Darunavir (Prezista): Uses, Side Effects and Dosage

What is the most important information I should know about darunavir tablets?

• Ask your healthcare provider or pharmacist about medicines that should not be taken with darunavir tablets. For more information, see “Who should not take darunavir tablets?” and “What should I tell my healthcare provider before taking darunavir tablets?”

• Darunavir tablets may cause liver problems.Some people taking darunavir tablets in combination with ritonavir have developed liver problems, which may be life-threatening. Your healthcare provider should do blood tests before and during your darunavir tablets and ritonavir combination treatment. 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. o dark (tea colored) urine o vomiting

  • yellowing of your skin or whites of your eyes o pain or tenderness on your right side below your ribs
  • pale colored stools (bowel movements) o loss of appetite
  • nausea o tiredness
• Darunavir tablets 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. Tell your healthcare provider right away if you develop a rash. Stoptaking darunavir tablets and ritonavir combination treatment and tell your healthcare provider right away if you have any skin changes with symptoms below:

• fever o blisters or skin lesions
• tiredness o mouth sores or ulcers
• muscle or joint pain
• red or inflamed eyes, like “pink eye” (conjunctivitis)

Rash occurred more often in people taking darunavir tablets and raltegravir together than with either drug separately, but was generally mild.

See “What are the possible side effects of darunavir tablets?”for more information about side effects.

What are darunavir tablets?

Darunavir tablets are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with ritonavir and other antiretroviral medicines to treat HIV-1 infection in adults and children 3 years of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

Darunavir tablets should not be used in children under 3 years of age.

When used with other antiretroviral medicines to treat HIV-1 infection, darunavir tablets may help:

• reduce the amount of HIV-1 in your blood. This is called “viral load”.
• increase the number of CD4+ (T) cells in your blood that help fight off other infections.

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Darunavir tablets does not cure HIV-1 infection or AIDS.You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

Avoid doing things that can spread HIV-1 infection to others:

• Do not share or re-use 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.

Who should not take darunavir tablets?

Do not take darunavir tabletswith any medicine that contains:

• 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

Serious problems can happen if you or your child take any of these medicines with darunavir tablets. This is not a complete list of medicines. Therefore, tell your healthcare provider about allmedicines you take.

What should I tell my healthcare provider before taking darunavir tablets?

Before taking darunavir tablets, 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
• have any other medical conditions

• are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant while taking darunavir tablets.

  • Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this 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. Do not breastfeed if you take darunavir tablets.

  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • It is not known if darunavir can pass into your breast milk.
  • Talk to your healthcare provider about the best way to feed your baby.

  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 tablets. 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 tablets.
• 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 tablets with other medicines.

How should I take darunavir tablets?

• Take darunavir tablets exactly as your healthcare provider tells you.
• You must take ritonavir at the same time as darunavir tablets.
• Do not change your dose or stop treatment with darunavir tablets without talking to your healthcare provider.
• Take darunavir tablets and ritonavir with food.
• If you have difficulty swallowing darunavir tablets, darunavir oral suspension is also available. Your healthcare provider will help decide whether darunavir tablets or oral suspension is right for you.
• If your child is taking darunavir tablets, 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 (tablets or oral suspension) and how much ritonavir (capsules, tablets or solution) your child should take. Your child should take darunavir tablets with ritonavir with food. If your child does not tolerate ritonavir oral solution, ask your child’s healthcare provider for advice.
• Darunavir oral suspension should be given with the supplied oral dosing syringe. Shake the suspension well before each use. See the “Instructions for Use” that come with darunavir oral suspension for information about the right way to prepare and take a dose.
• It is important that you do not miss or skip doses of darunavir tablets during treatment.
• If you take too much darunavir, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of darunavir tablets?

Darunavir tablets may cause serious side effects, including:

• See “ What is the most important information I should know about darunavir tablets?”
• Diabetes and high blood sugar (hyperglycemia).Some people who take protease inhibitors including darunavir tablets 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 tablets.
• Changes in body fatcan 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 start having new symptoms after starting your HIV-1 medicine.
• Increased bleeding for hemophiliacs.Some people with hemophilia have increased bleeding with protease inhibitors including darunavir tablets.

The most common side effects of darunavir tablets include:

• diarrhea • headache
• nausea • stomach-area (abdominal) pain
• rash • vomiting

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 tablets.

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 darunavir tablets?

• Store darunavir tablets at room temperature 77°F (25°C).

Keep darunavir tablets and all medicines out of the reach of children.

General information about the safe and effective use of darunavir tablets.

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

This leaflet summarizes the most important information about darunavir tablets. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about darunavir tablets that is written for health professionals. For more information, call 1-866-495-1995.

What are the ingredients in darunavir tablets?

Active ingredient: darunavir amorphous

Inactive ingredients:

colloidal silicon dioxide, crospovidone, magnesium stearate, silicified microcrystalline cellulose. The film coating contains iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Manufactured for:

Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854

By: Annora Pharma Pvt. Ltd.

Sangareddy - 502313, Telangana, India.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 01/2025