Darunavir; Cobicistat tablets

What is this medicine?

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.

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 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.

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

• 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

What may interact with this medicine?

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

• alfuzosin

• certain medicines for blood pressure, heart disease, irregular heart beat like dronedarone, ivabradine, ranolazine

• certain medicines for seizures like carbamazepine, fosphenytoin, phenytoin, phenobarbital

• cisapride

• colchicine (if you have liver or kidney problems)

• elbasvir and grazoprevir

• irinotecan

• lurasidone

• medicines for cholesterol like lomitapide, lovastatin, simvastatin

• medicines for headaches like 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 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 like amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, and trazodone

• certain medicines for erectile dysfunction like avanafil, sildenafil, tadalafil, vardenafil

• certain medicines for fungal infection like itraconazole, ketoconazole, posaconazole, voriconazole

• certain medicines for psychiatric disturbances like perphenazine, quetiapine, risperidone, thioridazine

• certain medicines for seizures like clonazepam, eslicarbazepine, oxcarbazepine

• certain medicines that treat or prevent blood clots like apixaban, 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

• salmeterol

• simeprevir

• steroid medicines like betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone

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 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.

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.

What should I tell my health care provider before I take this medicine?

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

What should I watch for while using this medicine?

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.