Signifor LAR (Pasireotide) belongs to the class of medications called somatostatin analogues. Somatostatin is a hormone that is responsible for controlling many processes in the body by blocking the action of other hormones.

Signifor LAR (Pasireotide) is used to treat acromegaly, a condition that develops as a result of the body producing too much growth hormone. This results in an increased growth of certain bones and tissues, particularly the hands and feet. Signifor LAR (Pasireotide) works by reducing the production of growth hormone and insulin-like growth factor-1. Signifor LAR (Pasireotide) is used when surgery has not been successful or is not an option.

Signifor LAR (Pasireotide) is also used to treat Cushing’s disease in adults, when surgery is not an option for treatment, or when surgery has not been effective. Cushing’s disease is a condition where the body produces too much of the hormone cortisol. Signifor LAR (Pasireotide) works by blocking the production of adrenocorticotropic hormone which then reduces the production of cortisol.

Signifor LAR (Pasireotide) may be available under multiple brand names and/or in several different forms. Any specific brand name of Signifor LAR (Pasireotide) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Signifor LAR (Pasireotide) may not be used for all of the conditions discussed here.

Your doctor may have suggested Signifor LAR (Pasireotide) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Signifor LAR (Pasireotide), speak to your doctor. Do not stop taking Signifor LAR (Pasireotide) without consulting your doctor.

Do not give Signifor LAR (Pasireotide) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Signifor LAR (Pasireotide) if their doctor has not prescribed it.

For the treatment of acromegaly, the recommended starting dose for Signifor LAR (Pasireotide) is 40 mg injected by deep intramuscular injection (into muscle of the buttocks) every 4 weeks. Depending on how well the medication works and whether you experience side effects, your doctor may increase or decrease your dose. The maximum recommended dose is 60 mg every 4 weeks.

For the treatment of Cushing’s disease, the recommended starting dose is 10 mg injected by deep intramuscular injection (into muscle of the buttocks) every 4 weeks. Depending on how well the medication works and whether you experience side effects, your doctor may increase or decrease your dose. The maximum recommended dose is 40 mg every 4 weeks.

Signifor LAR (Pasireotide) is injected by a health care professional. Injections should be alternated between the right and left buttock muscle.

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 LAR (Pasireotide) exactly as prescribed by your doctor.

If you miss an appointment to receive a Signifor LAR (Pasireotide) injection, contact your doctor as soon as possible to reschedule your appointment. 

Store Signifor LAR (Pasireotide) in the refrigerator, protect it from freezing, 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.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Signifor LAR (Pasireotide). If you are concerned about side effects, discuss the risks and benefits of Signifor LAR (Pasireotide) with your doctor.

The following side effects have been reported by at least 1% of people taking Signifor LAR (Pasireotide). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• back pain
• bloating
• changed sense of taste
• Constipation
• Diarrhea
• dizziness
• dry, flaking, peeling skin
• eye irritation
• fatigue
• hair loss
• headache
• lethargy
• loss of appetite
• muscle pain or cramps
• nausea
• redness, bruising, irritation, or swelling at site of injection
• trouble sleeping
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision
• high blood pressure
• limb swelling
• Low Blood Pressure (dizziness, fainting, lightheadedness)
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
• signs of too little cortisol in the body (e.g., weakness, fatigue, loss of appetite, nausea, vomiting, dizziness, low blood sugar)
• signs of heart problems (e.g., fast, irregular heartbeat or pulse, difficulty breathing, weakness, dizziness, fainting, seizures)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs and symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• slow heartbeat
• symptoms of gallstones (e.g., pain in back right shoulder blade, right sided chest pain below rib cage, nausea, vomiting, burping)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• seizures
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, Fever, chills, rapid heartbeat, swollen abdomen)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Signifor LAR (Pasireotide).

10 mg
Each vial of Signifor LAR (Pasireotide) powder for suspension contains 10 mg of Signifor LAR (Pasireotide) as Signifor LAR (Pasireotide) pamoate. Each prefilled syringe contains 2 mL of solution for reconstitution. Nonmedicinal ingredients: vial: poly (D,L-lactide-co-glycolide) (50-60:40-50), poly (D,L-lactide-co-glycolide) (50:50); prefilled syringe: carmellose sodium, mannitol, poloxamer 188, water for injection.

20 mg
Each vial of Signifor LAR (Pasireotide) powder for suspension contains 20 mg of Signifor LAR (Pasireotide) as Signifor LAR (Pasireotide) pamoate. Each prefilled syringe contains 2 mL of solution for reconstitution. Nonmedicinal ingredients: vial: poly (D,L-lactide-co-glycolide) (50-60:40-50), poly (D,L-lactide-co-glycolide) (50:50); prefilled syringe: carmellose sodium, mannitol, poloxamer 188, water for injection.

