In the U.S.—

In Canada—

• Antiviral, systemic

Delavirdine ( de-la-VIR-deen) is used, in combination with other medicines, in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Delavirdine will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Delavirdine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S.and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For delavirdine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to delavirdine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Delavirdine has not been studied in pregnant women. However, studies in animals have shown that delavirdine causes birth defects when given in doses higher than those given to humans. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether delavirdine passes into the breast milk. However, if your baby does not already have the AIDS virus, there is a chance you could pass it to your baby by breast-feeding. Talk to your doctor first if you are thinking about breast-feeding your baby.

Older adults—Delavirdine has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking delavirdine, it is especially important that your health care professional know if you are taking any of the following:

• Alprazolam (e.g., Xanax) or
• Carbamazepine (e.g., Tegretol) or
• Cisapride (e.g., Propulsid) or
• Dihydroergotamine (e.g., D.H.E. 45) or
• Ergonovine (e.g., Ergotrate) or
• Ergotamine (e.g., Gynergen) or
• Lovastatin (e.g., Mevacor) or
• Methylergonovine (e.g., Methergine) or
• Midazolam (e.g., Versed) or
• Phenobarbital or
• Phenytoin (e.g., Dilantin) or
• Pimozide (e.g., Orap) or
• Rifabutin (e.g., Mycobutin) or
• Rifampin (e.g., Rifadin) or
• Simvastatin (e.g., Zocor) or
• St. John's Wort or
• Triazolam (e.g., Halcion)—These medicines should not be given with delavirdine due to the possibility of serious side effects.

• Acid blocking medicines, such as
• Cimetidine (e.g., Tagamet) or
• Famotidine (e.g., Pepcid) or
• Lansoprazole (e.g., Prevacid) or
• Nizatidine (e.g., Axid) or
• Omeprazole (e.g., Prilosec) or
• Ranitidine (e.g., Zantac)—Use of any these medicines with delavirdine may decrease the amount of delavirdine in the body

• Amphetamines—Use of this medicine with delavirdine may increase the amount of amphetamine in the body

• Amprenavir (e.g., Agenerase)—Use of this medicine with delavirdine may decrease the amount of amprenavir in the body

• Antacids—Use of this medicine with delavirdine may decrease the amount of delavirdine in the body. Delavirdine and antacids should be taken at least one hour apart

• Antiarrhythmics, such as
• Amiodarone (e.g., Cordarone) or
• Flecainide (e.g., Tambocor) or
• Lidocaine, systemic (e.g., Xylocaine) or
• Propafenone (e.g., Rythmol) or
• Quinidine (e.g., Quinaglute)—Use of any of these medicines with delavirdine may increase the amount of these antiarrhythmics in the body

• Bepridil (e.g., Vascor)—Use of this medicine with delavirdine may increase your risk for certain side effects

• Clarithromycin (e.g., Biaxin)—Use of this medicine with delavirdine may increase the amount of clarithromycin in your body

• Dexamethasone (e.g., Decadron)—Use of this medicine with delavirdine may decrease the amount of delavirdine in your body

• Didanosine (e.g., Videx)—Use of this medicine with delavirdine may decrease the amounts of both medicines in your body. Delavirdine and didanosine should be taken at least one hour apart

• Calcium channel blockers, such as
• Amlodipine (e.g., Norvasc) or
• Diltiazem (e.g., Cardizem) or
• Felodipine (e.g., Plendil) or
• Isradipine (e.g., DynaCirc) or
• Nicardipine (e.g., Cardene) or
• Nifedipine (e.g., Adalat) or
• Nimodipine (e.g., Nimotop) or
• Nisoldipine (e.g., Sular) or
• Verapamil (e.g., Calan)—Use of any of these medicines with delavirdine may increase the amount of these calcium channel blocking medicines in the body

• HMG-CoA reductase inhibitors, such as
• Atorvastatin (e.g., Lipitor) or
• Fluvastatin (e.g., Lescol)—Use of any of these medicines with delavirdine may increase the amount of these HMG-CoA reductase inhibitor medicines in the body

