U.S. BRAND NAMES — Trizivir®
MEXICAN BRAND NAMES — Trizivir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
This medicine may cause liver damage and a change in the acid levels in the blood. Closely review the section in this leaflet which lists when to call healthcare provider. Pregnancy, obesity, and/or prolonged therapy may increase the risk.
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Do not restart this medicine if you have had an allergic reaction.
This medicine may cause muscle aches and stiffness if it is used for long periods of time. Closely review the section in this leaflet which lists when to call healthcare provider.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir, lamivudine, zidovudine, 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 have liver disease. If you are pregnant or may be pregnant. If you are breast-feeding.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir, lamivudine, and zidovudine work to injure the virus and fight the infection.
How is it best taken? To gain the most benefit, do not miss doses. Use prescription as directed, even if feeling better. Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? If this medicine is stopped because you have an allergy to it, do not restart it. It can cause a much more dangerous effect if restarted. If this medicine is stopped for any other reason, do not restart it without talking to healthcare provider. It could be very dangerous to restart on your own. If medicine changes for HIV infection, make sure to ask healthcare provider about hepatitis B treatment. Wear disease medical alert identification. Do not run out of this medicine. Check medicines with healthcare provider. This medicine may not mix well with other medicines. If you have kidney disease, talk with healthcare provider. If you have liver disease, talk with healthcare provider. Avoid alcohol (includes wine, beer, and liquor). You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Anemia and low white blood cell count. Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Diarrhea. Not hungry. Irritated pancreas can rarely occur.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Difficulty breathing. Severe belly pain. Severe nausea or vomiting. Severe diarrhea. Dark urine or yellow skin or eyes. Feeling extremely tired or weak. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen.
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.
Friday, February 1, 2008
Abacavir, lamivudine, and zidovudine
U.S. BRAND NAMES — Trizivir®
MEXICAN BRAND NAMES — Trizivir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
This medicine may cause liver damage and a change in the acid levels in the blood. Closely review the section in this leaflet which lists when to call healthcare provider. Pregnancy, obesity, and/or prolonged therapy may increase the risk.
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Do not restart this medicine if you have had an allergic reaction.
This medicine may cause muscle aches and stiffness if it is used for long periods of time. Closely review the section in this leaflet which lists when to call healthcare provider.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir, lamivudine, zidovudine, 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 have liver disease. If you are pregnant or may be pregnant. If you are breast-feeding.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir, lamivudine, and zidovudine work to injure the virus and fight the infection.
How is it best taken? To gain the most benefit, do not miss doses. Use prescription as directed, even if feeling better. Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? If this medicine is stopped because you have an allergy to it, do not restart it. It can cause a much more dangerous effect if restarted. If this medicine is stopped for any other reason, do not restart it without talking to healthcare provider. It could be very dangerous to restart on your own. If medicine changes for HIV infection, make sure to ask healthcare provider about hepatitis B treatment. Wear disease medical alert identification. Do not run out of this medicine. Check medicines with healthcare provider. This medicine may not mix well with other medicines. If you have kidney disease, talk with healthcare provider. If you have liver disease, talk with healthcare provider. Avoid alcohol (includes wine, beer, and liquor). You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Anemia and low white blood cell count. Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Diarrhea. Not hungry. Irritated pancreas can rarely occur.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Difficulty breathing. Severe belly pain. Severe nausea or vomiting. Severe diarrhea. Dark urine or yellow skin or eyes. Feeling extremely tired or weak. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen.
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.
MEXICAN BRAND NAMES — Trizivir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
This medicine may cause liver damage and a change in the acid levels in the blood. Closely review the section in this leaflet which lists when to call healthcare provider. Pregnancy, obesity, and/or prolonged therapy may increase the risk.
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Do not restart this medicine if you have had an allergic reaction.
