Drug information

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Brand Name:
Cimduo
Other Names:
3TC/TDF, Temixys
Drug Class:
Combination Drugs
Nucleoside Reverse Transcriptase Inhibitor (lamivudine, tenofovir DF)
Drug Image(s): (Click to enlarge)
 
What are the most important things to know about Cimduo?What are the most important things to know about Cimduo?

What are the most important things to know about Cimduo?

Cimduo can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), liver problems, and new or worsening kidney problems, including kidney failure.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Weakness or tiredness
  • Unusual muscle pain
  • Shortness of breath or fast breathing
  • Stomach pain with nausea and vomiting
  • Cold or blue hands and feet
  • Dizziness or lightheadedness
  • Fast or abnormal heartbeat

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Nausea or vomiting
  • Pain, aching, or tenderness on the right side of your stomach area
  • Itching

If you have both HIV and hepatitis B virus infection (HBV) and take Cimduo, your HBV infection may get worse (flare up) if you stop taking Cimduo. Do not stop taking Cimduo without first talking to your health care provider.

Worsening of liver disease (sometimes resulting in death) has occurred in people with both HIV and hepatitis C virus infection (HCV) who were taking HIV medicines and interferon alfa with or without ribavirin. If you are taking Cimduo and interferon alfa with or without ribavirin and you have any new symptoms, tell your health care provider.

Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called Fanconi Syndrome), which may be related to tenofovir-containing drugs:

  • Bone pain that does not go away or gets worse
  • Pain in your arms, hands, legs or feet
  • Broken bones
  • Muscle pain or weakness

While taking Cimduo, it is important to keep all of your appointments with your health care provider.

What is Cimduo?What is Cimduo?

What is Cimduo?

Cimduo is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children weighing at least 77 lb (35 kg). Cimduo is always used in combination with other HIV medicines.

Cimduo contains two different medicines: lamivudine and tenofovir disoproxil fumarate.

For more information on the use of Cimduo in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines can’t cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, don’t cut down on, skip, or stop taking them unless your health care provider tells you to.

Because lamivudine and tenofovir disoproxil fumarate are also effective against HBV infection, Cimduo may be included as part of an antiretroviral therapy (ART) regimen to treat both HIV and HBV infection in people with HIV/HBV coinfection. For information on the HBV-related use of lamivudine and tenofovir disoproxil fumarate, please refer to the HBV section of the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV and the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children.

What should I tell my health care provider before taking Cimduo?What should I tell my health care provider before taking Cimduo?

What should I tell my health care provider before taking Cimduo?

Before taking Cimduo, tell your health care provider:

  • If you are allergic to any of the HIV medicines in Cimduo (lamivudine and tenofovir disoproxil fumarate) or any other medicines.
  • If you have liver problems, including HBV infection or HCV infection.
  • If you have kidney problems, including end-stage renal disease (ESRD) that requires dialysis.
  • If you have bone problems, including a history of broken bones.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking Cimduo during pregnancy. For more information on the use of Cimduo during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.
  • If you are breastfeeding or plan to breastfeed. For women with HIV in the United States, the Guideline does not recommend breastfeeding. Before your baby is born, or if you are already breastfeeding, talk to your health care provider to discuss alternative options for feeding your baby.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Cimduo may affect the way other medicines or products work, and other medicines or products may affect how Cimduo works. Taking Cimduo together with certain medicines or products may cause serious side effects.
How should I take Cimduo?How should I take Cimduo?

How should I take Cimduo?

Cimduo comes in tablet form. Each tablet contains:

Take Cimduo according to your health care provider’s instructions.

Take Cimduo by mouth with or without food.

Always take Cimduo in combination with other HIV medicines.

If you have taken too much Cimduo, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take Cimduo, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of Cimduo, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can Cimduo cause?What side effects can Cimduo cause?

What side effects can Cimduo cause?

 

Cimduo may cause side effects. Some side effects of Cimduo can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of Cimduo include:
  • Inflammation of the pancreas (pancreatitis) in some children. Contact your health care provider right away if your child develops signs and symptoms of pancreatitis, including severe upper stomach-area pain, with or without nausea and vomiting.
  • Bone problems (bone pain, softening or thinning).
  • Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
  • Changes in body fat (lipodystrophy syndrome).

Tell your health care 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 Cimduo. To learn more about possible side effects of Cimduo, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should Cimduo be stored?How should Cimduo be stored?

How should Cimduo be stored?

 

  • Store Cimduo at room temperature, 68°F to 77°F (20°C to 25°C).
  • Keep Cimduo in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use Cimduo if the original seal over the container opening is broken or missing.
  • Throw away Cimduo that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Cimduo and all medicines out of reach of children.
Where can I find more information about Cimduo?Where can I find more information about Cimduo?

Where can I find more information about Cimduo?

Manufacturer Information

Mylan

Main number: 724-514-1800
Patient assistance: 800-796-9526

 

Last Reviewed: April 5, 2021