Viracept

Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV infection. 2).

Patients older than 13 years:

VIRACEPT 250 mg tablets are recommended for adults and older children (see Summary of Product Characteristics for VIRACEPT 250 mg tablets). The recommended dose of VIRACEPT 50 mg/g oral powder is 1250 mg twice a day (BID) or 750 mg three times a day (TID), for patients unable to take tablets.

All patients older than 13 years should take either 5 level scoops of the blue 5 gram spoon twice daily or 3 level scoops of the blue 5 gram spoon three times daily. 1)Medicinal product no longer authorised 3 Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/kg BID or if using a TID regimen, 25 – 35 mg/kg body weight per dose.

For children able to take tablets, VIRACEPT tablets may be administered instead of the oral powder (see Summary of Product Characteristics for VIRACEPT tablets). The recommended dose of VIRACEPT oral powder to be administered BID to children aged 3 to 13 years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the following table.

The prescriber should advise the patient to use the handle of the second scoop to scrape off extra powder and obtain a level scoop. 5 to 12 kg 2 plus 2 12 g 12 to 14 kg 2 plus 4 14 g 14 to 16 kg 3 plus 1 16 g 16 to 18 kg 3 plus 3 18 g 18 to 22 kg 4 plus 1 21 g over 22 kg 5 - 25 g The recommended dose of VIRACEPT oral powder to be administered TID to children aged 3 to 13 years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the following table.

The prescriber should advise the patient to use the handle of the second scoop to scrape off extra powder and obtain a level scoop. 5 to 12 kg 1 plus 2 7 g 12 to 14 kg 1 plus 3 8 g 14 to 16 kg 2 10 g 16 to 18 kg 2 plus 1 11 g 18 to 22 kg 2 plus 3 13 g over 22 kg 3 15 g The oral powder may be mixed with a small amount of water, milk, formula, soy formula, soy milk, dietary supplements, or pudding.

Once mixed, the entire contents must be consumed in order to obtain the full dose. If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours. , orange juice, apple juice or apple sauce) are not recommended to be used in combination with VIRACEPT, because the combination may result in a bitter taste.

4). Nelfinavir is principally metabolised and eliminated by the liver. 2). Caution should be used when administering VIRACEPT to patients with impaired renal or hepatic function.

The safety of the VIRACEPT 250 mg tablet was studied in controlled clinical trials with over 1300 patients. The majority of patients in these studies received either 750 mg TID either alone or in combination with nucleoside analogues or 1250 mg BID in combination with nucleoside analogues.

e. adverse reactions) were reported most frequently: diarrhoea, nausea, and rash. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions from clinical trials with nelfinavir Adverse reactions in clinical studies are summarised in Table 2.

Medicinal product no longer authorised 13 Table 2:

Incidences of Adverse Reactions and marked laboratory abnormalities from the phase II and phase III studies. (Very common (≥ 10 %); common (≥ 1 % and < 10 %) Body System Frequency of Reaction Adverse Reactions Grades 3&4 All Grades Gastrointestinal disorders Very common Diarrhoea Common Nausea, flatulence, Skin and subcutaneous tissue disorders Common Rash Investigations Common Increased alanine aminotransferase, increased aspartate aminotransferase, neutropenia, blood creatinine phosphokinase increased, neutrophil count decreased Children and neonates: A total of approximately 400 patients received nelfinavir in paediatric treatment trials (Studies 524, 556, PACTG 377/725, and PENTA-7) for up to 96 weeks.

The adverse reaction profile seen during paediatric clinical trials was similar to that for adults. Diarrhoea was the most commonly reported adverse event in children. Neutropenia/leukopenia was the most frequently observed laboratory abnormality.

During these trials less than 13% of patients in total discontinued treatment due to adverse events. 8, for which a causal relationship to nelfinavir cannot be excluded, are summarised below. As these data come from the spontaneous reporting system, the frequency of the adverse reactions is not confirmed.

1 % - ≤ 1 %): hypersensitivity including bronchospasm, pyrexia, pruritus, facial oedema and rash maculo-papular or dermatitis bullous. 01 % - ≤ 1 %): Combination antiretroviral therapy has been associated with redistribution of body fat (Lipodystrophy aquired) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (lipohypertrophy buffalo hump).

