Darunavir

Darunavir is a prescription medication used to treat human immunodeficiency virus (HIV) infection. Darunavir belongs to a group of HIV medicines called protease inhibitors. Darunavir blocks HIV protease, an enzyme which is needed for HIV to multiply.

This medication comes in tablet and oral (by mouth) solution forms and is usually taken once or twice daily, with food.

Common side effects include diarrhea, nausea, vomiting, and headache.

Darunavir 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.

Darunavir may be found in some form under the following brand names:

• Prezista

Darunavir can cause serious side effects. See "Drug Precautions" section.

The most common side effects of darunavir include:

• diarrhea
• nausea
• vomiting
• headache
• stomach pain
• rash

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 darunavir. 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)
• 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 
• sildenafil (Viagra)
• ticagrelor (Brilinta)

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, amiodarone (Pacerone, Cordarone), 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 trazodone and desipramine (Norpramin)
• clarithromycin (Biaxin)
• clonazepam
• 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, Combigan)
• midazolam
• 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)
• bosentan (Tracleer)
• perphenazine
• narcotic analgesics such as fentanyl (Duragesic), oxycodone (Oxycontin, Roxicodone), tramadol (Ultram)
• 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)
• 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) or paroxetine (Paxil)

This is not a complete list of darunavir interactions. 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 darunavir without first talking with your healthcare provider.

Darunavir may cause serious side effects, including:

• Liver problems. Darunavir may cause liver problems. Some people taking darunavir 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 darunavir. 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)
  • nausea
  • vomiting
  • pain or tenderness on your right side below your ribs
  • loss of appetite
• Skin reactions or rash. Darunavir 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. Rash occurred more often in patients taking darunavir and raltegravir together than with either drug separately, but was generally mild. However, stop taking darunavir and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below: 
  • fever
  • tiredness
  • muscle or joint pain
  • blisters or skin lesions
  • mouth sores or ulcers
  • red or inflamed eyes, like "pink eye" (conjunctivitis)

Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including darunavir 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 darunavir.

• 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 darunavir.

Children under 3 years of age should not take darunavir.

Darunavir can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with darunavir. See "Darunavir Interactions" section.

Darunavir 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 darunavir. 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.

Do not take this medication if you are allergic to darunavir or to any of its ingredients. 

Grapefruit and grapefruit juice may interact with darunavir and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking darunavir, tell your healthcare provider if you:

• are allergic to darunavir or to any of its ingredients
• 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. 

Tell your doctor if you are pregnant of plan to become pregnant. The effects of darunavir on pregnant women or their unborn babies are not known.

Pregnancy Registry: You and your healthcare provider will need to decide if taking darunavir is right for you. If you take darunavir 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 darunavir 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 darunavir every day exactly as prescribed by your healthcare provider. You must take ritonavir (Norvir) at the same time as darunavir.

• Do not change your dose of darunavir or stop treatment without talking to your healthcare provider first.
• Take darunavir and ritonavir (Norvir) with food.
• Swallow darunavir tablets whole with a drink.
• If your child is taking darunavir, 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 much darunavir and how much ritonavir (Norvir) (capsules, tablet or solution) your child should take.
• Your child should take darunavir with ritonavir twice a day with food. If your child does not tolerate ritonavir oral solution, ask your child's healthcare provider for advice.

If you miss a dose of darunavir or ritonavir (Norvir), follow the instructions that your health care provider has given you. 

Do not take more or less than your prescribed dose of darunavir or ritonavir (Norvir) at any one time.

Take darunavir 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 darunavir must be individualized.

Treatment-Naïve Adult Patients

The recommended oral dose of darunavir 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:

Darunavir 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:

Darunavir 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 darunavir, 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 darunavir/ritonavir for each individual child based on body weight (kg) and should not exceed the recommended dose for treatment-experienced adults.

Before prescribing darunavir, 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 darunavir oral suspension should be considered.

The recommended dose of darunavir/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 (darunavir/ritonavir 600/100 mg twice daily). Darunavir should be taken with ritonavir twice daily and with food.

If you take too much darunavir call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If darunavir is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Store darunavir 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.