Darunavir is an HIV-1 protease inhibitor. It works to treat HIV by preventing the enzyme HIV protease from cutting Gag-Pol polyproteins in infected cells into smaller functional viral proteins and enzymes. This process helps to stop infected cells’ from growing and infecting other healthy cells in the body.
What Is Prezista Used For?
Prezista is a prescription medication used along with ritonavir and other antiretroviral medications to treat HIV-1 infection in adults and children 3 years of age and older.
Brand Name(s): Prezista
Drug Availability: Prescription
Therapeutic Classification: HIV-1 protease inhibitor
Available Generically: No
Controlled Substance: No
Administration Route: Oral
Active Ingredient: Darunavir ethanolate
Dosage Form(s): Oral tablet, oral suspension
How to Take Prezista
Prezista should always be taken with ritonavir to treat your HIV-1 infection. Prezista and ritonavir must be taken at the same time. Your healthcare provider may have you take additional medications for your HIV-1 infection. Hence, it’s essential to take all medications at the right time and in the order prescribed by your healthcare provider.
Your healthcare provider will tell you how much Prezista to take daily. Do not take more than directed. Prezista should be taken by mouth with food, as follows:
If you take the oral tablet: Swallow it whole with water or milk. Do not crush, break, or chew the tablet. If you are taking the oral liquid: Measure the amount of liquid medicine prescribed with a marked measuring spoon, oral syringe, or medicine cup. Please be sure to shake the bottle well before each use.
Do not stop taking Prezista without first talking with your healthcare provider. If you stop taking this medication without your healthcare provider’s knowledge, your HIV-1 infection could become more challenging to treat.
Storage
Prezista should be stored in a closed container at room temperature (68 to 77 degrees Fahrenheit), away from heat, moisture, and direct light. Keep the oral liquid in its original container. Do not refrigerate or freeze it.
Keep all your medications away from the sight and reach of children and pets.
Discard any unused or expired drugs. Ask your pharmacist if you do not know the best ways to discard your medicine. Ask about drug take-back programs in your area.
Off-Label Uses
Healthcare providers may prescribe Prezista and other antiretroviral medications for off-label uses, meaning for conditions not specifically indicated by the Food and Drug Administration (FDA).
Off-label uses of Prezista include:
Nonoccupational post-exposure prophylaxis (nPEP): Prevention of HIV-1 infection in people exposed to the HIV-1 virus outside of work, for example, during sex or as a result of sharing needles to inject drugsOccupational postexposure prophylaxis (PEP): Prevention of HIV-1 infection in people exposed to the HIV-1 virus while working in a healthcare setting
What Are the Side Effects of Prezista?
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
Common side effects of Prezista include:
Nausea Vomiting Diarrhea Stomach pain Headache Rash Hypertriglyceridemia (increased triglyceride levels) Increased cholesterol levels
Severe Side Effects
Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you are having a medical emergency. Serious side effects and their symptoms can include the following:
Signs of an allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing Severe skin reactions like acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis: Blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like conjunctivitis (pink eye), fever, tiredness, muscle or joint pain Diabetes mellitus and hyperglycemia (increased blood sugar): Increased hunger or thirst, change in how much or how often you urinate Acute pancreatitis (inflammation of the pancreas) Hepatitis (inflammation of the liver): Jaundice (yellowing of the skin and whites of the eyes), dark (tea-colored) urine, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, loss of appetite, tiredness Unusual weight loss or weight gain Increased bleeding, bruising, or weakness
Long-term effects of Prezista are lacking.
Dosage: How Much Prezista Should I Take?
Modifications
Pregnancy: Not enough scientific evidence is available to determine harm to a fetus when a pregnant person takes Prezista. If you’re pregnant, talk with your healthcare provider before starting Prezista.
