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 ritonavir.

How to Use This Medicine:
Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Darunavir is used with other medicines to treat HIV infection. Take all of the medicines your doctor has prescribed at the right time of day and in the correct order. Do not stop using your medicine unless your doctor tells you to.
• It is best to take this medicine with food or milk.
• Tablet: Swallow whole with water or milk. Do not crush, break, or chew the tablet.
• Oral liquid: Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Shake the bottle well just before each use.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  
  • One time per day dose: If it is more than 12 hours since your last dose, wait and take your next dose at the normal time. If it is less than 12 hours since your last dose, take the missed dose as soon as you can, and then take your next dose at the normal time. Do not take extra medicine to make up for a missed dose.
  • Two times per day dose: If it is more than 6 hours since your last dose, wait and take your next dose at the normal time. If it is less than 6 hours since your last dose, take the missed dose as soon as you can, and then take your next dose at the normal 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. Keep the oral liquid in its original container. Do not refrigerate or freeze it.

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

• Do not use this medicine if you are also using alfuzosin, cisapride, colchicine, dronedarone, lovastatin, oral midazolam, pimozide, ranolazine, rifampin, St John's wort, sildenafil, simvastatin, triazolam, or an ergot medicine (including dihydroergotamine, ergotamine, methylergonovine).
• Many other drugs can interact with darunavir. Make sure your doctor knows about all other medicines you are using.
• If you also use didanosine, take it at least 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 diabetes, liver disease (including hepatitis), or hemophilia. Tell your doctor if you are allergic 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:
  
  • Liver problems
  • Serious skin reactions
  • High blood sugar levels, a problem that could become permanent
• Your immune system may get stronger when you start taking an HIV medicine. Infections that were hidden in your body, such as pneumonia or tuberculosis, might 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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Increased hunger or thirst, change in how much or how often you urinate, unusual weight loss

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

• Diarrhea or stomach pain
• Weight gain around your neck, upper back, breast, or waist

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