Signifor

Generic Name: pasireotide (PAS i REE oh tide)
Brand Names: Signifor

What is Signifor?

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.

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

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

Important information

Call your doctor at once if you have any signs that your cortisol levels are too low, such as: joint pain, muscle weakness, loss of appetite, weakness or tired feeling, weight loss, craving salty foods, mood changes, or irritability.

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Before using Signifor

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

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

To make sure Signifor 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).

FDA pregnancy category C. It is not known whether Signifor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether pasireotide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby while being treated with Signifor.

How is Signifor given?

Take Signifor exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Signifor is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Signifor comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Use a different place on your stomach or thigh each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Avoid injecting Signifor into skin that is swollen or irritated.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Store Signifor at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Signifor side effects

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:

  • nausea, stomach pain, diarrhea;

  • headache;

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

  • swelling in your hands or feet;

  • hair loss; or

  • pain, itching, redness, bruising, or bleeding where the injection was given.

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.

See also: Side effects (in more detail)

What other drugs will affect Signifor?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Signifor, especially:

  • bromocriptine;

  • cyclosporine;

  • methadone;

  • tacrolimus;

  • arsenic trioxide, vandetanib, vemurafenib;

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

  • an antidepressant--amitriptyline, citalopram, clomipramine, desipramine;

  • anti-malaria medication--artemether and lumefantrine, chloroquine, halofantrine, mefloquine;

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

  • insulin or oral diabetes medication;

  • medicine to prevent or treat nausea and vomiting--dolasetron, droperidol, ondansetron;

  • medicine to treat a psychiatric disorder--chlorpromazine, clozapine, haloperidol, mesoridazine, pimozide, thioridazine, ziprasidone; or

  • migraine headache medicine--sumatriptan, zolmitriptan.

This list is not complete. Other drugs may interact with Signifor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Signifor.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Signifor only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2013-05-14, 4:18:53 PM.

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