MEDICATION Guide

DidanosineDelayed-Release Capsules (enteric-coated pellets)

Read this Medication Guide before you start taking didanosine delayed-release 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 didanosine delayed-release capsules before you start taking it and at regular check-ups. You should stay under your healthcare provider’s care when taking didanosine delayed-release capsules.

What is the most important information I should know about Didanosine Delayed-Release Capsules?

Didanosine Delayed-Release Capsules may cause serious side effects, including:

1. Swelling of your pancreas (pancreatitis) that may cause death. Pancreatitis can happen at any time during your treatment with Didanosine Delayed-Release Capsules.  Before you start taking didanosine delayed-release capsules, tell your healthcare provider if you:

• have had pancreatitis
• have advanced HIV (human immunodeficiency virus) infection
• have kidney problems
• drink alcoholic beverages
• take a medicine called ZERIT® (stavudine)

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

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

1. Build-up of acid in your blood (lactic acidosis). Lactic acidosis must be treated in the hospital as it may cause death. Before you start taking didanosine delayed-release capsules, tell your healthcare provider if you:

• have liver problems
• are pregnant. There have been deaths reported in pregnant women who get lactic acidosis after taking didanosine delayed-release capsules and ZERIT (stavudine).
• are overweight
• have been treated for a long time with other medicines 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
  

1. Liver problems. Serious liver problems have happened in some people (including pregnant women) who take didanosine delayed-release capsules. These problems include liver enlargement (hepatomegaly), fat in the liver (steatosis), liver failure, and high blood pressure in the large vein of the liver (portal hypertension). Severe liver problems can lead to liver transplantation or death in some people taking didanosine delayed-release capsules. Your healthcare provider should check your liver function while you are taking didanosine delayed-release capsules. You should be especially careful if you have a history of heavy alcohol use or liver problems.

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
    • vomiting blood or dark colored stools (bowel movements)

What is Didanosine Delayed-Release Capsules?

Didanosine delayed-release capsules are a prescription medicine used with other antiretroviral medicines to treat human immunodeficiency virus (HIV) infection in children and adults. Didanosine delayed-release capsule belongs to a class of drugs called nucleoside analogues.

Didanosine delayed-release capsules will not cure your HIV infection. At present there is no cure for HIV infection. Even while taking didanosine delayed-release 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 Didanosine Delayed-Release Capsules?

Do not take Didanosine Delayed-Release Capsules if you take:

• ZYLOPRIM®, LOPURIN®, ALOPRIM® (allopurinol)

• COPEGUS®, REBETOL®, RIBASPHERE®, RIBAVIRIN®, VIRAZOLE® (ribavirin)

What should I tell my healthcare provider before takingDidanosine Delayed-Release Capsules?

Before you take didanosine delayed-release capsules, tell your healthcare provider if you:

• have or had kidney problems
• have or had liver problems (such as hepatitis)
• have or had persistent numbness, tingling, or pain in the hands or feet (neuropathy)
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if didanosine delayed-release capsules will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking didanosine delayed-release capsules. You and your healthcare provider will decide if you should take didanosine delayed-release 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 doctor about how you can take part in this registry.

• arebreastfeeding or plan to breastfeed. Do not breastfeed. It is not known if didanosine delayed-release capsules 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.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Didanosine delayed-release capsules may affect the way other medicines work, and other medicines may affect how didanosine delayed-release capsules works.

Especially tell your healthcare provider if you take:

• CYTOVENE®, VALCYTE® (ganciclovir)
• DOLOPHINE® HYDROCHLORIDE, METHADOSE® (methadone)
• VIRACEPT® (nelfinavir)
• VIREAD® (tenofovir disoproxil fumarate)
• alcoholic beverages

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 Didanosine Delayed-Release Capsules?

• Take didanosine delayed-release capsules exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much didanosine delayed-release capsules to take and when to take it.
• Your healthcare provider may change your dose. Do not change your dose of didanosine delayed-release capsules without talking to your healthcare provider.
• Do not take Didanosine Delayed-Release Capsuleswith food. Take didanosine delayed-release capsules on an empty stomach.
• Take didanosine delayed-release capsules whole. Do not break, crush, dissolve, or chew didanosine delayed-release capsules before swallowing. If you cannot swallow didanosine delayed-release capsules whole, tell your healthcare provider. You may need a different medicine.
• 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 should not be taken at the same time of day that you take Didanosine Delayed-Release Capsules. 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 didanosine delayed-release capsule. Your healthcare provider may also lower your dosage of didanosine delayed-release capsule if your kidneys are not working well.
• If you take too much Didanosine Delayed-Release Capsules, contact a poison control center or emergency room right away.

