Prezista

This drug, used in combination with ritonavir and at least 1 other medication, helps to control HIV infection, thereby improving your quality of life. It also lowers your risk of getting HIV complications (such as new infections, cancer). Darunavir belongs to a class of drugs known as protease inhibitors. If your HIV infection has become resistant to other protease inhibitors, darunavir may work for you. Darunavir is not a cure for HIV and it does not prevent the spread of HIV to others through sexual contact or blood contamination (such as sharing used needles).

If you are taking this medication 2 times daily and you miss a dose, take it as soon as you remember unless it is less than 6 hours before the time for your next dose. If you are taking this medication once daily and you miss a dose, take it as soon as you remember unless it is less than 12 hours before the time for your next dose. In either case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Read the Patient Information Leaflet provided by your pharmacist, before you start taking darunavir and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take your dose of darunavir and ritonavir by mouth, always with a meal, as directed by your doctor. It is important to take these medications with a meal so that they are properly absorbed into your blood. Swallow darunavir tablets whole. Do not split, crush, or chew the tablets. The dosage is based on your medical condition and response to therapy. In children the dosage is also based on age and body weight. If you are taking HIV medications for the first time, you may experience symptoms of an old infection as your immune system begins to work better. Tell your doctor immediately if you notice any trouble breathing, fever, new cough, new vision problems, new headaches, or new skin problems. It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day. Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some of the products that may interact with this drug include: efavirenz, pimozide, certain azole fungal medications (ketoconazole, itraconazole, voriconazole). Other medications can affect the removal of darunavir from your body, which may affect how darunavir works. Examples include certain anti-seizure drugs (carbamazepine, phenytoin, phenobarbital, primidone), dexamethasone, garlic supplements, rifamycins (such as rifabutin, rifampin, rifapentine), St. John's Wort, among others. Darunavir can speed up or slow down the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include antiarrhythmic drugs (such as amiodarone, lidocaine, quinidine), antidepressants (such as desipramine, paroxetine, sertraline, trazodone), artemether/lumefantrine, certain benzodiazepines (midazolam, triazolam), certain beta blockers (such as metoprolol, timolol), certain calcium channel blockers (such as nifedipine, felodipine, nicardipine), certain cancer drugs (sunitinib, lapatinib, dasatinib, temsirolimus), cisapride, digoxin, ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), drugs to treat erectile dysfunction/pulmonary hypertension (such as sildenafil, vardenafil), certain drugs that weaken the immune system (cyclosporine, sirolimus, tacrolimus), inhaled fluticasone, certain other HIV protease inhibitors (indinavir, lopinavir, saquinavir), methadone, ranolazine, "statin" cholesterol drugs (such as lovastatin, simvastatin), warfarin, among others. If any of these medications are taken with darunavir, your doctor may change your dose of darunavir or the other drug(s), or your doctor may monitor you specially. Consult your doctor or pharmacist for more details. This medication may decrease the effectiveness of hormonal birth control products (such as pills, patch, ring). This effect can result in pregnancy. Ask your doctor or pharmacist for details. Discuss whether you should use additional reliable birth control methods while using any of these drugs. To reduce the risk of spreading HIV to others, always use barrier protections during all sexual activity. (See also Notes section.) This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (US) or 1-800-668-1507 (Canada).

To reduce the risk of spreading HIV to others, always use effective barrier protections (such as latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details. Do not share this medication with others. Laboratory and/or medical tests (such as liver tests, viral load, T-cell counts, triglycerides/cholesterol, blood sugar) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Keep all medical and laboratory appointments.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Before taking darunavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Since darunavir must be taken with ritonavir, tell your doctor if you are allergic to ritonavir. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis B or C), alcohol use, diabetes, a certain bleeding problem (hemophilia), lipid problems (high cholesterol or triglycerides/fats), heart problems (coronary artery disease, heart attack). If you have diabetes, this product may increase your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar, such as increased thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. Your doctor may need to adjust your diabetes medication(s). During pregnancy, this medication should be used only when clearly needed. However, it is now normal to prescribe certain HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Since darunavir is always taken with other HIV medications, it may be difficult to tell whether darunavir is causing certain side effects. However, darunavir is known to cause diarrhea, nausea, vomiting, heartburn, stomach pain, weakness, and headache. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding. This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor immediately if you notice any of the following rare but very serious side effects: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin. Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Darunavir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.