darunavir (Oral route)

dar-UE-na-vir

Commonly used brand name(s)

In the U.S.

  • Prezista

Available Dosage Forms:

  • Tablet
  • Suspension

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

Uses For darunavir

Darunavir is used in combination with ritonavir (Norvir®) and other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). darunavir is given to patients who have already had previous treatment for HIV or who have never taken HIV medicines in the past.

Slideshow: Flashback: FDA Drug Approvals 2013

Darunavir will not cure HIV infection or prevent AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Darunavir will not keep you from spreading HIV to other people. People who receive darunavir may continue to have other problems related to AIDS or HIV disease.

darunavir is available only with your doctor's prescription.

Before Using darunavir

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 darunavir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to darunavir 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of darunavir in children 3 years of age and older. Because of darunavir's toxicity, use in children younger than 3 years of age is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of darunavir in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving darunavir.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 darunavir, 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 darunavir 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.

  • Alfuzosin
  • Astemizole
  • Cisapride
  • Colchicine
  • Dihydroergotamine
  • Ergonovine
  • Ergotamine
  • Lomitapide
  • Lovastatin
  • Methylergonovine
  • Midazolam
  • Pimozide
  • Primidone
  • Rifampin
  • Sildenafil
  • Simvastatin
  • St John's Wort
  • Terfenadine
  • Triazolam

Using darunavir 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
  • Atorvastatin
  • Bepridil
  • Boceprevir
  • Bosentan
  • Bosutinib
  • Carbamazepine
  • Clozapine
  • Cyclophosphamide
  • Dabrafenib
  • Dexamethasone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Eslicarbazepine Acetate
  • Fentanyl
  • Flecainide
  • Fluticasone
  • Hydrocodone
  • Ibrutinib
  • Lidocaine
  • Lopinavir
  • Lurasidone
  • Mitotane
  • Piperaquine
  • Propafenone
  • Quinidine
  • Rifabutin
  • Rifapentine
  • Salmeterol
  • Saquinavir
  • Simeprevir
  • Tacrolimus
  • Tadalafil
  • Telaprevir
  • Vilazodone
  • Voriconazole

Using darunavir 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.

  • Buprenorphine
  • Clarithromycin
  • Cobicistat
  • Desogestrel
  • Dienogest
  • Digoxin
  • Drospirenone
  • Efavirenz
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Indinavir
  • Ketoconazole
  • Levonorgestrel
  • Lumefantrine
  • Medroxyprogesterone Acetate
  • Mestranol
  • Methadone
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Paroxetine
  • Pravastatin
  • Sertraline
  • Tenofovir
  • Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

  • Diabetes mellitus or
  • Hemophilia (a bleeding problem) or
  • Hyperglycemia (high blood sugar) or
  • Liver disease or other liver problems (eg, cirrhosis, hepatitis)—Use with caution. May make these conditions worse.
  • Liver disease, severe—Use is not recommended in patients with this condition.
  • Sulfa allergy, known or suspected—Use with caution. May make side effects worse.

Proper Use of darunavir

Take darunavir exactly as directed by your doctor. Do not change the dose or stop using darunavir without checking first with your doctor. When your supply of darunavir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of darunavir.

darunavir is always taken with ritonavir (Norvir®). Take these two medicines at the same time, unless your doctor tells you otherwise.

darunavir comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.

If you also use didanosine (Videx®), take it at least 1 hour before or 2 hours after taking darunavir and ritonavir.

It is important that darunavir be taken with food in order to work properly.

Swallow the tablet whole with water or milk. Do not crush, break, or chew it.

If you are using the oral liquid, shake the bottle well before measuring each dose. Use the dosing syringe that comes with the package to measure each dose.