This medicine may cause muscle aches and stiffness if it is used for long periods of time. Closely review the section in this leaflet which lists when to call healthcare provider.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir, lamivudine, zidovudine, 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 have liver disease. If you are pregnant or may be pregnant. If you are breast-feeding.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir, lamivudine, and zidovudine work to injure the virus and fight the infection.
How is it best taken? To gain the most benefit, do not miss doses. Use prescription as directed, even if feeling better. Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? If this medicine is stopped because you have an allergy to it, do not restart it. It can cause a much more dangerous effect if restarted. If this medicine is stopped for any other reason, do not restart it without talking to healthcare provider. It could be very dangerous to restart on your own. If medicine changes for HIV infection, make sure to ask healthcare provider about hepatitis B treatment. Wear disease medical alert identification. Do not run out of this medicine. Check medicines with healthcare provider. This medicine may not mix well with other medicines. If you have kidney disease, talk with healthcare provider. If you have liver disease, talk with healthcare provider. Avoid alcohol (includes wine, beer, and liquor). You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Anemia and low white blood cell count. Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Diarrhea. Not hungry. Irritated pancreas can rarely occur.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Difficulty breathing. Severe belly pain. Severe nausea or vomiting. Severe diarrhea. Dark urine or yellow skin or eyes. Feeling extremely tired or weak. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen.
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.
Abacavir and lamivudine
U.S. BRAND NAMES — Epzicom™
CANADIAN BRAND NAMES — Kivexa™
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Do not restart this medicine if you have had an allergic reaction.
This medicine may cause liver damage and a change in the acid levels in the blood. Closely review the section in this leaflet which lists when to call healthcare provider. Pregnancy, obesity, and/or prolonged therapy may increase the risk.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir, lamivudine 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 have liver disease. If you are pregnant or may be pregnant. If you are breast-feeding.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir and lamivudine work to injure the virus and fight the infection.
How is it best taken? In HIV treatment, this medicine is usually taken with two other medicines. To gain the most benefit, do not miss doses. Use prescription as directed, even if feeling better. Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose, brand, or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? If this medicine is stopped because you have an allergy to it, do not restart it. It can cause a much more dangerous effect if restarted. If this medicine is stopped for any other reason, do not restart it without talking to healthcare provider. It could be very dangerous to restart on your own. If medicine changes for HIV infection, make sure to ask healthcare provider about hepatitis B treatment. Do not run out of this medicine. Wear disease medical alert identification. Avoid alcohol (includes wine, beer, and liquor). If you have kidney disease, talk with healthcare provider. If you have liver disease, talk with healthcare provider. Check medicines with healthcare provider. This medicine may not mix well with other medicines. You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Diarrhea. Not hungry. Irritated pancreas can rarely occur.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Severe belly pain. Severe nausea or vomiting. Severe diarrhea. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen.
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.
CANADIAN BRAND NAMES — Kivexa™
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Do not restart this medicine if you have had an allergic reaction.
This medicine may cause liver damage and a change in the acid levels in the blood. Closely review the section in this leaflet which lists when to call healthcare provider. Pregnancy, obesity, and/or prolonged therapy may increase the risk.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir, lamivudine 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 have liver disease. If you are pregnant or may be pregnant. If you are breast-feeding.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir and lamivudine work to injure the virus and fight the infection.
How is it best taken? In HIV treatment, this medicine is usually taken with two other medicines. To gain the most benefit, do not miss doses. Use prescription as directed, even if feeling better. Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose, brand, or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? If this medicine is stopped because you have an allergy to it, do not restart it. It can cause a much more dangerous effect if restarted. If this medicine is stopped for any other reason, do not restart it without talking to healthcare provider. It could be very dangerous to restart on your own. If medicine changes for HIV infection, make sure to ask healthcare provider about hepatitis B treatment. Do not run out of this medicine. Wear disease medical alert identification. Avoid alcohol (includes wine, beer, and liquor). If you have kidney disease, talk with healthcare provider. If you have liver disease, talk with healthcare provider. Check medicines with healthcare provider. This medicine may not mix well with other medicines. You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Diarrhea. Not hungry. Irritated pancreas can rarely occur.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Severe belly pain. Severe nausea or vomiting. Severe diarrhea. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen.
