NEVIRAPINE = NVP oral

Prescription under medical supervision


Therapeutic action

– Antiretroviral, HIV-1 non nucleoside reverse transcriptase inhibitor

Indications

– HIV-1 infection, in combination with other antiretroviral drugs

Forms and strengths

– 50 mg dispersible tablet
– 200 mg tablet
– 50 mg/5 ml oral suspension

Dosage

– Child from 2 months to 8 years: 4 mg/kg once daily for 14 days, then 7 mg/kg 2 times daily from the 15th day
– Child over 8 years: 4 mg/kg once daily for 14 days, then 4 mg/kg 2 times daily from the 15th day (max. 400 mg daily)
– Adult: 200 mg once daily for 14 days, then 200 mg 2 times daily from the 15th day


Weight
10 mg/ml oral suspension200 mg tablet

Initial

Maintenance

Initial

Maintenance

5 to < 10 kg

3 ml

6 ml x 2


Use oral suspension

10 to < 15 kg

5 ml

10 ml x 2

½ tab x 2

15 to < 20 kg

7 ml

14 ml x 2

½ tab

1 tab AM and ½ tab PM


20 to < 25 kg


10 ml

< 8 years: 16 ml x 2


½
tab

< 8 years: 1 tab AM and ½ tab PM

> 8 years: 10 ml x 2

> 8 years: ½ tab x 2


25 to < 30 kg


12 ml

< 8 years: 20 ml x 2


½
tab

< 8 years: 1 tab x 2

> 8 years: 12 ml x 2

> 8 years: ½ tab x 2

30 to < 40 kg

14 ml

14 ml x 2

1 tab

1 tab AM and ½ tab PM

40 to < 50 kg

1 tab

1 tab x 2

≥ 50 kg

1 tab

1 tab x 2

Duration

– The duration of treatment depends on the efficacy and tolerance of nevirapine.

Contra-indications, adverse effects, precautions

– Do not administer to patients with severe hepatic impairment, history of severe intolerance to nevirapine that led to permanent discontinuation of treatment.
– May cause:
• cutaneous reactions sometimes severe (Stevens-Johnson and Lyell syndromes), hepatic disorders possibly severe (fulminant hepatitis). In these cases, stop taking nevirapine immediately and permanently;
• gastrointestinal disturbances, headache, myalgia.
– Nevirapine reduces the efficacy of oral contraceptives: use a non-hormonal contraception or injectable medroxyprogesterone or an oral contraceptive containing 50 micrograms ethinylestradiol per tablet.
– Avoid combination with rifampicin (decreases the efficacy of nevirapine). Use rifabutin if possible. If rifabutin is not available, use efavirenz rather than nevirapine.
– Monitor liver enzyme level (ALAT) during the first 2 months, then every 3 to 6 months. If the enzyme level reaches 5 times the normal level, stop nevirapine immediately.
 Pregnancy: no contra-indication

Remarks

– For prophylactic treatment to reduce mother-to-child transmission, check national recommendations.
– To improve tolerance, respect the initial 14-day phase of treatment. In the event of restarting treatment after having stopped for more than 7 days, recommence initial 14-day phase.
– Tablets are not scored. When half a tablet is required, use a cutter to cut the tablet into two equal parts.
– Also comes in fixed-dose combination tablets incorporating nevirapine-lamivudine-zidovudine.
– Storage: below 25 °C
Once opened, oral suspension keeps for 2 months maximum.