NEODOSE

INDICATIONS

• Antiretroviral Management in the Newborn: 
• Prevention of maternal-fetal HIV transmission: In a phase III randomized trial (n=1684), the combination of 6 weeks of zidovudine plus 3 doses of nevirapine or the combination of 6 weeks of zidovudine plus nelfinavir and lamiVUDine for 2 weeks was associated with a lower intrapartum transmission rate when compared with zidovudine alone in infants born to women who received no antenatal antiretroviral therapy (2.2% versus 2.5% versus 4.9%, respectively). The zidovudine/nelfinavir/lamiVUDine regimen was associated with increased toxicity (eg, neutropenia).

FDA APPROVED INDICATION

Epivir®

Treatment of HIV-1 infection in combination with other antiretroviral agents in children 3 months of age and older.

CONTRAINDICATIONS

Dual-NRTI therapy with emtricitabine and lamiVUDine is NOT recommended in children due to similar resistance patterns and no additive benefit.

PRECAUTIONS

• Lactic acidosis and severe hepatomegaly with steatosis:
  • including fatal cases, has been reported, with increased risk in women and obese patients. Interrupt therapy if lactic acidosis or pronounced hepatotoxicity, which may include hepatomegaly and steatosis even in the absences of marked transaminase elevations, is suspected.
• Exacerbation of hepatitis:
  • has occurred after discontinuation of lamivudine. Most cases were self-limited, but fatalities have been reported. Monitoring for several months after treatment discontinuation is recommended.
• Emergence of lamivudine-resistant HBV:
  • has occurred in HIV-1 infected subjects on lamivudine in the presence of concurrent infection with hepatitis B virus.
• Pancreatitis may occur:
  • Exercise caution in patients with a history of antiretroviral nucleoside exposure, a history of pancreatitis, of other risk factors. Discontinue treatment if signs and symptoms of pancreatitis occur.
• Immune reconstitution syndrome:
  • has been reported with combination antiretroviral therapy and may require further evaluation or treatment.
• Autoimmune disorders:
  • (eg, Graves’ disease, polymyositis, Guillain-Barre syndrome) have been reported in the setting of immune reconstitution. May occur many months after initiation of treatment. Compared with tablets, the oral solution resulted in lower rates of virologic suppression, lower plasma lamivudine exposure, and increased development of viral resistance in pediatric patients.

ADVERSE EFFECTS

Adverse effects reported in neonates were increased liver function tests, anemia, diarrhea, electrolyte disturbances, hypoglycemia, jaundice and hepatomegaly, rash, respiratory infections, sepsis, gastroenteritis (with associated convulsions), and transient renal insufficiency associated with dehydration. Deaths (1 from gastroenteritis with acidosis and convulsions, 1 from traumatic injury, and 1 from unknown causes) were reported in 3 neonates.

BLACK BOX WARNING

Epivir®

• Exacerbations of Hepatitis B
• Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of antihepatitis B therapy may be warranted.
• Important Differences Among Lamivudine-Containing Products
• Epivir® tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than Epivir-HBV® tablets and oral solution (used to treat chronic hepatitis B virus infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1.

ADMINISTRATION

Can be given without regard to meals.

MONITORING

Monitor for signs/symptoms of pancreatitis (eg, persistent abdominal pain, fever, nausea, vomiting, or diarrhea). Consider more frequent monitoring of viral load when treating with the solution of lamivudine.