Darunavir and cobicistat

Darunavir and cobicistat are used to treat HIV-1 infection in treatment-naïve and treatment-experienced adults and children 3 years of age and older who weigh at least 33 pounds (15 kg) with no darunavir resistance. They are used in combination with other human immunodeficiency virus (HIV-1) medicines.

• HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
• Your healthcare provider will check for darunavir resistance-associated substitutions before starting darunavir and cobicistat.
• It is not known if these medicines are safe and effective in children weighing less than 33 pounds (15 kg).

Darunavir + cobicistat is a combination oral antiviral tablet that contains darunavir (a protease inhibitor) and cobicistat (a CYP3A inhibitor), taken once daily. Darunavir and cobicistat tablets for oral suspension must be dispersed in drinking water and taken immediately with food.

Darunavir and cobicistat (Prezcobix) gained FDA approval on January 29, 2015. Darunavir and cobicistat PED (Prezcobix PED) was FDA approved on February 27, 2026.

See the Instructions for Use for detailed instructions on how to prepare and give a dose of darunavir and cobicistat PED tablets for oral suspension.

Take exactly as your healthcare provider tells you to take it.

Do not change your dose or stop taking darunavir and cobicistat without talking to your healthcare provider. Stay under a healthcare provider’s care during treatment with darunavir and cobicistat.

Darunavir and cobicistat PED tablets for oral suspension are not the same as darunavir and cobicistat tablets. Check to make sure you receive the correct dosage form each time you or your child’s prescription is filled to avoid using the wrong medicine.

Take darunavir and cobicistat 1 time a day with food.

Darunavir and cobicistat PED tablets for oral suspension must be broken apart (dispersed) in drinking water and given right away after preparation. Do not crush, chew, or swallow darunavir and cobicistat PED tablets for oral suspension.

For children weighing at least 55 pounds (25 kg) who cannot swallow the 675 mg/150 mg tablet whole: The scored tablet can be split by hand into 2 pieces. The scored tablet can be split by hand into 2 pieces. The line on the tablet (score line) will help you break it. After splitting the tablet, swallow the 2 pieces right away to get the full dose of darunavir and cobicistat.

When your darunavir and cobicistat supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to darunavir and cobicistat and become harder to treat.

If you take too much darunavir and cobicistat, call your healthcare provider or go to the nearest hospital emergency room right away.

Darunavir and cobicistat may cause serious side effects, including:

• Liver problems. People taking darunavir and cobicistat may develop liver problems, which may be life-threatening and can lead to death. Your healthcare provider should do blood tests before and during your treatment with darunavir and cobicistat. If you have chronic hepatitis B or C or other liver problems, your healthcare provider may check your blood tests more often because you have an increased risk of developing liver problems. Tell your healthcare provider right away if you develop any new or worsening signs or symptoms of liver problems, including: Tiredness Dark (tea colored) urine Yellowing of your skin or the whites of your eyes Pale colored stools (bowel movements) Nausea Vomiting Pain or tenderness on your right side below your ribs Loss of appetite.
• Severe skin reactions or rash. A skin rash is common during treatment with darunavir and cobicistat, but it can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking darunavir and cobicistat and call your healthcare provider right away if you develop a severe rash or a rash with any of the following symptoms: Fever Tiredness Muscle or joint pain Blisters or skin lesions Mouth sores or ulcers Red or inflamed eyes, like “pink eye” (conjunctivitis).
• Kidney problems. Darunavir + cobicistat, when taken with certain other medicines, can cause new or worsening kidney problems, including kidney failure. Your healthcare provider should check your kidneys before you start and during treatment with darunavir and cobicistat.

Do not take darunavir and cobicistat if you take certain medications. See the list of medications under What other drugs will affect darunavir and cobicistat.

Before taking darunavir and cobicistat, tell your healthcare provider about all your medical conditions, including if you:

• Have liver problems, including hepatitis B or hepatitis C, or liver disease (cirrhosis)
• Have kidney problems
• Are allergic to sulfa (sulfonamide)
• Have diabetes
• Have hemophilia
• Are pregnant or plan to become pregnant
• Are you breastfeeding or plan to breastfeed.

Pregnancy

It is not known if darunavir and cobicistat will harm your unborn baby.

