|View printer-friendly version|
|September 29, 2016 3:52 p.m.|
|Teva Announces Launch of Generic Epzicom® Tablets in the United States|
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in the blood may help improve affected patients’ immune systems, and may reduce the risk of death or getting infections that can happen when a patient’s immune system is weak (opportunistic infections). Abacavir and lamivudine tablets are not a cure for HIV or AIDS.
Teva continues its commitment to strengthening its generics business
with continued investment in newer, higher-quality generic products.
With nearly 600 generic medicines available, Teva has the largest
To date, Teva has over 300 product registrations pending
Epzicom® (abacavir and lamivudine) tablets had annual sales
About Abacavir and Lamivudine Tablets
Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Important Safety Information
Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir-containing products. Hypersensitivity to abacavir is a multi-organ clinical syndrome. Patients who carry the HLA-B*5701 allele are at a higher risk of experiencing a hypersensitivity reaction to abacavir. Abacavir and lamivudine tablets are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, a component of abacavir and lamivudine tablets.
Abacavir and lamivudine tablets are contraindicated in patients who have the HLA-B*5701 allele; patients with prior hypersensitivity reaction to abacavir or lamivudine; and patients with moderate or severe hepatic impairment.
Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin. Discontinue abacavir and lamivudine tablets as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. Immune reconstitution syndrome and redistribution/accumulation of body fat have been reported in patients treated with combination antiretroviral therapy.
Abacavir and lamivudine tablets are not recommended with other products containing abacavir or lamivudine or emtricitabine-containing products. The underlying risk of coronary heart disease should be considered when prescribing antiretroviral therapies, including abacavir, and action taken to minimize all modifiable risk factors. The most commonly reported adverse reactions of at least moderate intensity (incidence greater than 5%) in an adult HIV-1 clinical trial were drug hypersensitivity, insomnia, depression/depressed mood, headache/migraine, fatigue/malaise, dizziness/vertigo, nausea, and diarrhea.
For more information, please see accompanying Full Prescribing Information, including Boxed Warning.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to integrate
1 Epzicom® is a registered trademark of GlaxoSmithKline.
Teva Pharmaceutical Industries Ltd.