Rescriptor (Oral)

Delavirdine is used with other medicines to treat infections caused by the human immunodeficiency virus (HIV). HIV is the virus that leads to acquired immune deficiency syndrome (AIDS).

Delavirdine will not cure or prevent HIV infection or AIDS; however, it helps stop HIV from multiplying and seems to slow down the damage to the immune system. This may help postpone the problems often linked to AIDS or HIV disease. Delavirdine will not prevent you from transmitting HIV to others. People taking this medicine may still experience other issues commonly associated with AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

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

In deciding to use a medicine, it's important to consider the risks of taking it compared to the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Geriatric

Delavirdine has not been specifically studied in older people. Therefore, it is not known if it causes different side effects or issues in the elderly compared to younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should never be used together, there are cases where two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole
• Carbamazepine
• Cisapride
• Conivaptan
• Dihydroergotamine
• Ergonovine
• Ergotamine
• Fosamprenavir
• Fosphenytoin
• Isavuconazonium Sulfate
• Maraviroc
• Methylergonovine
• Midazolam
• Naloxegol
• Nimodipine
• Phenytoin
• Pimozide
• Rifabutin
• Terfenadine
• Tolvaptan
• Triazolam

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alprazolam
• Amiodarone
• Artemether
• Bedaquiline
• Benzhydrocodone
• Bepridil
• Brentuximab Vedotin
• Buprenorphine
• Bupropion
• Cabazitaxel
• Cabotegravir
• Ceritinib
• Cilostazol
• Cimetidine
• Clozapine
• Cobicistat
• Codeine
• Crizotinib
• Darunavir
• Delamanid
• Dihydrocodeine
• Domperidone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Etravirine
• Famotidine
• Fentanyl
• Fexinidazole
• Finerenone
• Flecainide
• Hydrocodone
• Ifosfamide
• Ketoconazole
• Lansoprazole
• Lemborexant
• Lidocaine
• Lovastatin
• Lumefantrine
• Lurasidone
• Meperidine
• Methadone
• Nevirapine
• Nizatidine
• Olaparib
• Omeprazole
• Oxycodone
• Panobinostat
• Pentazocine
• Phenobarbital
• Piperaquine
• Propafenone
• Quinidine
• Ranitidine
• Rifampin
• Rilpivirine
• Saquinavir
• Simeprevir
• Simvastatin
• Sirolimus Protein-Bound
• St John's Wort
• Sufentanil
• Tacrolimus
• Tramadol
• Venlafaxine
• Voriconazole
• Zolpidem

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amprenavir
• Cerivastatin
• Clarithromycin
• Dalfopristin
• Didanosine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Ergoloid Mesylates
• Fluoxetine
• Indinavir
• Lacidipine
• Lercanidipine
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Manidipine
• Nelfinavir
• Nilvadipine
• Quinupristin
• Rifapentine
• Ritonavir
• Sildenafil

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

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

• Liver disease—Effects of delavirdine may be stronger because it is removed from the body more slowly.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

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

More common

• Severe skin rash with itching

Less common

• Skin rash with symptoms like fever, blistering, mouth sores, eye inflammation, swelling, muscle aches, or joint aches

Rare

• Trouble 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

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also have ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Body aches or pain
• Cough
• Diarrhea
• Feeling discouraged
• 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
• Localized pain
• 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

• Generalized abdominal pain
• Dryness or soreness of throat
• Hoarseness
• Sleeplessness
• Tender, swollen glands in neck
• Trouble swallowing
• Unable to sleep
• Voice changes

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Rescriptor

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor

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.

Note: 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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 possible. 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.