Type of medicine: protease inhibitor (anti-HIV)
Generic and brand names: darunavir, oral; Prezista
This medicine is taken by mouth to treat HIV-1 infection. It must be taken along with ritonavir (Norvir). It may also be taken with other medicines.
Before taking this medicine, tell your healthcare provider if you have ever had:
Taking this medicine with certain other medicines may be life-threatening. Tell your provider about ALL of the medicines and natural remedies you take, especially antibiotics, sedatives, St. John's Wort, and medicines to treat cholesterol, prostate problems, migraines, mental disorders, or heart rhythm problems.
Males: If you take sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) while you are taking this medicine, you may be at increased risk of side effects such as low blood pressure, vision changes or priapism (prolonged and painful erections).
Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.
Hormonal birth control may be less effective while you are taking this medicine. Talk to your healthcare provider if you need birth control.
Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not change your dosage on your own. Do not stop taking this medicine without your healthcare provider's approval. If you are not sure of how much and how often to take this medicine, ask your healthcare provider or pharmacist to explain.
Take this medicine with other medicines your healthcare provider prescribes. Follow your healthcare provider's instructions exactly.
Take this medicine with food. Do not chew, break, or crush the tablets. Swallow the tablets whole with a full glass of water or milk. Take this medicine at the same time that you take ritonavir.
If you take darunavir once daily, miss a dose, and realize it in less than 12 hours, take your missed dose immediately. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 12 hours, wait and take the next dose at the regularly scheduled time. Do not take double doses.
If you take darunavir twice daily, miss a dose, and realize it in less than 6 hours, take your missed dose immediately. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 6 hours, wait and take the next dose at the regularly scheduled time. Do not take double doses.
If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.
Symptoms of an acute overdose have not been reported.
You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.
This medicine is not a cure for HIV infection. You may continue to get illnesses associated with advanced HIV infection, including other infections. There is no evidence that this medicine will reduce the risk of spreading HIV through sexual contact or blood contamination.
If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.
Do not give this medicine to other people, even if they have the same symptoms you have.
Your body fat may change as a result of taking this medicine. Your legs and arms may be thin but your chest, belly, back and face may have more fat. Talk with your healthcare provider about this.
This medicine may increase the total cholesterol and triglyceride levels in your blood. You will need tests to check these levels regularly. Keep all appointments for tests.
You may develop diabetes when you take this medicine. If you already have diabetes, it may get worse. Talk with your healthcare provider about this.
Diabetics: Your dosage of insulin or medicines taken by mouth for diabetes may need to be changed. If you are controlling your diabetes with diet and exercise, you may need to start taking medicine. Talk to your healthcare provider about this.
Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider about any side effects that continue or get worse.
Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).
Serious (report these to your healthcare provider right away): Severe nausea, vomiting, and abdominal pain; bleeding; severe weakness; severe skin rash, blistering, or peeling; rash with fever, tiredness, muscle or joint aches, mouth sores, red or inflamed eyes; severe diarrhea; yellowing of eyes or skin; dark urine; pale stools; loss of appetite; leg pain; tingling or numbness in the hands, feet, or mouth; pounding heartbeat; increased thirst and urination.
Other: Diarrhea, mild nausea, trouble sleeping, headache, runny nose or stuffy nose, mild rash.
When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:
The effects of this medicine may be increased if you take it with grapefruit juice. Talk with your healthcare provider about this.
If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.
Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.
This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.
Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.
Keep all medicines out of the reach of children.
Do not share medicines with other people.
