirin: Use with aspirin and heparin may increase bleeding over aspirin and heparin alone. However, aspirin and heparin were used concurrently in the majority of patients in the major clinical studies of abciximab.
Monoclonal antibodies: Allergic reactions may be increased in patients who have received diagnostic or therapeutic monoclonal antibodies due to the presence of HACA antibodies.
Thrombolytic agents theoretically may increase the risk of bleeding; use with caution.
Warfarin and oral anticoagulants: Risk of bleeding may be increased during concurrent therapy.
Other IIb/IIIa antagonists: Avoid concomitant use of other glycoprotein IIb/IIIa antagonists (see Contraindications).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Animal reproduction studies have not been conducted. In vitro studies have shown only small amounts of abciximab to cross the placenta. It is not known whether abciximab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
LACTATION — Excretion in breast milk unknown/use caution
MONITORING PARAMETERS — Prothrombin time, activated partial thromboplastin time (aPTT), hemoglobin, hematocrit, platelet count, fibrinogen, fibrin split products, transfusion requirements, signs of hypersensitivity reactions, guaiac stools, Hemastix® urine. Platelet count should be monitored at baseline, 2-4 hours following bolus infusion, and at 24 hours (or prior to discharge, if before 24 hours). To minimize risk of bleeding: Abciximab initiated 18-24 hours prior to PCI: Maintain aPTT between 60-85 seconds during the heparin/abciximab infusion period During PCI: Maintain ACT between 200-300 seconds Following PCI (if anticoagulation is maintained): Maintain aPTT between 50-75 seconds
Sheath removal should not occur until aPTT is 50 seconds or ACT 175 seconds.
Maintain bleeding precautions, avoid unnecessary arterial and venous punctures, use saline or heparin lock for blood drawing, assess sheath insertion site and distal pulses of affected leg every 15 minutes for the first hour and then every 1 hour for the next 6 hours. Arterial access site care is important to prevent bleeding. Care should be taken when attempting vascular access that only the anterior wall of the femoral artery is punctured, avoiding a Seldinger (through and through) technique for obtaining sheath access. Femoral vein sheath placement should be avoided unless needed. While the vascular sheath is in place, patients should be maintained on complete bedrest with the head of the bed at a 30º angle and the affected limb restrained in a straight position.
Observe patient for mental status changes, hemorrhage; assess nose and mouth mucous membranes, puncture sites for oozing, ecchymosis, and hematoma formation; and examine urine, stool, and emesis for presence of occult or frank blood; gentle care should be provided when removing dressings.
TOXICOLOGY / OVERDOSE COMPREHENSIVE — The antiplatelet effects can be quickly reversed with the administration of platelets.
CANADIAN BRAND NAMES — Reopro®
INTERNATIONAL BRAND NAMES — ReoPro (AT, AU, BE, BR, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, IE, IN, IT, KR, MX, MY, NL, NO, NZ, PE, PK, PL, SE, SG, TH, TW, ZA)
MECHANISM OF ACTION — Fab antibody fragment of the chimeric human-murine monoclonal antibody 7E3; this agent binds to platelet IIb/IIIa receptors, resulting in steric hindrance, thus inhibiting platelet aggregation
PHARMACODYNAMICS / KINETICS — Half-life elimination: ~30 minutes
Use of UpToDate is subject to the Subscription and License Agreement.
Abciximab: Drug information
U.S. BRAND NAMES — ReoPro®
PHARMACOLOGIC CATEGORY Antiplatelet Agent, Glycoprotein IIb/IIIa Inhibitor
DOSING: ADULTS Prevention of restenosis (patients at high risk for abrupt closure): I.V.: 0.25 mg/kg bolus administered 10-60 minutes before the start of intervention followed by an infusion of 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours
Patients with unstable angina not responding to conventional medical therapy and with planned percutaneous coronary intervention within 24 hours: I.V.: 0.25 mg/kg intravenous bolus followed by an 18- to 24-hour intravenous infusion of 10 mcg/minute, concluding 1 hour after the percutaneous coronary intervention.
Acute MI combination regimen (unlabeled): Half-dose tenecteplase (15-25 mg based on weight), abciximab 0.25 mg/kg bolus then 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours and heparin dosing as follows: Concurrent bolus of 40 units/kg (maximum: 3000 units), then 7 units/kg/hour (maximum: 800 units/hour) as continuous infusion. Adjust to aPTT target of 50-70 seconds.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution: 2 mg/mL (5 mL)
DOSAGE FORMS: CONCISE Injection, solution: ReoPro®: 2 mg/mL (5 mL)
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Abciximab is intended for coadministration with aspirin postangioplasty and heparin infused and weight adjusted to maintain a therapeutic bleeding time (eg, ACT 300-500 seconds). Solution must be filtered prior to administration. Do not shake the vial.