30 mg
Each vial of Signifor LAR (Pasireotide) powder for suspension contains 30 mg of Signifor LAR (Pasireotide) as Signifor LAR (Pasireotide) pamoate. Each prefilled syringe contains 2 mL of solution for reconstitution. Nonmedicinal ingredients: vial: poly (D,L-lactide-co-glycolide) (50-60:40-50), poly (D,L-lactide-co-glycolide) (50:50); prefilled syringe: carmellose sodium, mannitol, poloxamer 188, water for injection.

40 mg
Each vial of Signifor LAR (Pasireotide) powder for suspension contains 40 mg of Signifor LAR (Pasireotide) as Signifor LAR (Pasireotide) pamoate. Each prefilled syringe contains 2 mL of solution for reconstitution. Nonmedicinal ingredients: vial: poly (D,L-lactide-co-glycolide) (50-60:40-50), poly (D,L-lactide-co-glycolide) (50:50); prefilled syringe: carmellose sodium, mannitol, poloxamer 188, water for injection.

60 mg
Each vial of Signifor LAR (Pasireotide) powder for suspension contains 60 mg of Signifor LAR (Pasireotide) as Signifor LAR (Pasireotide) pamoate. Each prefilled syringe contains 2 mL of solution for reconstitution. Nonmedicinal ingredients: vial: poly (D,L-lactide-co-glycolide) (50-60:40-50), poly (D,L-lactide-co-glycolide) (50:50); prefilled syringe: carmellose sodium, mannitol, poloxamer 188, water for injection.

Do not take Signifor LAR (Pasireotide) if you:

• are allergic to Signifor LAR (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 LAR (Pasireotide) and any of the following:

• acetylsalicylic acid (Asa)
• Alfuzosin
• amantadine
• Amiodarone
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, sotalol)
• Bromocriptine
• Ceritinib
• chloroquine
• Clonidine
• Codeine
• Cyclosporine
• Degarelix
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Digoxin
• Diltiazem
• Disopyramide
• dofetilide
• Domperidone
• Donepezil
• Dronedarone
• efavirenz
• Fingolimod
• Flecainide
• formoterol
• Galantamine
• Guanfacine
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Indapamide
• Ivabradine
• Lacosamide
• Lanreotide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mefloquine
• Methadone
• methyldopa
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Octreotide
• Pegvisomant
• pentamidine
• Primaquine
• procainamide
• Propafenone
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rilpivirine
• Rivastigmine
• Romidepsin
• Ruxolitinib
• salmeterol
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• somatostatin
• sulfamethoxazole
• tacrolimus
• Tamoxifen
• testosterone
• Tetrabenazine
• Tizanidine
• Tolterodine
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Triptorelin
• tyrosine kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib)
• Venlafaxine
• verapamil

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 LAR (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 LAR (Pasireotide).

Abnormal heart rhythms: Signifor LAR (Pasireotide) can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, 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 LAR (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 LAR (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor LAR (Pasireotide), and whether any special monitoring is needed.

Diabetes: Signifor LAR (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 LAR (Pasireotide). Your doctor should monitor your blood glucose levels regularly when you first start using Signifor LAR (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 LAR (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor LAR (Pasireotide), and whether any special monitoring is needed.

Drowsiness/dizziness: Signifor LAR (Pasireotide) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by Signifor LAR (Pasireotide).

Fluid and electrolyte balance: Signifor LAR (Pasireotide) may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking Signifor LAR (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 LAR (Pasireotide).

Liver function: People taking Signifor LAR (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 LAR (Pasireotide). Liver disease or reduced liver function may cause Signifor LAR (Pasireotide) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Signifor LAR (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor LAR (Pasireotide), and whether any special monitoring is needed.

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.

Pancreatitis: Signifor LAR (Pasireotide) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Signifor LAR (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor LAR (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 LAR (Pasireotide) during pregnancy, for the mother or developing baby, are not known. Women who may become pregnant should not use Signifor LAR (Pasireotide) unless they are using reliable birth control. Birth control should be used while using Signifor LAR (Pasireotide) and for at least 2 months after stopping the medication. If you become pregnant while taking Signifor LAR (Pasireotide), contact your doctor immediately.

Breast-feeding: It is not known if Signifor LAR (Pasireotide) passes into breast milk. If you are a breast-feeding mother and are taking Signifor LAR (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 LAR (Pasireotide) have not been established for children.