If you experience a serious side effect, you or your provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
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. Weighing 40 kg or more—800 mg (8 mL) with 100 mg (1. 25 mL) of ritonavir once a day. Weighing 30 kg to less than 40 kg—675 mg (6. 8 mL) with 100 mg (1. 25 mL) of ritonavir once a day. Weighing 15 kg to less than 30 kg—600 mg (6 mL) with 100 mg (1. 25 mL) of ritonavir once a 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. Weighing 14 kg to less than 15 kg—490 mg (5 mL) with 96 mg (1. 2 mL) of ritonavir once a day. Weighing 13 kg to less than 14 kg—455 mg (4. 6 mL) with 80 mg (1 mL) of ritonavir once a day. Weighing 12 kg to less than 13 kg—420 mg (4. 2 mL) with 80 mg (1 mL) of ritonavir once a day. Weighing 11 kg to less than 12 kg—385 mg (4 mL) with 64 mg (0. 8 mL) of ritonavir once a day. Weighing 10 kg to less than 11 kg—350 mg (3. 6 mL) with 64 mg (0. 8 mL) of ritonavir once a day. 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. 25 mL) 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. Weighing 40 kg or more—600 mg (6 mL) with 100 mg (1. 25 mL) of ritonavir 2 times a day. Weighing 30 kg to less than 40 kg—450 mg (4. 6 mL) with 60 mg (0. 75 mL) of ritonavir 2 times a day. Weighing 15 kg to less than 30 kg—375 mg (3. 8 mL) with 48 mg (0. 6 mL) of ritonavir 2 times a 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. Weighing 14 kg to less than 15 kg—280 (2. 8 mL) with 48 mg (0. 6 mL) of ritonavir 2 times a day. Weighing 13 kg to less than 14 kg—260 mg (2. 6 mL) with 40 mg (0. 5 mL) of ritonavir 2 times a day. Weighing 12 kg to less than 13 kg—240 mg (2. 4 mL) with 40 mg (0. 5 mL) of ritonavir 2 times a day. Weighing 11 kg to less than 12 kg—220 mg (2. 2 mL) with 32 mg (0. 4 mL) of ritonavir 2 times a day. Weighing 10 kg to less than 11 kg—200 mg (2 mL) with 32 mg (0. 4 mL) of ritonavir 2 times a 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. Weighing 40 kg or more—800 mg (8 mL) with 100 mg (1. 25 mL) of ritonavir once a day. Weighing 30 kg to less than 40 kg—675 mg (6. 8 mL) with 100 mg (1. 25 mL) of ritonavir once a day. Weighing 15 kg to less than 30 kg—600 mg (6 mL) with 100 mg (1. 25 mL) of ritonavir once a 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. Weighing 14 kg to less than 15 kg—490 mg (5 mL) with 96 mg (1. 2 mL) of ritonavir once a day. Weighing 13 kg to less than 14 kg—455 mg (4. 6 mL) with 80 mg (1 mL) of ritonavir once a day. Weighing 12 kg to less than 13 kg—420 mg (4. 2 mL) with 80 mg (1 mL) of ritonavir once a day. Weighing 11 kg to less than 12 kg—385 mg (4 mL) with 64 mg (0. 8 mL) of ritonavir once a day. Weighing 10 kg to less than 11 kg—350 mg (3. 6 mL) with 64 mg (0. 8 mL) of ritonavir once a day. Children younger than 3 years of age—Use is not recommended.
Breastfeeding: Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
Adults over the age of 65 years: Clinical studies haven’t included a large enough number of people in this age group to determine whether they respond differently than do younger adults.
Liver problems: The use of Prezista is not recommended for people with severe liver problems.
Contraception: Prezista may interfere with how well hormonal birth control works to prevent pregnancy. People wanting to prevent pregnancy should use a nonhormonal form of birth control such as condoms during sex in addition to taking their hormonal form of birth control.
Difficulty swallowing tablets: If you have difficulty swallowing or are unable to swallow whole tablets, your healthcare provider can prescribe the liquid suspension form of Prezista. Shake the bottle well before each use.
Sulfa allergy: Darunavir contains sulfonamide (contains sulfur). Prezista should be used with caution in people with a known sulfonamide allergy. In clinical studies with Prezista, the incidence and severity of rash were similar in people with or without a history of sulfonamide allergy.
Missed Dose
If you accidentally forget your Prezista dose, take it as soon as you remember. If it’s already close to your next scheduled dose, skip the missed dose and wait to take the following dose at your next scheduled dosing time.
To be more specific, if you take Prezista once a day and your missed dose is more than 12 hours late, skip the missed dose and take the following dose at your next scheduled dosing time.
If you take Prezista two times a day and your missed dose is more than six hours late, skip the missed dose and take the following dose at your next scheduled dosing time. Don’t take extra medicine to make up for a missed dose.
If you miss too many doses, your HIV-1 infection may become harder to treat. Try to find ways to help yourself remember to keep your appointments and take your medication routinely.
Overdose: What Happens If I Take Too Much Prezista?