• Darunavir and cobicistat should not be used during pregnancy because the darunavir and cobicistat levels in your blood may be lower during pregnancy and may not control your HIV-1.
• Tell your healthcare provider right away if you become pregnant during treatment with darunavir and cobicistat.
• Your healthcare provider will prescribe different medicines if you become pregnant during treatment with darunavir and cobicistat.
• Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patches, and some birth control pills, may not work during treatment with darunavir and cobicistat.
• Talk to your healthcare provider about forms of birth control that may be used during treatment with darunavir and cobicistat.
• Pregnancy Exposure Registry: There is a pregnancy exposure registry for people who take darunavir and cobicistat during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Breastfeeding

It is not known if darunavir and cobicistat passes into your breast milk. Talk to your healthcare provider about the following risks of breastfeeding during treatment with darunavir and cobicistat:

• The HIV-1 virus may pass to your baby if your baby does not have HIV-1.
• The HIV-1 virus may become harder to treat if your baby has HIV-1.
• Your baby may get side effects from darunavir and cobicistat.

The most common side effects of darunavir, one of the medicines in darunavir and cobicistat, are:

• Diarrhea
• Nausea
• Rash
• Headache
• Stomach-area (abdominal) pain
• Vomiting.

Serious Side Effects and Warnings

Darunavir and cobicistat may cause the following serious side effects (also see Important Information above):

• Diabetes and high blood sugar (hyperglycemia). New or worsening diabetes and hyperglycemia have happened in people who take protease inhibitors, including darunavir and cobicistat. Some people have had to start taking medicine to treat diabetes or have had to change their diabetes medicine. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often during treatment with darunavir and cobicistat.
• Changes in body fat can happen in people who take HIV-1 medicines. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). 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 HIV1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you have any symptoms of infection after starting your HIV-1 medicine.
• Increased bleeding for people with hemophilia. Some people with hemophilia have increased bleeding with protease inhibitors, including darunavir and cobicistat.

These are not all of the possible side effects of darunavir and cobicistat. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Darunavir and cobicistat contain 2 ingredients: darunavir and cobicistat. Darunavir is a protease inhibitor that works by blocking HIV-1 protease, preventing the HIV-1 virus from maturing and replicating in infected cells. Cobicistat is a CYP3A inhibitor that boosts the effectiveness of darunavir by inhibiting CYP3A enzymes, which increases its absorption into the bloodstream.

Darunavir and cobicistat belong to the drug class called antiviral combinations

Dose of darunavir and cobicistat for HIV-1

• Adults and Children ≥40 kg: One 800 mg/150 mg tablet taken once daily with food.
• Children 25 kg to l<40 kg: One 675 mg/150 mg tablet taken once daily with food.
• Children 3 years + weighing ≥15 kg to <25 kg: One 600 mg/90 mg tablet for oral suspension (Darunavir and cobicistat PED) taken once daily with food. Darunavir and cobicistat tablets for oral suspension must be dispersed in drinking water and taken immediately with food.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, topical creams, vitamins, and herbal supplements. Some medicines interact with darunavir and cobicistat. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with darunavir and cobicistat.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take darunavir and cobicistat with other medicines. Do not take Darunavir and cobicistat or Darunavir and cobicistat PED with any medicine that contains:

• Alfuzosin
• Carbamazepine
• 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
• Phenobarbital
• Phenytoin
• Pimozide
• Ranolazine
• Rifampin
• Sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH)
• Simvastatin
• St. John’s wort (Hypericum perforatum)
• Triazolam

If you also take enteric-coated didanosine (Videx EC), take it 1 hour before or 2 hours after you take Darunavir and cobicistat.

Serious problems can happen if you take any of these medicines with Darunavir and cobicistat or Darunavir and cobicistat PED. This is not a complete list of medicines. Therefore, tell your healthcare provider about all medicines you take.

Store darunavir and cobicistat at room temperature between 68 °F and 77 °F (20 °C and 25°C).

Both bottles have a child-resistant cap.

Store Darunavir and cobicistat PED tablets for oral suspension in the original container to protect from light. Keep the container tightly closed.

Keep out of reach of children.

Active ingredients: darunavir and cobicistat

Inactive ingredients 800 mg/150 mg tablet: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, and silicified microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.

Inactive ingredients 675 mg/150 mg tablet: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.

Inactive ingredients 600 mg/90 mg tablet for oral suspension: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, silicified microcrystalline cellulose, strawberry flavor, and sucralose. The tablets are film-coated with a coating material containing glycerol monocaprylocaprate type 1, iron oxide red, iron oxide black, macrogol polyvinyl alcohol graft copolymer, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.

Darunavir and cobicistat tablets/tablets for oral suspension are manufactured for: Janssen Products, LP, Horsham, PA 19044, USA.