PREZCOBIX contains the active ingredients darunavir (in the form of ethanolate) and cobicistat. It is a combination tablet that works by inhibiting HIV-1 protease and CYP3A enzymes. The drug is available as oral tablets in two dosage strengths: 800 mg/150 mg and 675 mg/150 mg. Key inactive ingredients include colloidal silicon dioxide, magnesium stearate, and polyvinyl alcohol in the film coating.

How should I use this medication?

Take this medication by mouth with water. Take it with food. You may cut the tablet in half if it is scored (has a line in the middle of it). This may help you swallow the tablet if the whole tablet is too big. Be sure to take both halves. Do not take just one-half of the tablet. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the virus resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While it may be prescribed to children 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.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer wanted or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Infection—fever, chills, cough, or sore throat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Lipodystrophy—increased fat in the upper back or midsection, decreased fat in the face, arms, or legs
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Nausea
• Stomach pain

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.

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 medications, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Alfuzosin
• Certain medications for blood pressure, heart disease, irregular heartbeat, such as dronedarone, ivabradine, ranolazine
• Certain medications for seizures, such as carbamazepine, fosphenytoin, phenytoin, phenobarbital
• Cisapride
• Colchicine (if you have liver or kidney problems)
• Elbasvir and grazoprevir
• Irinotecan
• Lurasidone
• Medications for cholesterol, such as lomitapide, lovastatin, simvastatin
• Medications for headaches, such as dihydroergotamine, ergotamine, methylergonovine
• Midazolam
• Naloxegol
• Pimozide
• Rifampin
• Sildenafil for pulmonary arterial hypertension
• St. John's wort
• Triazolam

This medication may also interact with the following:

• Artemether; lumefantrine
• Bosentan
• Certain antibiotics, such as clarithromycin, erythromycin, telithromycin, rifabutin, rifapentine
• Certain medications for anxiety or sleep, such as buspirone, diazepam, estazolam, zolpidem
• Certain medications for blood pressure and heart disease, such as amlodipine, carvedilol, diltiazem, felodipine, metoprolol, nifedipine, timolol, verapamil
• Certain medications for cancer, such as dasatinib, nilotinib, vinblastine, vincristine
• Certain medications for depression, such as amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, and trazodone
• Certain medications for erectile dysfunction, such as avanafil, sildenafil, tadalafil, vardenafil
• Certain medications for fungal infection, such as itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for mental health conditions, such as perphenazine, quetiapine, risperidone, thioridazine
• Certain medications for seizures, such as clonazepam, eslicarbazepine, oxcarbazepine
• Certain medications that treat or prevent blood clots, such as apixaban, rivaroxaban, warfarin
• Certain other antiviral medications for HIV or AIDS, such as atazanavir, didanosine, efavirenz, elvitegravir, etravirine, fosamprenavir, indinavir, lopinavir; ritonavir, maraviroc, nelfinavir, nevirapine, ritonavir, saquinavir, tenofovir, tipranavir
• Clopidogrel
• Estrogen or progestin hormones
• Medications for cholesterol, such as atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin
• Medications for irregular heartbeat, such as amiodarone, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine
• Medications that lower your chance of fighting infection, such as cyclosporine, everolimus, sirolimus, tacrolimus
• Opioid medications for pain, such as buprenorphine, buprenorphine; naloxone, fentanyl, methadone, oxycodone, tramadol
• Salmeterol
• Simeprevir
• Steroid medications, 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 care team for regular checks on your progress. Discuss any new symptoms with your care team. You will need to have important blood work done while taking this medication.

HIV is spread to others through sexual or blood contact. Talk to your care team about how to stop the spread of HIV.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team 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.

Estrogen and progestin hormones may not work as well while you are taking this medication. If you are using these hormones for contraception, talk to your care team about using a second type of contraception. A barrier contraceptive, such as a condom or diaphragm, is recommended.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.