Prezcobix contains a combination of darunavir and cobicistat. Darunavir is a protease inhibitor antiviral medication that prevents human immunodeficiency virus (HIV) cells 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 given together with other antiviral medicines to treat human immunodeficiency virus (HIV) in adults. HIV is the virus that causes 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, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), little or no urinating, swelling in your feet or ankles, feeling tired or short of breath, fever, swelling in your face or tongue, skin pain, or a skin rash that spreads and causes blistering and peeling.
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:
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alfuzosin;
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cisapride;
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colchicine;
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dronedarone;
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lovastatin, simvastatin;
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lurasidone;
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oral midazolam, triazolam;
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pimozide;
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ranolazine;
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rifampin;
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sildenafil (Revatio, for treating pulmonary arterial hypertension);
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St. John"s wort; or
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ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine.
To make sure Prezcobix is safe for you, tell your doctor if you have:
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liver disease (especially hepatitis B or C);
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kidney disease;
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a bleeding or blood clotting disorder such as hemophilia;
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an allergy to sulfa drugs;
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diabetes; or
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if you also take tenofovir.
Prezcobix is not expected to 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 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. 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)
What happens if I miss a dose?
Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose and take your medicine at the 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.
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:
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signs of a new infection - fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
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chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
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cold sores, sores on your genital or anal area;
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rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
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trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
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swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.
Call your doctor at once if you have:
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high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;
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liver problems - upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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severe skin reaction - fever, sore throat, swelling in your face or tongue, burning or redness in your eyes, skin pain, warmth or redness under your skin, red or purple skin rash that spreads and causes blistering and peeling.
Common Prezcobix side effects may include:
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nausea, vomiting, stomach pain, diarrhea
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headache;
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rash; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Prezcobix?
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 medicines you use, and those you start or stop using during your treatment with Prezcobix. Give a list of all your medicines to any healthcare provider who treats you.
