Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Prezista

Descriptions


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). This medicine is given to patients who have already had previous treatment for HIV or who have never taken HIV medicines in the past.

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 this medicine may continue to have other problems related to AIDS or HIV disease.

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

This product is available in the following dosage forms:

  • Tablet
  • Suspension

Before Using

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.

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

Information about this darunavir-oral-route
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.

Breastfeeding

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.

Drug Interactions

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.

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

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

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.

  • 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

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. 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 this medicine. 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

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

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

This medicine 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 this medicine 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 this medicine once a day and you miss a dose or forget to use it, and it is more than 12 hours 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 less than 12 hours 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 this medicine two times a day and you miss a dose or forget to use it, and it is more than 6 hours 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 less than 6 hours 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 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 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

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

Do not use this medicine 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.

This medicine 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 this medicine. Check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: 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 this medicine.

This medicine 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.

This medicine 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. This medicine 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.

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

  1. Blurred vision
  2. dry mouth
  3. flushed, dry skin
  4. fruit-like breath odor
  5. increased hunger
  6. increased thirst
  7. increased urination
  8. skin rash
  9. sweating
  10. troubled breathing
  11. unexplained weight loss
  12. unusual tiredness or weakness

Rare

  1. Abdominal or stomach pain or tenderness
  2. acid or sour stomach
  3. belching
  4. blistering, peeling, or loosening of the skin
  5. bloating
  6. chills
  7. clay colored stools
  8. constipation
  9. cough
  10. dark urine
  11. decreased appetite
  12. diarrhea
  13. difficulty with moving
  14. dizziness
  15. excess air or gas in the stomach or intestines
  16. fast heartbeat
  17. fever
  18. full feeling
  19. headache
  20. heartburn
  21. indigestion
  22. itching
  23. joint or muscle pain
  24. lack or loss of strength
  25. light-colored stools
  26. loss of appetite
  27. muscle aching or cramping
  28. nausea and vomiting
  29. passing gas
  30. red skin lesions, often with a purple center
  31. red, irritated eyes
  32. sore throat
  33. sores, ulcers, or white spots in the mouth or on the lips
  34. swelling of the feet or lower legs
  35. swollen joints
  36. unpleasant breath odor
  37. vomiting of blood
  38. yellow eyes or skin

Incidence not known

  1. Muscle pain or stiffness
  2. 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

  1. Stuffy or runny nose

Less common

  1. 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.