• Immunosuppressants, such as
• Cyclosporine (e.g., Neoral) or
• Sirolimus (e.g., Rapamune) or
• Tacrolimus (e.g., Prograf)—Use of any of these medicines with delavirdine may increase the amount of these immunosuppressant medicines in the body

• Indinavir (e.g., Crixivan)—Use of this medicine with delavirdine may increase the amount of indinavir in your body

• Lopinavir and Ritonavir combination therapy (e.g., Kaletra)—Use of this medicine with delavirdine may increase the amount lopinavir and ritonavir in your body

• Methadone (e.g., Dolophine)—Use of this medicine with delavirdine may increase the amount of methadone in your body

• Ritonavir (e.g., Norvir)—Use of this medicine with delavirdine may increase the amount of ritonavir in your body

• Saquinavir (e.g., Fortovase)—Use of this medicine with delavirdine may increase the amount of saquinavir in your body

• Sildenafil (e.g., Viagra)—Use of this medicine with delavirdine may increase the amount of sildenafil in your body

• Warfarin (e.g., Coumadin)—Use of this medicine with delavirdine may increase the amount of warfarin in your body

• Achlorhydria (absence of stomach acid)—Delavirdine should be taken with an acidic beverage such as orange or cranberry juice

• Liver disease—Effects of delavirdine may be increased because of slower removal from the body

This medicine can be taken with our without food.

It is very important that you find out about medicines that can not be taken with delavirdine.

It is best to swallow both the 100 milligram (mg) and 200 milligram (mg) tablets whole. However, if swallowing is difficult, the 100 milligram (mg) tablet can be put in a glass of water (at least 3 ounces), allowed to sit for a few minutes, and then stirred to mix. Drink the mixture right away. Then rinse the glass with water and drink that rinse to make sure the full dose is taken.Only the 100 milligram (mg) tablets can be put into a glass of water to dissolve. The 200 milligram (mg) tablets must be swallowed whole.

Do not take any antacid medications within 1 hour of the time you take delavirdine. They may prevent delavirdine from being absorbed into the body.

For patients with achlorhydria (absence of stomach acid) they should take delavirdine with a glass of orange juice or cranberry juice.

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Keep taking delavirdine for the full time of treatment, even if you begin to feel better.

Dosing—

The dose of delavirdine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of delavirdine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For treatment of HIV infection:
    • Adults—400 mg three times a day in combination with other antiretroviral medicines. Your healthcare professional will decide on the other medicines needed and how much you will use.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Skin rash (severe) with itching 
  
  

• Less common
  • Skin rash with symptoms such as fever, blistering, oral lesions, conjunctivitis, swelling, muscle aches, or joint aches 
  
  

• Rare
  • Difficulty in breathing 
  
  

• Incidence unknown
  • Agitation;  back, leg, or stomach pains ;  bleeding gums;  chills ;  coma;  confusion;  dark urine;  decreased urine output;  depression;  difficulty breathing;  dizziness;  fatigue;  fever;  general body swelling;  headache;  hostility;  irritability ;  lethargy;  loss of appetite ;  muscle twitching;  nausea ;  nosebleeds;  pale skin ;  rapid weight gain;  seizures (convulsions);  sore throat;  stupor;  swelling of face, ankles, or hands;  unusual tiredness or weakness;  vomiting ;  yellowing of the eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Body aches or pain;  cough;  diarrhea;  discouragement;  ear congestion;  fear;  feeling sad or empty;  general feeling of discomfort or illness;  joint pain;  lack or loss of strength;  loss of interest or pleasure ;  loss of voice;  muscle aches and pains;  nasal congestion;  nervousness;  pain, localized ;  pain or tenderness around eyes and cheekbones;  runny nose;  shivering;  shortness of breath;  sneezing;  sweating;  tightness in chest;  tiredness;  trouble concentrating;  trouble sleeping;  wheezing 
  
  

• Less common
  • Abdominal pain, generalized ;  dryness or soreness of throat;  hoarseness;  sleeplessness;  tender, swollen glands in neck;  trouble in swallowing;  unable to sleep ;  voice changes 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.