MEDICATION GUIDE
STAVUDINE CAPSULES, USP

15 mg, 20 mg, 30 mg and 40 mg
(stavudine, also known as d4T)
(stav' ue deen)

Read this Medication Guide before you start taking stavudine capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. You and your healthcare provider should talk about your treatment with stavudine capsules before you start taking it and at regular check-ups. You should stay under your healthcare provider’s care when taking stavudine capsules.

What is the most important information I should know about stavudine capsules?

Stavudine capsules 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 capsules and VIDEX®†, or stavudine capsules 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 capsules 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 capsules. You should be especially careful if you have a history of heavy alcohol use or liver problems. Use of stavudine capsules 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 capsules was used with VIDEX EC®† or VIDEX®† (didanosine). Pancreatitis can happen at any time during your treatment with stavudine capsules.

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

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

What are stavudine capsules?

Stavudine capsules are a prescription medicine used with other HIV medicines to treat human immunodeficiency virus (HIV) infection in children and adults. Stavudine capsules belong to a class of drugs called nucleoside analogues.

Stavudine capsules will not cure your HIV infection. At present there is no cure for HIV infection. Even while taking stavudine capsules, you may continue to have HIV-related illnesses, including infections with other disease-producing organisms. Continue to see your healthcare provider regularly and report any medical problems that occur.

Who should not take stavudine capsules?

Do not take stavudine capsules if you:

• are allergic to stavudine or any of the ingredients in stavudine capsules. See the end of this Medication Guide for a complete list of the ingredients in stavudine capsules.

What should I tell my healthcare provider before taking stavudine capsules?

Before you take stavudine capsules, tell your healthcare provider if you:

• have or had liver problems (such as hepatitis)
• have or had problems with your pancreas (pancreatitis)
• have or had kidney problems
• have or had persistent numbness, tingling or pain in the hands or feet (neuropathy)
• have gallstones
• drink alcoholic beverages
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if stavudine capsules will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking stavudine capsules. You and your healthcare provider will decide if you should take stavudine capsules 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.

• are breast-feeding or plan to breast-feed. Do not breast-feed. 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 breast-feed because HIV-1 can be passed to the baby in the breast milk.

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

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.

How should I take stavudine capsules?

• Take stavudine capsules exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much stavudine capsules to take and when to take it.
• If your child will be taking stavudine capsules, your child’s healthcare provider should give you instructions on how to give this medicine.
• Your healthcare provider may change your dose. Do not change your dose of stavudine capsules without talking to your healthcare provider.
• Stavudine capsules may be taken with or without food.
• Try not to miss a dose, but if you do, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
• Some medicines may require your healthcare provider to monitor your therapy or change your therapy. Check with your healthcare provider.
• If your kidneys are not working well, your healthcare provider will need to do regular blood and urine tests to check how they are working while you take stavudine capsules. Your healthcare provider may also lower your dosage of stavudine capsules if your kidneys are not working well.
• If you take too much stavudine capsules, contact a poison control center or emergency room right away.

What should I avoid while taking stavudine capsules?

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

What are the possible side effects of stavudine capsules?

Stavudine capsules can cause serious side effects including:

• Stavudine capsules can cause lactic acidosis, liver problems and pancreatitis. See “What is the most important information I should know about stavudine capsules?”
• 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 capsules. Neuropathy can be difficult to notice in children who take stavudine capsules. Ask you 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 capsules. Loss of body fat (lipoatrophy) happens more often in people who take stavudine capsules 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 capsules 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 capsules. 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.

How should I store stavudine capsules?

Store stavudine capsules in a tightly closed container at room temperature at 20° to 25°C (68° to 77°F).

Keep stavudine capsules and all medicines out of the reach of children and pets.

General Information about the safe and effective use of stavudine capsules.

Avoid doing things that can spread HIV-1 infection to others.

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions or blood.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use stavudine capsules for a condition for which it was not prescribed. Do not give stavudine capsules to other people, even if they have the same symptoms as you have. It may harm them. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place stavudine capsules in an unrecognizable closed container in the household trash.

This Medication Guide summarizes the most important information about stavudine capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about stavudine capsules that is written for health professionals. For more information, go to www.mylan.com or call Mylan Pharmaceuticals Inc. toll free at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in stavudine capsules, USP?

Active Ingredient: stavudine, USP

Inactive Ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The empty hard shell gelatin capsules contain gelatin and titanium dioxide. In addition, the 15 mg empty capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6; the 20 mg empty capsules contain D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40; the 30 mg empty capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, FD&C Yellow No. 6; and the 40 mg empty capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Yellow No. 6. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.

† The brand names mentioned are registered trademarks of their respective manufacturers.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured in India by:
Mylan Laboratories Limited
Hyderabad — 500 034, India
Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States