Darunavir and cobicistat
Generic Name: darunavir and cobicistat (dar-UE-na-vir & koe-BIK-i-stat)
Brand Name: Prezcobix
Darunavir and cobicistat is used for:
Treating HIV infection in certain patients along with other antiretroviral medicines.
Darunavir and cobicistat is an HIV protease inhibitor and medicine metabolism inhibitor combination. The HIV protease inhibitor works by blocking the growth of HIV. The medicine metabolism inhibitor works by boosting the action of other HIV medicines.
Do NOT use darunavir and cobicistat if:
- you are allergic to any ingredient in darunavir and cobicistat
- you have severe liver problems
- you are taking alfuzosin, apixaban, avanafil, boceprevir, cisapride, dihydroergotamine, dronedarone, efavirenz, elvitegravir, ergotamine, etravirine, everolimus, lovastatin, lurasidone, methylergonovine, nevirapine, oral midazolam, other HIV protease inhibitors (eg, ritonavir), pimozide, ranolazine, rifampin, rifapentine, rivaroxaban, salmeterol, simeprevir, simvastatin, St. John's wort, telaprevir, or triazolam
- you are taking sildenafil for pulmonary arterial hypertension (PAH)
- you are taking colchicine and you also have kidney or liver problems
- you are taking tenofovir and you also have kidney problems
- you are taking tenofovir and are also taking or have recently taken a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], tacrolimus, vancomycin). Ask your doctor if you are not sure if any of your medicines might harm your kidneys.
- you are taking another medicine that contains cobicistat or darunavir
Contact your doctor or health care provider right away if any of these apply to you.
Before using darunavir and cobicistat:
Some medical conditions may interact with darunavir and cobicistat. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide (sulfa) medicine (eg, sulfamethoxazole)
- if you have a history of liver problems (eg, hepatitis, cirrhosis), abnormal liver function tests, kidney problems, infection, hemophilia, diabetes or high blood sugar, or a family history of diabetes
- if you are taking tenofovir
- if you are taking other medicines to treat HIV. Certain HIV medicines should not be taken together with darunavir and cobicistat. Talk with your doctor.
Some MEDICINES MAY INTERACT with darunavir and cobicistat. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many other prescription and nonprescription medicines (eg, used for asthma or other lung or breathing problems, birth control, blood thinning, cancer, depression or other mental or mood problems, drug or other substance dependence, enlarged prostate, erectile dysfunction, gout, glaucoma or increased pressure in the eyes, heartburn, hepatitis C infection, high blood pressure, high cholesterol, HIV infection, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, migraine headaches, PAH, pain, seizures, sleeping problems), multivitamin products, or herbal or dietary supplements because they may interact with darunavir and cobicistat. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with darunavir and cobicistat
This may not be a complete list of all interactions that may occur. Ask your health care provider if darunavir and cobicistat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use darunavir and cobicistat:
Use darunavir and cobicistat as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with darunavir and cobicistat. Talk to your pharmacist if you have questions about this information.
- Take darunavir and cobicistat by mouth with food.
- If you also take didanosine, take it at least 1 hour before or 2 hours after darunavir and cobicistat.
- Taking darunavir and cobicistat at the same time each day will help you remember to take it.
- Take darunavir and cobicistat on a regular schedule to get the most benefit from it.
- Continue to take darunavir and cobicistat even if you feel well. Do not miss any doses.
- If you miss a dose of darunavir and cobicistat, take it with food as soon as possible. If it you miss a dose by more than 12 hours, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use darunavir and cobicistat.
Important safety information:
- Tell your doctor or dentist that you take darunavir and cobicistat before you receive any medical or dental care, emergency care, or surgery.
- Darunavir and cobicistat interacts with many other medicines. The risk of darunavir and cobicistat's side effects may be increased or darunavir and cobicistat's effectiveness may be decreased. The risk of the other medicines' side effects may also be increased. This may include severe, life-threatening, or fatal side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take darunavir and cobicistat with all of your other medicines (prescription or OTC, natural products, vitamins).
- Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk and loss of fat from the legs, arms, and face) may occur in some patients taking darunavir and cobicistat. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Do not stop taking darunavir and cobicistat or change your dose without talking with your doctor.
- Darunavir and cobicistat may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start darunavir and cobicistat.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Darunavir and cobicistat is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. The long-term effects of taking darunavir and cobicistat are unknown.
- Darunavir and cobicistat does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking darunavir and cobicistat, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
- Hormonal birth control (eg, birth control pills) may not work as well while you are taking darunavir and cobicistat. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Hemophilia patients - Some people with hemophilia have developed increased bleeding while taking protease inhibitors, such as darunavir and cobicistat. Report all bleeding episodes to your doctor.
- Serious kidney problems (eg, kidney failure) have happened in people taking cobicistat with another HIV medicine (tenofovir). Discuss any questions or concerns with your doctor.
- Darunavir and cobicistat may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests may be performed while you take darunavir and cobicistat. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Darunavir and cobicistat should not be used in CHILDREN younger than 3 years old. Discuss any questions or concerns with the doctor.
- PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking darunavir and cobicistat while you are pregnant. It is not known if this medicine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or darunavir and cobicistat to the baby.
Possible side effects of darunavir and cobicistat:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; headache; nausea; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); muscle or joint pain; swollen glands; symptoms of kidney problems (eg, increased or decreased urination, swelling of the feet, ankles, or hands); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; severe or persistent nausea, vomiting, or stomach pain; yellowing of the skin or eyes); unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of darunavir and cobicistat:
Store darunavir and cobicistat at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep darunavir and cobicistat out of the reach of children and away from pets.
- If you have any questions about darunavir and cobicistat, please talk with your doctor, pharmacist, or other health care provider.
- Darunavir and cobicistat is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take darunavir and cobicistat or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about darunavir and cobicistat. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to darunavir and cobicistat. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using darunavir and cobicistat.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
More about cobicistat/darunavir
- Other brands: Prezcobix