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Prezcobix

Generic Name: cobicistat and darunavir (koe BIK i stat and dar UE na vir)
Brand Names: Prezcobix

What is Prezcobix?

Prezcobix contains a combination of darunavir and cobicistat. Darunavir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Cobicistat reduces the action of enzymes in your liver that break down certain antiviral medicines. This allows the antiviral medicines to be used more safely and effectively at lower doses.

Prezcobix is a combination medicine given together with other antiviral medicines to treat human immunodeficiency virus (HIV) in adults, the virus that can cause acquired immunodeficiency syndrome (AIDS).

Prezcobix is not a cure for HIV or AIDS.

Important information

Serious drug interactions can occur when certain medicines are used together with Prezcobix. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Call your doctor at once if you have signs of a serious side effect - upper stomach pain, vomiting, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), fever, tiredness, eye redness, muscle or joint pain, skin sores, or a skin rash with blistering.

Before taking this medicine

You should not take Prezcobix if you are allergic to cobicistat or darunavir.

Some medicines can interact with cobicistat and darunavir and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • alfuzosin;

  • cisapride;

  • colchicine;

  • dronedarone;

  • elbasvir and grazoprevir (Zepatier);

  • ranolazine;

  • rifampin;

  • sildenafil (Revatio, for treating pulmonary arterial hypertension);

  • St. John's wort;

  • medicine to lower cholesterol - lovastatin, simvastatin;

  • antipsychotic medicine - lurasidone, pimozide;

  • oral sedatives - midazolam, triazolam;

  • ergot medicines - dihydroergotamine, ergotamine, methylergonovine; or

  • seizure medicine - carbamazepine, phenobarbital, phenytoin.

To make sure Prezcobix is safe for you, tell your doctor if you have ever had:

  • liver disease (especially hepatitis B or C);

  • kidney disease;

  • a bleeding or blood clotting disorder such as hemophilia;

  • an allergy to sulfa drugs;

  • diabetes; or

  • if you also take tenofovir or ritonavir.

It is not known whether Prezcobix will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Prezcobix on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Prezcobix is not approved for use by anyone younger than 18 years old.

How should I take Prezcobix?

Take Prezcobix exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Prezcobix once daily with food.

While using Prezcobix, your blood may need to be tested often. Your kidney and liver function may also need to be tested.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Skipping doses may increase the risk of your virus becoming resistant to antiviral medicine. Every person with HIV or AIDS should remain under the care of a doctor.

Store Prezcobix at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Prezcobix dosing information

Usual Adult Dose for HIV Infection:

1 tablet orally once a day with food

Comments:
-HIV genotypic testing is recommended before starting therapy in antiretroviral therapy-experienced patients.
-If HIV genotypic testing is not possible, this drug should be used in protease inhibitor-naive patients only.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in therapy-naive and therapy-experienced patients without darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V)

Dosage Information (comprehensive)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Prezcobix?

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

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Prezcobix side effects

Get emergency medical help if you have signs of an allergic reaction to Prezcobix: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

  • liver problems - upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning or redness in your eyes, tiredness, muscle or joint pain, skin sores, red or purple skin rash that spreads and causes blistering and peeling.

This medicine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Prezcobix. Tell your doctor if you have:

  • signs of a new infection - fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common Prezcobix side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;

  • headache;

  • rash; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects (complete list)

What other drugs will affect Prezcobix?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with cobicistat and darunavir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Prezcobix.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Prezcobix only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 2.02.

Date modified: September 05, 2017
Last reviewed: August 08, 2017

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