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 or acromegaly (endocrine disorders).
Signifor is usually given after surgery or other treatments have been tried without success.
Important information
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.
Before taking this medicine
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 pasireotide.
To make sure Signifor is safe for you, tell your doctor if you have:
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 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.
How is Signifor given?
Take Signifor exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Signifor.
Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Signifor is injected under the skin, usually twice per day. 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 LAR is injected into a muscle once every 4 weeks. A healthcare provider will give you this type of pasireotide injection.
Your care provider will show you the best places on your body to inject Signifor under the skin. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Avoid injecting Signifor into skin that is red or irritated.
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 disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Each Signifor single-use ampule is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
While using this medicine, you may need frequent blood tests. Check your blood sugar carefully if you are diabetic.
Store Signifor at room temperature, away from moisture, heat, and light.
If you store Signifor LAR at home, keep it in the original carton in the refrigerator. Do not freeze.
Signifor LAR should be at room temperature when you inject it. Take the medicine out of the refrigerator at least 30 minutes before your injection is to be given. Once the medicine reaches room temperature, you must use it within 24 hours.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Signifor dosing information
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.
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 while using Signifor?
Do not inject this medicine into skin that is red or irritated.
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:
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slow heart rate, feeling like you might pass out;
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low cortisol levels - joint or muscle pain, muscle weakness, loss of appetite, tired feeling, weight loss, craving salty foods, mood changes, irritability;
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high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
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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:
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feeling weak or tired;
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nausea, stomach pain, diarrhea;
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headache;
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swelling, bloated feeling;
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cold symptoms such as stuffy nose, sneezing, sore throat;
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hair loss; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Signifor?
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:
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bromocriptine;
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cyclosporine;
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anagrelide;
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droperidol;
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methadone;
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ondansetron;
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an antibiotic - azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;
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cancer medicine - arsenic trioxide, vandetanib;
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an antidepressant - citalopram, escitalopram;
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anti-malaria medication - chloroquine, halofantrine;
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heart or blood pressure medicine - amlodipine, atenolol, carvedilol, labetalol, metoprolol, nebivolol, sotalol, verapamil, and others;
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heart rhythm medicine - amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol;
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medicines to control electrolyte disorders - calcium gluconate, sodium polystyrene sulfonate, tolvaptan; or
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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.
