Pasireotide injection solution

What is this medication?

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.

COMMON BRAND NAME(S): Signifor

What should I tell my care team before I take this medication?

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

• diabetes
• gallbladder disease
• heart disease
• high blood sugar
• 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 medication?

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 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 medication?

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

• cisapride
• dronedarone
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• beta-blockers like metoprolol and propranolol
• bromocriptine
• calcium channel blockers like diltiazem and verapamil
• cyclosporine
• digoxin
• other medications that may prolong the QT interval (cause an abnormal heart rhythm) like dofetilide

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 medication?

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.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

What side effects may I notice from receiving this medication?

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
• loss of appetite
• palpitations
• right upper belly pain
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• unusually slow heartbeat
• unusually weak or tired
• weight loss
• 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
• hair loss
• headache
• pain, redness, or irritation at site where injected

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 medication?

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.