cobicistat and darunavir

Pronunciation: koe BIK i stat and dar UE na vir

Brand: Prezcobix

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

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

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 is cobicistat and darunavir?

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.

Cobicistat and darunavir is a combination medicine given with other medicines to treat human immunodeficiency virus (HIV) in adults, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Cobicistat and darunavir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking cobicistat and darunavir?

You should not take this medicine 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;
  • 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.

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 this medicine will harm an unborn baby. Tell your doctor if you are pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines to control your infection. Your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of cobicistat and darunavir 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.

Cobicistat and darunavir is not approved for use by anyone younger than 18 years old.

How should I take cobicistat and darunavir?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take this medicine once daily with food.

You will need frequent medical tests.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

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

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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 cobicistat and darunavir?

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.

What are the possible side effects of cobicistat and darunavir?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

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).

Cobicistat and darunavir 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;
  • 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 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.

What other drugs will affect cobicistat and darunavir?

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

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 affect cobicistat and darunavir. 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.

Where can I get more information?

Your pharmacist can provide more information about cobicistat and darunavir.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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