Pasireotide Injection

Pasireotide injection (Signifor and Signifor LAR) is used to treat Cushing's disease (an abnormal condition that is caused by excess hormones [cortisol]) in adults who cannot be treated with surgery or who did not respond to surgery. Pasireotide injection (Signifor LAR) is also used to decrease the amount of growth hormone (a natural substance) produced by people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who cannot be treated with surgery or who did not respond to surgery. Pasireotide injection is in a class of medications called somatostatin agonists. It works by decreasing the amounts of cortisol produced by the body.

Pasireotide comes a solution (liquid) (Signifor) to be injected subcutaneously (under the skin). Pasireotide also comes as a suspension (liquid) (Signifor LAR) to be mixed with another solution and injected into the muscles of the buttocks by a doctor or nurse. Pasireotide solution (Signifor) is usually injected twice a day at home. It should be injected around the same times every day. Pasireotide suspension (Signifor LAR) is usually injected once every 4 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use pasireotide injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

If you are using pasireotide solution (Signifor), you may be able to inject the medication yourself at home or have a friend or relative perform the injections. Your healthcare provider will show you or the person who will be giving the injections how to inject a dose of pasireotide solution (Signifor) at home. Before you use pasireotide solution (Signifor) for the first time, you or the person who will be giving the injections should read the manufacturer's information for the patient that comes with it. These instructions describe how to inject a dose of pasireotide solution (Signifor). Be sure that you understand these directions. Ask your healthcare provider if you have any questions about how to inject the medication or how to dispose of used needles and syringes after you inject the medication.

Always look at pasireotide solution (Signifor) before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless. The liquid should not be cloudy or contain visible particles. Do not use if the liquid is cloudy, discolored, or contains particles.

You can inject pasireotide solution (Signifor) anywhere on the front of your thighs (upper leg) or your stomach area. Choose a different spot each time you inject your medication. Do not inject your medication into skin that is irritated or reddened.

Continue to use pasireotide injection even if you feel well. Do not stop using pasireotide injection without talking to your doctor.

Your doctor may need to increase or decrease your dose depending on how well the medication works for you and the side effects you experience. Tell your doctor how you are feeling during your treatment with pasireotide injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using pasireotide injection,

• tell your doctor and pharmacist if you are allergic to pasireotide injection, any other medications, or any of the ingredients in pasireotide injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Pacerone); beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Kapspargo sprinkle, Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Hemangeol, Inderal); bromocriptine (Cycloset, Parlodel); calcium channel blockers such as amlodipine (Katerzia, Norvasc; in Caduet, Lotrel, others), diltiazem (Cardizem, Cartia, Tiazac, others), felodipine, nifedipine (Procardia), nisoldipine (Sular), and verapamil (Calan, Verelan); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); diuretics ('water pills'); insulin and oral medications for diabetes; procainamide; quinidine (in Nuedexta); and sotalol (Betapace, Sorine, Sotylize). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with pasireotide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have recently had a heart attack or if you have or ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), heart failure, irregular heartbeat, angina (chest pain), or other heart problems; diabetes; low levels of potassium or magnesium in your blood; gallstones or other gall bladder problems; thyroid, pituitary, or liver problems; or any other medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using pasireotide injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you are using pasireotide solution (Signifor), skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

If you miss an appointment to receive a dose of pasireotide suspension (Signifor LAR), call your doctor as soon as possible.

Pasireotide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• stomach pain
• constipation
• decreased appetite
• headache
• anxiety
• injection site pain, redness, swelling, or itching
• hair loss
• difficulty falling asleep or staying asleep
• swelling of arms, hands, feet, ankles, or lower legs
• runny nose, sneezing, cough, or sore throat
• dry or itchy skin
• muscle or joint pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• slowed or irregular heartbeat, dizziness, or fainting
• feeling more hungry or thirsty than usual, increased urination, extreme tiredness
• weakness, dizziness, extreme tiredness, nausea, vomiting, diarrhea, or decreased appetite
• pain in the upper back between the shoulder blades or under the right shoulder; stomach pain, especially in the upper right part of the stomach; nausea; or fever and chills
• yellowing of the skin or eyes

Pasireotide injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• diarrhea

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to pasireotide injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Signifor^®
• Signifor^® LAR