What is Prezista?

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 or prevent HIV infection or AIDS. It works by lowering the amount of HIV in the blood and it will also help your immune system. This may help delay some of the medical conditions that usually result from AIDS or HIV disease. Darunavir will not keep you from spreading HIV to other people.

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

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 and patient instructions. Read and follow these 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.

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.

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 8 milliliters [mL]) once a day with 100 mg (1.25 mL) 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) 2 times a day with 100 mg (1.25mL) of ritonavir (Norvir®).
      • Pregnant patients—600 mg taken with 100 mg of ritonavir (Norvir®) 2 times a day.
      • 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®) 2 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®) 2 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 8 milliliters [mL]) of darunavir once a day with 100 mg (1.25 mL) 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.

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.

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.

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:

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.

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.

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.

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.

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
• Carbamazepine
• Cisapride
• Colchicine
• Dihydroergotamine
• Domperidone
• Dronedarone
• Ergonovine
• Ergotamine
• Grazoprevir
• Lovastatin
• Lurasidone
• Maraviroc
• Methylergonovine
• Midazolam
• Phenobarbital
• Phenytoin
• Pimozide
• Ranolazine
• 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.

• Alfentanil
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Aprobarbital
• Atazanavir
• Atomoxetine
• Atorvastatin
• Avanafil
• Benzhydrocodone
• Boceprevir
• Bosentan
• Budesonide
• Buprenorphine
• Butabarbital
• Butalbital
• Ceritinib
• Clomipramine
• Codeine
• Conivaptan
• Cyclophosphamide
• Dabigatran Etexilate
• Dasabuvir
• Delavirdine
• Desipramine
• Desogestrel
• Dexamethasone
• Dextromethorphan
• Dibenzepin
• Didanosine
• Dienogest
• Dihydrocodeine
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Drospirenone
• Duloxetine
• Efavirenz
• Elvitegravir
• Erythromycin
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fentanyl
• Fluticasone
• Fluvastatin
• Fosamprenavir
• Fosnetupitant
• Gestodene
• Glecaprevir
• Haloperidol
• Hydrocodone
• Idelalisib
• Ifosfamide
• Imipramine
• Ivosidenib
• Levonorgestrel
• Lofepramine
• Lopinavir
• Lumacaftor
• Medroxyprogesterone Acetate
• Melitracen
• Meperidine
• Mephobarbital
• Mestranol
• Methadone
• Methohexital
• Modafinil
• Nafcillin
• Naloxegol
• Nelfinavir
• Netupitant
• Nevirapine
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Nortriptyline
• Olaparib
• Ombitasvir
• Ondansetron
• Opipramol
• Orlistat
• Oxcarbazepine
• Oxycodone
• Paritaprevir
• Pentazocine
• Pentobarbital
• Perphenazine
• Pibrentasvir
• Piperaquine
• Pitavastatin
• Pravastatin
• Prednisolone
• Prednisone
• Primidone
• Propranolol
• Protriptyline
• Quetiapine
• Rifabutin
• Rifapentine
• Rivaroxaban
• Rosuvastatin
• Salmeterol
• Saquinavir
• Secobarbital
• Simeprevir
• Sufentanil
• Tacrolimus
• Tadalafil
• Tamoxifen
• Telaprevir
• Thiopental
• Tianeptine
• Tipranavir
• Tramadol
• Trazodone
• Trimipramine
• Vardenafil
• Venlafaxine
• Vinblastine
• Vincristine

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.

• Clarithromycin
• Cobicistat
• Digoxin
• Indinavir
• Ketoconazole
• Tenofovir Disoproxil Fumarate

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.

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 (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.

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®), colchicine (Colcrys®), dronedarone (Multaq®), elbasvir/grazoprevir (Zepatier®), lomitapide (Juxtapid®, Lojuxta®), lovastatin (Altocor®, Altoprev®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Methergine®, Migranal®, Wigraine®).

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, diaphragm, contraceptive foam, or jelly. If you think you have become pregnant while using this medicine, tell your doctor right away.

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 right away if you or your child have increased thirst or increased urination. If you notice a change in the results of your or your child's blood or urine sugar tests, or if you have any questions, check with your doctor.

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, or may result in a flare-up of a hidden autoimmune disorder such as Graves disease, polymyositis, or Guillain-Barré syndrome.

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.

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.

This medicine may increase the risk of bleeding in patients with hemophilia (a bleeding disorder). Talk with your doctor about this risk.

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.

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.