1 %): new onset diabetes mellitus, or exacerbation of existing diabetes mellitus. 1 % - ≤ 1 %): vomiting, pancreatitis/blood amylase increased. 1 %): hepatitis, hepatic enzymes increased and jaundice when nelfinavir is used in combination with other antiretroviral agents.

1 %): increased spontaneous haemorrhage in patients with haemophilia. 01 %), including isolated reports: Erythema multiforme.

Paediatric population:

Additional adverse reactions have been reported in the post-marketing experience and are listed below. As these data come from the spontaneous reporting system, the frequency of the adverse reactions is unknown: hypertriglyceridemia, anaemia, blood lactic acid increased, and pneumonia.

Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART). 4). Combination antiretroviral therapy has been associated with metabolic abnormalities such asblood triglycerides increased, blood cholesterol increased, insulin resistance, hyperglycaemia and hyperlactaemia.

4). In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. 4).

1. 3. PHARMACEUTICAL FORM Oral powder. White to off-white amorphous powder. 4. 1 Therapeutic indications VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older.

In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual viral resistance testing and treatment history. 1. 2 Posology and method of administration Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV infection.

2).

Patients older than 13 years:

VIRACEPT 250 mg tablets are recommended for adults and older children (see Summary of Product Characteristics for VIRACEPT 250 mg tablets). The recommended dose of VIRACEPT 50 mg/g oral powder is 1250 mg twice a day (BID) or 750 mg three times a day (TID), for patients unable to take tablets.

All patients older than 13 years should take either 5 level scoops of the blue 5 gram spoon twice daily or 3 level scoops of the blue 5 gram spoon three times daily. 1)Medicinal product no longer authorised 3 Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/kg BID or if using a TID regimen, 25 – 35 mg/kg body weight per dose.

For children able to take tablets, VIRACEPT tablets may be administered instead of the oral powder (see Summary of Product Characteristics for VIRACEPT tablets). The recommended dose of VIRACEPT oral powder to be administered BID to children aged 3 to 13 years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the following table.

The prescriber should advise the patient to use the handle of the second scoop to scrape off extra powder and obtain a level scoop. 5 to 12 kg 2 plus 2 12 g 12 to 14 kg 2 plus 4 14 g 14 to 16 kg 3 plus 1 16 g 16 to 18 kg 3 plus 3 18 g 18 to 22 kg 4 plus 1 21 g over 22 kg 5 - 25 g The recommended dose of VIRACEPT oral powder to be administered TID to children aged 3 to 13 years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the following table.

The prescriber should advise the patient to use the handle of the second scoop to scrape off extra powder and obtain a level scoop. 5 to 12 kg 1 plus 2 7 g 12 to 14 kg 1 plus 3 8 g 14 to 16 kg 2 10 g 16 to 18 kg 2 plus 1 11 g 18 to 22 kg 2 plus 3 13 g over 22 kg 3 15 g The oral powder may be mixed with a small amount of water, milk, formula, soy formula, soy milk, dietary supplements, or pudding.

Once mixed, the entire contents must be consumed in order to obtain the full dose. If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours. , orange juice, apple juice or apple sauce) are not recommended to be used in combination with VIRACEPT, because the combination may result in a bitter taste.

4). Nelfinavir is principally metabolised and eliminated by the liver. 2). Caution should be used when administering VIRACEPT to patients with impaired renal or hepatic function. 3 Contraindications Hypersensitivity to the active substance or to any of the excipients.

5)]. , rifampicin, phenobarbital and carbamazepine) reduce nelfinavir plasma concentrations. Co- administration with rifampicin is contra-indicated due to a reduction in exposure to nelfinavir. 5). Herbal preparations containing St. 5).

VIRACEPT should not be co-administered with omeprazole due to a reduction in exposure to nelfinavir and its active metabolite M8 (Tert-butyl hydroxy nelfinavir). 5). 4 Special warnings and precautions for use Patients should be instructed that VIRACEPT is not a cure for HIV infection, that they may continue to develop infections or other […]

Hypersensitivity to the active substance or to any of the excipients. 5)]. , rifampicin, phenobarbital and carbamazepine) reduce nelfinavir plasma concentrations. Co- administration with rifampicin is contra-indicated due to a reduction in exposure to nelfinavir.

5). Herbal preparations containing St. 5). VIRACEPT should not be co-administered with omeprazole due to a reduction in exposure to nelfinavir and its active metabolite M8 (Tert-butyl hydroxy nelfinavir). 5).