DARUNAVIR

(da ROON a veer) Brand: Prezista

What is the most significant information I must know about darunavir?

• You must not take this medicine if you have severe liver disease.

• Unwanted or dangerous effects may occur if you take darunavir with alfuzosin, cisapride, pimozide, lovastatin, simvastatin, oral midazolam, triazolam, rifampin, sildenafil (for treating pulmonary arterial hypertension), St. John's wort, or an ergot medication (dihydroergotamine, ergonovine, ergotamine, methylergonovine).

What is darunavir?

• Darunavir is a protease (PRO-tee-ayz) inhibitor. Darunavir is an antiviral medicine that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

• Darunavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Darunavir is not a cure for HIV or AIDS.

• Darunavir may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking darunavir?

• You must not take this medicine if you are allergic to darunavir or ritonavir (Norvir, Kaletra), or if you have severe liver disease.

• Some medicines can reason unwanted or dangerous effects when used with darunavir. Your doctor may need to change your treatment plan if you use any of the next drugs:

· alfuzosin;

· cisapride;

· pimozide;

· lovastatin or simvastatin;

· rifampin;

· sildenafil (for pulmonary arterial hypertension);

· St. John's wort;

· triazolam or oral midazolam; or

· ergot medicines--dihydroergotamine, ergonovine, ergotamine, methylergonovine.

• To create certain darunavir is safety for you, speak your doctor if you have:

· liver malady (especially hepatitis or cirrhosis);

· diabetes;

· a bleeding mess such as hemophilia;

· tall cholesterol or triglycerides; or

· if you are allergic to sulfa drugs.

• FDA pregnancy category C. It is not known whether darunavir will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medicine. HIV can be passed to your child if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

• Darunavir can create birth control pills smaller effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking darunavir.

• Women with HIV or AIDS must not breast-feed a child. Even if your child is born without HIV, the virus may be passed to the child in your breast milk.

• Darunavir and ritonavir must not be given to a baby younger than 3 years old, or a baby who weighs smaller than 22 pounds.

How must I take darunavir?

• Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• Darunavir should be taken together with other medicine called ritonavir. Take the medicines together at the same time each day.

• Take darunavir tablets with a full glass (8 ounces) of water or milk. Swallow the darunavir tablet intact. Do not interrupt or chew.

• Darunavir works excellent if you take it with food.

• Shake the oral suspension (liquid) well just till you measure a doze. Measure the liquid with the oral dosing syringe provided with this medication. If you did not receive an oral syringe with your medicine, ask your pharmacist for one.

• While using darunavir, you may need frequent blood trials at your doctor's office.

• Use darunavir regularly to get the most benefit. Get your prescription refilled till you run out of medication completely.

• HIV/AIDS is generally treated with a combination of drugs. Use all medications as directed by your doctor. Read the medicine manual or patient instructions provided with every medicine. Do not change your doses or medicine schedule without your doctor's advice. Each face with HIV or AIDS must stay under the care of a doctor.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze of darunavir and ritonavir as soon as you remember and take your following doze at the regularly scheduled time.

• If you take darunavir once daily and you are more than 12 hours late in taking your medications, skip the missed doze and take the following regularly scheduled doze. Do not take extra medication to create up the missed dose.

• If you take darunavir twice daily and you are more than 6 hours late in taking your medications, skip the missed doze and take the following regularly scheduled dose.

• Always take darunavir and ritonavir together. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking darunavir?

• If you also take didanosine (Videx), take it 1 hour till or 2 hours after you take darunavir.

• Taking this medicine will not prevent you from passing HIV to another people. Do not have unprotected sex or share razors or toothbrushes. Conversation with your doctor about safety ways to prevent HIV transmission during sex. Sharing drug or medication needles is never safety, even for a healthy person.

What are the possible side effects of darunavir?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Stop using darunavir and call your doctor at once if you have:

· the first sign of any skin rash, no matter how mild;

· severe pain in your upper stomach spreading to your back, nausea and vomiting, quick heart rate;

· loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

· tall blood sugar (increased thirst, heighten urination, famine, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision); or

· severe skin reaction -- fever, sore throat, swelling in your person or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the person or upper body) and causes blistering and peeling.

• Darunavir may magnify your risk of determined infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with darunavir. Speak your doctor if you have:

· signs of a new infection--fever, night sweats, swollen glands, diarrhea, weight loss;

· chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

· cool sores, sores on your genital or anal area;

· rapid heart course, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

· trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

· swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

• General side effects may include:

· vomiting, mild stomach pain;

· headache;

· mild skin rash; or

· changes in the shape or location of body thick (especially in your arms, legs, person, neck, breasts, and waist).

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect darunavir?

• Much drugs can interact with darunavir. Not all possible interactions are listed here. Speak your doctor about all your medications and any you start or stop using during treatment with darunavir, especially:

· artemether and lumefantrine;

· bosentan;

· colchicine;

· risperidone or thioridazine;

· salmeterol;

· an antibiotic or antifungal medicine;

· an antidepressant--desipramine, paroxetine, sertraline, trazodone, and others;

· any another HIV/AIDS medicines;

· a blood thinner such as warfarin, Coumadin;

· cholesterol lowering medication--atorvastatin, pravastatin, rosuvastatin;

· heart or blood pressure medicine--felodipine, metoprolol, nicardipine, nifedipine, timolol, and others;

· drugs that weaken the immune system--cyclosporine, sirolimus, tacrolimus;

· a heart rhythm medication--amiodarone, digoxin, digitalis, flecainide, lidocaine, propafenone, quinidine;

· the hepatitis C medications boceprevir or telaprevir;

· insulin or diabetes medicine you take by mouth;

· medicines to treat erectile dysfunction--sildenafil, tadalafil, vardenafil, Viagra;

· narcotic medication--buprenorphine, methadone;

· seizure medications--carbamazepine, phenobarbital, phenytoin; or

· steroids (oral, nasal, inhaled, or injectable).

• This list is not complete and much another drugs can interact with darunavir. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about darunavir.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.