Stavudine

Zerit

GENERIC AVAILABLE: Yes

Yes

You should not take stavudine if you are allergic to it.

Stavudine should not be taken together with any HIV combination that includes zidovudine (Combivir, Retrovir, or Trizivir).

Some people have developed a life-threatening condition called lactic acidosis while taking stavudine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

Stavudine can also cause severe or life-threatening effects on your liver or pancreas. Tell your doctor if you have liver disease or a history of pancreatitis.

To make sure you can safely take stavudine, tell your doctor if you have any of these other conditions:

• kidney disease;
• diabetes (stavudine liquid contains 250 milligrams of sucrose per teaspoon); or
• if you have used a medicine similar to stavudine in the past, such as abacavir (Ziagen), didanosine (Videx), emtricitabine (Atripla, Complera, Emtriva, Truvada), lamivudine (Epivir, Combivir, Epzicom, Trizivir), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Stavudine may also be more likely to cause lactic acidosis in a pregnant woman. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of stavudine on the baby.

You should not breast-feed while you are using stavudine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Stavudine is part of the drug class:

• Nucleoside and nucleotide reverse transcriptase inhibitors

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 not take stavudine if you are allergic to it.

Do not take this medicine with any other medicine that contains zidovudine or stavudine, including: Combivir, Trizivir, or Retrovir.

Some people taking stavudine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

Stavudine can also cause severe or life-threatening effects on your liver or pancreas. Tell your doctor if you have liver disease or a history of pancreatitis.

To make sure stavudine is safe for you, tell your doctor if you have ever had:

• kidney disease;

• liver disease;

• gallstones;

• numbness, tingling, or burning pain in your hands or feet;

• problems with your pancreas; or

• if you drink large amounts of alcohol.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of stavudine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• didanosine;

• zidovudine or AZT;

• doxorubicin;

• hydroxyurea;

• interferon-alfa; or

• ribavirin.

This list is not complete. Other drugs may interact with stavudine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Stavudine is used in combination with other antivirus medicines for the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Stavudine will not cure or prevent HIV infection or AIDS. It helps to keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease.

Stavudine will not keep you from spreading HIV to other people. People who receive stavudine may continue to have the problems usually related to AIDS or HIV disease.

stavudine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure that stavudine is working properly. Blood tests may be needed to check for unwanted effects.

Two rare but serious reactions to stavudine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Stop taking the medicine and call your doctor right away if you have abdominal discomfort or cramping; dark urine; decreased appetite; diarrhea; a general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.

Stop using stavudine and check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Pancreatitis may occur while you are using stavudine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

stavudine may cause you to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (eg, pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

Avoid drinking alcohol or alcoholic beverages while taking stavudine.

Do not take any other medicines without checking first with your doctor. To do so may increase the chance for side effects from stavudine.

(STAV yoo deen)

May be taken without regard to meals. Some products may contain sucrose.

Capsules and powder for reconstitution may be stored at controlled room temperature of 25°C (77°F). Reconstituted oral solution should be stored in refrigerator at 2°C to 8°C (36°F to 46°F) and is stable for 30 days.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, or diarrhea. Have patient report immediately to prescriber signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of infection, muscle weakness, burning or numbness feeling, or change in body fat (HCAHPS)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Hemodialysis:
Adult patients:
Less than 60 kg: 15 mg orally every 24 hours
60 kg or more: 20 mg orally every 24 hours
The dose should be taken after hemodialysis when given on dialysis days.

Pediatric patients: There are insufficient data to recommend a specific dose adjustment in this patient population.