Pronunciation:

del-a-VIR-deen

Brand Names:

• Rescriptor

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Non-Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Delavirdine 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.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

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

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.

Breast-feeding—

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

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 required 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 cause an increased 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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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

Side Effects of This Medicine:

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care 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

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 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.