Rescriptor

Generic Name: delavirdine (DEL-a-VIR-deen)
Brand Name: Rescriptor

Rescriptor is used for:

Treating HIV infection. It must be used in combination with at least 2 other anti-HIV medicines.

Rescriptor is a nonnucleoside reverse transcriptase inhibitor (NNRTI). It works by blocking the growth of HIV.

Do NOT use Rescriptor if:

  • you are allergic to any ingredient in Rescriptor
  • you are taking another NNRTI (eg, efavirenz, nevirapine)
  • you are taking alprazolam, astemizole, carbamazepine, cisapride, an ergot alkaloid (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), everolimus, fosamprenavir, hydantoins (eg, phenytoin), lovastatin, midazolam, phenobarbital, pimozide, rifamycins (eg, rifampin), simvastatin, St. John's wort, terfenadine, or triazolam

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Rescriptor:

Some medical conditions may interact with Rescriptor. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems or decreased acid production in the stomach (achlorhydria)
  • if you have never taken medicine to treat HIV before
  • if you have kidney problems, especially if you are also taking clarithromycin

Some MEDICINES MAY INTERACT with Rescriptor. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Carbamazepine, dexamethasone, H2-receptor antagonists (eg, famotidine, ranitidine), nelfinavir, phenobarbital, phenytoin, proton pump inhibitors (PPIs) (eg, omeprazole), rifamycins (eg, rifampin), or St. John's wort because they may decrease Rescriptor's effectiveness
  • Alprazolam, amphetamines (eg, dextroamphetamine), antiarrhythmics (eg, amiodarone, bepridil quinidine), anticoagulants (eg, warfarin), calcium channel blockers (eg, amlodipine, verapamil), ciclesonide, cisapride, cyclosporine, ergot alkaloids (eg, dihydroergotamine, ergotamine, methylergonovine), everolimus, fluticasone, HIV protease inhibitors (eg, ritonavir), HMG-CoA reductase inhibitors (statins) (eg, atorvastatin, lovastatin, simvastatin), certain hormonal birth control (eg, containing ethinyl estradiol), ixabepilone, maraviroc, methadone, midazolam, nilotinib, pimozide, rapamycin, sildenafil, tacrolimus, trazodone, or triazolam because the risk of their side effects may be increased by Rescriptor

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rescriptor may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rescriptor:

Use Rescriptor as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Rescriptor. Talk to your pharmacist if you have questions about this information.
  • Take Rescriptor with or without food. Patients with achlorhydria (low stomach acid levels) should take Rescriptor with an acidic drink, such as orange or cranberry juice.
  • Do NOT take antacids or didanosine within 1 hour of taking Rescriptor.
  • Certain strengths of Rescriptor may be dissolved in water. Before doing so, make sure that your strength of Rescriptor can be dissolved in water. To dissolve, add the tablets to at least 3 ounces (90 mL) of water. Allow the medicine to stand in the water for a few minutes. Stir the mixture until the tablets dissolve completely and drink it immediately. Rinse the glass with water and drink the rinse to be sure the entire dose is taken. Do not store the mixture for future use.
  • Take Rescriptor on a regular schedule around the clock, unless your doctor tells you otherwise.
  • Continue to take Rescriptor even if you feel well. Do not miss any doses.
  • If you miss a dose of Rescriptor, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss several doses, contact your health care provider.

Ask your health care provider any questions you may have about how to use Rescriptor.

Important safety information:

  • Rescriptor may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Rescriptor with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not take more than the recommended dose, change your dose, or stop taking Rescriptor without checking with your doctor. Taking more than the recommended dose of Rescriptor may not provide additional benefits and may increase the risk of side effects.
  • Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using Rescriptor. Be sure that each of your health care providers knows all the medicines that you are taking.
  • Rescriptor is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Rescriptor does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • You may develop a rash while taking Rescriptor. This usually occurs within 1 to 3 weeks after starting Rescriptor and usually lasts less than 2 weeks. Check with your doctor if you develop a rash. Contact your doctor immediately if you develop a serious or severe rash, with or without fever, blisters, mouth or tongue swelling or sores, eye redness or inflammation, swelling, or muscle or joint aches.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Rescriptor, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Rescriptor. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Rescriptor may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Rescriptor.
  • Lab tests, including liver function tests, may be performed while you use Rescriptor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Rescriptor should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if Rescriptor can cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rescriptor while you are pregnant. It is not known if Rescriptor is found in breast milk. Do not breast-feed while taking Rescriptor. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Rescriptor to the baby.

Possible side effects of Rescriptor:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild stomach pain; nausea; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; burning, numbness, or tingling; changes in the amount of urine produced; confusion; decreased coordination; fast, slow, or irregular heartbeat; fever, chills, or persistent cough or sore throat; hallucinations; memory problems; mental or mood changes (eg, anxiety, depression); mouth or tongue swelling or sores; muscle pain or weakness; red, swollen, blistered, or peeling skin; severe or persistent dizziness or headache; severe stomach or back pain (with or without nausea or vomiting); shortness of breath; skin rash (with or without blisters, eye redness or inflammation, swelling, or muscle or joint aches); swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine; pale stools; persistent loss of appetite; yellowing of the skin or eyes); tremors; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Rescriptor:

Store Rescriptor at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rescriptor out of the reach of children and away from pets.

General information:

  • If you have any questions about Rescriptor, please talk with your doctor, pharmacist, or other health care provider.
  • Rescriptor is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Rescriptor or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Rescriptor. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Rescriptor. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Rescriptor.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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