Stavudine

Stavudine is a prescription medication used with other medicines to treat human immunodeficiency virus (HIV) infection. Stavudine belongs to a class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). It works by preventing the virus from multiplying.

This medication comes in capsule and liquid forms and is usually taken twice daily. Stavudine can be taken with or without food.

Common side effects of stavudine include headaches, diarrhea, rash, and nausea.

Stavudine is a prescription medicine used with other HIV medicines to treat human immunodeficiency virus (HIV) infection in children and adults. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your weight
• your age
• your renal function

WARNING: LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS; PANCREATITIS

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk.

Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression.

Stavudine can cause serious side effects, including:

1. Build up of acid in your blood (lactic acidosis). Lactic acidosis can cause death and must be treated in the hospital. The risk of lactic acidosis may be higher if you:

• have liver problems
• are pregnant. There have been deaths reported in pregnant women who get lactic acidosis after taking stavudine and Videx, or stavudine and Videx EC (didanosine).
• are female
• are overweight
• have been treated for a long time with other medicines used to treat HIV

It is important to call your healthcare provider right away if you:

• feel weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have stomach pain with nausea and vomiting
• feel cold, especially in your arms and legs
• feel dizzy or light-headed
• have a fast or irregular heartbeat

2. Liver problems. Some people (including pregnant women) who have taken stavudine have had serious liver problems. These problems include liver enlargement (hepatomegaly), fat in the liver (steatosis), liver failure, and death due to liver problems. Your healthcare provider should check your liver function while you are taking stavudine. You should be especially careful if you have a history of heavy alcohol use or liver problems. Use of stavudine with Videx EC or Videx (didanosine) may increase your risk for liver damage.

It is important to call your healthcare provider right away if you have:

• yellowing of your skin or the white of your eyes (jaundice)
• dark urine
• pain on the right side of your stomach
• swelling of your stomach
• easy bruising or bleeding
• loss of appetite
• nausea or vomiting

3. Swelling of the pancreas (pancreatitis) that may cause death has occurred when stavudine was used with Videx EC or Videx (didanosine). Pancreatitis can happen at any time during your treatment with stavudine.

It is important to call your healthcare provider right away if you have:

• stomach pain
• swelling of your stomach
• nausea and vomiting
• fever

Do not take stavudine if you are allergic to stavudine or any of the ingredients in stavudine.

Stavudine is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using this medication. Patients should be advised that the use of stavudine has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or blood contamination.

Stavudine can cause serious side effects including:

• Stavudine can cause lactic acidosis, liver problems, and pancreatitis. See “Drug Precautions”.
• Neurologic symptoms. Symptoms include: weakness of your legs, feet, arms, or hands (motor weakness) and numbness or tingling in your hands or feet (neuropathy). These problems can happen more often in people who have advanced HIV disease, have a history of peripheral neuropathy, or in people who take other medicines that also are associated with neuropathy including didanosine. In some cases, neuropathy may temporarily worsen after you stop taking stavudine. Neuropathy can be difficult to notice in children who take stavudine. Ask your child’s healthcare provider for the signs and symptoms of peripheral neuropathy in children.
  • It is important to call your healthcare provider right away if you have:
    • numbness in your hands or feet
    • tingling in your hands or feet
    • weakness in your legs, feet, arms, or hands
• Changes in body fat (fat redistribution). Changes in body fat (lipoatrophy or lipodystrophy) have been seen in some people taking HIV medicines including stavudine. Loss of body fat (lipoatrophy) happens more often in people who take stavudine than in people who take other similar HIV medicines.

• These changes may include:

• more fat in or around your
  • trunk
  • upper back and neck (buffalo hump)
  • breast or chest
• loss of fat in your
  • legs
  • arms
  • face

Your healthcare provider will monitor you for changes in your body fat. It is important to tell your healthcare provider if you notice any of these changes.

• Changes in your immune system (immune reconstitution syndrome). Your immune system may begin to fight infections that have been in your body for a long time. Tell your healthcare provider if you start having new or worse symptoms of infection after you start taking HIV medicine.

The most common side effects of stavudine include:

• headache
• diarrhea
• rash
• nausea
• vomiting

Tell your healthcare 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. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, or herbal supplements. Stavudine may affect the way other medicines work, and other medicines may affect how stavudine works.

Especially tell your healthcare provider if you take:

• Combivir, Retrovir, Trizivir (zidovudine or AZT)
• Videx or Videx EC (didanosine)
• Adriamycin, Rubex (doxorubicin)
• Copegus, Rebetol, Ribasphere, Ribavirin, Virazole (ribavirin)
• Roferon-A, Intron-A, and others (interferon)
• Hydrea, Droxia (hydroxyurea)

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Ask your healthcare provider if you are not sure if you take one of the medicines listed above.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if stavudine will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking stavudine. You and your healthcare provider will decide if you should take stavudine while you are pregnant.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Do not breastfeed. It is not known if stavudine can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

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

Stavudine is not a cure for HIV-1 infection.

Changes in body fat (fat redistribution) can occur with stavudine. These changes may include more fat in or around your trunk, upper back and neck (buffalo hump), or chest.

When your stavudine supply starts to run low, get more from your healthcare provider or pharmacy. It is very important not to run out of this medication. The amount of virus in your blood may increase if the medicine is stopped for even a short time.