Pasireotide (pas-i-REE-oh-tide)

Treats acromegaly (a growth hormone disorder) and Cushing disease.

Brand Name(s):

Signifor, Signifor LAR

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Use this medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Signifor® LAR:
  • A nurse or other health provider will give you this medicine.
  • This medicine is given as a shot into a muscle, usually in the buttocks.
  • Missed dose: Call your doctor or pharmacist for instructions.
• Signifor®:
  • This medicine is usually injected under the skin of the thigh or stomach.
  • You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
  • You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
  • Use a new needle and syringe each time you inject your medicine.
  • You might not use all of the medicine in each ampul (glass container). Do not save an opened ampul. Do not use the medicine if it has changed color or has particles floating in it.
  • Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
  • If you store this medicine at home, keep it at room temperature, away from heat and direct light.
  • Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how pasireotide works. Tell your doctor if you are using any of the following:
  • Bromocriptine, cyclosporine
  • Beta-blocker or calcium channel blocker
  • Medicine that causes heart rhythm changes

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, gallbladder disease, adrenal problems, diabetes, heart problems (including angina, bradycardia, heart failure, heart rhythm problems), infection, pancreas problems, or a history of heart attack or gallstones.
• This medicine may cause the following problems:
  • Changes in heart rhythm (including QT prolongation)
  • Low levels of cortisol in the blood (hypocortisolism)
  • High blood sugar, which may lead to ketoacidosis (increased ketones in the urine or blood)
  • Gallstones, which may lead to swelling of the gallbladder or bile ducts
  • Adrenal problems
  • Problems with absorbing dietary fats and steatorrhea (fatty stools)
• This medicine may increase fertility in women, which could increase the risk for unplanned pregnancies. Talk to your doctor if you have concerns.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Diarrhea, fat in stools, stomach cramps, weight loss
• Darkening of the skin, diarrhea, dizziness, depression, rash, unusual tiredness or weakness
• Fast, slow, pounding, or uneven heartbeat, dizziness or lightheadedness
• Increased hunger or thirst, frequent urination, tiredness, blurred vision, dry mouth, weight loss
• Loss of appetite, nausea, vomiting
• Severe stomach pain with nausea and vomiting, yellow skin or eyes, stomach fullness, fever
• Shaking, trembling, sweating, hunger, faintness or lightheadedness, confusion

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Hair loss
• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot is given
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088