Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

VIRAMUNE

NFPA

PRODUCT USE

Antiviral agent used in the management of AIDS and AIDS- related complex. A non-
nucleoside reverse transcriptase inhibitor (NNRTI) of HIV- I. The drug binds directly to
reverse transcriptase (RT) and blocks RNA- dependent and DNA- dependent DNA polymerase
activities by causing a disruption of the enzymes catalytic site. Normally taken by mouth.

SYNONYMS

C15-H14-N4-O, "5H-dipyrido(3, 2-b:2', 3'-e)(1, 4)diazepin-6-one, 5, 11-dihydro-11-
cyclopropyl-4-methyl-", "5H-dipyrido(3, 2-b:2', 3'-e)(1, 4)diazepin-6-one, 5, 11-dihydro-
11-cyclopropyl-4-methyl-", "11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido(3, 2-b:2',
3'-e)(1, 4)-diazepin-6-one", "11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido(3, 2-b:2',
3'-e)(1, 4)-diazepin-6-one", BI-RG-587, Nevarapine, Nevirapine, NVP, "NNRTI
dipyridodiazepinone antiviral/ antiretroviral/ HIV-I treatment"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Although ingestion is not thought to produce harmful effects, the material may still be damaging to the health of the individual following ingestion, especially where pre-  existing organ (e.g. liver, kidney) damage is evident. Present definitions of harmful or toxic substances are generally based on doses producing mortality (death) rather than those producing morbidity (disease, ill-health). Gastrointestinal tract discomfort may produce nausea and vomiting. In an occupational setting however, ingestion of insignificant quantities is not thought to be cause for concern.  Considered an unlikely route of entry in commercial/industrial environments.  The most significant adverse events associated with the therapeutic use of non-nucleoside reverse transriptase inhibitors (NNRTIs) are rash and nervous system symptoms. Rashes are usually mild to moderate skin eruptions which occur early in the treatment but which resolve within a few weeks. Signs range from erythema and pruritus, to a diffuse maculopapular rash and dry desquamation, to vesiculation, moist desquamation and ulceration. More severe rashes occur occasionally, especially in children; signs include erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, necrosis (requiring surgery) and exfoliative dermatitis. Nervous system and psychiatric system disturbances might include dizziness, impaired concentration, somnolence , abnormal dreams and insomnia. Patients receiving highly active antiretroviral therapy (HAART), generally a combination of reverse transcriptase and protease inhibitors, frequently develop lipodystrophy with elevated levels of serum cortisol, lowered levels of serum DHEA (dehydroepiandrosterone) and increased levels of atherogenic lipids (important in the pathogenesis of arteriosclerosis). In one study researchers have also identified lipid abnormalities associated with coronary heart disease, along with alterations in glucose and insulin metabolism amongst patients undergoing HAART. There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in haemophiliacs given protease inhibitors.  At sufficiently high doses the material may be hepatotoxic(i.e. poisonous to the liver).  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may produce transient discomfort characterized by tearing or conjunctival redness (as with windburn).  

SKIN

  The material is not thought to produce adverse health effects or skin irritation following contact (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  

INHALED

  The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting.  Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur further disability if excessive concentrations of particulate are inhaled.  

CHRONIC HEALTH EFFECTS

  Principal routes of exposure are usually by skin contact/absorption and inhalation of generated dust.  Rapid emergence of HIV strains which are cross-resistant to the non-nucleoside reverse transcriptase inhibitors (NNRTIs) has been observed in vitro. NNRTIs when used alone or in combination, may confer cross-resistance to other NNRTIs.