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Pasireotide Injection 0.3 mg/mL (1 mL) (PASIREOTIDE - SUBCUTANEOUS INJECTION)

For endocrine disorder.

Brand Name(s): Signifor

Generic Name: Pasireotide

Instructions

This medicine is used by injecting it into the skin. Please ask your doctor, nurse or pharmacist for the correct places on your body where this medicine can be injected.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

Always inspect the medicine before using.

The liquid should be clear and colorless.

Do not use the medicine if it contains any particles or if it has changed color.

Keep medicine at room temperature. Protect from light.

Never use any medicine that has expired.

Discard any remaining medicine after your dose is given.

You or a family member can be trained to give this medicine at home.

Do not inject into skin that is red, swollen or itchy.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

Do not rub or massage the area where the injection was given.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine may affect your blood sugar levels. If you have diabetes, talk to your doctor before changing the dose of your diabetes medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than twice during 24 hours.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Ask your doctor, nurse or pharmacist how to safely discard unused medicines, needles and syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • bloating
  • diarrhea
  • dizziness
  • swelling of the legs, feet, and hands
  • excess gas
  • hair loss
  • headaches
  • pain, redness, swelling near injection

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • decreased appetite
  • change in blood sugar level
  • blurry vision
  • fainting
  • fast, irregular, or slow heartbeat
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • nausea
  • seizures
  • severe stomach or bowel pain
  • light colored stool
  • sweating
  • excessive thirst
  • increased urinary frequency
  • severe or persistent vomiting
  • weight loss

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.