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stavudine (d4T)


Pharmacologic class: Nucleoside reverse transcriptase inhibitor

Therapeutic class: Antiretroviral

Pregnancy risk category C

FDA Box Warning

• Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have occurred with use of drug alone or in combination with other nucleoside analogs. Fatal lactic acidosis has been reported in pregnant women who received stavudine-didanosine combination with other antiretrovirals. Use this combination cautiously in pregnant women and only if potential benefit clearly outweighs potential risk.

• Pancreatitis (fatal and nonfatal cases) has occurred when stavudine was used as part of combination regimen that included didanosine, in both treatment-naive and treatment-experienced patients.


Inhibits replication of human immunodeficiency virus (HIV) by interfering with the enzyme reverse transcriptase, thereby terminating DNA chain


Capsules: 15 mg, 20 mg, 30 mg, 40 mg

Powder for oral solution: 1 mg/ml

Indications and dosages

HIV-1 infection

Adults weighing 60 kg (132 lb) or more: 40 mg P.O. q 12 hours

Adults and children weighing less than 60 kg (132 lb): 30 mg P.O. q 12 hours

Children weighing 30 kg (66 lb) or more: 30 mg P.O. q 12 hours

Children 14 days and older who weigh less than 30 kg (66 lb): 1 mg/kg P.O. q 12 hours

Newborns to infants 13 days old: 0.5 mg/kg P.O. q 12 hours

Dosage adjustment

• Renal impairment
• Elderly patients


• Hypersensitivity to drug or its components


Use cautiously in:
• advanced HIV infection, bone marrow depression, renal failure, peripheral neuropathy, hepatic dysfunction, hyperlactatemia, lactic acidosis
• concurrent use of hydroxyurea or didanosine (avoid use)
• elderly patients (with renal impairment)
• pregnant or breastfeeding patients.


• Give with or without food.
• Know that drug is usually given with other antiretrovirals.

Adverse reactions

CNS: headache, insomnia, peripheral neuropathy

GI: nausea, vomiting, diarrhea, abdominal pain, anorexia, pancreatitis

Hematologic: anemia, leukopenia, thrombocytopenia

Hepatic: hepatic steatosis, hepatitis, hepatic failure

Metabolic: increased glucose tolerance, lactic acidosis

Musculoskeletal: myalgia

Skin: rash

Other: body fat redistribution or accumulation, chills, fever, allergic reaction, immune reconstitution syndrome


Drug-drug.Chloramphenicol, dapsone, didanosine, ethambutol, hydralazine, hydroxyurea, lithium, phenytoin, vincristine, zalcitabine: increased risk of peripheral neuropathy

Doxorubicin, ribavarin, zidovudine: inhibition of stavudine's absorption and metabolism

Myelosuppressants: increased bone marrow depression

Drug-diagnostic tests.Alanine aminotransferase, amylase, aspartate aminotransferase, bilirubin, gamma-glutamyl transferase, lipase: increased levels

Neutrophils, platelets: decreased counts

Patient monitoring

Monitor closely for signs and symptoms of lactic acidosis, hyperlactatemia, or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Consult prescriber about suspending drug if these occur. Consider permanent discontinuation of drug for patients with confirmed lactic acidosis.
• Monitor patient for signs and symptoms of immune reconstitution syndrome.
• Watch for and report onset and worsening of peripheral neuropathy.

Monitor CBC. Report evidence of bone marrow depression.
• Monitor liver function tests and blood chemistry results.

Patient teaching

• Tell patient he may take with or without food.

Teach patient to recognize and promptly report signs and symptoms of lactic acidosis (such as fatigue, GI distress, and difficult or rapid breathing), hepatotoxicity, immune reconstitution syndrome, and pancreatitis.
• Instruct patient to report numbness or tingling in arms, legs, hands, or feet.
• Caution female patient not to breastfeed, because she may transmit drug effects and HIV to infant.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.




symbol for dideoxythymidine.


Stavudine, Zerit AIDS An anti-HIV reverse transcriptase inhibitor/nucleoside analogue Adverse effects Neuropathies of hands and feet, stomach upset, pancreatitis, liver damage,. See AIDS. Cf AZT, DDC, ddC.
References in periodicals archive ?
Only in group 3, and 2 years post-implementation of the 2010 guidelines, was a slightly more drug-dependent approach observed regarding prescription of TDF and d4T and timing of blood tests (Table 5).
Vitamin deficiency can aggravate PN, and supplementation with vitamin B complex concurrently with d4T or ddI therapy may be advisable.
Prior to undertaking the drug assays, calibration standards of NVP, 3TC and d4T were run on six consecutive days by HPLC and spectrophotometric methods.
However, lactic acidosis attributed to d4T was strongly suspected as the cause of one of the maternal deaths in this cohort.
No such increase was seen with ZDV or d4T, and the additional risk due to ABC and ddI largely disappeared after the drugs were discontinued.
Priority group 3: Established patients receiving d4T, 3TC and EFV
However, both these drugs are more expensive than d4T, and in the case of tenofovir, only available in a 3-drug fixed-dose combination with efavirenz, also more expensive than the other mainstay of treatment scale-up, nevirapine.
All the blood samples were centrifuged immediately and plasma stored at -20[degrees]C until estimations of 3TC and d4T were undertaken.
At the 12th Retroviruses Conference (February 2005) there was considerable discussion of switching patients away from thymidine analogs (d4T or AZT; d4T may be particularly important to avoid) to other regimens such as those using tenofovir or abacavir, if lipoatrophy starts to become a problem.
In the study 100 antiretroviral-naive patients were randomized to one of three dosage levels of Kaletra plus d4T (stavudine, 40 rug twice daily) and 3TC (lamivudine, 150 mg twice daily), with the latter two drugs started either at the same time as Kaletra or 3 weeks later.
About one-quarter of the participants took either of two other anti-HIV drugs known as AZT or d4T.
The study enrolled 105 adult patients receiving the thymidine analogs stavudine, or d4T (n=71) or zidovudine, or AZT (n=34) as part of their combination therapy.