Bolus dose: Aseptically withdraw the necessary amount of abciximab for the bolus dose into a syringe using a 0.2 or 5 micron low protein-binding syringe filter (or equivalent); the bolus should be administered 10-60 minutes before the procedure.
Continuous infusion: Aseptically withdraw 4.5 mL (9 mg) of abciximab for the infusion through a 0.2 or 5 micron low protein-binding syringe filter into a syringe; inject this into 250 mL of NS or D5W to make a solution with a final concentration of 35 mcg/mL. Infuse at a rate of 17 mL/hour (10 mcg/minute) for 12 hours via pump. If a syringe filter was not used when preparing the infusion, administer using an in-line 0.02 or 0.22 low protein-binding filter.
COMPATIBILITY — Abciximab should be administered in a separate intravenous line. No incompatibilities have been observed with glass bottles or PVC bags.
USE — Prevention of acute cardiac ischemic complications in patients at high risk for abrupt closure of the treated coronary vessel and patients at risk of restenosis; an adjunct with heparin to prevent cardiac ischemic complications in patients with unstable angina not responding to conventional therapy when a percutaneous coronary intervention (PCI) is scheduled within 24 hours
USE - UNLABELED / INVESTIGATIONAL — Acute MI - combination regimen of abciximab (full dose), tenecteplase (half dose), and heparin (unlabeled dose)
ADVERSE REACTIONS SIGNIFICANT — As with all drugs which may affect hemostasis, bleeding is associated with abciximab. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables, including the concurrent use of multiple agents which alter hemostasis and patient susceptibility.
>10%: Cardiovascular: Hypotension (14.4%), chest pain (11.4%) Gastrointestinal: Nausea (13.6%) Hematologic: Minor bleeding (4.0% to 16.8%) Neuromuscular & skeletal: Back pain (17.6%)
1% to 10%: Cardiovascular: Bradycardia (4.5%), peripheral edema (1.6%) Central nervous system: Headache (6.45) Gastrointestinal: Vomiting (7.3%), abdominal pain (3.1%) Hematologic: Major bleeding (1.1% to 14%), thrombocytopenia: <100,000 cells/mm3 (2.5% to 5.6%); <50,000 cells/mm3 (0.4% to 1.7%) Local: Injection site pain (3.6%)
<1% (Limited to important or life-threatening): Abnormal thinking, allergic reactions/anaphylaxis (possible), AV block, bronchospasm, bullous eruption, coma, confusion, diabetes mellitus, embolism, hyperkalemia, ileus, inflammation, intracranial hemorrhage, myalgia, nodal arrhythmia, pleural effusion, pulmonary embolism, prostatitis, pruritus, stroke, urinary retention, ventricular tachycardia, xerostomia
CONTRAINDICATIONS — Hypersensitivity to abciximab, to murine proteins, or any component of the formulation; active internal hemorrhage or recent (within 6 weeks) clinically-significant GI or GU bleeding; history of cerebrovascular accident within 2 years or cerebrovascular accident with significant neurological deficit; clotting abnormalities or administration of oral anticoagulants within 7 days unless prothrombin time (PT) is 1.2 times control PT value; thrombocytopenia (<100,000 cells/µL); recent (within 6 weeks) major surgery or trauma; intracranial tumor, arteriovenous malformation, or aneurysm; severe uncontrolled hypertension; history of vasculitis; use of dextran before PTCA or intent to use dextran during PTCA; concomitant use of another parenteral GP IIb/IIIa inhibitor
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Administration may result in human antichimeric antibody formation that can cause hypersensitivity reactions (including anaphylaxis). Bleeding: The most common complication is bleeding, including retroperitoneal, pulmonary, and spontaneous GI and/or GU bleeding; watch closely for bleeding, especially the arterial access site for the cardiac catheterization. Use with extreme caution in patients with platelet counts <150,000/mm3,>70 minutes duration, or PTCA performed within 12 hours of symptom onset for acute myocardial infarction. Thrombocytopenia: Administration may result in human antichimeric antibody formation that can cause thrombocytopenia; readministration within 30 days or in patients with human antichimeric antibodies (HACA) increases the incidence and severity of thrombocytopenia.
