Pasireotide Injection Suspension

What is this medication?

PASIREOTIDE (PAS i REE oh tide) treats Cushing syndrome, a condition that causes high levels of the hormone cortisol. Cortisol plays an important role in helping your body manage metabolism and respond to stress. Too much cortisol can cause weight gain, high blood pressure, diabetes, and bone loss. This medication works by decreasing levels of cortisol in the body. It may also be used to treat high levels of growth hormone (acromegaly). It works by reducing the amount of growth hormone your body makes. This reduces symptoms and the risk of health problems caused by too much growth hormone, such as diabetes and heart disease.

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

COMMON BRAND NAME(S): Signifor LAR

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
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Pancreatic disease
• Thyroid disease
• An unusual or allergic reaction to pasireotide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. It is usually given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication 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?

It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Dronedarone
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Beta blockers, such as metoprolol and propranolol
• Bromocriptine
• Calcium channel blockers, such as diltiazem and verapamil
• Cyclosporine
• Digoxin
• Other medications that may cause heart rhythm changes, such as 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?

Visit your care team for regular checks on your progress. Tell your care team 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 medication.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Oily or light-colored stools, diarrhea, bloating, weight loss
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue

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

• Diarrhea
• Hair loss
• Headache
• Nausea
• Pain, redness, or irritation at injection site
• Stomach pain

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?

This medication is given in a hospital or clinic. It 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.