Generic Name: lamivudine and tenofovir disoproxil fumarate
Dosage Form: Tablets
Date of Approval: February 28, 2018
Company: Mylan N.V.
Treatment for: HIV Infection
FDA Approves Cimduo
The U.S. Food and Drug Administration (FDA) has approved Cimduo (lamivudine and tenofovir disoproxil fumarate), a combination of two nucleo(t)side reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Read this Patient Information carefully before you start treatment. This information does not take the place of talking with your doctor about your medical condition or your treatment.
Cimduo can cause serious side effects, including:
- Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious medical emergency that can lead to death.
Tell your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:
- feel very weak or tired
- unusual (not normal) muscle pain
- trouble breathing
- stomach pain with nausea or vomiting
- feel cold, especially in your arms and legs
- feel dizzy or lightheaded
- have a fast or irregular heartbeat
- Severe liver problems. In some cases, severe liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis).
Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
- your skin or the white part of your eyes turns yellow (jaundice)
- dark or “tea-colored” urine
- light-colored stools (bowel movements)
- loss of appetite for several days or longer
- nausea and vomiting
- pain, aching, or tenderness on the right side of your stomach-area
- 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 Cimduo. 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.
- It is not known if Cimduo is safe and effective in people who have both HIV-1 and HBV infection.
- Do not run out of this medicine. Refill your prescription or talk to your healthcare provider before your Cimduo is all gone.
- Do not stop treatment without first talking to your healthcare provider. If you stop taking Cimduo, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.
- 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 Cimduo. 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.
For more information about side effects, see Cimduo side effects.
What is Cimduo?
Cimduo is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in adults and children weighing at least 35 kg.
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
Cimduo contains the prescription medicines lamivudine and tenofovir disoproxil fumarate.
Who should not take Cimduo?
You should not take Cimduo if you:
- are allergic to lamivudine, tenofovir disoproxil fumarate, or any of the other ingredients. See the end of this Patient Information leaflet for a complete list of ingredients.
Before taking Cimduo
Before you take Cimduo, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems, including hepatitis B or C 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 Cimduo will harm your unborn baby. There is a pregnancy registry for women who take Cimduo 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 Cimduo.
- You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
- Talk to 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 Cimduo. Cimduo may affect the way other medicines work, and vice versa. 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 Cimduo.
- Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Cimduo with other medicines.
How should I take Cimduo?
- Take this medicine exactly as your healthcare provider tells you to take it.
- Take Cimduo one time each day with or without food.
- Do not miss a dose. If you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time.
- Stay under the care of your healthcare provider during treatment.
- Do not run out of this medicine. 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 or overdose, go to the nearest hospital emergency room right away.
What should I avoid while taking Cimduo?
You should avoid taking medicines that contain sorbitol during treatment.
Cimduo side effects
Cimduo may cause serious side effects, including:
- See Important information
- 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 Cimduo and interferon alfa with or without ribavirin, tell your healthcare provider if you have any new symptoms.
- Risk of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment with Cimduo if they:
- have taken nucleoside analogue medicines in the past
- have a history of pancreatitis
- have other risk factors for pancreatitis
- Bone problems can happen in some people who take Cimduo. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do 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.
- 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.
- Changes in body fat can happen in some people who take HIV-1 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.
The most common side effects include:
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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
How should I store Cimduo?
- Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep the tablets in the original container.
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Cimduo
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients in Cimduo?
Active ingredient: lamivudine and tenofovir disoproxil fumarate
Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating contains polyethylene glycol, titanium dioxide, polyvinyl alcohol and talc.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.