Special populations: Elderly: Use with caution in patients >65 years of age; increased risk of bleeding. Low weight patients: Use with caution in patients weighing <75 kg; increased risk of bleeding. Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Diminished efficacy: Administration may result in human antichimeric antibody formation that can cause diminished efficacy. Sheath removal: Prior to pulling the sheath, heparin should be discontinued for 3-4 hours and ACT 175 seconds or aPTT 50 seconds. Use standard compression techniques after sheath removal. Watch the site closely afterwards for further bleeding.
DRUG INTERACTIONS Heparin and aspirin: Use with aspirin and heparin may increase bleeding over aspirin and heparin alone. However, aspirin and heparin were used concurrently in the majority of patients in the major clinical studies of abciximab.
Monoclonal antibodies: Allergic reactions may be increased in patients who have received diagnostic or therapeutic monoclonal antibodies due to the presence of HACA antibodies.
Thrombolytic agents theoretically may increase the risk of bleeding; use with caution.
Warfarin and oral anticoagulants: Risk of bleeding may be increased during concurrent therapy.
Other IIb/IIIa antagonists: Avoid concomitant use of other glycoprotein IIb/IIIa antagonists (see Contraindications).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Animal reproduction studies have not been conducted. In vitro studies have shown only small amounts of abciximab to cross the placenta. It is not known whether abciximab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
LACTATION — Excretion in breast milk unknown/use caution
MONITORING PARAMETERS — Prothrombin time, activated partial thromboplastin time (aPTT), hemoglobin, hematocrit, platelet count, fibrinogen, fibrin split products, transfusion requirements, signs of hypersensitivity reactions, guaiac stools, Hemastix® urine. Platelet count should be monitored at baseline, 2-4 hours following bolus infusion, and at 24 hours (or prior to discharge, if before 24 hours). To minimize risk of bleeding: Abciximab initiated 18-24 hours prior to PCI: Maintain aPTT between 60-85 seconds during the heparin/abciximab infusion period During PCI: Maintain ACT between 200-300 seconds Following PCI (if anticoagulation is maintained): Maintain aPTT between 50-75 seconds
Sheath removal should not occur until aPTT is 50 seconds or ACT 175 seconds.
Maintain bleeding precautions, avoid unnecessary arterial and venous punctures, use saline or heparin lock for blood drawing, assess sheath insertion site and distal pulses of affected leg every 15 minutes for the first hour and then every 1 hour for the next 6 hours. Arterial access site care is important to prevent bleeding. Care should be taken when attempting vascular access that only the anterior wall of the femoral artery is punctured, avoiding a Seldinger (through and through) technique for obtaining sheath access. Femoral vein sheath placement should be avoided unless needed. While the vascular sheath is in place, patients should be maintained on complete bedrest with the head of the bed at a 30º angle and the affected limb restrained in a straight position.
Observe patient for mental status changes, hemorrhage; assess nose and mouth mucous membranes, puncture sites for oozing, ecchymosis, and hematoma formation; and examine urine, stool, and emesis for presence of occult or frank blood; gentle care should be provided when removing dressings.
TOXICOLOGY / OVERDOSE COMPREHENSIVE — The antiplatelet effects can be quickly reversed with the administration of platelets.
CANADIAN BRAND NAMES — Reopro®
INTERNATIONAL BRAND NAMES — ReoPro (AT, AU, BE, BR, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, IE, IN, IT, KR, MX, MY, NL, NO, NZ, PE, PK, PL, SE, SG, TH, TW, ZA)
MECHANISM OF ACTION — Fab antibody fragment of the chimeric human-murine monoclonal antibody 7E3; this agent binds to platelet IIb/IIIa receptors, resulting in steric hindrance, thus inhibiting platelet aggregation
PHARMACODYNAMICS / KINETICS — Half-life elimination: ~30 minutes
Use of UpToDate is subject to the Subscription and License Agreement.
PHARMACOLOGIC CATEGORY Antiplatelet Agent, Glycoprotein IIb/IIIa Inhibitor
DOSING: ADULTS Prevention of restenosis (patients at high risk for abrupt closure): I.V.: 0.25 mg/kg bolus administered 10-60 minutes before the start of intervention followed by an infusion of 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours
Patients with unstable angina not responding to conventional medical therapy and with planned percutaneous coronary intervention within 24 hours: I.V.: 0.25 mg/kg intravenous bolus followed by an 18- to 24-hour intravenous infusion of 10 mcg/minute, concluding 1 hour after the percutaneous coronary intervention.
