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Signifor LAR

Signifor LAR

(pasireotide)

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.

Available form

Dosage

Injectable, Lyophilized Powder

20MG

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Signifor LAR information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

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.

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.

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