d4T


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stavudine (d4T)

Zerit

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.

Action

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

Availability

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

Contraindications

• Hypersensitivity to drug or its components

Precautions

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.

Administration

• 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

Interactions

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.

d4T

(dē′fôr′tē′)
n.

d4T

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 ?
Considering only EFV-containing regimens, adolescents on d4T + 3TC + EFV and TDF + FTC + EFV were more likely to report multiple symptoms than those on ABC + 3TC + EFV (aOR 3.26; 95% CI 1.01-10.52, aOR 2.86; 95% CI 1.35-6.05 and aOR 1.08; 95% CI 0.64 1.82, respectively) (Table 6).
It is important to observe that the most common substitution was from ZDV to d4T. Adverse drug reactions associated with ZDV, principally anemia, are widely described, supporting substitution of ZDV [23].
[2] However, at the baseline visit, AZT was required to be substituted by d4T because of anemia (n = 6, 3.8%) and NVP was to be substituted by EFV (n = 4, 2.5%) because of its non-availability in NACO supply.
Two women died of PCP, and 2 of liver failure - 1 maternal death was presumed to be a result of complications from lactic acidosis following d4T toxicity.
In contrast, those who had been taking d4T showed better recovery of limb fat when they switched to TDF.
[5] Nonstandard abbreviations: NRTI, nucleoside reverse transcriptase inhibitor; mtDNA, mitochondrial DNA; PBMC, peripheral blood mononuclear cell; nDNA, nuclear DNA; NASBA, nucleic acid sequence-based amplification; AZT, zidovudine; 3TC, lamivudine; IDV, indinavir; d4T stavudine; ddI, didanosine; ACTG, AIDS Clinical Trial Group; FCS, fetal calf serum; DMSO dimethyl sulfoxide; and ddC, zalcitabine.
Protease inhibitors and other HIV medications (including d4T) are usually associated with lipodystrophy.
Severe hepatotoxicity occurred in patients on zidovudine (ZDV), lamivudine (3TC), or nevirapine (NVP) and with antiretroviral regimens containing didanosine (ddI) or stavudine (d4T).
But the effect was seen only in patients taking neurotoxic antiretroviral therapy with agents such as didanosine (ddI), stavudine (d4T), and zalcitabine (ddC).
NRTIs--Ziagen, Trizivir, Videx, Epivir, 3TC, Combivir, Zerit, d4T, Viread, Hivid, Retrovir, AZT
Refinements to existing medications--including Videx (ddI), Zerit (d4T), and Sustiva--have resulted in once-a-day versions; Viread and Epivir also come in daily formulations [see sidebar, "Cocktail menu"].
Thailand's state-run pharmaceutical agency on Monday started manufacturing the antiretroviral cocktail Stavudine, better known as d4T, for sale at a price 85% lower than that of U.S.