Acute MI combination regimen (unlabeled): Half-dose tenecteplase (15-25 mg based on weight), abciximab 0.25 mg/kg bolus then 0.125 mcg/kg/minute (maximum: 10 mcg/minute) for 12 hours and heparin dosing as follows: Concurrent bolus of 40 units/kg (maximum: 3000 units), then 7 units/kg/hour (maximum: 800 units/hour) as continuous infusion. Adjust to aPTT target of 50-70 seconds.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution: 2 mg/mL (5 mL)
DOSAGE FORMS: CONCISE Injection, solution: ReoPro®: 2 mg/mL (5 mL)
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Abciximab is intended for coadministration with aspirin postangioplasty and heparin infused and weight adjusted to maintain a therapeutic bleeding time (eg, ACT 300-500 seconds). Solution must be filtered prior to administration. Do not shake the vial.
Bolus dose: Aseptically withdraw the necessary amount of abciximab for the bolus dose into a syringe using a 0.2 or 5 micron low protein-binding syringe filter (or equivalent); the bolus should be administered 10-60 minutes before the procedure.
Continuous infusion: Aseptically withdraw 4.5 mL (9 mg) of abciximab for the infusion through a 0.2 or 5 micron low protein-binding syringe filter into a syringe; inject this into 250 mL of NS or D5W to make a solution with a final concentration of 35 mcg/mL. Infuse at a rate of 17 mL/hour (10 mcg/minute) for 12 hours via pump. If a syringe filter was not used when preparing the infusion, administer using an in-line 0.02 or 0.22 low protein-binding filter.
COMPATIBILITY — Abciximab should be administered in a separate intravenous line. No incompatibilities have been observed with glass bottles or PVC bags.
USE — Prevention of acute cardiac ischemic complications in patients at high risk for abrupt closure of the treated coronary vessel and patients at risk of restenosis; an adjunct with heparin to prevent cardiac ischemic complications in patients with unstable angina not responding to conventional therapy when a percutaneous coronary intervention (PCI) is scheduled within 24 hours
USE - UNLABELED / INVESTIGATIONAL — Acute MI - combination regimen of abciximab (full dose), tenecteplase (half dose), and heparin (unlabeled dose)
ADVERSE REACTIONS SIGNIFICANT — As with all drugs which may affect hemostasis, bleeding is associated with abciximab. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables, including the concurrent use of multiple agents which alter hemostasis and patient susceptibility.
>10%: Cardiovascular: Hypotension (14.4%), chest pain (11.4%) Gastrointestinal: Nausea (13.6%) Hematologic: Minor bleeding (4.0% to 16.8%) Neuromuscular & skeletal: Back pain (17.6%)
1% to 10%: Cardiovascular: Bradycardia (4.5%), peripheral edema (1.6%) Central nervous system: Headache (6.45) Gastrointestinal: Vomiting (7.3%), abdominal pain (3.1%) Hematologic: Major bleeding (1.1% to 14%), thrombocytopenia: <100,000 cells/mm3 (2.5% to 5.6%); <50,000 cells/mm3 (0.4% to 1.7%) Local: Injection site pain (3.6%)
<1% (Limited to important or life-threatening): Abnormal thinking, allergic reactions/anaphylaxis (possible), AV block, bronchospasm, bullous eruption, coma, confusion, diabetes mellitus, embolism, hyperkalemia, ileus, inflammation, intracranial hemorrhage, myalgia, nodal arrhythmia, pleural effusion, pulmonary embolism, prostatitis, pruritus, stroke, urinary retention, ventricular tachycardia, xerostomia
CONTRAINDICATIONS — Hypersensitivity to abciximab, to murine proteins, or any component of the formulation; active internal hemorrhage or recent (within 6 weeks) clinically-significant GI or GU bleeding; history of cerebrovascular accident within 2 years or cerebrovascular accident with significant neurological deficit; clotting abnormalities or administration of oral anticoagulants within 7 days unless prothrombin time (PT) is 1.2 times control PT value; thrombocytopenia (<100,000 cells/µL); recent (within 6 weeks) major surgery or trauma; intracranial tumor, arteriovenous malformation, or aneurysm; severe uncontrolled hypertension; history of vasculitis; use of dextran before PTCA or intent to use dextran during PTCA; concomitant use of another parenteral GP IIb/IIIa inhibitor
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Administration may result in human antichimeric antibody formation that can cause hypersensitivity reactions (including anaphylaxis). Bleeding: The most common complication is bleeding, including retroperitoneal, pulmonary, and spontaneous GI and/or GU bleeding; watch closely for bleeding, especially the arterial access site for the cardiac catheterization. Use with extreme caution in patients with platelet counts <150,000/mm3,>70 minutes duration, or PTCA performed within 12 hours of symptom onset for acute myocardial infarction. Thrombocytopenia: Administration may result in human antichimeric antibody formation that can cause thrombocytopenia; readministration within 30 days or in patients with human antichimeric antibodies (HACA) increases the incidence and severity of thrombocytopenia.
