Darunavir, Cobicistat Oral tablet
What is this medicine?
DARUNAVIR; COBICISTAT (da ROON a veer; koe BIS i stat) is an antiretroviral medicine and a medication booster in one tablet. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an unusual or allergic reaction to darunavir, cobicistat, sulfa medicines, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take that missed dose. Take the next dose at your regular time. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
certain medicines for blood pressure, heart disease, irregular heart beat like dronedarone, ranolazine
certain medicines for depression, anxiety, or psychotic disturbances like lurasidone, pimozide
medicines for cholesterol like lovastatin, simvastatin
medicines for headaches like dihydroergotamine, ergotamine, methylergonovine
St. John's wort
This medicine may also interact with the following medications:
certain antibiotics like clarithromycin, erythromycin, telithromycin, rifabutin, rifapentine
certain other antiviral medicines for HIV or AIDS like atazanavir, didanosine, efavirenz, elvitegravir, etravirine, fosamprenavir, indinavir, lopinavir; ritonavir, maraviroc, nelfinavir, nevirapine, ritonavir, saquinavir, tenofovir, tipranavir
certain medications for anxiety or sleep like buspirone, diazepam, estazolam, zolpidem
certain medicines for blood pressure and heart disease like amlodipine, carvedilol, diltiazem, felodipine, metoprolol, nifedipine, timolol, verapamil
certain medicines for cancer like dasatinib, nilotinib, vinblastine, vincristine
certain medicines for depression, anxiety, or psychiatric disturbances
certain medicines for erectile dysfunction like avanafil, sildenafil, tadalafil, vardenafil
certain medicines for fungal infection like itraconazole, ketoconazole, posaconazole, voriconazole
certain medicines for hepatitis infection like boceprevir, simeprevir
certain medicines for seizures like clonazepam, oxcarbazepine
certain medicines that treat or prevent blood clots like apixaban, dabigatran, rivaroxaban, warfarin
female hormones, like estrogens and progestins and birth control pills
medicines for cholesterol like atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin
medicines for irregular heart beat like amiodarone, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine
medicines that lower your chance of fighting infection like cyclosporine, everolimus, sirolimus, tacrolimus
narcotic medicines for pain like buprenorphine, buprenorphine; naloxone, fentanyl, methadone, oxycodone, tramadol
phenothiazines like perphenazine, thioridazine
steroid medicines like budesonide, dexamethasone, fluticasone, prednisolone
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.
HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.
Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom.
This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
loss of appetite
pain in the lower back or side
pain when urinating
pain, tingling, numbness in the hands or feet
redness, blistering, peeling or loosening of the skin, including inside the mouth
right upper belly pain
trouble passing urine or change in the amount of urine
unusually weak or tired
yellowing of the eyes or skin
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
weight gain around waist, back, or thinning of face, arms, legs
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert