Brand Name: Complera
Generic Names: Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
Complera is a combination drug used to reduce the levels of the HIV virus in the bloodstream and improve the functioning of the immune system. Complera includes three drugs in one tablet. This helps to simplify treatment in appropriate patients. The drug is commonly prescribed for people who have never taken an HIV medication before. It’s also given to some patients who have been previously and successfully treated for at least six months, with no history of treatment failure. To take Complera, the patient’s viral load must be less than 100,000 copies per milliliter (mL).
Read the FDA description of Complera.
What Does Complera Do?
Complera is not a cure for HIV. It reduces the ability of the HIV virus to multiply in the body. This results in an increase the number of CD4+ T cells in the blood. Adequate numbers of CD4+ cells are required by the body to maintain a healthy immune system.
Complera is approved to treat adults with HIV. The adult dose of Complera is one tablet daily. The one tablet contains emtricitabine 200 milligrams (mg), rilpivirine 25 mg, and tenofovir disoproxil fumarate 300 mg. Take Complera with a full meal for the best absorption.
If you miss a dose of Complera and the time is less than 12 hours from when you typically take it, you can take the missed dose with a meal. Resume your normal medication schedule. However, if it’s longer than 12 hours from when you take it, take your next dose. Do not double up on doses or take Complera with other medications used to treat HIV.
When rifabutin (for tuberculosis) is taken with complera, an additional 25 mg tablet of rilpivirine should be added.
Since Complera is a fixed (single strength) combination product, it’s not recommended for patients with kidney disease who require reduced doses.
Do not stop taking or change the dosage of Complera without first discussing your treatment with your doctor.
This information is a summary. Before starting this medication, discuss questions with your healthcare provider and make sure you understand dosage instructions.
Tell your doctor before taking Complera if you:
- are breastfeeding or planning on breastfeeding, as the HIV virus and Complera can pass through breast milk
- are pregnant or are planning on becoming pregnant
- have bone problems
- have kidney issues
- have liver issues, such as hepatitis B or C or abnormal liver enzymes
- have mental health conditions, such as bipolar disorder or depression
Always tell your physician about any prescription medications or herbal remedies you are taking. And tell your doctor if you have taken other medications for HIV in the past. Complera can interact with numerous medications and herbal remedies. Provide your physician with a complete medication list before starting to take Complera.
Medications used for several conditions interact with Complera and may require dose adjustments or should not be used at the same time. The following list of health conditions includes common medications used to treat them. If you are taking any of these medications, ask your physician or pharmacist if you should take them with Complera.
- For infections: erythromycin, clarithromycin and aminoglycosides (usually used in the hospital) and antifungal drugs (ketoconazole, for example) may all interact with Complera.
- For seizures: carbamazepine (for example, Tegretrol), oxcarbazepine (for example, Trileptal), phenobarbitol (for example, Luminal), or phenytoin (for example, Dilantin)
- For stomach or intestinal conditions: proton pump inhibitors (PPIs) including esomeprazole (for example, Nexium), lansoprazole (for example, Prevacid), omeprazole (for example, Prilosec), or pantoprazole sodium (Protonix). These reduce the blood level of Complera and should not be taken with it. Cisapride taken with Complera increases the risk of heart arrhythmias and they should not be taken together.
- For tuberculosis: rifabutin (Mycobutin), rifampin (Rifadin), or rifapentine (Priftin)
- Nonsteroidal anti-inflammatory medications (ibuprofen, naproxen and others) and the steroid dexamethasone can also affect blood levels of Complera. Discuss with your physician before taking any of these drugs while taking Complera.
- St. John’s wort should not be taken while you are also taking Complera.
If you take antacids (calcium, magnesium or aluminum containing products) tell your physician, as they could affect absorption. Antacids and calcium may be taken, when correctly separated from doses of Complera.
Possible Adverse and Emergency Side Effects
The following are possible severe side effects of Complera. Contact your medical provider immediately if you experience:
- severe mood changes, such as suicidal thoughts or thoughts of hurting yourself
- symptoms of lactic acidosis (excess acid in your blood), including unusual muscle pain, difficulty breathing, feeling cold in your arms and legs, dizziness, and/or irregular heartbeat
- symptoms that indicate a liver problem, such as yellowing of the skin or whites of the eyes, darkened urine, appetite loss, nausea, stomach pain, and pale-colored stools
- slower kidney function
Bone density may be affected by Complera (from tenofovir component). Ask your physician if bone density monitoring should be part of your treatment plan. Your physician may want to add calcium and vitamin D supplements to your treatment, while you take Complera.
Possible Nonemergency Side Effects
The following side effects may occur but do not usually represent an emergency. Discuss them with your doctor or healthcare professional if they continue or are bothersome. They include:
- increased cholesterol (requires lab testing)
- difficulty sleeping
- nausea or vomiting
- skin discoloration
- unexplained fatigue
- unusual dreams
This list may not describe all possible side effects. Call your doctor or healthcare provider for advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Complera and Weight Gain
Complera can change the distribution of fat in your body. You may notice more fat in your upper back and neck area. You also may have increased fat in the abdomen and breast/chest area. Weight may be lost in the legs, arms and face.
Complera should be stored at room temperature or between 68 and 77 degrees Fahrenheit (20 to 25 degrees Celsius). Avoid storing the medication near a shower or anyplace where moisture or heat may affect the medication. Keep the medication in its original container. Refrain from using Complera if the original seal is broken and/or missing.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
FDA WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS AND POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
- LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGS, INCLUDING TENOFOVIR DISOPROXIL FUMARATE, A COMPONENT OF COMPLERA, IN COMBINATION WITH OTHER ANTIRETROVIRALS.
- COMPLERA IS NOT APPROVED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND THE SAFETY AND EFFICACY OF COMPLERA HAVE NOT BEEN ESTABLISHED IN PATIENTS COINFECTED WITH HBV AND HIV-1. SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE COINFECTED WITH HBV AND HIV-1 AND HAVE DISCONTINUED EMTRIVA® (EMTRICITABINE) OR VIREAD® (TENOFOVIR DISOPROXIL FUMARATE), WHICH ARE COMPONENTS OF COMPLERA. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO ARE COINFECTED WITH HIV-1 AND HBV AND DISCONTINUE COMPLERA. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED
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