There is limited information available about Prezista overdose.
If you think that you’re experiencing an overdose or life-threatening symptoms, however, seek immediate medical attention.
Precautions
What Are Reasons I Shouldn’t Take Prezista?
You should not take Prezista if you have a known allergic reaction to Prezista, ritonavir, or any of their ingredients. In addition, do not use Prezista if you are taking any medications that contain:
If someone collapses or isn’t breathing after taking Prezista, call 911 immediately.
Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), dronedarone (Multaq®), elbasvir/grazoprevir (Zepatier®), ivabradine (Corlaonor®), lomitapide (Juxtapid®, Lojuxta®), lovastatin (Altocor®, Altoprev®, Mevacor®), lurasidone (Latuda®), naloxegol (Movantik®, Moventig®), 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®). Do not use this medicine together with colchicine (Colcrys®) if you have kidney or liver disease.
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. Autoimmune disorders (eg, Graves’ disease, polymyositis, or Guillain-Barré syndrome) may also occur.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis can occur with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
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.
AlfuzosinColchicine, if you have liver or kidney problemsDronedaroneElbasvir and grazoprevirErgot-containing medicines, such as dihydroergotamine, ergotamine tartrate, methylergonovineIvabradineLomitapideLovastatinLurasidoneMidazolam, when taken by mouthNaloxegolPimozideRanolazineRifampinSildenafil, when used for the treatment of pulmonary arterial hypertension (PAH)SimvastatinSaint-John’s-wort (Hypericum perforatum)Triazolam
Serious problems can occur if you take any of these medicines with Prezista.
Please let your healthcare provider know if you have liver disease (including hepatitis or cirrhosis), diabetes, or hemophilia because taking Prezista may worsen your condition. Tell your healthcare provider if you are allergic to sulfa drugs because you could have an allergic reaction to Prezista.
What Other Medications Interact With Prezista?
There are several major interactions for Prezista. Do not take Prezista with the following medications:
Alfuzosin Colchicine, if you have liver or kidney problems Dronedarone Elbasvir and grazoprevir Ergot-containing medicines: dihydroergotamine, ergotamine tartrate, methylergonovine Ivabradine Lomitapide Lovastatin Lurasidone Midazolam, when taken by mouth Naloxegol Pimozide Ranolazine Rifampin Sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH) Simvastatin St. John’s wort (Hypericum perforatum) Triazolam
Use caution when taking Prezista with the following medications:
Birth control pills that contain drospirenone, ethinyl estradiol, or norethindrone Blood thinners (including clopidogrel, prasugrel, ticagrelor, and warfarin) Medicine to treat mental illness (including quetiapine) Steroid medicine (including betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, and triamcinolone)
This is not a complete list of medicines that interact with Prezista. Be sure to talk with your healthcare provider before taking any new medication (including nonprescription, over-the-counter (OTC) products, vitamins, herbs, or plant-based medicines. and herbal drugs).
If you are also taking didanosine, take it at least one hour before or two hours after you take Prezista.
Asl your pharmacist or healthcare provider for more detailed information about medication interactions with Prezista.
What Medications Are Similar?
Other HIV-1 protease inhibitors like Prezista include:
Reyataz (atazanavir) Lexiva (fosamprenavir) Crixivan (indinavir) Kaletra (lopinavir/ritonavir) Viracept (nelfinavir) Norvir (ritonavir) Aptivus (tipranavir) Evotaz (atazanavir/cobicistat) Prezcobix (darunavir/cobicistat)
How Can I Stay Healthy While Taking Prezista?
Prezista does not cure HIV-1 infection or AIDS. You must keep taking Prezista along with ritonavir and the other HIV-1 medications prescribed to you to control HIV-1 infection and decrease HIV-related illnesses. Refer to the Verywell Health guide for living with HIV/AIDS and the following tips:
Prezista will not keep you from giving HIV to others. Always practice safer sex, even if your partner also has HIV. Use a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Do not share needles or other items that may have blood or body fluids on them. Continue to follow up and attend scheduled healthcare provider’s appointments while taking Prezista. Your healthcare provider will perform regular lab tests to determine how Prezista works for you. If you’ve not already done so, begin to build a support network. This can help your emotional well-being. Quit smoking or using tobacco if you do. Eat a balanced diet. Consider working with a team that includes a registered dietitian (RD) or registered dietitian nutritionist (RDN) to help identify your specific nutritional needs.
