- It is used to treat HIV infection.
For all patients taking this drug:
- If you have an allergy to darunavir, ritonavir, or any other part of this drug.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have liver disease.
- If you are not taking cobicistat or ritonavir.
- If you are taking sildenafil to treat pulmonary arterial hypertension (PAH).
- If you take colchicine and have kidney or liver problems.
- If you are taking St. John’s wort. Do not take St. John’s wort with this drug. This drug may not work as well.
- If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with this drug.
- If your child is younger than 3 years of age. Do not give to a child younger than 3 years of age.
For all patients taking this drug:
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- This drug interacts with many other drugs. The chance of this drug’s side effects may be raised or how well this drug works may be lowered. The chance of the other drugs’ side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take this drug with all of your other drugs (prescription or OTC, natural products, vitamins).
- If you have high blood sugar (diabetes), talk with your doctor. This drug may raise blood sugar.
- Check your blood sugar as you have been told by your doctor.
- Some people with hemophilia have had times of more bleeding when taking drugs like this one. If you have hemophilia, talk with your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This drug is not a cure for HIV. Stay under the care of your doctor.
- This drug does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
- Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this drug.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
- Do not breast-feed if you have HIV disease unless your doctor tells you to.
- This drug must be taken with cobicistat or ritonavir. Cobicistat is not approved for use in children. Talk with the doctor.
- If your child’s weight changes, talk with the doctor. The dose of this drug may need to be changed.
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Very bad dizziness or passing out.
- Very bad headache.
- Feeling very tired or weak.
- Change in body fat.
- Muscle or joint pain.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Very bad and sometimes deadly liver problems have happened with this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- This drug may help the immune system work. If you have an infection that you did not know you had, it may show up when you take this drug. Tell your doctor right away if you notice any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start this drug.
- Loose stools (diarrhea).
- Belly pain.
- Upset stomach or throwing up.
- Take this drug with food.
- Take this drug at the same time as cobicistat or ritonavir as you have been told.
- Do not take antacids or didanosine within 2 hours of this drug.
- Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
- It is important that you do not miss or skip a dose of this drug during treatment.
- Take with a full glass of water or milk.
- If you have trouble swallowing, talk with your doctor.
- Shake well before use.
- Measure liquid doses carefully. Use the measuring device that comes with this drug.
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- If you are not sure what to do if you miss a dose, call your doctor.
- Store at room temperature.
- Store at room temperature. Do not refrigerate or freeze.
- Store in original container.
- Protect from heat.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.