Nelfinavir


Full Prescribing Info
Dosage/Direction for Use

Oral
HIV infection
Adult: Combined with other antiretrovirals: 1.25 g bid or 0.75 g tid.
Child: Combined with other antiretrovirals: 2-<13 yr
45-55 mg/kg bid or 25-35 mg/kg tid; ≥13 yr Same as adult dose.
Max Dosage: Child: 0.75 g tid.
Hepatic impairment:
Dose reduction may be required.
Administration
Should be taken with food.
Contraindications
Hypersensitivity; lactation.
Special Precautions
Pregnancy. Hepatic and renal impairment; haemophilia A or B; diabetes. Monitor for signs of lipodystrophy.
Adverse Reactions
Hyperglycaemia, dyslipidaemia and redistribution of body fat (protease paunch, buffalo hump, facial atrophy and heart engorgement); hypertriglyceridaemia, hypercholesterolaemia. Diarrhoea, rash, nausea, flatulence, decreased lymphocytes, decreased neutrophils, decreased haemoglobin, increased creatine kinase, increased transaminases.
Drug Interactions
Reduced levels/effects with antacids, phenobarbital, carbamazepine, aminoglutethimide, phenytoin, rifampicin, nafcillin, nevirapine, omeprazole, nevirapine. Increased serum levels/effects with azole antifungal agents, cimetidine, efavirenz. Increased serum levels/effects of azithromycin, calcium channel blockers, clarithromycin, corticosteroids (e.g. fluticasone), mirtazapine, nateglinide, nefazodone, ciclosporin, sirolimus, tacrolimus, venlafaxine, eplerinone, fentanyl, atorvastatin, phosphodiesterase-5 (PDE-5) inhibitors, rifabutin, trazodone, TCAs. Reduced serum levels/effects of hormonal contraceptives, methadone, theophylline derivatives.
Potentially Fatal: Increased serum levels/toxicity of amiodarone, cisapride, pimozide, midazolam, triazolam, ergot alkaloids, lovastatin, simvastatin, quinidine.
Food Interaction
Combination with acidic food or juice may produce bitter taste. Plasma concentration time curve (AUC) increased by 2- to 3-fold with food. Reduced serum levels with St John's wort.
Action
Nelfinavir is a selective, competitive, reversible HIV protease inhibitor. It inhibits HIV-1 protease preventing the cleavage of the gag-pol polyprotein resulting in the production of noninfectious virus.
Absorption: Absorbed from the GI tract. Peak plasma levels in 2-4 hr. Absorption increased with food.
Distribution: Extensively bound to plasma proteins (98%). Enters breast milk.
Metabolism: Hepatic via oxidation.
Excretion: Mainly via faeces (as metabolites); via urine (about 1-2%). Terminal half-life: 3.5-5 hr.
Storage
Oral: Store at 15-30° (59-86°F).
CIMS Class
ATC Classification
J05AE04 - nelfinavir ; Belongs to the class of protease inhibitors. Used in the systemic treatment of viral infections.
Disclaimer: This information is independently developed by CIMS based on nelfinavir from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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