Darunavir; Cobicistat tablets

What is this medication?

DARUNAVIR; COBICISTAT (da ROON a veer; koe BIS i stat) is an antiretroviral medicine and a medication booster in 1 tablet. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): PREZCOBIX

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• diabetes
• hemophilia
• kidney disease
• liver disease
• an unusual or allergic reaction to darunavir, cobicistat, sulfa medicines, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

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 or health care professional's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have 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 medication?

Do not take this medicine with any of the following medications:

• alfuzosin
• certain medicines for blood pressure, heart disease, irregular heart beat such as dronedarone, ivabradine, ranolazine
• certain medicines for seizures such as carbamazepine, fosphenytoin, phenytoin, phenobarbital
• cisapride
• colchicine (if you have liver or kidney problems)
• elbasvir and grazoprevir
• irinotecan
• lurasidone
• medicines for cholesterol such as lomitapide, lovastatin, simvastatin
• medicines for headaches such as dihydroergotamine, ergotamine, methylergonovine
• midazolam
• naloxegol
• pimozide
• rifampin
• sildenafil (for the treatment of pulmonary arterial hypertension)
• St. John's Wort
• triazolam

This medicine may also interact with the following medications:

• artemether; lumefantrine
• bosentan
• certain antibiotics such as clarithromycin, erythromycin, telithromycin, rifabutin, rifapentine
• certain other antiviral medicines for HIV or AIDS such as atazanavir, didanosine, efavirenz, elvitegravir, etravirine, fosamprenavir, indinavir, lopinavir; ritonavir, maraviroc, nelfinavir, nevirapine, ritonavir, saquinavir, tenofovir, tipranavir
• certain medications for anxiety or sleep such as buspirone, diazepam, estazolam, zolpidem
• certain medicines for blood pressure and heart disease such as amlodipine, carvedilol, diltiazem, felodipine, metoprolol, nifedipine, timolol, verapamil
• certain medicines for cancer such as dasatinib, nilotinib, vinblastine, vincristine
• certain medicines for depression such as amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, and trazodone
• certain medicines for erectile dysfunction such as avanafil, sildenafil, tadalafil, vardenafil
• certain medicines for fungal infection such as itraconazole, ketoconazole, posaconazole, voriconazole
• certain medicines for psychiatric disturbances such as perphenazine, quetiapine, risperidone, thioridazine
• certain medicines for seizures such as clonazepam, eslicarbazepine, oxcarbazepine
• certain medicines that treat or prevent blood clots such as apixaban, rivaroxaban, warfarin
• clopidogrel
• female hormones, such as estrogens and progestins and birth control pills
• medicines for cholesterol such as atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin
• medicines for irregular heart beat such as amiodarone, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine
• medicines that lower your chance of fighting infection such as cyclosporine, everolimus, sirolimus, tacrolimus
• narcotic medicines for pain such as buprenorphine, buprenorphine; naloxone, fentanyl, methadone, oxycodone, tramadol
• salmeterol
• simeprevir
• steroid medicines such as betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone
• ticagrelor

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 medication?

Visit your doctor or healthcare provider for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

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 increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

What side effects may I notice from receiving this medication?

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
• dark urine
• loss of appetite
• nausea, vomiting, abdominal pain
• pain in the lower back or side
• pain when urinating
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• 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 to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• sore throat
• 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 medication?

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.