An Overview of Zerit (Stavudine, d4T)

Brand Name: Zerit
Other Name: d4T
Drug Class: Nucleoside Reverse Transcriptase Inhibitors

What Is Stavudine?

Stavudine is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults, children, and infants. Stavudine is always used in combination with other HIV medicines.

Stavudine belongs to a class (group) of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, including stavudine, don't cut down on, skip, or stop taking them unless your health care provider tells you to.

What Should I Tell My Health Care Provider Before Taking Stavudine?

Before taking stavudine, tell your health care provider:

• If you are allergic to stavudine or any other medicines.
• If you have or have ever had liver problems (such as hepatitis).
• If you have or have ever had kidney problems.
• If you have or had problems with your pancreas (such as pancreatitis).
• If you have or had persistent numbness, tingling, or pain in the hands or feet (peripheral neuropathy).
• If you have gallstones.
• If you drink alcoholic beverages.
• If you have any other medical conditions.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
• If you are pregnant or plan to become pregnant. Whether stavudine can harm an unborn baby is unknown. The combination of stavudine and didanosine (another HIV medicine) should be used with caution during pregnancy and only if the potential benefit clearly outweighs the potential risk to the fetus. Tell your healthcare provider right away if you become pregnant while taking stavudine. You and your healthcare provider will decide if you should continue taking stavudine while you are pregnant.
• If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking stavudine.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Especially tell your doctor if you take any of the following medicines: zidovudine (brand name: Trizivir), didanosine (brand name: Videx), doxorubicin, ribavirin, interferon, or hydroxyurea. Stavudine may affect the way other medicines or products work, and other medicines or products may affect how stavudine works. Taking stavudine together with certain medicines or products may cause serious, life-threatening side effects.

How Should I Take Stavudine?

Stavudine (brand name: Zerit) comes in capsule form in the following strengths:

• 15-mg capsules
• 20-mg capsules
• 30-mg capsules
• 40-mg capsules

Stavudine also comes as a 1-mg/mL oral solution for those who have trouble swallowing capsules. A pharmacist prepares the stavudine oral solution by mixing stavudine powder with purified water.

Take stavudine according to your health care provider's instructions.

Take stavudine with or without food.

Avoid drinking alcohol while taking stavudine. Alcohol may increase your risk of pancreatitis (pain and swelling of your pancreas) or liver damage.

When giving stavudine oral solution to a child, shake the bottle well before measuring each dose.

Always take stavudine in combination with other HIV medicines.

If you take too much stavudine, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take stavudine, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

What Should I Do If I Forget a Dose?

If you miss a dose of stavudine, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What Side Effects Can Stavudine Cause?

Stavudine may cause side effects. Most side effects from stavudine are manageable, but a few can be serious. Serious side effects of stavudine include lactic acidosis (buildup of lactic acid in the blood), liver problems, and pancreatitis (inflammation of the pancreas). (See the WARNING box above.)

Other possible side effects of stavudine include:

• Neurologic symptoms (signs that stavudine may be affecting the nerves). Tell your health care provider right away if you have any numbness or tingling in your hands or feet or weakness in your arms, legs, hands, or feet. It may be difficult to recognize neurologic symptoms in children who take stavudine. Ask your child's healthcare provider for the signs and symptoms of this side effect in children.
• Worsening of existing kidney problems. If you had kidney problems before taking stavudine, your health care provider may want to do regular blood and urine tests to monitor the functioning of your kidneys. Your health care provider may adjust your dosage if your kidneys are not working well.
• Changes in body fat (including gain or loss of fat).
• Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of stavudine. To learn more about possible side effects of stavudine, read the drug label or package insert or talk to your health care provider or pharmacist.

The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to stavudine.

You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.

How Should Stavudine Be Stored?

• Stavudine capsules:
  • Store stavudine capsules at 59°F to 86°F (15°C to 30°C).
  • Keep stavudine capsules in the container that they came in and keep the container tightly closed.
  • Throw away capsules that are no longer needed or expired (out of date).
• Stavudine oral solution:
  • Keep stavudine oral solution in the container that it came in and keep the container tightly closed.
  • Store the container of stavudine oral solution in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Throw away any unused stavudine oral solution after 30 days.
  • Throw away stavudine oral solution that is no longer needed or expired (out of date).
• Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep stavudine capsules, stavudine oral solution, and all medicines out of reach of children.

Where Can I Find More Information About Stavudine?

More information about stavudine is available:

• The stavudine drug label, from DailyMed. The Medication Guide section of the label includes information for people taking stavudine.
• Stavudine-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
• A list of FDA-approved HIV medicines, from AIDSinfo.

Manufacturer Information

Bristol-Myers Squibb
Main number: 800-332-2056
Patient assistance: 888-281-8981

The above Patient Version drug summary is based on the following FDA label(s): Capsule (gelatin coated), powder (for solution).