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IMPORTANT SAFETY INFORMATION
What is the most important information you should know about COMPLERA?
COMPLERA can cause serious side effects:
- Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat
- Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain
- You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking COMPLERA for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions
- Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking COMPLERA, your hepatitis may suddenly get worse. Do not stop taking COMPLERA without first talking to your healthcare provider, as they will need to monitor your health. COMPLERA is not approved for the treatment of HBV
Who should not take COMPLERA?
Do not take COMPLERA if you have ever taken other anti-HIV medicines.
COMPLERA may change the effect of other medicines and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses.
Do not take COMPLERA if you also take these medicines:
- anti-seizure medicines: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol), oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek)
- anti-tuberculosis medicines: rifabutin (Mycobutin), rifampin (Rifater, Rifamate, Rimactane, Rifadin), rifapentine (Priftin)
- proton pump inhibitors for stomach or intestinal problems: esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), dexlansoprazole (Dexilant), omeprazole (Prilosec), pantoprazole sodium (Protonix), rabeprazole (Aciphex)
- more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
- St. John’s wort (Hypericum perforatum)
If you are taking COMPLERA you should not take other HIV medicines or other medicines containing tenofovir (Viread, Truvada, Stribild or Atripla); other medicines containing emtricitabine or lamivudine (Emtriva, Combivir, Epivir, Epivir-HBV, Epzicom, Trizivir, Atripla, Stribild or Truvada); rilpivirine (Edurant) or adefovir (Hepsera)
In addition, tell your healthcare provider if you are taking the following medications because they may interfere with how COMPLERA works and may cause side effects:
- certain antacid medicines containing aluminum, magnesium hydroxide, or calcium carbonate (examples: Rolaids, TUMS). These medicines must be taken at least 2 hours before or 4 hours after COMPLERA
- medicines to block stomach acid including cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine HCL (Zantac). These medicines must be taken at least 12 hours before or 4 hours after COMPLERA
- any of these medicines: clarithromycin (Biaxin); erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Ilosone), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral) methadone (Dolophine); posaconazole (Noxafil), telithromycin (Ketek) or voriconazole (Vfend)
- medicines that are eliminated by the kidneys like acyclovir (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), valacyclovir (Valtrex) and valganciclovir (Valcyte)
These are not all the medicines that may cause problems if you take COMPLERA. Tell your healthcare provider about all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.
Before taking COMPLERA, tell your healthcare provider if you:
- Have liver problems, including hepatitis B or C virus infection, or have abnormal liver tests
- Have kidney problems
- Have ever had a mental health problem
- Have bone problems
- Are pregnant or planning to become pregnant. It is not known if COMPLERA can harm your unborn child
- Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, COMPLERA may pass through breast milk and could cause harm to the baby
COMPLERA can cause additional serious side effects:
- New or worsening kidney problems, including kidney failure: If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider should do regular blood tests
- Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide) or have tried to hurt yourself
- Changes in liver enzymes: People who have had hepatitis B or C, or who have had changes in their liver function tests in the past may have an increased risk for liver problems while taking COMPLERA. Some people without prior liver disease may also be at risk. Your healthcare provider may need to check your liver enzymes before and during treatment with COMPLERA
- Bone problems can happen in some people who take COMPLERA. 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
- Changes in body fat can happen in people taking HIV medicine
- Changes in your 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 COMPLERA
The most common side effects reported with COMPLERA are trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, and depression. Some side effects also reported include vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles) and pain.
This is not a complete list of side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking COMPLERA, and call you doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information with Patient Information, including “What is the most important information I should know about COMPLERA?” in the Patient Information section.
Indication and Use
What is COMPLERA?
COMPLERA is a prescription HIV medicine that is used as a complete regimen to treat HIV-1 in adults who have never taken HIV medicines before and who have an amount of HIV in their blood (this is called “viral load”) that is no more than 100,000 copies/mL. COMPLERA contains 3 medicines – (rilpivirine), (emtricitabine) and (tenofovir disoproxil fumarate). It is not known if COMPLERA is safe and effective in children under the age of 18 years.
COMPLERA does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking COMPLERA. Avoid doing things that can spread HIV-1 to others: always practice safer sex and use condoms to lower the chance of sexual contact with body fluids; never reuse or share needles or other items that have body fluids on them, do not share personal items that may contain bodily fluids. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others.
Additional Information about taking COMPLERA:
- Always take COMPLERA exactly as your healthcare provider tells you to take it
- Take COMPLERA with a meal. Taking COMPLERA with a meal is important to help get the right amount of medicine in your body. (A protein drink does not replace a meal)
Stay under the care of your healthcare provider during treatment with COMPLERA and see your healthcare provider regularly.