Cimduo

Cimduo is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV). 

It is a single product containing 2 medications: lamivudine and tenofovir disoproxil. These drugs, called nucleoside reverse transcriptase inhibitors, help to decrease the amount of HIV in the blood. 

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

Common side effects include headache, pain, depression, diarrhea, and rash. 

Cimduo can also cause dizziness. Do not drive or operate heavy machinery until you know how Cimduo affects you.

Cimduo is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV). 

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

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

Common side effects of Cimduo include the following:

• headache
• pain 
• depression
• diarrhea
• rash 

This is not a complete list of Cimduo 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:

• Drugs that can decrease kidney function such as:
  • NSAIDs such as aspirin, ibuprofen, and naproxen
  • acyclovir
  • aminoglycoside medications
  • certain antibiotics
  • ACEIs such as lisinopril or quinapril
  • statins such as rosuvastatin and simvastatin
  • water pills (diuretic medications)
• HIV protease inhibitors such as atazanavir, darunavir, lopinavir, and ritonavir
• Medications that inhibit OATP transporters such as atazanavir (Reyataz), clarithromycin (Biaxin), cyclosporine (Neoral), erythromycin, gemfibrozil (Lopid), lopinavir/ritonavir (Kaletra), ritonavir/lopinavir (Kaletra), saquinavir (Invirase), simeprevir (Olysio), telithromycin (Ketek), tipranavir (Aptivus), rifampin, and velpatasvir (Epclusa)
• Sorbitol

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

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

• Too much lactic acid in your blood (lactic acidosis). This is a serious medical emergency that can lead to death. Tell your healthcare provider right away if you have some or all of the following symptoms of lactic acidosis:
  • feeling very weak or tired
  • unusual muscle pain
  • trouble breathing
  • stomach pain with nausea or vomiting
  • feeling dizzy or lightheaded
  • have a fast or irregular heartbeat
  • feel cold, especially in your arms or legs
• Severe liver problems. Tell your healthcare provider right away if you have some or all of the following symptoms of severe liver problems:
  • dark or "tea-colored" urine
  • your skin or the white parts of your eyes turn yellow (jaundice)
  • loss of appetite for several days or longer
  • nausea and vomiting
  • pain or tenderness on the right side of your stomach-area
  • light-colored stools (bowel movements)
• Worsening of hepatitis B infection. Your healthcare provider will test you for hepatitis B infection before you start treatment with Cimduo. Do not stop Cimduo 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. Tell your healthcare provider right away if you have some or all of the following symptoms of severe kidney problems:
  • muscle pain or weakness
  • worsening bone pain or bone pain that does not go away
  • pain in your arms, hands, legs or feet
• Thinning bones (decreased bone mineral density). Your healthcare provider may need to do tests to check your bones. Tell your healthcare provider right away if you have bone pain or fractures. 
• Inflammation of the pancreas (pancreatitis). Tell your healthcare provider right away if you have some or all of the following symptoms of pancreatitis:
  • severe upper stomach area pain
  • nausea or vomiting
• Changes in immune system. 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 Cimduo. 
• Redistribution of body fat. Patients taking anti-HIV medications sometimes experience an increased amount of fat in the upper back and neck, which is sometimes referred to as "buffalo hump." The cause and long-term effects of this is not known. 

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

Avoid doing things that can spread HIV infection since Cimduo does not stop you from passing the HIV infection to others.

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.

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 Cimduo, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Cimduo or to any of its ingredients
• have liver problems, including hepatitis B or C infection
• have kidney problems, including end-stage renal disease that requires dialysis
• have bone problems, including a history of bone fractures
• are pregnant or plan to become pregnant. 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. You should not breastfeed if you have HIV infection because of the risk of passing it to your baby. 

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.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cimduo falls into category B. This medication has been evaluated in a limited number of women during pregnancy and postpartum. Human and animal data suggest that Cimduo does not increase the risk of major birth defects overall. However, there are no well controlled studies in pregnant women. Cimduo should be used during pregnancy only if clearly needed.

If you use Cimduo while you are pregnant, talk to your doctor about how you can be on the Antiviral Pregnancy Registry.

Tell your doctor if you are breastfeeding. You should not breastfeed if you are HIV-positive because of the chance of passing the HIV virus to your baby.

Also, Cimduo can pass into your breast milk, and it is not known if it can harm your baby. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.

Take Cimduo exactly as prescribed.

Cimduo comes in tablet form and is taken once a day, with or without food. 

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

Do not run out of Cimduo. 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. 

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

The recommended dose of Cimduo for the treatment of HIV infection is 1 tablet by mouth once daily, with or without food. 

Cimduo is a fixed-dose combination tablet, so the dose cannot be adjusted. Because of this, Cimduo is not recommended in patients with poor kidney function or kidney disease that requires dialysis. Talk to your healthcare provider if you have concerns about your kidney function. 

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

• Store Cimduo tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Cimduo tablets in the original container.
• Keep Cimduo and all medicines out of the reach of children. 

WARNING: POST TREATMENT ACUTE EXACERBATONS OF HEPATITIS B

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and human immunodeficiency virus (HIV-1) and have discontinued Cimduo. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.