Pasireotide Solution for injection

What is this medicine?

PASIREOTIDE (PAS i REE oh tide) is used to reduce blood levels of cortisol in patients with a condition called Cushing's disease. It is used when surgery is not an option or has not worked well enough.

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

• gallbladder disease

• heart disease

• history of irregular heartbeat

• history of pancreatitis

• liver disease

• low levels of magnesium or potassium in the blood

• thyroid disease

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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 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:

• cisapride

• dofetilide

• dronedarone

• pimozide

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• beta-blockers like metoprolol and propranolol

• bromocriptine

• calcium channel blockers like diltiazem and verapamil

• certain antibiotics like clarithromycin, erythromycin, telithromycin

• cyclosporine

• digoxin

• droperidol

• haloperidol

• medicines for depression called tricyclic antidepressants

• medicines for fungal infections like itraconazole, ketoconazole, voriconazole

• medicines for malaria like chloroquine and halofantrine

• medicines to control heart rhythm like amiodarone, disopyramide, flecainide, ibutilide, quinidine, propafenone, sotalol

• methadone

• pentamidine

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this 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

• dizziness

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• increased hunger or thirst

• increased urination

• loss of appetite

• palpitations

• right upper belly pain

• unusually slow heartbeat

• 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.):

• anxious

• diarrhea

• hair loss

• headache

• pain, redness, or irritation at site where injected

• trouble sleeping

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 this medicine at room temperature between 20 to 25 degrees C (68 to 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date on the label.

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.

Pasireotide Suspension for injection

What is this medicine?

PASIREOTIDE (PAS i REE oh tide) is used to reduce blood levels of growth hormone in patients with a condition called acromegaly. It is used when surgery is not an option or has not worked well enough.

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

• gallbladder disease

• heart disease

• history of irregular heartbeat

• history of pancreatitis

• liver disease

• low levels of magnesium or potassium in the blood

• thyroid disease

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It is usually given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

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

• cisapride

• dofetilide

• dronedarone

• pimozide

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• beta-blockers like metoprolol and propranolol

• bromocriptine

• calcium channel blockers like diltiazem and verapamil

• certain antibiotics like clarithromycin, erythromycin, telithromycin

• cyclosporine

• digoxin

• droperidol

• haloperidol

• medicines for depression called tricyclic antidepressants

• medicines for fungal infections like itraconazole, ketoconazole, voriconazole

• medicines for malaria like chloroquine and halofantrine

• medicines to control heart rhythm like amiodarone, disopyramide, flecainide, ibutilide, quinidine, propafenone, sotalol

• methadone

• pentamidine

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine

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?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this 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

• dizziness

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• increased hunger or thirst

• increased urination

• loss of appetite

• palpitations

• right upper belly pain

• unusually slow heartbeat

• 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.):

• anxious

• diarrhea

• hair loss

• headache

• pain, redness, or irritation at site where injected

• trouble sleeping

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.

This drug is given in a hospital or clinic and will not be stored at home.

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.