Signifor

Pasireotide is a man-made protein that is similar to a hormone in the body called somatostatin. Pasireotide lowers certain hormone substances produced in the body.

Pasireotide is used to treat Cushing's disease or acromegaly (endocrine disorders). Pasireotide is usually given after surgery or other treatments have been tried without success.

Pasireotide may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use pasireotide if you are allergic to it.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using pasireotide.

To make sure pasireotide is safe for you, tell your doctor if you have:

• diabetes;
• liver disease;
• a heart rhythm disorder;
• personal or family history of long QT syndrome;
• gallbladder disease; or
• a history of an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

It is not known whether pasireotide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether pasireotide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Signifor may cause serious side effects, including:

• See “Drug Precautions".
• slow heart rate (bradycardia). Signifor 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 Signifor.
• gallstones (cholelithiasis). Your doctor should do an ultrasound to check for gallstones before you start using Signifor and while you use it.

The most common side effects of Signifor 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 Signifor. 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.

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 Signifor there are no specific foods that you must exclude from your diet when receiving Signifor.

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

• Synthetic polypeptide pharmacologically related to natural endocrine hormone somatostatin.1 12

• Binds to and activates somatostatin receptors in the anterior pituitary, or resulting in inhibition of ACTH secretion and decreased cortisol secretion from adrenal glands.1 12

• Binds preferentially to somatostatin receptors 1, 2, 3, and 5 with greatest affinity for receptor subtype 5 (frequently overexpressed in corticotroph tumor cells from patients with Cushing's disease).1 12

• Differs from other currently available somatostatin analogs (lanreotide, octreotide) in its distinct somatostatin receptor-binding profile.12 17

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Usual Adult Dose for Cushing's Syndrome:

Initial dose: 0.6 mg or 0.9 mg subcutaneously twice daily.
Maintenance dose: 0.3 to 0.9 mg subcutaneously twice daily.
Maximum dose: 0.9 mg subcutaneously twice daily
Duration of therapy: Treatment should be continued as long as benefit is derived.

Comments: Titrate dose based on response and tolerability.

Use: The treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction to Signifor: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• slow heart rate, feeling like you might pass out;

• low cortisol levels - joint or muscle pain, muscle weakness, loss of appetite, tired feeling, weight loss, craving salty foods, mood changes, irritability;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

• gallbladder problem - chalky-colored stools, stomach pain just after eating a meal, nausea, heartburn, bloating, and severe upper stomach pain that may spread to your back.

Common Signifor side effects may include:

• feeling weak or tired;

• nausea, stomach pain, diarrhea;

• headache;

• swelling, bloated feeling;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• hair loss; or

• pain, redness, itching, bruising or bleeding where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with pasireotide. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Signifor, especially:

• bromocriptine;

• cyclosporine;

• anagrelide;

• droperidol;

• methadone;

• ondansetron;

• an antibiotic - azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;

• cancer medicine - arsenic trioxide, vandetanib;

• an antidepressant - citalopram, escitalopram;

• anti-malaria medication - chloroquine, halofantrine;

• heart or blood pressure medicine - amlodipine, atenolol, carvedilol, labetalol, metoprolol, nebivolol, sotalol, verapamil, and others;

• heart rhythm medicine - amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol;

• medicines to control electrolyte disorders - calcium gluconate, sodium polystyrene sulfonate, tolvaptan; or

• medicine to treat a psychiatric disorder - chlorpromazine, haloperidol, pimozide, thioridazine.

This list is not complete and many other drugs can interact with pasireotide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.