When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to darunavir or cobicistat.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If it has been less than 12 hours since you missed your dose, take a dose right away. If it has been more than 12 hours, skip the missed dose and take the next dose at your usual time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• You must avoid many other medicines while you are using darunavir/cobicistat. These medicines used together could cause serious health problems, including death. Medicines you must avoid include the following: alfuzosin, cisapride, colchicine, dronedarone, lovastatin, lurasidone, midazolam, pimozide, ranolazine, rifampin, sildenafil for pulmonary hypertension, simvastatin, St John's wort, triazolam, and ergot medicines (including dihydroergotamine, ergotamine, methylergonovine).
• There are many other drugs that can interact with this medicine. Ask your doctor before you use any other medicine.
• If you also take didanosine, take it 1 hour before or 2 hours after you take this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or if you have kidney disease, liver disease, diabetes, hemophilia, or an allergy to sulfa drugs.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  
  • Severe liver problems
  • Serious skin reactions
  • New or worsening kidney problems
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not share needles or other items that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, lower back or side pain
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Rash with a fever, tiredness, or joint or muscle pain
• Increased hunger or thirst

If you notice these less serious side effects, talk with your doctor:

• Weight gain around your neck, upper back, breast, or waist, moon-shaped face

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088