Patient information: uses, side effects, how to take - Prezcobix

What is the most important information I should know about PREZCOBIX and PREZCOBIX PED?

PREZCOBIX and PREZCOBIX PED may cause serious side effects, including:

Liver problems. People taking PREZCOBIX or PREZCOBIX PED 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 PREZCOBIX or PREZCOBIX PED. 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 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. Skin rash is common during treatment with PREZCOBIX or PREZCOBIX PED but can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking PREZCOBIX or PREZCOBIX PED 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. PREZCOBIX and PREZCOBIX PED 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 PREZCOBIX or PREZCOBIX PED.

See "What are the possible side effects of PREZCOBIX or PREZCOBIX PED?" for more information about side effects.

What are PREZCOBIX and PREZCOBIX PED?

PREZCOBIX and PREZCOBIX PED are prescription medicines that are used with other human immunodeficiency virus (HIV-1) medicines to treat HIV-1 in adults and in children 3 years of age and older who weigh at least 33 pounds (15 kg).

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

PREZCOBIX and PREZCOBIX PED contain the prescription medicines darunavir and cobicistat.

It is not known if PREZCOBIX or PREZCOBIX PED are safe and effective in children weighing less than 33 pounds (15 kg).

Do not take PREZCOBIX or PREZCOBIX 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

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

Before taking PREZCOBIX or PREZCOBIX PED, 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. It is not known if PREZCOBIX or PREZCOBIX PED will harm your unborn baby.
- PREZCOBIX or PREZCOBIX PED should not be used during pregnancy because the PREZCOBIX or PREZCOBIX PED 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 PREZCOBIX or PREZCOBIX PED.
- Your healthcare provider will prescribe different medicines if you become pregnant during treatment with PREZCOBIX or PREZCOBIX PED.
- 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 PREZCOBIX or PREZCOBIX PED. Talk to your healthcare provider about forms of birth control that may be used during treatment with PREZCOBIX or PREZCOBIX PED.
- Pregnancy Exposure Registry: There is a pregnancy exposure registry for people who take PREZCOBIX or PREZCOBIX PED 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.
are breastfeeding or plan to breastfeed. It is not known if PREZCOBIX or PREZCOBIX PED passes into your breast milk.
- Talk to your healthcare provider about the following risks of breastfeeding during treatment with PREZCOBIX or PREZCOBIX PED:
  - 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 PREZCOBIX or PREZCOBIX PED.

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 PREZCOBIX or PREZCOBIX PED. 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 PREZCOBIX or PREZCOBIX PED.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take PREZCOBIX or PREZCOBIX PED with other medicines.

How should I take PREZCOBIX or PREZCOBIX PED?

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

Take PREZCOBIX or PREZCOBIX PED exactly as your healthcare provider tells you to take it.
Do not change your dose or stop taking PREZCOBIX or PREZCOBIX PED without talking to your healthcare provider. Stay under a healthcare provider's care during treatment with PREZCOBIX or PREZCOBIX PED.
PREZCOBIX PED tablets for oral suspension are not the same as PREZCOBIX 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 PREZCOBIX or PREZCOBIX PED 1 time a day with food.
PREZCOBIX 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 PREZCOBIX 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 PREZCOBIX.
When your PREZCOBIX or PREZCOBIX PED 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 PREZCOBIX or PREZCOBIX PED and become harder to treat.
If you take too much PREZCOBIX or PREZCOBIX PED, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of PREZCOBIX or PREZCOBIX PED?

PREZCOBIX or PREZCOBIX PED may cause serious side effects, including:

See " What is the most important information I should know about PREZCOBIX or PREZCOBIX PED? "
Diabetes and high blood sugar (hyperglycemia). New or worsening diabetes and hyperglycemia have happened in people who take protease inhibitors including PREZCOBIX or PREZCOBIX PED. 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 PREZCOBIX or PREZCOBIX PED.
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 HIV-1 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 PREZCOBIX or PREZCOBIX PED.

The most common side effects of darunavir, one of the medicines in PREZCOBIX or PREZCOBIX PED, include:

diarrhea
nausea
rash

headache
stomach-area (abdominal) pain
vomiting

These are not all of the possible side effects of PREZCOBIX or PREZCOBIX PED.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store PREZCOBIX or PREZCOBIX PED?