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.
Abacavir and lamivudine
U.S. BRAND NAMES — Epzicom™
CANADIAN BRAND NAMES — Kivexa™
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Do not restart this medicine if you have had an allergic reaction.
This medicine may cause liver damage and a change in the acid levels in the blood. Closely review the section in this leaflet which lists when to call healthcare provider. Pregnancy, obesity, and/or prolonged therapy may increase the risk.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir, lamivudine 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 have liver disease. If you are pregnant or may be pregnant. If you are breast-feeding.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir and lamivudine work to injure the virus and fight the infection.
How is it best taken? In HIV treatment, this medicine is usually taken with two other medicines. To gain the most benefit, do not miss doses. Use prescription as directed, even if feeling better. Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose, brand, or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? If this medicine is stopped because you have an allergy to it, do not restart it. It can cause a much more dangerous effect if restarted. If this medicine is stopped for any other reason, do not restart it without talking to healthcare provider. It could be very dangerous to restart on your own. If medicine changes for HIV infection, make sure to ask healthcare provider about hepatitis B treatment. Do not run out of this medicine. Wear disease medical alert identification. Avoid alcohol (includes wine, beer, and liquor). If you have kidney disease, talk with healthcare provider. If you have liver disease, talk with healthcare provider. Check medicines with healthcare provider. This medicine may not mix well with other medicines. You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Diarrhea. Not hungry. Irritated pancreas can rarely occur.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Severe belly pain. Severe nausea or vomiting. Severe diarrhea. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen.
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.
CANADIAN BRAND NAMES — Kivexa™
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Do not restart this medicine if you have had an allergic reaction.
This medicine may cause liver damage and a change in the acid levels in the blood. Closely review the section in this leaflet which lists when to call healthcare provider. Pregnancy, obesity, and/or prolonged therapy may increase the risk.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir, lamivudine 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 have liver disease. If you are pregnant or may be pregnant. If you are breast-feeding.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir and lamivudine work to injure the virus and fight the infection.
How is it best taken? In HIV treatment, this medicine is usually taken with two other medicines. To gain the most benefit, do not miss doses. Use prescription as directed, even if feeling better. Take this medicine with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose, brand, or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? If this medicine is stopped because you have an allergy to it, do not restart it. It can cause a much more dangerous effect if restarted. If this medicine is stopped for any other reason, do not restart it without talking to healthcare provider. It could be very dangerous to restart on your own. If medicine changes for HIV infection, make sure to ask healthcare provider about hepatitis B treatment. Do not run out of this medicine. Wear disease medical alert identification. Avoid alcohol (includes wine, beer, and liquor). If you have kidney disease, talk with healthcare provider. If you have liver disease, talk with healthcare provider. Check medicines with healthcare provider. This medicine may not mix well with other medicines. You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you. To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Headache. Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Diarrhea. Not hungry. Irritated pancreas can rarely occur.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! Severe belly pain. Severe nausea or vomiting. Severe diarrhea. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen.
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.
Abacavir
U.S. BRAND NAMES — Ziagen®
CANADIAN BRAND NAMES — Ziagen®
MEXICAN BRAND NAMES — Ziagenavir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Never restart this medicine if you have had an allergic reaction. Swollen liver and an acid condition in the blood have occurred with the use of this medicine.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir 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 have liver disease.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir works to injure the virus and fight the infection.