Special populations: Elderly: Use with caution in patients >65 years of age; increased risk of bleeding. Low weight patients: Use with caution in patients weighing <75 kg; increased risk of bleeding. Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Diminished efficacy: Administration may result in human antichimeric antibody formation that can cause diminished efficacy. Sheath removal: Prior to pulling the sheath, heparin should be discontinued for 3-4 hours and ACT 175 seconds or aPTT 50 seconds. Use standard compression techniques after sheath removal. Watch the site closely afterwards for further bleeding.
DRUG INTERACTIONS Heparin and aspirin: Use with aspirin and heparin may increase bleeding over aspirin and heparin alone. However, aspirin and heparin were used concurrently in the majority of patients in the major clinical studies of abciximab.
Monoclonal antibodies: Allergic reactions may be increased in patients who have received diagnostic or therapeutic monoclonal antibodies due to the presence of HACA antibodies.
Thrombolytic agents theoretically may increase the risk of bleeding; use with caution.
Warfarin and oral anticoagulants: Risk of bleeding may be increased during concurrent therapy.
Other IIb/IIIa antagonists: Avoid concomitant use of other glycoprotein IIb/IIIa antagonists (see Contraindications).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Animal reproduction studies have not been conducted. In vitro studies have shown only small amounts of abciximab to cross the placenta. It is not known whether abciximab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
LACTATION — Excretion in breast milk unknown/use caution
MONITORING PARAMETERS — Prothrombin time, activated partial thromboplastin time (aPTT), hemoglobin, hematocrit, platelet count, fibrinogen, fibrin split products, transfusion requirements, signs of hypersensitivity reactions, guaiac stools, Hemastix® urine. Platelet count should be monitored at baseline, 2-4 hours following bolus infusion, and at 24 hours (or prior to discharge, if before 24 hours). To minimize risk of bleeding: Abciximab initiated 18-24 hours prior to PCI: Maintain aPTT between 60-85 seconds during the heparin/abciximab infusion period During PCI: Maintain ACT between 200-300 seconds Following PCI (if anticoagulation is maintained): Maintain aPTT between 50-75 seconds
Sheath removal should not occur until aPTT is 50 seconds or ACT 175 seconds.
Maintain bleeding precautions, avoid unnecessary arterial and venous punctures, use saline or heparin lock for blood drawing, assess sheath insertion site and distal pulses of affected leg every 15 minutes for the first hour and then every 1 hour for the next 6 hours. Arterial access site care is important to prevent bleeding. Care should be taken when attempting vascular access that only the anterior wall of the femoral artery is punctured, avoiding a Seldinger (through and through) technique for obtaining sheath access. Femoral vein sheath placement should be avoided unless needed. While the vascular sheath is in place, patients should be maintained on complete bedrest with the head of the bed at a 30º angle and the affected limb restrained in a straight position.
Observe patient for mental status changes, hemorrhage; assess nose and mouth mucous membranes, puncture sites for oozing, ecchymosis, and hematoma formation; and examine urine, stool, and emesis for presence of occult or frank blood; gentle care should be provided when removing dressings.
TOXICOLOGY / OVERDOSE COMPREHENSIVE — The antiplatelet effects can be quickly reversed with the administration of platelets.
CANADIAN BRAND NAMES — Reopro®
INTERNATIONAL BRAND NAMES — ReoPro (AT, AU, BE, BR, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, IE, IN, IT, KR, MX, MY, NL, NO, NZ, PE, PK, PL, SE, SG, TH, TW, ZA)
MECHANISM OF ACTION — Fab antibody fragment of the chimeric human-murine monoclonal antibody 7E3; this agent binds to platelet IIb/IIIa receptors, resulting in steric hindrance, thus inhibiting platelet aggregation
PHARMACODYNAMICS / KINETICS — Half-life elimination: ~30 minutes
Use of UpToDate is subject to the Subscription and License Agreement.
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")
Subscribe to:
Posts (Atom)