Delavirdine

>10%

Rash (32-35%)

Headache (19-20%)

Fever (4-12%)

Depression (10-15%)

Nausea (20%)

Vomiting (3-11%)

1-10%

Diarrhea (4-6%)

Anxiety (6-8%)

Abdominal pain (4-6%)

Increased prothrombin time (2%)

Bronchitis (6-8%)

Decreased hemoglobin (1-3%)

Frequency Not Defined

Adenopathy

Anorexia

Chest congestion

Colitis

Conjunctivitis

Gastroenteritis

Hypertension

Urinary tract infection

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.

Unless your doctor tells you otherwise, continue your normal diet.

• Rescriptor^®

Tablets: 100 and 200 mg

Delavirdine should be stored at room temperature, 15 C to 30 C (59 F to 86 F).

Avoid taking an antacid within 1 hour before or after you take delavirdine. Some antacids can make it harder for your body to absorb delavirdine.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Tell your doctor about all other medicines you use, especially:

• methadone (Methadose, Dolophine);
• sildenafil (Viagra, Revatio);
• ADHD medication such as Adderall;
• an antibiotic such as clarithromycin (Biaxin) or rifapentine (Priftin);
• an antidepressant such as nefazodone or trazodone (Desyrel);
• antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend);
• atorvastatin (Lipitor, Caduet) or fluvastatin (Lescol);
• a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal);
• a blood thinner such as warfarin (Coumadin, Jantoven);
• heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cardizem, Cartia, Dilacor, Diltia, Diltzac, Taztia, Tiazac), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan, Tarka), and others;
• heart rhythm medicine such as amiodarone (Cordarone), flecainide (Tambocor), or propafenone (Rythmol), or quinidine (Quin-G);
• the hepatitis C medications boceprevir (Victrelis) or telaprevir (Incivek);
• HIV/AIDS medication such as didanosine (Videx), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, Kaletra), saquinavir (Invirase);
• medicine to treat or prevent organ transplant rejection;
• steroid medicine such as dexamethasone (Cortastat, Dexasone, Solurex, DexPak) or fluticasone (Advair, Flovent, Flonase); or
• stomach medications such as Axid, Pepcid, Prevacid, Prilosec, Tagamet, or Zantac.

This list is not complete and there are many other medicines that can interact with delavirdine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Tell your doctor if you are breastfeeding, it is very important that you speak with your healthcare provider about the best way to feed your baby. If your baby does not already have HIV, there is a chance that it can be transmitted through breastfeeding. The Centers for Disease Control and Prevention recommends that women with HIV do not breastfeed.

If you take too much delavirdine call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

In the U.S.

• Rescriptor

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor

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 delavirdine may continue to have other problems usually related to AIDS or HIV disease.

delavirdine is available only with your doctor's prescription.

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 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.

Geriatric

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.

Pregnancy

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.

Interactions with 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 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 delavirdine 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.

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

Using delavirdine 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.

• Amiodarone
• Artemether
• Bedaquiline
• Bepridil
• Bosutinib
• Brentuximab Vedotin
• Bupropion
• Cabazitaxel
• Ceritinib
• Cilostazol
• Cimetidine
• Cobicistat
• Crizotinib
• Darunavir
• Delamanid
• Domperidone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Etravirine
• Famotidine
• Flecainide
• Idelalisib
• Ifosfamide
• Ixabepilone
• Ketoconazole
• Lansoprazole
• Lidocaine
• Lovastatin
• Lumefantrine
• Lurasidone
• Methadone
• Nevirapine
• Nizatidine
• Olaparib
• Omeprazole
• Panobinostat
• Paroxetine
• Phenobarbital
• Piperaquine
• Propafenone
• Quinidine
• Ranitidine
• Rifabutin
• Rifampin
• Rilpivirine
• Ruxolitinib
• Saquinavir
• Simeprevir
• Simvastatin
• St John's Wort
• Tacrolimus
• Vilazodone
• Voriconazole

Using delavirdine 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
• Desogestrel
• Didanosine
• Dienogest
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Drospirenone
• Ergoloid Mesylates
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fluoxetine
• Indinavir
• Lacidipine
• Lercanidipine
• Levonorgestrel
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Manidipine
• Medroxyprogesterone Acetate
• Mestranol
• Nelfinavir
• Nilvadipine
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Quinupristin
• Rifapentine
• Ritonavir
• Sildenafil

Interactions with Food/Tobacco/Alcohol

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 delavirdine. 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

delavirdine 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 delavirdine 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 delavirdine 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.

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 delavirdine, 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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Hypersensitivity to delavirdine or any component of the formulation; concurrent use of alprazolam, astemizole, cisapride, ergot alkaloids, midazolam, pimozide, rifampin, terfenadine, or triazolam

HIV-1 infection (part of combination): Adolescents ≥16 years: Refer to adult dosing.

Store at 20°C to 25°C (68°F to 77°F). Protect from humidity.

Liver function tests if administered with saquinavir

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea or vomiting. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), burning or numbness feeling, urinary retention, change in amount of urine passed, confusion, change in balance, abnormal heartbeat, hallucinations, memory impairment, mood changes, severe dizziness, passing out, severe headache, shortness of breath, excessive weight gain, swelling of arms or legs, pale skin, bruising, bleeding, severe loss of strength and energy, vision changes, eye pain, severe eye irritation, change in body fat, severe diarrhea; black, tarry, or bloody stools; vomiting blood; involuntary eye movements; or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

400 mg orally 3 times a day

The US Department of Health and Human Services does not recommend delavirdine as part of an initial regimen due to its inferior antiviral efficacy. Efavirenz is currently the NNRTI of choice.

16 years or older: 400 mg orally 3 times a day

The US Department of Health and Human Services does not recommend delavirdine as part of an initial regimen due to its inferior antiviral efficacy. Efavirenz is currently the NNRTI of choice.

Data not available

Since delavirdine is extensively metabolized by the liver and is highly protein-bound, it is not expected to be significantly removed by dialysis.

Substance Name

Delavirdine

CAS Registry Number

147221-93-0

Drug Class

Antiinfective Agents

Anti-HIV Agents

Antiviral Agents

Anti-Retroviral Agents

Reverse Transcriptase Inhibitors