Dosing & Uses
Dosage Forms & Strengths
capsule
- 15mg
- 20mg
- 30mg
- 40mg
powder for oral solution
- 1mg/mL (200mL)
HIV Infection
<60 kg: 30 mg PO q12hr
≥60 kg: 40 mg PO q12hr
Renal Impairment
≥60 kg
- CrCl >50 mL/min: 40 mg PO q12hr
- CrCl 26-50 mL/min: 20 mg PO q12hr
- CrCl 10-25 mL/min: 20 mg PO qDay
<60 kg
- CrCl >50 mL/min: 30 mg PO q12hr
- CrCl 26-50 mL/min: 15 mg PO q12hr
- CrCl 10-25 mL/min: 15 mg PO qDay
Dosage Forms & Strengths
capsule
- 15mg
- 20mg
- 30mg
- 40mg
powder for oral solution
- 1mg/mL (200mL)
HIV Infection
Indicated for treatment of HIV infection in combination with other antiretroviral agents
Birth-13 days: 0.5 mg/kg PO q12hr
<30 kg, ≥14 days: 1 mg/kg PO q12hr
30-60 kg: As adults; 30 mg PO q12hr
>60 kg: As adults; 40 mg PO q12hr
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
stavudine, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.
Serious - Use Alternative (7)
- betibeglogene autotemcel
stavudine, betibeglogene autotemcel. Other (see comment). Avoid or Use Alternate Drug. Comment: Do not take antiretroviral medications for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed. Antiretroviral medications may interfere with manufacturing of apheresed cells.
- cabotegravir
stavudine, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.
- elivaldogene autotemcel
elivaldogene autotemcel, stavudine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- hydroxyurea
hydroxyurea, stavudine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred in HIV patients treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, avoid this combination. .
- ribavirin
ribavirin decreases effects of stavudine by Other (see comment). Contraindicated. Comment: Mechanism: Competition for thymidine kinase for conversion to active form.
- selinexor
selinexor, stavudine. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- zidovudine
zidovudine decreases effects of stavudine by Other (see comment). Contraindicated. Comment: Mechanism: Competition for thymidine kinase for conversion to active form.
Monitor Closely (20)
- abacavir
abacavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- atazanavir
atazanavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- didanosine
didanosine, stavudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. May cause pancreatitis; risk of peripheral neuropathy. Possibility of fatal lactic acidosis (esp. in pregnant pts.).
- doxorubicin
doxorubicin decreases effects of stavudine by Other (see comment). Use Caution/Monitor. Comment: Mechanism: inhibition of phosphorylation process.
- doxorubicin liposomal
doxorubicin liposomal decreases effects of stavudine by Other (see comment). Use Caution/Monitor. Comment: Mechanism: inhibition of phosphorylation process.
- efavirenz
efavirenz and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- emtricitabine
emtricitabine and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- enfuvirtide
enfuvirtide and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- fosamprenavir
fosamprenavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- indinavir
indinavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- lamivudine
lamivudine and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- nelfinavir
nelfinavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- nevirapine
nevirapine and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- orlistat
orlistat will decrease the level or effect of stavudine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.
- ritonavir
ritonavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- saquinavir
saquinavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tenofovir DF
stavudine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tipranavir
tipranavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- ublituximab
ublituximab decreases effects of stavudine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely.