How is it best taken? Use prescription as directed, even if feeling better. This medicine is usually taken with at least two other medicines. Take this medicine with or without food. Take with food if it causes an upset stomach. A liquid (solution) is available if you cannot swallow pills. Those who have feeding tubes can also use the liquid. Flush the feeding tube before and after medicine is given.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Do not run out of this medicine. Wear disease medical alert identification. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Avoid alcohol (includes wine, beer, and liquor). To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Weight gain. Diarrhea. Not hungry.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! 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. Dark urine or yellow skin or eyes. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store tablets at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen. Store liquid (solution) at room temperature or in a refrigerator. Do not freeze.
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. Read the package insert for more details.
CANADIAN BRAND NAMES — Ziagen®
MEXICAN BRAND NAMES — Ziagenavir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Never restart this medicine if you have had an allergic reaction. Swollen liver and an acid condition in the blood have occurred with the use of this medicine.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir 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 have liver disease.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir works to injure the virus and fight the infection.
How is it best taken? Use prescription as directed, even if feeling better. This medicine is usually taken with at least two other medicines. Take this medicine with or without food. Take with food if it causes an upset stomach. A liquid (solution) is available if you cannot swallow pills. Those who have feeding tubes can also use the liquid. Flush the feeding tube before and after medicine is given.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Do not run out of this medicine. Wear disease medical alert identification. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Avoid alcohol (includes wine, beer, and liquor). To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Weight gain. Diarrhea. Not hungry.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! 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. Dark urine or yellow skin or eyes. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store tablets at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen. Store liquid (solution) at room temperature or in a refrigerator. Do not freeze.
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. Read the package insert for more details.
Abacavir
U.S. BRAND NAMES — Ziagen®
CANADIAN BRAND NAMES — Ziagen®
MEXICAN BRAND NAMES — Ziagenavir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Never restart this medicine if you have had an allergic reaction. Swollen liver and an acid condition in the blood have occurred with the use of this medicine.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir 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 have liver disease.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir works to injure the virus and fight the infection.
How is it best taken? Use prescription as directed, even if feeling better. This medicine is usually taken with at least two other medicines. Take this medicine with or without food. Take with food if it causes an upset stomach. A liquid (solution) is available if you cannot swallow pills. Those who have feeding tubes can also use the liquid. Flush the feeding tube before and after medicine is given.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Do not run out of this medicine. Wear disease medical alert identification. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Avoid alcohol (includes wine, beer, and liquor). To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Weight gain. Diarrhea. Not hungry.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! 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. Dark urine or yellow skin or eyes. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store tablets at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen. Store liquid (solution) at room temperature or in a refrigerator. Do not freeze.
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. Read the package insert for more details.
CANADIAN BRAND NAMES — Ziagen®
MEXICAN BRAND NAMES — Ziagenavir
PHARMACOLOGIC CATEGORY Antiretroviral Agent, Reverse Transcriptase Inhibitor (Nucleoside)
What key warnings should I know about before taking this medicine?
Dangerous allergic reactions can occur. Tell healthcare provider about any fever, rash, feeling tired, nausea, vomiting, diarrhea, belly pain, flu-like symptoms, sore throat, cough, or difficulty breathing. Never restart this medicine if you have had an allergic reaction. Swollen liver and an acid condition in the blood have occurred with the use of this medicine.
Please read the medication guide given to you.
REASONS NOT TO TAKE THIS MEDICINE If you have an allergy to abacavir 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 have liver disease.
What is this medicine used for? This medicine is used to treat HIV infection.
How does it work? Abacavir works to injure the virus and fight the infection.
How is it best taken? Use prescription as directed, even if feeling better. This medicine is usually taken with at least two other medicines. Take this medicine with or without food. Take with food if it causes an upset stomach. A liquid (solution) is available if you cannot swallow pills. Those who have feeding tubes can also use the liquid. Flush the feeding tube before and after medicine is given.
What do I do if I miss a dose? (does not apply to patients in the hospital) Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose or extra doses. Do not change dose or stop medicine. Talk with healthcare provider.
