Complera (Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Coadministration with Other Products
- Complera should not be administered with rilpivirine (Edurant) unless needed for dose adjustment (e.g., with rifabutin).
- Table 4 Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction:
- (* Table 4- addition of rifabutin under Antimycobacterials )
Drugs with No Observed or Predicted Interactions with Complera
- …No clinically significant drug interactions… Rilpivirine did not have a clinically significant effect on the pharmacokinetics of digoxin or metformin…
PATIENT COUNSELING INFORMATION
- For patients receiving rifabutin, an additional 25 mg tablet of rilpivirine (Edurant) once per day is recommended to be taken concomitantly with COMPLERA and with a meal for the duration of rifabutin coadministration.
- If you take Complera, you should not take:
- ….rilpivirine (Edurant), unless recommended by your healthcare provider and you are taking rifabutin (Mycobutin®)
Especially tell your healthcare provider if you take:
- rifabutin (Mycobutin), a medicine to treat some bacterial infections. Talk to your doctor or pharmacist about the right amount of rilpivirine you should take.
- added ..... proton pump inhibitors, such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole
5 WARNINGS AND PRECAUTIONS
5.5 Depressive Disorders
- ... Suicidal ideation was reported in 4 subjects in each arm while suicide attempt was reported in 2 subjects in the rilpivirine arm...
5.6 Hepatotoxicity (new section added)
- Hepatic adverse events have been reported in patients receiving a rilpivirine containing regimen. Patients with underlying hepatitis B or C, or marked elevations in serum liver biochemistries prior to treatment may be .....
6 ADVERSE REACTIONS
6.1 Adverse Reactions from Clinical Trials Experience
- Studies C209 and C215 – Treatment-Emergent Adverse Drug Reactions
- multiple section changes with data from week 96 pooled data
6.2 Postmarketing Experience
- Rilpivirine: Renal and Urinary Disorders, nephrotic syndrome
8 USE IN SPECIFIC POPULATIONS
8. Nursing Mothers
- Emtricitabine: Samples of breast milk obtained from five HIV-1 infected mothers show that emtricitabine is secreted in human milk. Breastfeeding infants whose mothers are being treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in infants breastfed by mothers being treated with emtricitabine are unknown.
- Rilpivirine: Studies in lactating rats and their offspring indicate that rilpivirine was present in rat milk. It is not known whether rilpivirine is secreted in human milk.
- Tenofovir Disoproxil Fumarate: Samples of breast milk obtained from five HIV-1 infected mothers in the first post-partum week show that tenofovir is excreted in human milk. The impact of this exposure in breastfed infants is unknown.
17 PATIENT COUNSELING INFORMATION
Information for Patients
- Patients should be advised not to breastfeed because at least two of the drugs contained in COMPLERA can be passed to the baby in breast milk. It is not known whether this could harm the baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in breast milk.
- Patients should be informed that hepatotoxicity has been reported with COMPLERA [See Warnings and Precautions (5.6)].
- COMPLERA should not be coadministered with ATRIPLA, Edurant, EMTRIVA, STRIBILD, TRUVADA, or VIREAD; or with drugs containing lamivudine, including Combivir, Epivir or Epivir-HBV, Epzicom, or Trizivir; or with HEPSERA [See Warnings and Precautions (5.8)].
WARNINGS AND PRECAUTIONS
Immune Reconstitution Syndrome
- Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Complera…
- Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.