NEVIRAPINE = NVP oral

Therapeutic action

• Antiretroviral, HIV-1 non nucleoside reverse transcriptase inhibitor

Indications

• Prevention of mother-to-child transmission (PMTCT) of HIV in neonates, alone or in combination with other antiretrovirals

Forms and strengths

• 50 mg/5 ml oral suspension
• 50 mg scored dispersible tablet

Dosage 

• Full term neonate:

Follow national recommendations. For information (WHO simplified age-based dosage):

• From birth to 6 weeks of age (from 0 to 42 days): 15 mg (1.5 ml) oral suspension or 25 mg (1/2 tab) dispersible tablet once daily. From birth to 4 weeks of age, preferably use the oral suspension.

Then, when indicated,

• After 6 weeks and up to 12 weeks of age (from 43 to 84 days): 20 mg (2 ml) oral suspension or 25 mg (1/2 tab) dispersible tablet once daily

• Preterm or low-birth weight neonate: seek specialist advice.

Duration

Depending on the risk of acquiring HIV infection (for information):

• High risk: 6 weeks (NVP combined with zidovudine). For breastfed children, treatment is extended for an additional 6 weeks (NVP alone or combined with zidovudine).
• Low risk (NVP alone): 4 to 6 weeks for non-breastfed children; 6 weeks for breastfed children. 

Contra-indications, adverse effects, precautions

• Do not administer to neonates:
  • with severe hepatic impairment;
  • born to mothers with resistance to NVP or HIV-2 mono-infection.
• May cause:
  • rash and hepatic disorders, especially in the first 6 weeks of treatment; gastrointestinal disturbances;
  • less frequently, hypersensitivity reactions (including severe cutaneous reactions such as Stevens-Johnson, Lyell and DRESS syndromes) and life-threatening hepatotoxicity.

• Any isolated rash requires immediate medical attention and surveillance.

• Stop NVP immediately and permanently in the event of:

  • severe rash or rash associated with signs and symptoms of hypersensitivity reaction (e.g. fever, mouth ulcer, cutaneous blister, conjunctivitis, facial oedema);

  • signs and symptoms of hepatic disorders (e.g. anorexia, nausea, general malaise, dark urine, pale stools, hepatomegaly, jaundice).

• NVP is a hepatic enzyme inducer. It may interact with many drugs and concomitant use requires monitoring (e.g. azole derivates, phenobarbital, phenytoin, carbamazepine, clarithromycin).
• Avoid combination with rifampicin (decreased NVP plasma concentrations).

Remarks

• Shake the oral suspension well before use. The 50 mg tablet should be dispersed in 10 ml of water immediately before administration.
• NVP is also used for the treatment of HIV-1 infection in children and adults, in combination with other antiretrovirals. Check national recommendations.
• Also comes in fixed-dose combinations with other antiretrovirals. For PMTCT, NVP is sometimes given as a fixed-dose combination of zidovudine/lamivudine/nevirapine.

Storage