Prezista (generic: darunavir) is a prescription medication used to treat human immunodeficiency virus (HIV) infection. Prezista belongs to a group of HIV medicines called a protease inhibitors. Prezista blocks HIV protease, an enzyme which is needed for HIV to multiply.
This medication comes in tablet form and is usually taken twice daily, with food.
Common side effects include diarrhea, nausea, vomiting, and headache.
Prezista is a prescription medication used with ritonavir and other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Prezista can cause side effects including:
- See "Drug Precautions" section.
- Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including Prezista can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking Prezista.
- Changes in body fat. These changes can happen in people who take antiretroviral therapy. The changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV medicine.
- Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including Prezista.
The most common side effects of Prezista include:
- stomach pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Prezista. For more information, ask your health care provider.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Prezista and many other medicines can interact. Sometimes serious side effects will happen if Prezista is taken with certain other medicines.
Do NOT take Prezista with any of the following medicines:
- alfuzosin (Uroxatral)
- dihydroergotamine (D.H.E. 45, Embolex, Migranal), ergonovine, ergotamine (Cafergot,Ergomar) methylergonovine
- pimozide (Orap)
- oral midazolam, triazolam (Halcion)
- the herbal supplement St. John's Wort (Hypericum perforatum)
- the cholesterol lowering medicines lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin)
- rifampin (Rifadin, Rifater, Rifamate, Rimactane)
- sildenafil (Revatio) only when used for the treatment of pulmonary arterial hypertension.
Serious problems can happen if you or your child take any of these medicines with Prezista.
Be sure to tell your healthcare provider if you take:
- medicine to treat HIV
- estrogen-based contraceptives (birth control). Prezista might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom.
- medicine for your heart such as bepridil, lidocaine (Xylocaine Viscous), quinidine (Nuedexta) , amiodarone (Pacerone, Cardarone), digoxin (Lanoxin), flecainide (Tambocor), propafenone (Rythmol)
- warfarin (Coumadin, Jantoven)
- medicine for seizures such as carbamazepine (Carbatrol, Equetro, Tegretol, Epitol), phenobarbital, phenytoin (Dilantin, Phenytek)
- medicine for depression such as trazadone and desipramine (Norpramin)
- clarithromycin (Prevpac, Biaxin)
- medicine for fungal infections such as ketoconazole (Nizoral), itraconazole (Sporanox, Onmel), voriconazole (VFend)
- colchicine (Colcrys, Col-Probenecid)
- rifabutin (Mycobutin)
- medicine used to treat blood pressure, a heart attack, heart failure, or to lower pressure in the eye such as metoprolol (Lopressor, Toprol-XL), timolol (Cosopt, Betimol, Timoptic, Isatolol, Combigan)
- midazolam administered by injection
- medicine for heart disease such as felodipine (Plendil), nifedipine
(Procardia, Adalat CC, Afeditab CR), nicardipine (Cardene)
- steroids such as dexamethasone, fluticasone (Advair Diskus, Veramyst, Flovent, Flonase)
- medicine to treat chronic hepatitis C such as boceprevir (Victrelis), telaprevir (Incivek)
- medicine for cholesterol such as pravastatin (Pravachol), atorvastatin (Lipitor), rosuvastatin (Crestor)
- medicine to prevent organ transplant failure such as cyclosporine
(Gengraf, Sandimmune, Neoral), tacrolimus (Prograf), sirolimus (Rapamune)
- salmeterol (Advair, Serevent)
- medicine for narcotic withdrawal such as methadone (Methadose, Dolophine Hydrochloride), buprenorphine (Butrans, Buprenex, Subutex), buprenorphine/naloxone (Suboxone)
- medicine to treat schizophrenia such as risperidone (Risperdal), thioridazine
- medicine to treat erectile dysfunction or pulmonary hypertension such as sildenafil (Viagra, Revatio), vardenafil (Levitra, Staxyn), tadalafil (Cialis, Adcirca)
- medicine to treat anxiety, depression or panic disorder such as sertraline (Zoloft), paroxetine (Paxil)
This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Do not start any new medicines while you are taking Prezista without first talking with your healthcare provider.
- Prezista can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with Prezista. See "Drug Interactions" section.
- Prezista may cause liver problems. Some people taking Prezista in combination with Norvir (ritonavir) have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with Prezista. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems.
- Tell your healthcare provider if you have any of the below signs and symptoms of liver problems.
- Dark (tea colored) urine
- yellowing of your skin or whites of your eyes
- pale colored stools (bowel movements)
- pain or tenderness on your right side below your ribs
- loss of appetite
Prezista may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking Prezista and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below:
- muscle or joint pain
- blisters or skin lesions
- mouth sores or ulcers
- red or inflamed eyes, like "pink eye" (conjunctivitis)
Rash occurred more often in patients taking Prezista and raltegravir together than with either drug separately, but was generally mild.