- zidovudine
stavudine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
Minor (0)
Adverse Effects
>10%
Headache
Chills/fever
Malaise
Insomnia
Anxiety
Depression
Pain
Rash
Nausea
Vomiting
Diarrhea
Pancreatitis
Abdominal pain
Peripheral neuropathy
1-10%
Neutropenia
Thrombocytopenia
Incr hepatic transaminases
Incr bilirubin
Myalgia
Back pain
Weakness
Postmarketing Reports
Metabolic disorders: lipoatrophy, lipodystrophy
Warnings
Black Box Warnings
Fatal and nonfatal pancreatitis reported; suspend if pancreatitis suspected and discontinue if confirmed
Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with use of nucleoside analogues alone or in combination
Fatal lactic acidosis reported in pregnant women who have received didanosine and stavudine with other antiretroviral agents. Combination is contraindicated in pregnant women
Contraindications
Hypersensitivity
Coadministration with didanosine
Cautions
Risk of potentially fatal lactic acidosis & severe hepatomegaly with steatosis, with use alone & especially with didanosine
Risk of potentially fatal pancreatitis when used with didanosine
Decrease dose in renal impairment
Severe motor weakness reported
Risk of immune reconstitution syndrome if used in combination w/ other antiretroviral drugs
Randomized controlled trials found lipoatrophy or lipodystrophy developed in a higher proportion of patients treated with stavudine compared to other nucleosides (tenofovir or abacavir)
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to drug during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263
Fatal lactic acidosis reported in pregnant individuals who received combination of stavudine and didanosine with other antiretroviral agents; unclear if pregnancy augments risk of lactic acidosis/hepatic steatosis syndrome reported in non-pregnant individuals receiving nucleoside analogues; combination of with didanosine is contraindicated
Prospective pregnancy data from APR not sufficient to adequately assess risk of major birth defects, miscarriage or adverse developmental outcomes
Animal data
- In animal reproduction studies, no adverse developmental effects observed with oral administration of stavudine at clinically relevant exposures; no developmental toxicities observed in rats and rabbits at systemic exposures 112 (AUC) and 183 (Cmax) times, respectively, exposures in humans at recommended human dose
Lactation
The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV; based on limited data, the drug has been detected in human milk; no data are available regarding effects of stavudine on breastfed infant, or effects on milk production
Because of potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants) and adverse reactions in breastfed infants similar to those seen in adults, instruct mothers not to breastfeed if they are receiving therapy
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitor (NRTI); thymidine analog that interferes with HIV viral DNA dependent DNA polymerase and inhibits viral replication
Pharmacokinetics
Half-Life: 1-1.6 hr
Peak Plasma Time: 1 hr; 3 hr (XR)
Peak Plasma Concentration: (conventional) 228±62 ng/mL; (XR) 536±146 ng/mL
AUC: (conventional) 1966±629 ng.hr/mL; (XR) 2568±454 ng.hr/mL
Bioavailability: 86.4% (adults); 76.9% (children)
Vd: 46 L
Clearance: 594±165 mL/min (total body); 237±98 mL/min (renal)
Excretion: Urine (95%); feces (3%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| stavudine oral - | 20 mg capsule |  | |
| stavudine oral - | 15 mg capsule |  | |
| stavudine oral - | 40 mg capsule |  | |
| stavudine oral - | 30 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
stavudine oral
STAVUDINE - ORAL
(STAV-you-deen)
COMMON BRAND NAME(S): Zerit
WARNING: Rarely, stavudine has caused a severe (sometimes fatal) pancreas problem (pancreatitis) when used alone or with other HIV medicines. Immediately tell your doctor if you develop symptoms of pancreatitis (such as nausea/vomiting that doesn't stop, stomach/abdominal/back pain).Rarely, stavudine has caused a severe (sometimes fatal) liver and blood problem (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (such as nausea that doesn't stop, stomach/abdominal pain, dark urine, yellowing eyes/skin) or lactic acidosis (such as rapid breathing, drowsiness, muscle aches). Pregnant women with HIV may be more likely to have this problem.Do not use stavudine with didanosine because of the increased risk of serious side effects.
USES: This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Stavudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTI).Stavudine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
HOW TO USE: Read the Medication Guide and the Patient Information Leaflet provided by your pharmacist before you start using stavudine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually every 12 hours.The dosage is based on your weight, medical condition, and response to treatment.For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same times every day.It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Refill your medication before you run out.Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.
SIDE EFFECTS: See also Warning section.Headache or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).This medication can cause severe nerve problems in the hands/feet/legs (peripheral neuropathy). Symptoms may include numbness/tingling/pain, muscle weakness, or decreased muscle control. If you experience any of these symptoms, contact your doctor right away so that you can be monitored closely. Your doctor may decide to reduce or stop your dose of stavudine.Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking stavudine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis, kidney problems, liver problems (such as hepatitis, cirrhosis), nerve problems (such as peripheral neuropathy), alcohol use, gall bladder problems (such as gall stones).Avoid alcoholic beverages because they may increase your risk for liver problems and/or pancreatitis.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially the increased risk of nerve problems.Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
DRUG INTERACTIONS: See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: didanosine, doxorubicin, hydroxyurea, orlistat, zidovudine, drugs that can cause nerve problems (such as isoniazid, vincristine).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as kidney function, liver tests, viral load, T-cell counts) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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