Adult Dosing
Treatment of HIV infection
- Recommended dose: 1 mg/kg IV infused over 1 hr; administer 5-6 times/day (5-6 mg/kg/day)
- Administer IV infusion only until oral therapy can be given
Prevention of maternal-fetal HIV transmission
- Pregnant women: Begin treatment between 14 and 34 wks gestation (to be on oral formulation until the start of labor)
- During labor and delivery: Start with 2 mg/kg IV infused over 1 hr, then administer a continuous IV infusion of 1 mg/kg/hr until the umbilical cord is clamped
- Full-term neonates: Within 12 hrs after birth, start 2 mg/kg oral syrup q6 hrs continuing through 6 wks of age; those unable to receive oral dosing may be given 1.5 mg/kg IV, infused over 30 minutes, q6 hrs (convert to oral syrup as soon as possible)
Note:
- Avoid rapid infusion or bolus injection; do not give intramuscularly
Pediatric Dosing
Treatment of HIV infection (Non-FDA approved)
- Children 6 weeks-12 yrs: 120 mg/m2 IV q6 hrs; alternatively, 20 mg/m2/hr given by continuous IV infusion
- >13 yrs: 1 mg/kg IV infused over 1 hr; administer 5-6 times/day
Prevention of HIV infection (Non-FDA approved):
Premature neonates (<30 wks gestation)
- 3 mg/kg/day IV divided q12 hrs x 4 wks, then 4.5 mg/kg/day IV divided q8 hrs (convert to oral when possible)
- Initiate therapy within 12 hrs after birth
Premature neonates (>30 wks gest)
- 3 mg/kg/day IV divided q12 hrs x 2 wks, then 4.5 mg/kg/day IV divided q8 hrs (convert to oral when possible)
- Initiate therapy within 12 hrs after birth
Term neonates
- 6 mg/kg/day IV divided q6 hrs x 6 wks (convert to oral when possible)
- Initiate therapy within 12 hrs after birth
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <15 mL/min: 1 mg/kg IV q6-8 hrs
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined; consider dose reduction
See Supplemental Patient Information
- Therapy may cause hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV disease [US Black Box Warning]
- Therapy may cause lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, when used alone or in combination with other antiretrovirals. Risk factors include obesity and prolonged exposure to antiretroviral nucleoside analogues. Discontinue therapy if clinical or laboratory findings suggestive of lactic acidosis or significant hepatotoxicity occur [US Black Box Warning]
- Administer therapy cautiously in patients who have bone marrow compromise evidenced by granulocyte count <1,000 cells/mm3 or hemoglobin <9.5 g/dL
- Profound anemia, requiring dose adjustment, therapy discontinuation, and/or blood transfusions, has been reported during zidovudine therapy alone or in combination with other antiretrovirals
- Periodic blood counts are strongly recommended for HIV-infected individuals receiving zidovudine therapy, particularly those with advanced HIV disease. Consider dose adjustments if anemia or neutropenia develops
- Symptomatic myopathy has been associated with prolonged use of zidovudine [US Black Box Warning]
- Hepatic decompensation, sometimes fatal, has occurred in HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon alfa with or without ribavirin. Closely monitor patients for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia. Consider discontinuation of zidovudine as medically appropriate
- Dose reduction is recommended in patients with severely impaired renal function
- Immune reconstitution syndrome may occur in patients treated with combination antiretroviral therapy, including zidovudine. Autoimmune disorders have also been reported to occur in the setting of immune reconstitution
- Avoid concomitant administration with other zidovudine-containing products
- Incidence of adverse reactions increases with disease progression; carefully monitor patients as disease progression occurs
Cautions: Use cautiously in
- Severe renal impairment
- Advanced HIV disease
- Hepatic impairment
- Hepatic disease risk
- Obesity
- Female patients
- Long-term nucleoside treatment
Supplemental Patient Information
- Inform patients that zidovudine is not a cure for HIV-1 infection and they may continue to experience illnesses associated with HIV infection such as opportunistic infections. Advise patients to seek medical help for any significant health changes
- Advise HIV-infected mothers not to breastfeed their infants due to the risk of HIV transmission
Pregnancy Category:C
Breastfeeding: Unsafe; women with HIV infection should not breastfeed their infants. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 January 2011).The Centers for Disease Control and Prevention recommend that HIV-infected mothers should not breastfeed their infants to avoid risking postnatal HIV transmission. As per manufacturer's data, HIV-infected mothers should be instructed not to breastfeed their infants during zidovudine therapy.
