Pronunciation(STAV yoo deen)
U.S. Brand NamesZerit®
Synonymsd4T
Generic AvailableNo
Canadian Brand NamesZerit®
UseTreatment of HIV infection in combination with other antiretroviral agents
Pregnancy Risk FactorC
Pregnancy ImplicationsCases of fatal and nonfatal lactic acidosis, with or without pancreatitis, have been reported in pregnant women. It is not known if pregnancy itself potentiates this known side effect; however, pregnant women may be at increased risk of lactic acidosis and liver damage. Hepatic enzymes and electrolytes should be monitored frequently during the 3rd trimester of pregnancy. Pharmacokinetics of stavudine are not significantly altered during pregnancy; dose adjustments are not needed. The Perinatal HIV Guidelines Working Group considers stavudine to be an alternative NRTI in dual nucleoside combination regimens; use with didanosine only if no alternatives are available, do not use with zidovudine. Health professionals are encouraged to contact the antiretroviral pregnancy registry to monitor outcomes of pregnant women exposed to antiretroviral medications (1-800-258-4263 or www.APRegistry.com).
LactationExcretion in breast milk unknown/contraindicated
ContraindicationsHypersensitivity to stavudine or any component of the formulation
Warnings/PrecautionsUse with caution in patients who demonstrate previous hypersensitivity to zidovudine, didanosine, zalcitabine, pre-existing bone marrow suppression, renal insufficiency, or peripheral neuropathy. Peripheral neuropathy may be the dose-limiting side effect. Zidovudine should not be used in combination with stavudine. Lactic acidosis and severe hepatomegaly with steatosis have been reported with stavudine use, including fatal cases. Risk may be increased in obesity, prolonged nucleoside exposure, or in female patients. Suspend therapy in patients with suspected lactic acidosis; consider discontinuation of stavudine if lactic acidosis is confirmed. Pregnant women may be at increased risk of lactic acidosis and liver damage. Severe motor weakness (resembling Guillain-Barré syndrome) has also been reported (including fatal cases, usually in association with lactic acidosis); manufacturer recommends discontinuation if motor weakness develops (with or without lactic acidosis). Pancreatitis (including some fatal cases) has occurred during combination therapy (didanosine with or without hydroxyurea). Risk increased when used in combination regimen with didanosine and hydroxyurea. Suspend therapy with agents toxic to the pancreas (including stavudine, didanosine, or hydroxyurea) in patients with suspected pancreatitis.
Adverse ReactionsAll adverse reactions reported below were similar to comparative agent, zidovudine, except for peripheral neuropathy, which was greater for stavudine. Selected adverse events reported as monotherapy or in combination therapy include:>10%: Central nervous system: Headache Dermatologic: Rash Gastrointestinal: Nausea, vomiting, diarrhea Hepatic: Transaminases increased Neuromuscular & skeletal: Peripheral neuropathy Miscellaneous: Amylase increased 1% to 10%: Hepatic: Bilirubin increased Postmarketing and/or case reports: Abdominal pain, allergic reaction, anemia, anorexia, chills, fever, hepatitis, hepatomegaly, hepatic failure, hepatic steatosis, insomnia, lactic acidosis, leukopenia, motor weakness (severe), myalgia, pancreatitis, redistribution/accumulation of body fat, thrombocytopenia
Overdosage/ToxicologyAcute toxicity was not reported following administration of 12-24 times the recommended dose in adults. Peripheral neuropathy and hepatic toxicity have been reported following chronic overdose. Stavudine may be removed by hemodialysis.
Drug InteractionsDidanosine: Risk of pancreatitis may be increased with concurrent use. Cases of fatal lactic acidosis have been reported with this combination when used during pregnancy; use only if clearly needed. Doxorubicin: May inhibit intracellular phosphorylation of stavudine; use with caution. Hydroxyurea: Risk of hepatotoxicity or pancreatitis may be increased with concurrent use. Ribavirin: May inhibit intracellular phosphorylation of stavudine; use with caution. Zalcitabine: May increase risk of peripheral neuropathy; concurrent use not recommended. Zidovudine: Inhibits intracellular phosphorylation of stavudine; concurrent use not recommended.
StabilityCapsules and powder for reconstitution may be stored at room temperature. Reconstituted oral solution should be refrigerated and is stable for 30 days.