Children under 3 years of age should not take Prezista.
Prezista does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using Prezista.
Avoid doing things that can spread HIV-1 infection.
- Do not share needles or other injection equipment.
- Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
- Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.
Grapefruit and grapefruit juice may interact with Prezista and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Before taking Prezista, tell your healthcare provider if you:
- have liver problems, including hepatitis B or hepatitis C
- are allergic to sulfa medicines
- have high blood sugar (diabetes)
- have hemophilia
- are pregnant or planning to become pregnant.
- are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using
Tell your doctor if you are pregnant of plan to become pregnant. The effects of Prezista on pregnant women or their unborn babies are not known.
Pregnancy Registry: You and your healthcare provider will need to decide if taking Prezista is right for you. If you take Prezista while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is follow the health of you and your baby.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Prezista is excreted in human breast milk or if it will harm your nursing baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk.
- Take Prezista tablets every day exactly as prescribed by your healthcare provider. You must take ritonavir (Norvir) at the same time as Prezista.
- Do not change your dose of Prezista or stop treatment without talking to your healthcare provider first.
- Take Prezista and ritonavir (Norvir) with food.
- Swallow Prezista tablets whole with a drink.
- If your child is taking Prezista, your child's healthcare provider will decide the right dose based on your child's weight. Your child's healthcare provider will tell you how many Prezista tablets and how much ritonavir (Norvir) (capsules, tablet or solution) your child should take.
- Your child should take Prezista with ritonavir twice a day with food. If your child does not tolerate ritonavir oral solution, ask your child's healthcare provider for advice.
People who take Prezista one time a day:
- If you miss a dose of Prezista or ritonavir (Norvir) by more than 12 hours, wait and then take the next dose of Prezista and ritonavir (Norvir) at your regularly scheduled time. If you miss a dose of Prezista or ritonavir (Norvir) by less than 12 hours, take your missed dose of Prezista and ritonavir (Norvir) right away. Then take your next dose of Prezista and ritonavir (Norvir) at your regularly scheduled time.
People who take Prezista two times a day
- If you miss a dose of Prezista or ritonavir (Norvir) by more than 6 hours, wait and then take the next dose of Prezista and ritonavir (Norvir) at your regularly scheduled time.
- If you miss a dose of Prezista or ritonavir (Norvir) by less than 6 hours, take your missed dose of Prezista and ritonavir (Norvir) right away. Then take your next dose of Prezista and ritonavir (Norvir) at your regularly scheduled time.
- If a dose of Prezista or ritonavir (Norvir) is skipped, do not double the next dose. Do not take more or less than your prescribed dose of Prezista or ritonavir (Norvir) at any one time.
Take Prezista exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of Prezista must be individualized.
Treatment-Naïve Adult Patients
The recommended oral dose of Prezista is 800 mg taken with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL of a 80 mg/mL ritonavir oral solution) once daily and with food.
Treatment-Experienced Adult Patients with No Darunavir resistance associated substitutions:
Prezista 800 mg once daily with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL) once daily and with food.
Treatment-Experienced Adult Patients with at Least one Darunavir resistance associated substitutions:
Prezista 600 mg twice daily with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL) twice daily and with food.
Pediatric Patients (age 3 to less than 18 years)
Do not use once daily dosing in pediatric patients.
Healthcare professionals should pay special attention to accurate dose selection of Prezista, transcription of the medication order, dispensing information and dosing instruction to minimize risk for medication errors, overdose, and underdose.
Prescribers should select the appropriate dose of Prezista/ritonavir for each individual child based on body weight (kg) and should not exceed the recommended dose for treatment-experienced adults.
Before prescribing Prezista, children weighing greater than or equal to 15 kg should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a tablet, the use of Prezista oral suspension should be considered.
The recommended dose of Prezista/ritonavir for pediatric patients (3 to less than 18 years of age and weighing at least 10 kg is based on body weight and should not exceed the recommended treatment-experienced adult dose (Prezista/ritonavir 600/100 mg twice daily). Prezista should be taken with ritonavir twice daily and with food.
If you take too much Prezista, call your local Poison Control Center or seek emergency medical attention right away.
Active ingredient: darunavir
PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloric acid (for pH adjustment), purified water.
PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY White (polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).
PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY Orange (FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).
PREZISTA 800 MG Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, hypromellose. The film coating contains: OPADRY Dark Red (iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).
Store Prezista tablets at room temperature (77°F (25°C)). Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C)] is acceptable. Ask your healthcare provider or pharmacist if you have any questions about storing your tablets.