What are the precautions when taking this medicine? Do not run out of this medicine. Wear disease medical alert identification. Check medicines with healthcare provider. This medicine may not mix well with other medicines. Avoid alcohol (includes wine, beer, and liquor). To protect against sexually-transmitted diseases, use a latex condom. Use birth control that you can trust to prevent pregnancy while taking this medicine. Breast-feeding is not recommended in HIV disease.
What are some possible side effects of this medicine? Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Weight gain. Diarrhea. Not hungry.
What should I monitor? Change in condition being treated. Is it better, worse, or about the same? Check blood work regularly. Talk with healthcare provider. 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. Allergic reaction (fever, rash, feeling tired, nausea/vomiting, diarrhea, belly pain, sore throat, cough, difficulty breathing, or flu-like symptoms). Stop medicine and talk with healthcare provider right away! 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. Dark urine or yellow skin or eyes. Any rash. No improvement in condition or feeling worse.
How should I store this medicine? Store tablets at room temperature. Protect tablets from moisture. Do not store in a bathroom or kitchen. Store liquid (solution) at room temperature or in a refrigerator. Do not freeze.
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. Read the package insert for more details.
Thursday, January 31, 2008
Agalsidase bet
U.S. BRAND NAMES — Fabrazyme®
CANADIAN BRAND NAMES — Fabrazyme®
SYNONYMS — Fabrase; Recombinant Human Alpha-Galactosidase A
THERAPEUTIC CATEGORY Enzyme, alpha-galactosidase AFabry's Disease, Treatment Agent
DOSING — I.V.: Children and Adults: 1 mg/kg/dose every two weeks
(For additional information see "Agalsidase beta: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution: 5 mg [contains mannitol 33 mg; derived from Chinese hamster cells]; 35 mg [contains mannitol 222 mg/vial; derived from Chinese hamster cells]
GENERIC AVAILABLE — No
ADMINISTRATION — I.V.: Reconstitute vial with 7.2 mL SWI to result in 5 mg/mL concentration; swirl to dissolve; do not shake; further dilute dosage in 500 mL NS*. Initial infusion not to exceed 15 mg/hour (0.25 mg/minute); after patient tolerance to initial infusion rate is established, the infusion rate may be increased in increments of 3-5 mg/hour (0.05-0.08 mg/minute) with subsequent infusions. In clinical studies, patients have tolerated infusion rates 33 mg/hour. Pretreatment with acetaminophen and an antihistamine is recommended to reduce infusion related side effects (See Warnings)
*Agalsidase beta stability when diluted in NS at a concentration of 2.55 mg/mL has been demonstrated by the manufacturer. Infusion volumes as low as 100 mL were used in phase I/II clinical trials. (Personal communication, Genzyme Corporation, 2003)
USE — Treatment of Fabry's disease
ADVERSE REACTIONS Cardiovascular: Tachycardia, hypertension, hypotension, chest pain, chest tightness, bradycardia, arrhythmias, cardiac arrest, edema, pallor
Central nervous system: Headache, dizziness, fever, anxiety, depression, chills, rigors, vertigo
Dermatologic: Pruritus, urticaria
Gastrointestinal: Dyspepsia, nausea, abdominal pain, vomiting
Genitourinary: Testicular pain
Neuromuscular & skeletal: Arthrosis, skeletal pain, myalgia
Otic: Hypoacousia
Respiratory: Bronchitis, bronchospasm, laryngitis, pharyngitis, sinusitis, rhinitis, dyspnea
Miscellaneous: Hypersensitivity reactions
CONTRAINDICATIONS — Hypersensitivity to agalsidase beta or any component
PRECAUTIONS — Use with caution in patients with compromised cardiac function (seen in advanced Fabry's disease) due to an increased potential for severe infusion related reactions; monitor these patients closely; patients may develop IgG antibodies to agalsidase beta
WARNINGS — Infusion-related reactions (ranging from mild to severe) including fever, rigors, chest tightness, hypertension, hypotension, pruritus, myalgia, dyspnea, urticaria, abdominal pain, and headache have been reported; these reactions may be minimized by pretreatment with acetaminophen and an antihistamine; if an infusion related reaction occurs, regardless of pretreatment, decreasing the infusion rate, temporarily stopping the infusion, and/or additional administration of analgesics, antihistamines, or corticosteroids may ameliorate the reaction.
