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EMTRIVA™ (em-treeví-ah) Capsules
Generic name: emtricitabine (em tri SIT uh bean)
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Information for Patients: EMTRIVA is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients should remain under the care of a physician when using EMTRIVA. Patients should be advised that:
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Read the Patient Information that comes with EMTRIVA before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. You should stay under a healthcare providerís care when taking EMTRIVA. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about EMTRIVA.
What is the most important information I should know about EMTRIVA?
· Some people who have taken medicines like EMTRIVA (a nucleoside analog) have developed a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital.
Call your healthcare provider right away if you get the following signs of lactic acidosis.
· You feel very weak or tired.
· You have unusual (not normal) muscle pain.
· You have trouble breathing.
· You have stomach pain with nausea and vomiting.
· You feel cold, especially in your arm and legs.
· You feel dizzy or lightheaded.
· You have a fast or irregular heartbeat.
· Some people who have taken medicines like EMTRIVA have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get the following signs of liver problems.
· Your skin or the white part of your eyes turns yellow (jaundice).
· Your urine turns dark.
· Your bowel movements (stools) turn light in color.
· You donít feel like eating food for several days or longer.
· You feel sick to your stomach (nausea).
· You have lower stomach area (abdominal) pain.
· You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog medicines, like EMTRIVA, for a long time.
· EMTRIVA is not for the treatment of Hepatitis B Virus (HBV) infection. Patients with both HBV and human immunodeficiency virus (HIV) infection who take EMTRIVA need close medical follow-up for several months after stopping treatment with EMTRIVA. Follow-up includes medical exams and blood tests to check for HBV that is getting worse.
Patients with HBV infection, who take EMTRIVA and then stop it, may get "flare-ups" of their hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before.
What is EMTRIVA?
EMTRIVA is a type of medicine called an HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitor (NRTI). EMTRIVA is always used with other anti-HIV medicines to treat people with HIV infection. EMTRIVA is for adults age 18 and older. EMTRIVA has not been studied fully in children under age 18 or adults over age 65.
HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.
EMTRIVA helps to block HIV reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV to multiply. EMTRIVA may lower the amount of HIV in the blood (viral load). EMTRIVA may also help to increase the number of T cells called CD4 cells. Lowering the amount of HIV in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).
EMTRIVA does not cure HIV infection or AIDS. The long-term effects of EMTRIVA are not known at this time. People taking EMTRIVA may still get opportunistic infections or other conditions that happen with HIV infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. It is very important that you see your healthcare provider regularly while taking EMTRIVA.
EMTRIVA does not lower your chance of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles.
Who should not take EMTRIVA?
Do not take EMTRIVA if you are allergic to EMTRIVA or any of its ingredients. The active ingredient is emtricitabine. See the end of this leaflet for a complete list of ingredients.
What should I tell my healthcare provider before taking EMTRIVA?
Tell your healthcare provider
· If you are pregnant or planning to become pregnant. We do not know if EMTRIVA can harm your unborn child. You and your healthcare provider will need to decide if EMTRIVA is right for you. If you use EMTRIVA while you are pregnant, talk to your healthcare provider about how you can be on the EMTRIVA Antiviral Pregnancy Registry.
· If you are breast-feeding. You should not breast feed if you are HIV-positive because of the chance of passing the HIV virus to your baby. Also, it is not known if EMTRIVA can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby.
· If you have kidney problems. You may need to take EMTRIVA less often.
· If you have any liver problems including Hepatitis B Virus infection.
· Tell your healthcare provider about all your medical conditions.
· Tell your healthcare provider about all the medicines you take such as prescription and non-prescription medicines and dietary supplements. Keep a complete list of all the medicines that you take. Make a new list when medicines are added or stopped. Give copies of this list to all of your healthcare providers and pharmacist every time you visit or fill a prescription.
How should I take EMTRIVA?
· Take EMTRIVA every day by mouth exactly as your healthcare provider prescribed it. Follow the directions from your healthcare provider, exactly as written on the label.
· The usual dose of EMTRIVA is 1 capsule once a day. EMTRIVA is always used with other anti-HIV medicines.
· EMTRIVA may be taken with or without a meal. Food does not affect how EMTRIVA works.
