Signifor

The recommended starting dose for Signifor (Pasireotide) is 0.6 mg injected subcutaneously (under the skin) twice a day, approximately every 12 hours. Depending on how well the medication works and whether you experience side effects, your doctor may increase the dose to a maximum of 0.9 mg twice daily.

Signifor (Pasireotide) is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses) and can teach you how to give yourself the injection at home. Do not attempt to inject Signifor (Pasireotide) on your own until you completely understand how to inject a dose. If you are unsure of how to prepare or administer a dose, ask a health care professional to clarify for you. If you are having difficulty giving yourself injections, ask a family member or other caregiver for help if they are willing to become involved with your treatment and are willing to learn how to give you your injections.

Use a different injection site for each dose. Avoid injecting Signifor (Pasireotide) into an area of skin that is sore, red, infected, or otherwise damaged.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Signifor (Pasireotide) exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Signifor (Pasireotide) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

0.3 mg/mL
Each 1 mL of clear, colourless, sterile solution contains 0.3 mg of Signifor (Pasireotide) as Signifor (Pasireotide) diaspartate. Nonmedicinal ingredients: mannitol, sodium hydroxide, tartaric acid, and water for injection.

0.6 mg/mL
Each 1 mL of clear, colourless, sterile solution contains 0.6 mg of Signifor (Pasireotide) as Signifor (Pasireotide) diaspartate. Nonmedicinal ingredients: mannitol, sodium hydroxide, tartaric acid, and water for injection.

0.9 mg/mL
Each 1 mL of clear, colourless, sterile solution contains 0.9 mg of Signifor (Pasireotide) as Signifor (Pasireotide) diaspartate. Nonmedicinal ingredients: mannitol, sodium hydroxide, tartaric acid, and water for injection.

Do not take Signifor (Pasireotide) if you:

• are allergic to Signifor (Pasireotide) or any ingredients of the medication
• have moderately to severely reduced liver function
• have uncontrolled Diabetes
• have any of the following heart conditions: severe heart failure, cardiogenic shock, AV block, sinoatrial block, sick sinus syndrome, very low heart rate, or long QT syndrome

There may be an interaction between Signifor (Pasireotide) and any of the following:

• acetylsalicylic acid (Asa)
• Alfuzosin
• alpha-agonists (e.g., Clonidine, methyldopa)
• Amiodarone
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Atomoxetine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, sotalol)
• beta-2 agonists (e.g., formoterol, salbutamol, salmeterol)
• Bromocriptine
• Capecitabine
• chloroquine
• Codeine
• Cyclosporine
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Digoxin
• Diltiazem
• Disopyramide
• diuretics (water pills; e.g., Amiloride, Furosemide, Hydrochlorothiazide)
• Domperidone
• Donepezil
• Dronedarone
• Fingolimod
• Flecainide
• Galantamine
• Guanfacine
• HIV protease inhibitors (e.g., darunavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• Ivabradine
• Lacosamide
• Lanreotide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mefloquine
• Methadone
• Midodrine
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Octreotide
• Ondansetron
• pentamidine
• procainamide
• Propafenone
• rilpivirine
• Rivastigmine
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• siponimod
• testosterone
• Tizanidine
• Tofacitinib
• Tramadol
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• tyrosine kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib, Sunitinib)
• verapamil
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Signifor (Pasireotide). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Signifor (Pasireotide).

Abnormal heart rhythms: Signifor (Pasireotide) can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, l, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with Signifor (Pasireotide). You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have diabetes
• have had a Stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Signifor (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor (Pasireotide), and whether any special monitoring is needed.

Diabetes: Signifor (Pasireotide) often causes increased blood sugar levels, causing the loss of blood glucose control. Glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Signifor (Pasireotide). Your doctor should monitor your blood glucose levels regularly when you first start using Signifor (Pasireotide), even if you do not have diabetes.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Signifor (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor (Pasireotide), and whether any special monitoring is needed.

Fluid and electrolyte balance: Signifor (Pasireotide) may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking Signifor (Pasireotide). If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking Signifor (Pasireotide).

Liver function: People taking Signifor (Pasireotide) may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking Signifor (Pasireotide). Liver disease or reduced liver function may cause Signifor (Pasireotide) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Signifor (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor (Pasireotide), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Signifor (Pasireotide).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low levels of cortisol: Treatment with Signifor (Pasireotide) causes a decrease in the amount of cortisol produced by the body. Cortisol is a hormone the body needs to function.

If the amount of cortisol in the body is reduced too much, it can cause weakness, fatigue, loss of appetite, nausea, vomiting, low blood pressure, low blood glucose, and low amounts of sodium in the body.

Pancreatitis: Signifor (Pasireotide) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Signifor (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor (Pasireotide), and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Pregnancy: The potential risks of using Signifor (Pasireotide) during pregnancy, for the mother or developing baby, are not known. Women who may become pregnant should not use Signifor (Pasireotide) unless they are using reliable birth control. If you become pregnant while taking Signifor (Pasireotide), contact your doctor immediately.

Breast-feeding: It is not known if Signifor (Pasireotide) passes into breast milk. If you are a breast-feeding mother and are taking Signifor (Pasireotide), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Signifor (Pasireotide) have not been established for children.