DRUG INTERACTIONS — None as yet have been identified
PREGNANCY RISK FACTOR — B (show table)
MONITORING PARAMETERS — Vital signs during infusion; globotriaosylceramide (GL3) plasma levels; improvement in symptomatology
REFERENCE RANGE — Normal endogenous activity of alpha-galactosidase A in plasma is approximately 170 nmol/hour/mL; in patients with Fabry's disease this activity is <1.5 nmol/hour/mL
Normal (goal) globotriaosylceramide (GL3) <1.2 ng/microliter
STABILITY — Store in refrigerator 2ºC to 8ºC (36ºF to 46ºF); reconstituted solution is stable for 24 hours refrigerated
MECHANISM OF ACTION — Agalsidase beta is a recombinant human alpha-galactosidase A enzyme with the same amino acid sequence as the naturally-occurring enzyme. Fabry's disease is an X-linked genetic disorder occurring in 1 in 50,000 male births, which results in a deficiency of alpha-galactosidase A. Lack of this enzyme leads to a progressive accumulation of glycosphingolipids, predominantly GL-3, in the vascular endothelium, leading to ischemia and infarction, especially in the kidney, heart, and brain. Clinical manifestations of Fabry's disease in childhood include intermittent severe pain in the extremities, characteristic vascular skin lesions (angiokeratomas), corneal and lenticular opacities that do not affect vision, decreased ability to sweat, intolerance to heat, cold, and exercise, mild proteinuria, and GI problems. By adulthood, this progresses to renal failure, cardiomyopathy, and cerebrovascular accidents.
PHARMACOKINETICS Distribution: Vd: Adults: 80-330 mL/kg
Half-life: Adults: 45-102 minutes (dose dependent)
ADDITIONAL INFORMATION — Agalsidase beta is an orphan drug; a Fabry Patient Support Group (800-745-4447) is available to assist patients in obtaining reimbursement from private insurers, Medicare, and Medicaid, and a Charitable Access Program sponsored by Genzyme provides the drug gratis to those patients in need. Detailed information regarding organizations and websites is also available in the Expert Panel Recommendations (Desnick, 2003)
CANADIAN BRAND NAMES — Fabrazyme®
SYNONYMS — Fabrase; Recombinant Human Alpha-Galactosidase A
THERAPEUTIC CATEGORY Enzyme, alpha-galactosidase AFabry's Disease, Treatment Agent
DOSING — I.V.: Children and Adults: 1 mg/kg/dose every two weeks
(For additional information see "Agalsidase beta: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution: 5 mg [contains mannitol 33 mg; derived from Chinese hamster cells]; 35 mg [contains mannitol 222 mg/vial; derived from Chinese hamster cells]
GENERIC AVAILABLE — No
ADMINISTRATION — I.V.: Reconstitute vial with 7.2 mL SWI to result in 5 mg/mL concentration; swirl to dissolve; do not shake; further dilute dosage in 500 mL NS*. Initial infusion not to exceed 15 mg/hour (0.25 mg/minute); after patient tolerance to initial infusion rate is established, the infusion rate may be increased in increments of 3-5 mg/hour (0.05-0.08 mg/minute) with subsequent infusions. In clinical studies, patients have tolerated infusion rates 33 mg/hour. Pretreatment with acetaminophen and an antihistamine is recommended to reduce infusion related side effects (See Warnings)
*Agalsidase beta stability when diluted in NS at a concentration of 2.55 mg/mL has been demonstrated by the manufacturer. Infusion volumes as low as 100 mL were used in phase I/II clinical trials. (Personal communication, Genzyme Corporation, 2003)
USE — Treatment of Fabry's disease
