Prezcobix

Generic name: Cobicistat And Darunavir
Drug class: Antiviral combinations

Usage of 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.

Prezcobix is for use in adults and children who weigh at least 88 pounds (40 kilograms).

Prezcobix side effects

Get emergency medical help if you have signs of an allergic reaction to Prezcobix (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes).

Call your doctor at once if you have:

high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor, headache, blurred vision; or

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

Prezcobix affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

stomach pain, tiredness, itching, skin redness, yellowing of the skin or eyes;

trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

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.

Before taking Prezcobix

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

Some medicines can cause unwanted or dangerous effects when used with cobicistat and darunavir. Your doctor may change your treatment plan if you also use:

alfuzosin;

cisapride;

colchicine;

elbasvir and grazoprevir (Zepatier);

naloxegol;

rifampin;

sildenafil (Revatio, for treating pulmonary arterial hypertension);

St. John's wort;

heart medication - dronedarone, ivabradine, ranolazine;

medicine to lower cholesterol - lomitapide, lovastatin, simvastatin;

antipsychotic medicine - lurasidone, pimozide;

oral sedatives - midazolam, triazolam;

ergot medicines - dihydroergotamine, ergotamine, methylergonovine; or

seizure medicine - Carbamazepine, phenobarbital, phenytoin.

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.

Prezcobix may not work as well if you take it during pregnancy. Do not start taking this medicine if you are pregnant, and tell your doctor if you become pregnant.

If you plan to get pregnant, ask your doctor for another antiviral medicine to use during pregnancy. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of Prezcobix on the baby.

If you do not plan to get pregnant, ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy. Cobicistat and darunavir can increase certain side effects when taken with hormonal birth control (pills, injections, implants, skin patches, vaginal rings).

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 should not be given to children younger than 3 years of age, or to people who weigh less than 88 pounds (40 kilograms).

Relate drugs

How to use Prezcobix

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)

Warnings

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.

What other drugs will affect Prezcobix

If you also take enteric-coated didanosine (Videx EC), take it 1 hour before or 2 hours after you take 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 Prezcobix. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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