See Supplemental Patient Information
- Plasma concentrations of this drug are altered by substrates, inhibitors, or inducers of CYP3A. Therapy may alter plasma concentrations of drugs metabolized by CYP3A
- Avoid using as a single agent or add on as a sole agent to a failing regimen. Consider potential for cross resistance when choosing other agents
- Avoid concomitant use with efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
- Serious psychiatric adverse experiences such as depression, suicidal ideation, nonfatal suicide attempts, aggressive behavior, paranoid reactions, and manic reactions have occurred in treated patients. Factors associated with an increase in the occurrence of these psychiatric symptoms are history of injection drug use, psychiatric history, and receipt of psychiatric medication at study entry
- Rare postmarketing reports of death by suicide, delusions, and psychosis-like behavior have occurred. Assess the possibility that the psychiatric symptoms are related to the therapy and determine whether the risks of continued therapy outweigh the benefits
- CNS symptoms beginning during the first or second day of therapy and generally resolving after the first 2-4 weeks of therapy have occurred
- Potentially fetal harm has occurred on administering to pregnant women during the first trimester
- Perform pregnancy test before initiation of therapy
- Register patients in antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women
- Discontinue therapy in patients having developed severe rash associated with blistering, desquamation, mucosal involvement or fever
- Consider alternative therapy if life-threatening cutaneous reaction such as Stevens-Johnson syndrome occurs
- Monitor liver enzymes before and during therapy in patients with underlying hepatic disease, including hepatitis B or C infection, pre-existing hepatic dysfunction, patients with marked transaminase elevations, and patients treated with other medications associated with liver toxicity
- Assess potential benefits of therapy against the unknown risks of significant liver toxicity in patients with persistent elevations of serum transaminases >5x ULN
- Convulsions have occurred in patients receiving therapy having known medical history of seizures. Periodically monitor plasma levels in patients receiving concomitant anticonvulsant medications
- Determine total cholesterol and triglycerides before initiating therapy and at periodic intervals during therapy as therapy is associated with increase in the concentration of total cholesterol and triglycerides
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy
- Redistribution/accumulation of body fat is observed in patients treated with this drug
Cautions: Use cautiously in
- Hepatic impairment
- Psychiatric disorder
- History of seizure
- History of drug abuse
- HBV or HCV co-infection
Supplemental Patient Information
- Advise patients with serious psychiatric adverse experiences to immediately seek medical evaluation
- Inform patients that CNS symptoms were likely to improve with continued therapy and were not predictive of subsequent onset of the less frequent psychiatric symptoms
- Alert patients to the potential for additive CNS effects during concomitant use of this drug with alcohol or psychoactive drugs
- Advise patients against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle
- Advise women of child bearing potential to use barrier contraceptives in combination with other methods of contraception (e.g., oral or other hormonal contraceptives) to avoid pregnancy. Advise them to continue use of adequate contraceptive measures for 12 wks after discontinuation of therapy
- Apprised patients about the potential hazard to the fetus if the drug is used during first trimester of pregnancy, or if the patient becomes pregnant
- Instruct patients to adhere to dosing schedule
Pregnancy Category:D
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 reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Prefer an alternate drug especially while nursing a newborn or preterm infant as there is little published experience with efavirenz during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 4 January 2011). Centers for disease control and prevention recommends avoiding breast-feeding their infants as risk for postnatal transmission of HIV-1 infection exists. Unknown whether efavirenz is excreted in human milk. Manufacturer advises to instruct infected mothers to avoid breast-feeding during therapy because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants.
Pricing data from www.DrugStore.com in U.S.A.
- Sustiva 200 MG CAPS [Bottle] (B-M SQUIBB U.S. (PRIMARY CARE))
90 mg = $633.96
270 mg = $1786.92 - Sustiva 600 MG TABS [Bottle] (B-M SQUIBB U.S. (PRIMARY CARE))
30 mg = $643.97
90 mg = $1817.95
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.
3 yrs and 10 to <15 kg): 200 mg PO qhs