· If you forget to take EMTRIVA, take it as soon as you remember that day. Do not take more than 1 dose of EMTRIVA in a day. Do not take 2 doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do. It is important that you do not miss any doses of EMTRIVA or your other anti-HIV medicines.
· When your EMTRIVA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to EMTRIVA and become harder to treat.
· Stay under a healthcare providerís care when taking EMTRIVA. Do not change your treatment or stop treatment without first talking with your healthcare provider.
· If you take too much EMTRIVA, call your local poison control center or emergency room right away.
What should I avoid while taking EMTRIVA?
· Do not breast-feed. See "What should I tell my healthcare provider before taking EMTRIVA?" Talk with your healthcare provider about the best way to feed your baby.
· Avoid doing things that can spread HIV infection since EMTRIVA doesn't stop you from passing the HIV infection to others.
· Do not share needles or other injection equipment.
· Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
· Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.
What are the possible side effects of EMTRIVA?
EMTRIVA may cause the following serious side effects (see "What is the most important information I should know about EMTRIVA?"):
· lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your doctor right away if you get signs of lactic acidosis.
· serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any signs of liver problems.
· "flare-ups" of hepatitis B virus infection, in which the disease suddenly returns in a worse way than before, can occur if you stop taking EMTRIVA. EMTRIVA is not for the treatment of Hepatitis B Virus (HBV) infection.
Other side effects with EMTRIVA when used with other anti-HIV medicines Include:
·Changes in body fat have been seen in some patients taking EMTRIVA and other anti-HIV medicines. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effects of these conditions are not known at this time.
The most common side effects of EMTRIVA used with other anti-HIV medicines are headache, diarrhea, nausea and rash. Skin discoloration may also happen with EMTRIVA.
There have been other side effects in patients taking EMTRIVA. However, these side effects may have been due to other medicines that patients were taking or to HIV itself. Some of these side effects can be serious.
This list of side effects is not complete. If you have questions about side effects, ask your healthcare provider or pharmacist. You should report any new or continuing symptoms to your healthcare provider right away. Your healthcare provider may be able to help you manage these side effects.
How do I store EMTRIVA?
· Keep EMTRIVA and all other medicines out of reach of children.
· Store EMTRIVA at between 59 °F and 86 °F (15 °C to 30 °C). Do not keep your medicine in places that are too hot or cold.
· Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.
General information about EMTRIVA:
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use EMTRIVA for a condition for which it was not prescribed. Do not give EMTRIVA to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about EMTRIVA. If you would like more information, talk with your doctor. You can ask your healthcare provider or pharmacist for information about EMTRIVA that is written for health professionals. For more information, you may also call 1-800-GILEAD5.
What are the ingredients of EMTRIVA?
Active Ingredient: emtricitabine
Inactive Ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, and povidone.
EMTRIVA is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients should remain under the care of a physician when using EMTRIVA.
Patients should be advised that:
· the use of EMTRIVA has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.
· the long term effects of EMTRIVA are unknown.
·EMTRIVA Capsules are for oral ingestion only.
· it is important to take EMTRIVA with combination therapy on a regular dosing schedule to avoid missing doses.
· redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known.
Fat Redistribution
Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are unknown. A causal relationship has not been established.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis: Long-term carcinogenicity studies of emtricitabine in rats and mice are in progress.
Mutagenesis: Emtricitabine was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or mouse micronucleus assays.
Impairment of Fertility: Emtricitabine did not affect fertility in male rats at approximately 140-fold or in male and female mice at approximately 60-fold higher exposures (AUC) than in humans given the recommended 200 mg daily dose. Fertility was normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60-fold higher than human exposures at the recommended 200 mg daily dose.
Pregnancy
Pregnancy Category B
The incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures (AUC) approximately 60-fold higher and in rabbits at approximately 120-fold higher than human exposures at the recommended daily dose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, EMTRIVA should be used during pregnancy only if clearly needed.
Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women exposed to emtricitabine, an antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263.
Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV. It is not known whether emtricitabine is secreted into human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving EMTRIVA.
Pediatric Use:
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
Clinical studies of EMTRIVA did not contain sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
September 2004 © 2004 Gilead Sciences, Inc. RM-1466
