IMPORTANT SAFETY INFORMATION
What is the most important information I 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 or “tea-colored” urine; light-colored stools (bowel movements); loss of appetite; nausea; and/or pain, aching, or tenderness on the right side of your stomach area.
- 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 or a similar medicine for a long time. In some cases, lactic acidosis and serious liver problems have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
- Worsening of hepatitis B (HBV) infection. COMPLERA is not approved to treat HBV. If you have HBV and stop taking COMPLERA, your HBV may suddenly get worse. Do not stop taking COMPLERA without first talking to your healthcare provider, as they will need to monitor your health.
Who should not take COMPLERA?
Do not take COMPLERA if you:
- Take a medicine that contains: carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR, Teril), oxcarbazepine (Oxtellar XR,Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek), rifampin (Rifater, Rifamate, Rimactane, Rifadin), rifapentine (Priftin), dexlansoprazole (Dexilant), esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid, Prevpac), omeprazole (Prilosec, Zegerid), pantoprazole sodium (Protonix), rabeprazole (Aciphex, Aciphex Sprinkle), more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate, or the herbal supplement St. John’s wort.
What are the other possible side effects of COMPLERA?
Serious side effects of COMPLERA may also include:
- Severe skin rash and allergic reactions. Call your healthcare provider right away if you get a rash. Some rashes and allergic reactions may need to be treated in a hospital. Stop taking COMPLERA and get medical help right away if you get a rash with any of the following symptoms: fever, skin blisters, mouth sores, redness or swelling of the eyes (conjunctivitis), swelling of the face, lips, mouth, tongue or throat, trouble breathing or swallowing, pain on the right side of the stomach (abdominal) area, and/or dark or “tea-colored” urine.
- New or worse kidney problems, including kidney failure. Your healthcare provider should do blood tests to check your kidneys before starting treatment with COMPLERA. If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider may also check your kidneys during treatment with COMPLERA.
- 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 do tests to check your liver enzymes before and during treatment with COMPLERA.
- Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.
- Changes in body fat can happen in people taking HIV-1 medicines.
- Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking COMPLERA.
The most common side effects of rilpivirine, one of the medicines in COMPLERA, include depression, trouble sleeping, and headache.
The most common side effects of emtricitabine and tenofovir disoproxil fumarate, two of the medicines in COMPLERA, include diarrhea, nausea, tiredness, headache, dizziness, depression, trouble sleeping, abnormal dreams, and rash.
Tell your healthcare provider if you have any side effects that bother you or do not go away.
What should I tell my healthcare provider before taking COMPLERA?
- All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney, mental health, bone, or liver problems, including hepatitis virus infection.
- All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how COMPLERA works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Ask your healthcare provider if it is safe to take COMPLERA with all of your other medicines.
- If you take antacids. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA.
- If you take stomach acid blockers. Take acid blockers at least 12 hours before or at least 4 hours after you take COMPLERA. Ask your healthcare provider if your acid blocker is okay to take, as some acid blockers should never be taken with COMPLERA.
- If you are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking COMPLERA.
- If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.
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.
What is COMPLERA?
COMPLERA is a prescription medicine used to treat HIV-1 in people 12 years and older. It can be used in people who have never taken HIV-1 medicines before and who have an amount of HIV-1 in their blood (“viral load”) that is no more than 100,000 copies/mL. It can also replace current HIV-1 medicines for some people who have an undetectable viral load (less than 50 copies/mL) and whose healthcare provider determines that they meet certain other requirements. COMPLERA combines 3 medicines into 1 pill taken once a day with food. COMPLERA is a complete HIV-1 treatment and should not be used with other HIV-1 medicines.
COMPLERA does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking COMPLERA. Ask your healthcare provider if you have questions about how to reduce the risk of passing 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.