Darunavir Oral suspension

What is this medicine?

DARUNAVIR (da ROON a veer) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• hemophilia

• liver disease

• an unusual or allergic reaction to darunavir, sulfa medicines, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Take this medicine with food. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 years for selected conditions, precautions do apply.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If you usually take your medicine once a day and your next dose is to be taken in less than 12 hours, then do not take the missed dose. If you usually take your medicine twice a day and your next dose is to be taken in less than 6 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alfuzosin

• cisapride

• colchicine (if you have liver or kidney problems)

• dronedarone

• medicines for cholesterol like lovastatin, simvastatin

• medicines for headaches like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• midazolam

• pimozide

• ranolazine

• red yeast rice

• rifampin

• salmeterol or fluticasone; salmeterol

• sildenafil (for the treatment of pulmonary arterial hypertension)

• St. John's wort

• triazolam

This medicine may also interact with the following medications:

• artemether; lumefantrine

• bosentan

• certain antibiotics like clarithromycin, rifabutin, rifapentine

• certain other antiviral medicines for HIV like didanosine, indinavir, maraviroc, saquinavir, or lopinavir; ritonavir

• certain medicines for anxiety or sleep like buspirone, diazepam, zolpidem

• certain medicines for blood pressure and heart disease like amlodipine, carvedilol, diltiazem, felodipine, metoprolol, nicardipine, nifedipine, timolol, verapamil

• certain medicines for cancer like dasatinib, nilotinib, vinblastine, vincristine

• certain medicines for depression like amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, and trazodone

• certain medicines for erectile dysfunction like avanafil, sildenafil, tadalafil, vardenafil

• certain medicines for fungal infection like itraconazole, ketoconazole, posaconazole, voriconazole

• certain medicines for hepatitis infection like boceprevir, simeprevir, telaprevir

• certain medicines for psychotic disturbances like quetiapine, risperidone, thioridazine

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• certain medicines that treat or prevent blood clots likes apixaban, dabigatran, rivaroxaban, warfarin

• female hormones, like estrogens and progestins and birth control pills

• medicines for cholesterol like atorvastatin, pravastatin, rosuvastatin

• medicines for irregular heart beat like amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine

• medicines that lower your chance of fighting infection like cyclosporine, everolimus, sirolimus, tacrolimus

• narcotic medicines for pain such as buprenorphine, buprenorphine; naloxone, methadone

• steroid medicines like budesonide, dexamethasone, fluticasone, prednisolone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• dark urine

• increased hunger or thirst

• loss of appetite

• pain in the lower back or side

• pain when urinating

• pain, tingling, numbness in the hands or feet

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• right upper belly pain

• trouble passing urine or change in the amount of urine

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• headache

• sore throat

• stomach pain

• weight gain around waist, back, or thinning of face, arms, legs

• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Darunavir Oral tablet

What is this medicine?

DARUNAVIR (da ROON a veer) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• hemophilia

• liver disease

• an unusual or allergic reaction to darunavir, sulfa medicines, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alfuzosin

• cisapride

• colchicine (if you have liver or kidney problems)

• dronedarone

• medicines for cholesterol like lovastatin, simvastatin

• medicines for headaches like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• midazolam

• pimozide

• ranolazine

• red yeast rice

• rifampin

• salmeterol or fluticasone; salmeterol

• sildenafil (for the treatment of pulmonary arterial hypertension)

• St. John's wort

• triazolam

This medicine may also interact with the following medications:

• artemether; lumefantrine

• bosentan

• certain antibiotics like clarithromycin, rifabutin, rifapentine

• certain other antiviral medicines for HIV like didanosine, indinavir, maraviroc, saquinavir, or lopinavir; ritonavir

• certain medicines for anxiety or sleep like buspirone, diazepam, zolpidem

• certain medicines for blood pressure and heart disease like amlodipine, carvedilol, diltiazem, felodipine, metoprolol, nicardipine, nifedipine, timolol, verapamil

• certain medicines for cancer like dasatinib, nilotinib, vinblastine, vincristine

• certain medicines for depression like amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, and trazodone

• certain medicines for erectile dysfunction like avanafil, sildenafil, tadalafil, vardenafil

• certain medicines for fungal infection like itraconazole, ketoconazole, posaconazole, voriconazole

• certain medicines for hepatitis infection like boceprevir, simeprevir, telaprevir

• certain medicines for psychotic disturbances like quetiapine, risperidone, thioridazine

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• certain medicines that treat or prevent blood clots likes apixaban, dabigatran, rivaroxaban, warfarin

• female hormones, like estrogens and progestins and birth control pills

• medicines for cholesterol like atorvastatin, pravastatin, rosuvastatin

• medicines for irregular heart beat like amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine

• medicines that lower your chance of fighting infection like cyclosporine, everolimus, sirolimus, tacrolimus

• narcotic medicines for pain such as buprenorphine, buprenorphine; naloxone, methadone

• steroid medicines like budesonide, dexamethasone, fluticasone, prednisolone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• dark urine

• loss of appetite

• pain in the lower back or side

• pain when urinating

• pain, tingling, numbness in the hands or feet

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• right upper belly pain

• trouble passing urine or change in the amount of urine

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• headache

• increased hunger or thirst

• sore throat

• weight gain around waist, back, or thinning of face, arms, legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.