ADVERSE REACTIONS Cardiovascular: Tachycardia, hypertension, hypotension, chest pain, chest tightness, bradycardia, arrhythmias, cardiac arrest, edema, pallor
Central nervous system: Headache, dizziness, fever, anxiety, depression, chills, rigors, vertigo
Dermatologic: Pruritus, urticaria
Gastrointestinal: Dyspepsia, nausea, abdominal pain, vomiting
Genitourinary: Testicular pain
Neuromuscular & skeletal: Arthrosis, skeletal pain, myalgia
Otic: Hypoacousia
Respiratory: Bronchitis, bronchospasm, laryngitis, pharyngitis, sinusitis, rhinitis, dyspnea
Miscellaneous: Hypersensitivity reactions
CONTRAINDICATIONS — Hypersensitivity to agalsidase beta or any component
PRECAUTIONS — Use with caution in patients with compromised cardiac function (seen in advanced Fabry's disease) due to an increased potential for severe infusion related reactions; monitor these patients closely; patients may develop IgG antibodies to agalsidase beta
WARNINGS — Infusion-related reactions (ranging from mild to severe) including fever, rigors, chest tightness, hypertension, hypotension, pruritus, myalgia, dyspnea, urticaria, abdominal pain, and headache have been reported; these reactions may be minimized by pretreatment with acetaminophen and an antihistamine; if an infusion related reaction occurs, regardless of pretreatment, decreasing the infusion rate, temporarily stopping the infusion, and/or additional administration of analgesics, antihistamines, or corticosteroids may ameliorate the reaction.
DRUG INTERACTIONS — None as yet have been identified
PREGNANCY RISK FACTOR — B (show table)
MONITORING PARAMETERS — Vital signs during infusion; globotriaosylceramide (GL3) plasma levels; improvement in symptomatology
REFERENCE RANGE — Normal endogenous activity of alpha-galactosidase A in plasma is approximately 170 nmol/hour/mL; in patients with Fabry's disease this activity is <1.5 nmol/hour/mL
Normal (goal) globotriaosylceramide (GL3) <1.2 ng/microliter
STABILITY — Store in refrigerator 2ºC to 8ºC (36ºF to 46ºF); reconstituted solution is stable for 24 hours refrigerated
MECHANISM OF ACTION — Agalsidase beta is a recombinant human alpha-galactosidase A enzyme with the same amino acid sequence as the naturally-occurring enzyme. Fabry's disease is an X-linked genetic disorder occurring in 1 in 50,000 male births, which results in a deficiency of alpha-galactosidase A. Lack of this enzyme leads to a progressive accumulation of glycosphingolipids, predominantly GL-3, in the vascular endothelium, leading to ischemia and infarction, especially in the kidney, heart, and brain. Clinical manifestations of Fabry's disease in childhood include intermittent severe pain in the extremities, characteristic vascular skin lesions (angiokeratomas), corneal and lenticular opacities that do not affect vision, decreased ability to sweat, intolerance to heat, cold, and exercise, mild proteinuria, and GI problems. By adulthood, this progresses to renal failure, cardiomyopathy, and cerebrovascular accidents.
PHARMACOKINETICS Distribution: Vd: Adults: 80-330 mL/kg
Half-life: Adults: 45-102 minutes (dose dependent)
ADDITIONAL INFORMATION — Agalsidase beta is an orphan drug; a Fabry Patient Support Group (800-745-4447) is available to assist patients in obtaining reimbursement from private insurers, Medicare, and Medicaid, and a Charitable Access Program sponsored by Genzyme provides the drug gratis to those patients in need. Detailed information regarding organizations and websites is also available in the Expert Panel Recommendations (Desnick, 2003)
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