Delavirdine

IMPORTANT NOTICE:

Delavirdine is no longer available in the United States.

WHY is this medicine prescribed?

Delavirdine is used along with other medications to treat human immunodeficiency virus (HIV) infection. Delavirdine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by decreasing the amount of HIV in the blood. Although delavirdine 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 life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Are there OTHER USES for this medicine?

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Delavirdine comes as a tablet to take by mouth. It usually is taken three times a day with or without food. Take delavirdine around the same times 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 delavirdine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you have trouble swallowing the 100-mg tablets, they may be dispersed in water. To prepare, add four tablets to at least 3 ounces (90 milliliters) of water, allow to stand for a few minutes, and then stir until all tablets dissolve. Drink the delavirdine-water mixture right away. Rinse the glass and swallow the rinse to ensure that you have gotten the entire dose. The 200-mg tablets (which are smaller than the 100-mg tablets) should always be swallowed whole, because they do not readily dissolve in water.

Your doctor may tell you to take delavirdine tablets with orange or cranberry juice if you have certain medical conditions such as achlorhydria (a condition in which stomach has little or no acid). Follow these directions carefully.

Delavirdine may control HIV but will not cure it. Continue to take delavirdine even if you feel well. Do not stop taking delavirdine or any of the other medications that you are taking to treat HIV or AIDS without talking to your doctor. When your supply of delavirdine starts to run low, get more from your doctor or pharmacist. If you miss doses or stop taking delavirdine, your condition may become more difficult to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking delavirdine,

• tell your doctor and pharmacist if you are allergic to delavirdine, any other medications, or any of the ingredients in delavirdine tablets. Ask your pharmacist for a list of the ingredients.

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

• The following nonprescription or herbal products may interact with delavirdine: St. John's wort; medications for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), lansoprazole (Prevacid), omeprazole (Prilosec), and ranitidine (Zantac). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking delavirdine. Do not start any of these medications while taking delavirdine without discussing with your healthcare provider..

• if you are taking didanosine (Videx), take it at least 1 hour before or 1 hour after taking delavirdine.

• if you are taking antacids, take the antacid at least 1 hour before or 1 hour after taking delavirdine.

• tell your doctor if you have or have ever had achlorhydria (condition in which stomach has little or no acid) or liver or kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking delavirdine, call your doctor. Tell your doctor if you are breast-feeding. You should not breast-feed if you are infected with HIV or if you are taking delavirdine.

• you should know that your body fat may increase or move to different areas of your body such as your breasts, upper back and neck, or around the middle of your body. Loss of fat from the legs, arms, and face can also happen.

• 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 delavirdine, 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. If you miss several doses, call your doctor to ask how you should continue taking delavirdine.

What SIDE EFFECTS can this medicine cause?

Delavirdine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• excessive tiredness
• headache
• nausea
• diarrhea
• rash

Some side effects can be serious. If you experience any of the following symptoms, stop taking delavirdine and call your doctor immediately or get emergency medical treatment:

• rash along with other symptoms such as fever, blistering, sores in the mouth, red or swollen eyes, or muscle or joint pain
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Delavirdine 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to delavirdine.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.