Adult Dosing
Treatment of HIV-1 infection
- 1 tab (200 mg/25 mg/300 mg) PO qd with a meal
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <50 mL/min: Contraindicated
Hepatic Dose Adjustment
- Child-Pugh Class A: No dose adjustments
- Child-Pugh Class B: No dose adjustments
- Child-Pugh Class C: Dose adjustments not defined
See Supplemental Patient Information
- Women are more prone to lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, with the use of nucleoside analogs such as tenofovir or in combination with other antiretroviral [US Black Box Warning]; obesity and prolonged nucleoside therapy may be the associated risk factors
- Discontinue therapy on developing clinical or lab findings suggestive of lactic acidosis or pronounced hepatotoxicity including hepatomegaly and steatosis even in the absence of marked transaminase elevations
- Test all patients with HIV-1 for the presence of chronic hepatitis B virus (HBV) before initiating antiretroviral therapy. This combination drug is not approved for the treatment of chronic HBV infection and the safety and efficacy of this drug have not been established in patients co-infected with HBV and HIV-1
- Patients who are co-infected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir are susceptible for development of severe acute exacerbations of hepatitis B [US Black Box Warning]
- Exacerbations of hepatitis B were associated with liver decompensation and liver failure in certain patients infected with HBV and treated with emtricitabine. Closely monitor hepatic functions with both clinical and lab follow-up for at least several months after discontinuation of therapy in patients who are co-infected with HIV-1 and HBV. If required, initiate appropriate anti-hepatitis B therapy [US Black Box Warning]
- New onset or worsening renal impairment may occur during therapy. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has occurred with the use of tenofovir
- Calculate creatinine clearance in all patients prior to initiating therapy and as clinically appropriate during therapy. Routinely monitor calculated creatinine clearance and perform serum phosphorus in patients at risk for renal impairment, including patients having previous experience of renal events with Hepsera. Avoid treatment in patients with creatinine clearance <50 mL/min. Avoid concurrent use of a nephrotoxic agent or in patients with recent use of a nephrotoxic agent
- Exercise caution while prescribing this combination drug with drugs that may reduce the exposure of rilpivirine. Rilpivirine component of this combination drug is associated with depressive disorders. Advise patients with severe depressive symptoms to immediately seek medical evaluation for assessing the possibility that the symptoms are related to this combination drug, and if so, for determining whether the risks of continued therapy outweigh the benefits
- Monitor bone mineral density (BMD) for HIV-1 infected patients having a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Tenofovir component is associated with significant increases in biochemical markers of bone metabolism (serum bone-specific alkaline phosphatase, serum osteocalcin, serum C-telopeptide, and urinary N-telopeptide). Tenofovir component is also associated with higher serum parathyroid hormone levels and 1,25 Vitamin D levels
- Avoid concurrent administration with other medicinal products containing any of the same active components, emtricitabine, rilpivirine or tenofovir, and with medicinal products containing lamivudine or with adefovir dipivoxil
- Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance may occur in patients receiving antiretroviral therapy
- Immune reconstitution syndrome may occur in patients treated with combination antiretroviral therapy. Patients may develop opportunistic infections during the initial phase of combination antiretroviral treatment, which may necessitate further evaluation and treatment
Cautions: Use cautiously in
- Renal disease risk
- Patients with known risk factors for liver disease
- Hepatic disease risk
- Concurrent use with a drug having known risk of Torsade de Pointes
- Psychiatric disorder
- History of seizure
- HBV or HCV co-infection
- Osteopenia
- History of pathologic fracture
Supplemental Patient Information
- Inform patients that emtricitabine/relpivirine/tenofovir combination therapy is not a cure for HIV infection and that they should stay on continuous HIV therapy to control HIV infection and reduce HIV-related illnesses
- Advise patients to continue to practice safer sex and to use latex or polyurethane condoms
- Instruct patients to promptly report any symptoms of infection to their physician
Pregnancy Category:B
Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral drugs reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Emtricitabine/rilpivirine/tenofovir has been successfully used as part of a regimen that decreases mother-to-child transmission. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 9 September 2011). The Centers for Disease Control and Prevention recommend HIV infected mothers not to breastfeed their infants to avoid risking postnatal transmission of HIV. Manufacturer advises infected mothers to avoid breastfeeding during therapy because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants.
US Trade Name(s)
US Availability
Complera (emtricitabine/rilpivirine/tenofovir)
- TABS: 200 mg/25 mg/300 mg
Canadian Trade Name(s)
Canadian Availability
Complera (emtricitabine/rilpivirine/tenofovir)
- TABS: 200 mg/25 mg/300 mg
UK Trade Name(s)
UK Availability
Eviplera (emtricitabine/rilpivirine/tenofovir)
- TABS: 200 mg/25 mg/245 mg
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Complera 200-25-300 MG TABS [Bottle] (GILEAD SCIENCES)
30 mg = $1940.02
90 mg = $5720.03
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.