Didanosine

IMPORTANT WARNING:

Didanosine may cause serious or life-threatening pancreatitis (swelling of the pancreas). Tell your doctor if you drink or have ever drunk large amounts of alcoholic beverages and if you have or have ever had pancreatitis, or pancreas or kidney disease.If you experience any of the following symptoms, call your doctor immediately: stomach pain or swelling, nausea, vomiting, or fever.

Didanosine may cause life-threatening damage to the liver and a potentially life-threatening condition called lactic acidosis (buildup of lactic acid in the blood). The risk that you will develop lactic acidosis may be higher if you are a woman, if you are overweight, or if you have been treated with medications for HIV for a long time. Tell your doctor if you have or have ever had liver disease. Tell your doctor if you are taking stavudine (Zerit^®). Your doctor will probably tell you not to take didanosine if you are taking this medication. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: shortness of breath; fast breathing; changes in heartbeat; nausea; vomiting; loss of appetite; weight loss; diarrhea; pain in the upper right part of your stomach; unusual bleeding or bruising; yellowing of the skin or eyes; dark-colored urine; light-colored bowel movements; extreme tiredness; cold or blue-colored hands and feet; or muscle pain.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to didanosine.

Talk to your doctor about the risks of taking didanosine.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with didanosine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

IMPORTANT NOTICE:

Didanosine is no longer commercially available in the U.S. See the FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/) for information on drugs that have been discontinued.

Because this drug is no longer available in the U.S. market, this document is no longer updated by AHFS DI. If this drug is used in countries other than the U.S., it is essential that the manufacturers' labeling be consulted for more recently available information.

WHY is this medicine prescribed?

Didanosine is used along with other medications to treat human immunodeficiency virus (HIV) infection.Didanosine is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV in the blood. Although didanosine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer.Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Are there OTHER USES for this medicine?

Didanosine is also sometimes used with other medications to help prevent infection in healthcare workers or other people who were accidentally exposed to HIV. Talk to your doctor about the possible risks of using this medication for your condition.

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

HOW should this medicine be used?

Didanosine comes as extended-release (long-acting) capsules and as an oral solution (liquid) to take by mouth.The oral solution is usually taken once or twice a day 30 minutes before or 2 hours after eating. The extended-release capsules are usually taken once a day on an empty stomach. Take didanosine around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take didanosine exactly as directed. Do not take more or less of it, or take it more often than prescribed by your doctor.

If you are using the extended-release capsules, swallow them whole; do not split, chew, crush, break, or dissolve them. Tell your doctor if you are unable to swallow the extended-release capsules whole.

If you are taking the oral solution, you should shake it well before each use to mix the medication evenly. Use a dose-measuring spoon or cup to measure the correct amount of liquid for each dose, not a regular household spoon.

Didanosine controls HIV infection but does not cure it. Continue to take didanosine even if you feel well. Do not stop taking didanosine without talking to your doctor. If you miss doses or stop taking didanosine, your condition may become more difficult to treat.

What SPECIAL PRECAUTIONS should I follow?

Before taking didanosine,

• tell your doctor and pharmacist if you are allergic to didanosine, any other medications, or any of the ingredients in didanosine capsules or oral solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• some medications should not be taken with didanosine. Other medications may cause dosing changes or extra monitoring when taken with didansoine. Make sure you have discussed any medications you are currently taking or plan to take before starting didanosine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking didanosine, please get the advice of your doctor or pharmacist.

• the following nonprescription product may interact with didanosine: ranitidine (Zantac^®). Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking didanosine. Do not start this medication while taking didanosine without discussing with your healthcare provider.

• tell your doctor if you have or have ever had peripheral neuropathy (numbness, tingling, burning, or pain sensation in your hands or feet, or decreased ability to feel temperature or touch in your hands or feet) or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking didanosine, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking didanosine.

• you should know that didanosine may cause side effects that must be treated right away before they become serious. Children who are taking didanosine may not be able to tell you about the side effects they are feeling. If you are giving didanosine to a child, ask the child's doctor how you can tell if the child is having these serious side effects.

• you should know that you may have a loss of body fat from your face, legs, arms, and buttocks. Talk to your doctor if you notice this change.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms after starting treatment with didanosine, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Didanosine may cause side effects. Tell your doctor if this symptom is severe or does not go away:

• headache

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

• hives
• rash
• itching
• difficulty breathing or swallowing
• numbness, tingling, burning, or pain in hands or feet
• vision changes
• difficulty in seeing colors clearly

Didanosine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep didanosine capsules in the container they came in, tightly closed, and out of reach of children. Store them at room temperature and away from excess heat and moisture (not in the bathroom). Keep didanosine oral solution in the refrigerator, closed tightly, and dispose of any unused medication after 30 days.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• diarrhea
• numbness, tingling, burning, or pain in hands or feet
• nausea
• vomiting
• loss of appetite
• stomach pain
• swelling of the stomach
• muscle or joint pain
• extreme tiredness
• weakness
• dizziness
• lightheadedness
• fast, slow or irregular heartbeat
• deep or rapid breathing
• shortness of breath
• dark yellow or brown urine
• unusual bleeding or bruising
• vomiting a substance that is bloody or looks like coffee grounds
• dark stools
• yellowing of the skin or eyes
• feeling cold
• fever
• flu-like symptoms

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of didanosine on hand. Do not wait until you run out of medication to refill your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.