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

symbol for dideoxythymidine.

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 ?
However, looking at the three common LPV/r-containing cART regimens in this study (Table 7), the number of symptoms reported by adolescents on AZT + 3TC + LPV/r and ABC + AZT + LPV/r was higher than that reported by those on ABC + 3TC + LPV/r and comparable to that reported by those on d4T + 3TC + EFV.
EFV-related ADRs were significantly associated with female gender, younger age, advanced HIV disease, and use of AZT or d4T.
In subjects with anemia, AZT was substituted by d4T and in the event of non-availability, skin reactions, or hepatic dysfunction, or possible drug interactions, NVP was replaced by EFV.
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.
The GPO has received the first initial order for d4T worth 500,000 baht from Medicins Sans Frontieres (MSF) in Thailand for 100 patients, Krisana said.
CurrWt MutScor 0 Mut A5 D4T NELFINAVIR SAQUINAVIR: 0.
When assessing the predominant drugs used over the duration of this study (Tables 2 and 3), it was noted that the mean number of d4T prescriptions used in first-line regimens declined significantly in all groups (p<0.
A gradual, phased approach to introducing the FDC treatment to new patients, pregnant patients and those receiving d4T should help to ensure a smooth transition.
In one patient (ID 14) who had previously been exposed to several therapeutic regimens containing ZDV, 3TC, NFV and RTV, the viral load first reached undetectable levels in October 2001 while the patient was undergoing the eighth therapeutic regimen, which contained d4T, ddI, EFV and LPV/r.