Indications - Nelfinavir is indicated for the treatment of HIV infection when antiretroviral therapy is warranted
Dosage & Administration - Adults: The recommended dose is 1250 mg (five 250 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. Nelfinavir should be taken with a meal. Antiviral activity is enhanced when Nelfinavir is administered in combination with nucleoside analogues. Therefore, it is recommended that Nelfinavir should be used in combination with nucleoside analogues. Paediatric patients (2-13 years): The recommended oral dose of Nelfinavir for paediatric patients 2 to 13 years of age is 20-30 mg/kg per dose, three times daily with a meal.
Side Effects - The safety of Nelfinavir was studied in over 1500 patients who received drug either alone or in combination with nucleoside analogues. The majority of adverse events were of mild intensity. The most frequently reported adverse event among patients receiving Nelfinavir was diarrhoea, which was generally of mild to moderate intensity. Adverse events occurring in less than 2% of patients receiving Nelfinavir in all phase II/III clinical trials and considered at least possibly related or of unknown relationship to treatment and of at least moderate severity are listed below. General: Abdominal pain, accidental injury, allergic reaction, asthenia, back pain, fever, headache, malaise, pain and redistribution/accumulation of body fat. Digestive system: Anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, hepatitis, mouth ulceration, pancreatitis and vomiting. Haemic/Lymphatic system: Anaemia, leukopenia and thrombocytopenia. Metabolic/Nutritional: Increase in alkaline phosphate, amylase, creatinine phosphokinase, lactic dehydrogenase, SGOT, SGPT and g glutamyl transpeptidase, hyperlipaemia, hyperuricaemia, hyperglycaemia, hypoglycaemia, dehydration and liver function tests abnormal. Musculoskeletal system: Arthralgia, arthritis, cramps, myalgia, myasthenia and myopathy. Nervous system: Anxiety, depression, dizziness, emotional lability, hyperkinesia, insomnia, migraine, paraesthesia, seizures, sleep disorder, somnolence and suicide ideation. Respiratory system: Dyspnoea, pharyngitis, rhinitis and sinusitis. Skin/Appendages: Dermatitis, folliculitis, fungal dermatitis, maculopapular rash, pruitus, sweating, and urticaria. Ophthalmic: Acute iritis and eye disorder. Urogenital system: Kidney calculas, sexual dysfunction.
Contraindications - Nelfinavir is contraindicated in patients with clinically significant hypersensitivity to any of its components. Co-administration of Avifix is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening adverse events
Others - Pregnancy & Lactation Pregnancy Category B. There are no adequate and well controlled studies in pregnant women. Lactation: The US Public Health Service Centers for Disease Control and Prevention advises HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child.