- 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
- for seizures: carbamazepine (for example, Tegretrol), oxcarbazepine (for example, Trileptal), phenobarbitol (for example, Luminal), or phenytoin (for example, Dilantin)
- for stomach or intestinal conditions: esomeprazole (for example, Nexium), lansoprazole (for example, Prevacid), omeprazole (for example, Prilosec), or pantoprazole sodium (Protonix)
- for tuberculosis: rifabutin (Mycobutin), rifampin (Rifadin), or rifapentine (Priftin)
- 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
- worsening kidney problems
- difficulty sleeping
- nausea or vomiting
- skin discoloration
- unexplained fatigue
- unusual dreams
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
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. Instead of taking three pills per day, a patient needs to take only one. The drug is commonly prescribed for people who have never taken an HIV medication before. To take Complera, the patient’s viral load must be less than 100,000 copies/mL.
Read the FDA description of Complera.
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.
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 is 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.
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:
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.
The following is a list of health conditions and common medications for them that patients should not take with Complera:
You also should not take Complera with St. John’s wort or more than one dose of dexamethasone, a steroid.
If you take any medications that affect stomach acid, such as antacids or acid reflux reducers, notify your physician, as they could affect absorption. Complera should be taken with a meal. (Note that protein meal-replacement shakes are not sufficient for proper absorption.)
The following are possible severe side effects of Complera. Contact your medical provider immediately if you experience:
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.
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 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
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