Pasireotide

Pasireotide is a prescription medication used to treat Cushing's disease in adults who can't have surgery or who have failed surgery. Pasireotide long-acting release (LAR) has been approved for acromegaly.

Pasireotide belongs to a group of drugs called somatostatin analogues. It works by regulating hormone levels in the body.

The medication comes in injectable form, and is usually administered twice daily for Cushing's disease and once-monthly for acromegaly.

Common side effects include diarrhea, nausea, and high blood sugar.

Pasireotide is a prescription medication used to treat:

• Cushing's disease in adults who can't have surgery or who have failed surgery. 

Pasireotide long-acting release (LAR) has been approved for use in acromegaly, a potentially life-threatening endocrine disorder caused by elevated growth hormone levels.

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

Pasireotide may be found in some form under the following brand names:

• Signifor

• Signifor LAR

Pasireotide may cause serious side effects, including:

• See “Drug Precautions".
• slow heart rate (bradycardia). Pasireotide can cause your heart to beat slower, which may cause you to feel weak, dizzy or even faint. People who have, or have had, heart problems are at higher risk for bradycardia.
• problems with the electrical system of your heart (QT interval prolongation) which can put you at risk for abnormal heart beats, dizziness and fainting spells that can be very serious. Call your doctor right away if you experience such spells.
• elevation of your liver tests. Your doctor should do blood tests to check your liver tests while you use pasireotide.
• gallstones (cholelithiasis). Your doctor should do an ultrasound to check for gallstones before you start using pasireotide and while you use it.

The most common side effects of pasireotide include:

• diarrhea
• nausea
• high blood sugar
• headache
• abdominal pain
• fatigue
• diabetes mellitus
• injection site reactions
• common cold
• hair loss
• weakness
• fluid retention

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of pasireotide. For more information, ask your doctor or pharmacist.

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

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking pasireotide with certain other medicines can affect each other and cause side effects.

Especially tell your doctor if you take:

• medicines to control your heart beat (anti-arrhythmics)
• medicines that can affect the electrical system of your heart (QT prolongation)
• medicines to control your blood pressure (such as beta-blockers or calcium channel blockers)
• medicines to control the electrolyte (such as potassium or magnesium) levels in your blood
• cyclosporine (Gengraf, Neoral, Restasis, Sandimmune)
• bromocriptine (Cycloset, Parlodel)

Ask your doctor for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

Pasireotide can cause serious side effects, including:

• Low cortisol levels in your blood (hypocortisolism). Tell your doctor right away if you have any signs and symptoms of hypocortisolism. Signs and symptoms of hypocortisolism may include:
  • weakness
  • fatigue
  • loss of appetite
  • nausea
  • vomiting
  • low blood pressure
  • low level of sodium in your blood
  • low blood sugar

If you get hypocortisolism while taking pasireotide, your doctor may change your dose or ask you to stop taking it.

• High blood sugar (hyperglycemia). Your doctor should check your blood sugar level before you start taking pasireotide and while you take it. Signs and symptoms of hyperglycemia may include:
  • excessive thirst
  • high urine output
  • increased appetite with weight loss
  • tiredness

If you get hyperglycemia while taking pasireotide, your doctor may give you another medicine to take to lower your blood sugar. Your doctor may also change your dose of pasireotide or ask you to stop taking it.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pasireotide there are no specific foods that you must exclude from your diet when receiving pasireotide.

Before you take pasireotide, tell your doctor if you:

• have or have had high blood sugar (hyperglycemia)
• have diabetes
• have or have had heart problems
• have a history of low levels of potassium or magnesium in your blood
• have or have had liver problems
• have or have had gallstones
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if pasireotide will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if pasireotide passes into your breast milk. You and your doctor should decide if you will take pasireotide or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if pasireotide will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if pasireotide passes into breast milk. You and your doctor should decide if you will take pasireotide or breastfeed. The importance of pasireotide to the mother should be determined in any decision to stop or continue using pasireotide.

Pasireotide Usage for Cushing's Disease:

• Use pasireotide exactly as your doctor tells you to.
• Your doctor may change your dose if needed.
• Before you use pasireotide for the first time, your doctor should do a blood test to check your blood sugar levels and your liver tests.
• Before you use pasireotide for the first time, your doctor should do a test to check your heart (electrocardiogram) and your gallbladder (ultrasound).
• Pasireotide should be clear and colorless. Before you inject your dose, check to make sure that pasireotide is clear and colorless, and does not have any clumps or particles in it.
• Pasireotide is given as an injection into the fat just under your skin (subcutaneous injection).
• Do not inject pasireotide into skin that is red or irritated.
• The recommended injection sites for pasireotide are the top of your thigh or stomach area (abdomen).
• Change (rotate) your injection site with each dose. Do not inject pasireotide into the exact same spot for each injection.
• Your doctor should show you how to prepare and give your dose of pasireotide before you use it for the first time.
• You should not inject pasireotide until your doctor has shown you how to use it the right way.

Pasireotide LAR for Acromegaly:

• Your healthcare provider will inject pasireotide once a month into your buttock muscle.
• Keep all appointments.
• If you must miss a regularly scheduled appointment for an injection, reschedule as soon as possible.

For Cushing's Disease:

The recommended dosage range of pasireotide is 0.3 to 0.9 mg by subcutaneous injection (just under the skin) twice a day.

The recommended starting dose is either 0.6 mg or 0.9 mg twice a day.

Injectable Long-Acting Release (LAR) form for Acromegaly:

If you take too much pasireotide, tell your doctor right away or get emergency treatment.

• Store pasireotide at 68°F to 77°F (20°C to 25°C).
• Keep pasireotide out of the light.
• Keep pasireotide and all medicines out of the reach of children.