What should I avoid while taking Didanosine Delayed-Release Capsules?

• Alcohol. Do not drink alcohol while taking didanosine delayed-release 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 Didanosine Delayed-Release Capsules?

Didanosine delayed-release capsules can cause pancreatitis, lactic acidosis, and liver problems. See “What is the most important information I should know about didanosine delayed-release capsules?” at the beginning of this Medication Guide.

• Vision changes. You should have regular eye exams while taking didanosine delayed-release capsules.
• Peripheral neuropathy. Symptoms include: numbness, tingling, or pain in your hands or feet. This condition is more likely to happen in people who have had it before, in patients taking medicines that affect the nerves, and in people with advanced HIV disease. A child may not notice these symptoms. Ask the child’s healthcare provider for the signs and symptoms of peripheral neuropathy in children.
• Changes in your immune system (immune reconstitution syndrome). Your immune system may get stronger and begin to fight infections that have been hidden 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.
• Changes in body fat (fat redistribution). Changes in body fat have been seen in people who take antiretroviral medicines. These changes may include:
• more fat in or around your

− upper back and neck (buffalo hump)

− breasts or chest

− trunk

• less fat in your

− legs

− arms

− face

Tell your healthcare provider if you have any of the symptoms listed above.

The most common side effects of didanosine delayed-release capsules include:

• diarrhea
• stomach pain
• nausea
• vomiting
• headache
• rash

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 didanosine delayed-release 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 Didanosine Delayed Release Capsules?

• Store didanosine delayed-release capsules at 20o to 25o C (68o to 77o F)
• Safely throw away any unused didanosine delayed-release capsules

Keep Didanosine Delayed-Release Capsulesand all medicines out of the reach of children and pets.

General Information about the safe and effective use of Didanosine Delayed-Release 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 didanosine delayed-release capsules for a condition for which it was not prescribed. Do not give didanosine delayed-release 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 didanosine delayed-release capsules in an unrecognizable closed container in the household trash.

This Medication Guide summarizes the most important information about didanosine delayed-release capsules. If you would like more information about didanosine delayed-release capsules, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about didanosine delayed-release capsules that is written for health professionals. For more information call 1-888-838-2872, Medical Affairs.

What are the ingredients in Didanosine Delayed-Release Capsules?

Active Ingredients: didanosine

Inactive Ingredients:

Black iron oxide, croscarmellose sodium, D&C yellow no. 10 aluminum lake, FD&C blue no. 1,  FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, methacrylic acid copolymer dispersion, microcrystalline cellulose, polydextrose, polyethylene glycol, propylene glycol, shellac glaze, silicon dioxide, sodium hydroxide, talc, titanium dioxide, triacetin and triethyl citrate.  The 200 mg and 400 mg capsule also contains D&C red no. 33 and FD&C yellow no. 6, and the 250 mg also contains D&C red no. 28.

ZERIT® is a registered trademark of Bristol-Myers Squibb Company.

LOPURIN® is a registered trademark of Dr. Reddy’s Labs.

ALOPRIM® is a registered trademark of Bioniche Pharma.

COPEGUS®, CYTOVENE®, and VALCYTE® are registered trademarks of Hoffman-La Roche.

REBETOL® is a registered trademark of Schering Corporation.

RIBASPHERE® is a registered trademark of Three Rivers Pharms.

VIRAZOLE® is a registered trademark of Valeant Pharm.

DOLOPHINE® is a registered trademark of Roxane Labs.

METHADOSE® is a registered trademark of Mallinckrodt, Inc.

VIRACEPT® is a registered trademark of Aguoron Pharmaceuticals, Inc.

VIREAD® is a registered trademark of Gilead Sciences, Inc.

TEVA PHARMACEUTICALS USA
Sellersville, PA 18960

Rev. D 12/2011

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