Temixys

Temixys is a prescription medication used to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children weighing 35 kg and up.

It is a single product containing 2 medications: lamivudine and tenofovir disoproxil fumarate. Temixys belongs to a group of drugs called nucleoside reverse transcriptase inhibitors which block reverse transcriptase (an HIV-1 enzyme) thereby preventing HIV-1 from replicating.

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects include rash, headache, pain, depression and diarrhea. Temixys can also cause dizziness. Do not drive or operate heavy machinery until you know how Temixys affects you.

Temixys is a prescription medication used to treat HIV-1 infection in adults and children weighing 35 kg and greater. Temixys is used in combination with other antiretroviral medications.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Temixys. See the “Temixys Precautions” section.

Common side effects of Temixys include the following:

• Rash
• Headache
• Generalized pain
• Depression
• Diarrhea

This is not a complete list of Temixys side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Adefovir dipivoxil (Hepsera)

• Medications that reduce drug clearance through the kidneys such as acyclovir (Zovirax, cidofovir (Vistide), ganciclovir (Cytovene), valacyclovir (Valtrex), and valganciclovir (Valcyte)

This is not a complete list of Temixys drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Temixys including the following:

• Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take Temixys. Call your healthcare provider right away if you get the following symptoms lactic acidosis:

  • Weakness or tiredness
  • Muscle pain
  • Trouble breathing
  • Stomach pain with nausea and vomiting
  • Feeling cold, especially in your arms or legs
  • Feeling dizzy or lightheaded
  • Fast or irregular heartbeat
• 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.

• Severe liver problems. Tell your healthcare provider about any signs or symptoms of liver damage, which include the following:

  • loss of appetite or start losing weight (anorexia)
  • nausea or vomiting
  • feel tired
  • stomach pain or tenderness on the right side of the stomach area
  • dark urine or light colored stools
  • yellowing of your skin or the whites of your eyes

• Pancreas problems (Pancreatitis). Temixys can increase risk of pancreas problems in children that have a history or increased risks of pancreas problems or if they have taken nucleoside analogue medicines in the past. Tell your healthcare provider right away if you have any of the following symptoms of pancreatitis:

  • Stomach pain, can spread to the back
  • Nausea / Vomiting
  • Fever

• A decline in kidney function. Toxicity from Temixys may occur with kidney dysfunction. Your doctor may want to monitor your kidney functions with certain blood tests as well. Tell your healthcare provider right away if you have any of the following symptoms of kidney dysfunction:

  • Swelling of face, ankles, hands, or feet
  • Fatigue
  • Paleness of skin
  • Decreased urination
  • Shortness of breath

• Risk of developing other viral or bacterial infections (Immune Reconstitution Syndrome). Talk to your healthcare provider about your risks of developing these other infections and diseases as your HIV-1 infection is being treated and your immune system is improving.

• Bone problems. Temixys can cause the density of your bones to decrease leading increased chances of fractures. Talk to your healthcare provider to evaluate your risks while on Temixys.

• Treatment failure. Talk to your healthcare provider to make sure you are on the correct combination of medications for effective treatment of HIV-1 infection.

Do not take Temixys if you are allergic to Temixys or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Temixys, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Temixys, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to Temixys or to any of its ingredients
• 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
• Are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Temixys may harm your unborn baby.

Both medications in Temixys, lamivudine and tenofovir disoproxil fumarate, have been studied in pregnant women. When pregnant women used lamivudine or tenofovir disoproxil fumarate, their babies did not have any additional risk of major birth defects related to this medication.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed. Do not breastfeed if you take Temixys.

The Center for Disease Control and Prevention recommends mothers infected with HIV-1 virus not breastfeed to avoid transmission on HIV-1 infection to their baby.

Additionally, both medications in Temixys, lamivudine and tenofovir disoproxil fumarate, have been detected in human breast milk.

• Take Temixys exactly as your healthcare provider tells you to take it.
• Take Temixys at the same time every day.
• Take Temixys 1 time each day with or without food.
• Do not miss a dose of Temixys. If you miss a dose of Temixys, take it as soon as you remember. If it is almost time for your next dose of Temixys, do not take the missed dose. Take the next dose of Temixys at your regular time.
• Do not take 2 doses at the same time or take more Temixys than prescribed. 
• Stay under the care of a healthcare provider during treatment with Temixys.
• Do not run out of Temixys. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
• If you take too much Temixys, go to the nearest hospital emergency room right away.

You should avoid taking medicines that contain sorbitol during treatment with Temixys.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your weight

• other medical conditions you have

• other medications you are taking

The recommended dosage of Temixys HIV-1 infected adult and pediatric patients weighing at least 35 kg is one tablet taken orally once daily with or without food. Temixys is a two-drug fixed-dose combination product containing 300 mg of lamivudine (3TC) and 300 mg of tenofovir disoproxil fumarate (TDF).

If you take too much Temixys, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Temixys tablets below 86°F (30°C).
• Keep Temixys in the original bottle.
• Keep the bottle of Temixys tightly closed. The bottle contains a desiccant that helps to keep the tablets dry. Do not remove or eat the desiccant.
• Do not use Temixys if the seal over the bottle opening is broken or missing.

Keep Temixys and all medicines out of the reach of children.

WARNING: POSTTREATMENT EXACERBATIONS OF HEPATITIS B

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 or tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Temixys and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti- hepatitis B therapy may be warranted.