Store PREZCOBIX or PREZCOBIX PED at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
PREZCOBIX and PREZCOBIX PED come in a bottle with a child-resistant cap.
Store PREZCOBIX PED tablets for oral suspension in the original container to protect from light. Keep the container tightly closed.

Keep PREZCOBIX, PREZCOBIX PED and all medicines out of reach of children.

General information about the safe and effective use of PREZCOBIX or PREZCOBIX PED.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZCOBIX or PREZCOBIX PED for a condition for which it was not prescribed. Do not give PREZCOBIX or PREZCOBIX PED to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about PREZCOBIX or PREZCOBIX PED that is written for health professionals.

What are the ingredients in PREZCOBIX and PREZCOBIX PED?

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.

Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA

For patent information: www.janssenpatents.com

For more information call 1-800-526-7736.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.		Issued: 02/2026
INSTRUCTIONS FOR USE PREZCOBIX^®PED (prez-koe-bix ped) (darunavir and cobicistat) tablets for oral suspension
This Instructions for Use contains information on how to prepare and give PREZCOBIX PED. Read this Instructions for Use before your child starts taking PREZCOBIX PED for the first time and each time you get a refill. There may be new information. Important information you need to know before giving PREZCOBIX PED: Give PREZCOBIX PED exactly as your healthcare provider tells you. Each time you receive your child's prescription, check the bottle to make sure that you received PREZCOBIX PED tablets for oral suspension. PREZCOBIX PED tablets for oral suspension are not the same as PREZCOBIX tablets. Contact your pharmacist or healthcare provider if you did not receive the correct dosage form. Do not crush, chew or swallow PREZCOBIX PED tablets for oral suspension. Talk to your healthcare provider or pharmacist if you have any questions on how to prepare or give the prescribed dose of PREZCOBIX PED.
Supplies needed to prepare and give PREZCOBIX PED: bottle of PREZCOBIX PED tablets for oral suspension (not included with PREZCOBIX PED) a clean empty cup non-carbonated room temperature drinking water tablespoon teaspoon orange juice, applesauce, or yogurt (optional)
Step 1: Remove the child-resistant cap from the PREZCOBIX PED bottle
	Open the bottle by pushing down on the child-resistant cap while turning it left (counter-clockwise). Remove the unscrewed cap. Remove 1 tablet. Do not crush the tablet.
Step 2: Place the tablet in a cup
	Place the tablet in a clean empty cup.
Step 3: Replace the child-resistant cap on the PREZCOBIX PED bottle
	Close the bottle by replacing the child-resistant cap and turning it right (clockwise).
Step 4: Add 30 mL (2 tablespoons) of non-carbonated room temperature drinking water.
	Add 30 mL (2 tablespoons) of non-carbonated room temperature drinking water to the cup. Do not crush the tablet.
Step 5: Stir well with a spoon
	Stir well with a spoon until the tablet completely breaks apart (disperses). The prepared medicine will appear reddish purple.
If you spill any medicine, clean up the spill. Throw away the rest of the prepared medicine and make a new dose. You must give the prepared medicine right away. If you do not give the prepared medicine right away, throw away the mixture and prepare a new dose of medicine.
Step 6: Give PREZCOBIX PED
Give all the prepared medicine right away or you may add 10 mL (2 teaspoons) of non-carbonated room temperature drinking water or orange juice, or 1 teaspoon of applesauce or yogurt to the prepared medicine to make it easier to take. Mix and give all of the prepared medicine right away. Add another 5 mL (1 teaspoon) of non-carbonated drinking water to the cup, swirl and give to drink completely. Repeat this step as needed to make sure the entire dose is taken.
Step 7: Clean the dosing items
Wash all the items used to prepare the medicine thoroughly with water. Make sure they are clean and dry before preparing the next dose.
Storing PREZCOBIX PED Store PREZCOBIX PED at room temperature between 68 °F to 77 °F (20 °C to 25 °C). PREZCOBIX PED comes in a bottle with a child-resistant cap. Store PREZCOBIX PED tablets for oral suspension in the original container to protect from light. Keep the container tightly closed. Keep PREZCOBIX PED and all medicines out of the reach of children.
Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA For patent information: www.janssenpatents.com © Johnson & Johnson and its affiliates 2026 For more information call 1-800-526-7736.