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Complera (Emtricitabine / Rilpivirine / Tenofovir Disoproxil Fumarate)
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Product Details
Description
Complera is three drugs in one: two nucleoside analog HIV-1 reverse transcriptase inhibitors, emtricitabine and tenofovir disoproxil fumarate, and one non-nucleoside reverse transcriptase inhibitor, rilpivirine, for the treatment of HIV-1 infection in patients who weigh 35 kg or more.
Complera may not be right for everyone, so talk to your doctor about which treatment option is best for you.
Complera is available in an oral tablet containing 200 mg of emtricitabine, 25 mg of rilpivirine, and 300 mg of tenofovir disoproxil fumarate.
Directions
Carefully read and follow the instructions that come with your prescription. Take Complera as your doctor has prescribed. Any questions or concerns should be addressed with your doctor or pharmacist.
The recommended dose in adult and pediatric patients who weigh 35 kg or more is one tablet by mouth once daily. Take with food.
Fact Table
Formula
Emtricitabine: C8H10FN3O3S Rilpivirine: C22H18N6O Tenofovir Disoproxil Fumarate: C19H30N5O10P
License
Approved by the FDA and EMA for the treatment of HIV
Bioavailability
Emtricitabine: 93% Rilpivirine: 33% (under fasting conditions) Tenofovir Disoproxil Fumarate: 25% (boosted to 39% with a high-fat meal)
Legal status
Rx-Only
Chemical Name
Emtricitabine / Rilpivirine / Tenofovir Disoproxil Fumarate
Elimination half-life
Emtricitabine: 10 hours Rilpivirine: 45 hours Tenofovir Disoproxil Fumarate: 14-17 hours
Dosage (Strength)
200mg / 25mg / 300mg
Pregnancy
Consult doctor
Brands
Complera
Protein binding
Emtricitabine: 4% Rilpivirine: 99.7% Tenofovir Disoproxil Fumarate: 0.7% to 7.2%
PubChem CID
Emtricitabine: 60877 Rilpivirine: 6451161 Tenofovir Disoproxil Fumarate: 5481350
MedlinePlus
a611036
ChEBI
Emtricitabine: 31552 Rilpivirine: 59527 Tenofovir Disoproxil Fumarate: 63625
ATC code
J05AR08
DrugBank
Emtricitabine: DB00879 Rilpivirine: DB08864 Tenofovir Disoproxil Fumarate: DB00300
KEGG
Emtricitabine: D01199 Rilpivirine: D09727 Tenofovir Disoproxil Fumarate: D01982
Routes of administration
Oral
Ingredients
Two nucleoside analog HIV-1 reverse transcriptase inhibitors, emtricitabine and tenofovir disoproxil fumarate, and one non-nucleoside reverse transcriptase inhibitor, rilpivirine, are contained in each Complera tablet.
Contraindications
Complera should not be given with medications that can decrease its response to HIV-1 or cause the virus to be resistant to Complera. These medications include carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, dexamethasone, St. John's wort, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole. Ask your doctor if you are unsure whether or not you take any of these medications.
Cautions
Complera contains a FDA Boxed Warning regarding severe worsening of hepatitis B virus (HBV) in patients with HIV-1 and HBV who stopped taking medications containing emtricitabine and/or tenofovir disoproxil fumarate.
- Before you start treatment with Complera, you should discuss the following with your doctor:
- About all the medications you take, including prescription and over-the-counter
- Your allergies
- Your medical history and health problems
- Your pregnancy or breastfeeding status
- Allergic reactions, including fever, rash, blisters, and swelling, can occur with the use of Complera.
- Complera can cause liver problems in patients. The risk is greater in patients who have hepatitis B or C or elevated liver enzymes.
- Complera can cause depression and other mood changes.
- Kidney problems can occur with the use of Complera and should not be given to patients with moderate or severe kidney problems.
- Bone mineral density can be decreased by Complera.
- Taking Complera with medications that can prolong the QTc interval can increase the risk of Torsade de Pointes, a serious abnormal heart rhythm.
- Lactic acidosis and liver enlargement with extra fat in the liver that can be fatal may occur with the use of Complera.
- Immune system problems can occur with the use of Complera.
Side Effects
Complera side effects include depression, headache, trouble sleeping, abnormal dreams, dizziness, nausea, and rash. However, these are not all the side effects that can occur.
Call your doctor immediately if you have side effects that are concerning or won't go away.
Reference:
- Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use. Foster City, CA: Gilead Sciences, Inc.; 2019.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 12932
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