TEMIXYS

About TEMIXYS

What is TEMIXYS™?

TEMIXYS™ is one tablet taken orally once daily with or without food. TEMIXYS is used to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 77 lbs.
TEMIXYS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

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Important Safety Information

What is the most important information I should know about TEMIXYS?

TEMIXYS can cause serious side effects, including:

Worsening of hepatitis B infection. If you have Human Immunodeficiency Virus type 1 (HIV-1) and hepatitis B virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking TEMIXYS. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Your healthcare provider will test you for HBV infection before you start treatment with TEMIXYS.

  • It is not known if TEMIXYS is safe and effective in people who have both HIV-1 and HBV infection.
  • Do not run out of TEMIXYS. Refill your prescription or talk to your healthcare provider before your TEMIXYS is all gone.
  • Do not stop taking TEMIXYS without first talking to your healthcare provider. If you stop taking TEMIXYS, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.

Use with interferon and ribavirin-based regimens. Worsening of liver disease that has caused death has happened in people infected with HIV-1 and hepatitis C virus who were taking antiretroviral medicines for HIV-1 and were also being treated for hepatitis C with interferon alfa with or without ribavirin. If you are taking TEMIXYS and interferon with or without ribavirin, tell your healthcare provider if you have any new symptoms.

What are the possible side effects of TEMIXYS?

TEMIXYS may cause serious side effects, including:

Risk of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment with TEMIXYS if they: o have taken nucleoside analogue medicines in the past o have a history of pancreatitis o have other risk factors for pancreatitis Call your healthcare provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach-area pain, with or without nausea and vomiting. Your healthcare provider may tell you to stop giving TEMIXYS to your child if their symptoms and blood test results show that your child may have pancreatitis.

New or worse kidney problems, including kidney failure.Your healthcare provider may do blood and urine tests to check your kidneys before and during treatment with TEMIXYS. Tell your healthcare provider if you get signs and symptoms of kidney problems, including bone pain that does not go away or worsening bone pain, pain in your arms, hands, legs or feet, broken (fractured) bones, muscle pain or weakness.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV-1 medicine.

Bone problems can happen in some people who take TEMIXYS. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones. Tell your healthcare provider if you have any bone pain, pain in your hands or feet, or muscle pain or weakness during treatment with TEMIXYS.

The most common side effects of TEMIXYS include:
rash / headache / pain / diarrhea / depression

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TEMIXYS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you take TEMIXYS, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems, including hepatitis B or C virus infection.

have kidney problems, including end-stage renal disease (ESRD) that requires dialysis.

have bone problems, including a history of bone fractures.

are pregnant or plan to become pregnant. It is not known if TEMIXYS may harm your unborn baby.
Pregnancy Registry. There is a pregnancy registry for women who take TEMIXYS during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

are breastfeeding or plan to breastfeed. Do not breastfeed if you take TEMIXYS.

  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines interact with TEMIXYS. TEMIXYS may affect the way other medicines work, and other medicines may affect how TEMIXYS works. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with TEMIXYS.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TEMIXYS with other medicines.

You should not take TEMIXYS if you also take:

adefovir (HEPSERA™)