Mechanism of ActionStavudine is a thymidine analog which interferes with HIV viral DNA dependent DNA polymerase resulting in inhibition of viral replication; nucleoside reverse transcriptase inhibitor
Pharmacodynamics/KineticsDistribution: Vd: 0.5 L/kg Bioavailability: 86.4% Metabolism: Undergoes intracellular phosphorylation to an active metabolite Half-life elimination: 1-1.6 hours Time to peak, serum: 1 hour Excretion: Urine (40% as unchanged drug)
DosageOral:Newborns (Birth to 13 days): 0.5 mg/kg every 12 hours Children: >14 days and <30 kg: 1 mg/kg every 12 hours
Adults:
<60 kg: 30 mg every 12 hours Dosing adjustment for toxicity: If symptoms of peripheral neuropathy occur, discontinue until symptoms resolve. Treatment may then be resumed at 50% the recommended dose. If symptoms recur at lower dose, permanent discontinuation should be considered. Dosing adjustment in renal impairment: Children: Specific recommendations not available. Reduction in dose or increase in dosing interval should be considered. Adults: Clcr >50 mL/minute:
<60 kg: 30 mg every 12 hours Clcr 26-50 mL/minute:
<60 kg: 15 mg every 12 hours Clcr 10-25 mL/minute, hemodialysis (administer dose after hemodialysis on day of dialysis):
<60 kg: 15 mg every 24 hours Elderly: Older patients should be closely monitored for signs and symptoms of peripheral neuropathy; dosage should be carefully adjusted to renal function
AdministrationMay be administered without regard to meals. Oral solution should be shaken vigorously prior to use.
Monitoring ParametersMonitor liver function tests and signs and symptoms of peripheral neuropathy; monitor viral load and CD4 count
Dietary ConsiderationsMay be taken without regard to meals.
Patient EducationInform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. This drug will not cure HIV; use appropriate precautions to prevent spread of HIV to other persons. Take as directed, with or without food. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. You may be more susceptible to infection (avoid crowds and exposure to infection and do not have any vaccinations without consulting prescriber). May cause nausea or vomiting (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); diarrhea (boiled milk, yogurt, or buttermilk may help); or headache, back, muscle, or joint pain (consult prescriber for approved analgesic). Report immediately any loss of sensation, numbness, or tingling in fingers, toes, or feet. Report persistent unresolved abdominal distress (nausea, vomiting, diarrhea); or signs of infection (burning on urination, perineal itching, white plaques in mouth, unhealed sores, persistent sore throat or cough). Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not breast-feed.
Additional InformationPotential compliance problems, frequency of administration and adverse effects should be discussed with patients before initiating therapy to help prevent the emergence of resistance.
Dental Health: Effects on Dental TreatmentNo significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic PrecautionsNo information available to require special precautions
Mental Health: Effects on Mental StatusMay cause drowsiness, insomnia, anxiety, or depression
Mental Health: Effects on Psychiatric TreatmentMay cause neutropenia; use caution with clozapine and carbamazepine; concurrent use with lithium may increase the risk of peripheral neuropathy
Dosage FormsCapsule: 15 mg, 20 mg, 30 mg, 40 mg Powder, for oral solution: 1 mg/mL (200 mL) [dye-free; fruit flavor]
ReferencesBrowne MJ, Mayer KH, Chafee SB, et al, "2',3'-Didehydro-3'-deoxythymidine (d4T) in Patients With AIDS or AIDS-Related Complex - A Phase I Trial,"J Infect Dis, 1993, 167(1):21-9. Dudley MN, Graham KK, Kaul S, et al, "Pharmacokinetics of Stavudine in Patients With AIDS and AIDS-Related Complex,"J Infect Dis, 1992, 166(3):480-5. "Guidelines for the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents, Panel on Clinical Practices for Treatment of HIV Infection," March 23, 2004. Available at: http://www.aidsinfo.nih.gov. Accessed July 12, 2004. Hilts AE and Fish DN, "Dosage Adjustment of Antiretroviral Agents in Patients With Organ Dysfunction,"Am J Health Syst Pharm, 1998, 55:2528-33. Kline MW, Dunkle LM, Church JA, et al, "A Phase I/II Evaluation of Stavudine (d4T) in Children With Human Immunodeficiency Virus Infection,"Pediatrics, 1995, 96(2 Pt 1):247-52. Lea AP and Faulds D, "Stavudine: A Review of Its Pharmacodynamic and Pharmacokinetic Properties and Clinical Potential in HIV Infection,"Drugs, 1996, 51(5):846-64. "Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States, Perinatal HIV Guidelines Working Group," June 23, 2004. Available at: http://www.aidsinfo.nih.gov. Accessed July 12, 2004. Sandstrom E and Oberg B, "Antiviral Therapy in Human Immunodeficiency Virus Infections. Current Status,"Drugs, 1993, 45(4):488-508. Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children, "Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection," January 20, 2004. Available at: http://www.aidsinfo.nih.gov. Accessed July 12, 2004.
International Brand NamesAspen Stavudine® (ZA); Birac® (AR); Exvihr® (CO); Lion® (AR); Revixil® (AR); Stamar® (AR); Stavir® (IN); Stavubergen® (AR); Stavudina Dosa® (AR); Tonavir® (AR); Zerit® (AR, AT, AU, BE, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, HR, HU, ID, IE, IL, IT, LU, MX, NL, NO, NZ, PL, PT, RO, RU, SE, SG, SI, TH, TR, YU, ZA); Zeritavir® (BR)
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30 kg: Refer to Adults dosing