If you take darunavir once a day and you miss a dose or forget to use it, and it is since your last dose, wait and take your next dose at the normal time. If you miss a dose or forget to use it, and it is since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

If you take darunavir two times a day and you miss a dose or forget to use it, and it is since your last dose, wait and take your next dose at the normal time. If you miss a dose or forget to use it, and it is since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

Dosing

The dose of darunavir 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 darunavir. 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 forms (suspension or tablets):
    • For HIV infection (patient already had HIV treatment):
      • For patients with no darunavir resistance associated substitution:
        • Adults—800 milligrams (mg) (one 800 mg tablet or two 400 mg tablet or 8 milliliters [mL]) once a day with 100 mg of ritonavir (Norvir®).
        • Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 600 to 800 mg (6 to 8 mL) of darunavir once a day with 100 mg (1.25 mL) of ritonavir (Norvir®).
        • Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 350 to 490 mg (3.6 to 5 mL) of darunavir once a day with 64 to 96 mg (0.8 to 1.2 mL) of ritonavir (Norvir®).
        • Children younger than 3 years of age—Use is not recommended.
      • For patients with at least one darunavir resistance associated substitution:
        • Adults—600 milligrams (mg) (one 600 mg tablet or 6 mL) two times a day with 100 mg of ritonavir (Norvir®).
        • Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 375 to 600 mg (3.8 to 6 mL) of darunavir taken with 48 to 100 mg (0.6 to 1.25 mL) of ritonavir (Norvir®) two times per day.
        • Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 200 to 280 mg (2 to 2.8 mL) of darunavir taken with 32 to 48 mg (0.4 to 0.6 mL) of ritonavir (Norvir®) two times per day.
        • Children younger than 3 years of age—Use is not recommended.
    • For HIV infection (patient never had HIV treatment):
      • Adults—800 milligrams (mg) (one 800 mg tablet or two 400 mg tablet or 8 milliliters [mL]) of darunavir once a day with 100 mg of ritonavir (Norvir®).
      • Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 600 to 800 mg (6 to 8 mL) of darunavir once a day with 100 mg (1.25 mL) of ritonavir (Norvir®).
      • Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 350 to 490 mg (3.6 to 5 mL) of darunavir once a day with 64 to 96 mg (0.8 to 1.2 mL) of ritonavir (Norvir®).
      • Children younger than 3 years of age—Use is not recommended.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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

Keep the oral liquid in its original container. Do not refrigerate or freeze it.

Precautions While Using darunavir

It is very important that your doctor check your or your child's progress at regular visits to make sure darunavir is working properly. Blood tests may be needed to check for unwanted effects.

Do not use darunavir if you or your child are also using alfuzosin (Uroxatral®), cisapride (Propulsid®), lovastatin (Altocor®, Altoprev®, Mevacor®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, Wigraine®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (eg, St. John's wort) or vitamin supplements.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

darunavir may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders such as Graves' disease, polymyositis, and Guillain-Barré syndrome may also occur.

Serious skin reactions can occur with darunavir. Check with your doctor right away if you or your child have any of the following symptoms while taking darunavir: blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, joint or muscle aches, sores or ulcers on the skin, or fever or chills while you are using darunavir.

darunavir may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Birth control pills may not work as well while you are using darunavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, a diaphragm, contraceptive foam or jelly.

darunavir will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. darunavir will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

darunavir Side Effects

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 immediately if any of the following side effects occur:

Less common
  • Blurred vision
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • skin rash
  • sweating
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
Rare
  • Abdominal or stomach pain or tenderness
  • acid or sour stomach
  • belching
  • blistering, peeling, or loosening of the skin
  • bloating
  • chills
  • clay colored stools
  • constipation
  • cough
  • dark urine
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • dizziness
  • excess air or gas in the stomach or intestines
  • fast heartbeat
  • fever
  • full feeling
  • headache
  • heartburn
  • indigestion
  • itching
  • joint or muscle pain
  • lack or loss of strength
  • light-colored stools
  • loss of appetite
  • muscle aching or cramping
  • nausea and vomiting
  • passing gas
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling of the feet or lower legs
  • swollen joints
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin
Incidence not known
  • Muscle pain or stiffness
  • swelling or puffiness of the face

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
  • Stuffy or runny nose
Less common
  • Gaining weight around your neck, upper back, breast, face, or waist

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.

See also: Side effects (in more detail)

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