See Supplemental Patient Information
- Prolongation of therapeutic and adverse effects has occurred on concomitant administration with drugs primarily metabolized by CYP3A
- Concomitant administration with drugs that induce CYP3A or CYP2C19 reduces therapeutic effect
- Concomitant administration with drugs that inhibit CYP3A or CYP2C19 may increase nelfinavir plasma concentrations
- Concurrent use of this drug with lovastatin or simvastatin is not recommended
- Exercise caution if HIV protease inhibitors are used concurrently with HMG-CoA reductase inhibitors that are also metabolized by the CYP3A pathway; risk of myopathy including rhabdomyolysis may be increased
- Concurrent use with sildenafil, or other PDE5 inhibitors, increases PDE5 inhibitor-associated adverse events, including hypotension, visual changes, and priapism
- Concomitant use of St. John’s wort (hypericum perforatum) or St. John’s wort-containing products with this drug is not recommended as loss of virologic response and possible resistance to this drug or to the class of protease inhibitors has occurred
- New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus and hyperglycemia have occurred in HIV-infected patients receiving protease inhibitor therapy. Some patients may require either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment
- Diabetic ketoacidosis has occurred
- HIV cross-resistance between protease inhibitors has occurred
- Increased bleeding, including spontaneous skin hematomas and hemarthrosis has occurred in patients with hemophilia type A and B
- Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance have occurred in patients receiving antiretroviral therapy
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy
Cautions: Use cautiously in:
- Hepatic impairment
- Diabetes mellitus
- Hemophilia
- Concomitant use with inhibitors of CYP3A
- Concomitant use with drugs causing prolongation of QT interval
- Patients with phenylketonuria
- Concurrent use with sildenafil, or other PDE5 inhibitors
Supplemental Patient Information
- Advise patients to take each dose within 20 minutes following a full meal or liquid nutritional supplement
- Advise patients to inform clinician if they develop severe diarrhea or vomiting
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 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 nelfinavir during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 12 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 nelfinavir is excreted in human milk. Manufacturer advises to instruct infected mothers avoiding 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.
- Viracept 250 MG TABS [Bottle] (VIIV HEALTHCARE)
300 mg = $731.06
900 mg = $2154.38
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.
2 yrs) 45-55 mg/kg/dose given twice daily (Tablets):
