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Darunavir suspension

Generic Name: darunavir (dar-UE-na-vir)
Brand Name: Prezista

Darunavir suspension is used for:

Treating HIV infection in certain patients along with other antiretroviral medicines. Darunavir suspension must always be taken along with another medicine called ritonavir.

Darunavir suspension is an HIV protease inhibitor. It works by blocking the growth of HIV.

Do NOT use darunavir suspension if:

  • you are allergic to any ingredient in darunavir suspension or to ritonavir
  • you have severe liver problems
  • you are taking alfuzosin, boceprevir, cisapride, dronedarone, an ergot derivative (eg, dihydroergotamine, ergonovine, ergotamine), certain other HIV protease inhibitors (eg, lopinavir, saquinavir), inhaled fluticasone, ivabradine, lovastatin, oral midazolam, pimozide, rifampin, salmeterol, silodosin, simvastatin, St. John's wort, tamsulosin, telaprevir, or triazolam
  • you are taking sildenafil for pulmonary arterial hypertension (PAH)

Contact your doctor or health care provider right away if any of these apply to you.

Before using darunavir suspension:

Some medical conditions may interact with darunavir suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide (sulfa) medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
  • if you have a history of liver problems (eg, hepatitis, cirrhosis), abnormal liver function tests, kidney problems, high blood cholesterol or triglycerides, pancreatitis, infection, hemophilia, diabetes or high blood sugar, or a family history of diabetes

Some MEDICINES MAY INTERACT with darunavir suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many other prescription and nonprescription medicines (eg, used for asthma or other lung or breathing problems, birth control, blood thinning, depression or other mental or mood problems, drug or other substance dependence, enlarged prostate, erectile dysfunction, glaucoma or increased pressure in the eyes, gout, heartburn, hepatitis C infection, high blood pressure, high cholesterol, HIV infection, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, migraine headaches, PAH, pain, seizures, sleeping problems), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) because they may interact with darunavir suspension. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with darunavir suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if darunavir suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use darunavir suspension:

Use darunavir suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with darunavir suspension. Talk to your pharmacist if you have questions about this information.
  • Take darunavir suspension by mouth with food. Ritonavir should be taken at the same time as darunavir suspension.
  • Shake well before each use.
  • Use the oral dosing syringe that comes with darunavir suspension to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you also take didanosine, do not take it within 1 hour before or 2 hours after taking darunavir suspension. Check with your doctor if you have questions.
  • Taking darunavir suspension at the same time(s) each day will help you remember to take it.
  • Take darunavir suspension on a regular schedule to get the most benefit from it.
  • Continue to take darunavir suspension even if you feel well. Do not miss any doses.
  • If you take darunavir suspension 1 time per day and you miss a dose by less than 12 hours, take it as soon as possible and go back to your regular dosing schedule. If you miss a dose by more than 12 hours, skip the missed dose and go back to your regular dosing schedule. If you take darunavir suspension 2 times per day and miss a dose by less than 6 hours, take it as soon as possible and go back to your regular dosing schedule. If you miss a dose of darunavir suspension by more than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use darunavir suspension.

Important safety information:

  • Tell your doctor or dentist that you take darunavir suspension before you receive any medical or dental care, emergency care, or surgery.
  • Darunavir suspension interacts with many other medicines. The risk of darunavir suspension's side effects may be increased or darunavir suspension's effectiveness may be decreased. The risk of the other medicines' side effects may also be increased. This may include severe, life-threatening, or fatal side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take darunavir suspension with all of your other medicines (prescription or OTC, natural products, vitamins).
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking darunavir suspension. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Do not stop taking darunavir suspension or change your dose without talking with your doctor.
  • Darunavir suspension may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start darunavir suspension.
  • Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) have occurred in patients taking darunavir suspension. They can cause serious 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.
  • Darunavir suspension is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. The long-term effects of taking darunavir suspension are unknown.
  • Darunavir suspension does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Do NOT take more than the recommended dose, change the dose, or stop taking darunavir suspension or ritonavir without checking with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking darunavir suspension, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using darunavir suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Hemophilia patients - Some people with hemophilia have developed increased bleeding while taking protease inhibitors, such as darunavir suspension. Report all bleeding episodes to your doctor.
  • Darunavir suspension may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Darunavir suspension may increase triglyceride and lipid levels. The long-term chance of complications from this, such as heart attack and stroke, are not known at this time.
  • Lab tests, including liver function, blood cholesterol, triglyceride, and blood glucose levels, may be performed while you use darunavir suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use darunavir suspension with caution in the ELDERLY; they may be more sensitive to its effects.
  • Darunavir suspension should not be used in CHILDREN younger than 3 years old; they may be at increased risk of darunavir suspension's side effects.
  • The dose of darunavir suspension in CHILDREN is determined based on body weight; they will need to have regular weight checks while they take darunavir suspension.
  • PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using darunavir suspension while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking darunavir suspension. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or darunavir suspension to the baby.

Possible side effects of darunavir suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild stomach pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); eye pain, inflammation, or redness; fever; muscle or joint pain; severe headache or dizziness; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; severe or persistent nausea, vomiting, or stomach pain; yellowing of the skin or eyes); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); unusual drowsiness, tiredness, or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of darunavir suspension:

Store darunavir suspension at 77 degrees F (25 degrees C) in the original container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not refrigerate or freeze. Do not store in the bathroom. Keep darunavir suspension out of the reach of children and away from pets.

General information:

  • If you have any questions about darunavir suspension, please talk with your doctor, pharmacist, or other health care provider.
  • Darunavir suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take darunavir suspension or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about darunavir suspension. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to darunavir suspension. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using darunavir suspension.

Review Date: November 3, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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