Patient Medication Information: uses, side effects, how to take - Signifor Lar
Serious warnings and precautions box
Serious side effects include:
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What SIGNIFOR LAR is used for:
SIGNIFOR LAR is used in adults to treat Acromegaly and Cushing’s disease. It is used in adults who cannot have surgery or for whom surgery has not worked well enough. SIGNIFOR LAR should not be used in children or adolescents under 18 years old.
SIGNIFOR LAR should only be prescribed by a qualified doctor. It can be given by qualified health care providers. They work under the supervision of that doctor.
How SIGNIFOR LAR works:
In Acromegaly, SIGNIFOR LAR lowers the production of growth hormone and insulin-like growth factor-1 to reduce the symptoms of acromegaly.
In Cushing’s disease, SIGNIFOR LAR lowers the production of ACTH to lower the production of cortisol and reduce symptoms.
The ingredients in SIGNIFOR LAR are:
Medicinal ingredients: Pasireotide pamoate
Non-medicinal Ingredients:
Vial: Poly (D,L-lactide-co-glycolide) (50-60:40-50), Poly(D,L-lactide-co-glycolide) (50:50).
Pre-filled syringe: Carmellose sodium, mannitol, poloxamer 188, water for injections.
SIGNIFOR LAR comes in the following dosage forms:
SIGNIFOR LAR is supplied in a kit which includes:
- One vial containing powder for suspension: 10 mg, 20 mg, 30 mg, 40 mg, or 60 mg pasireotide.
- One prefilled syringe containing 2 mL of the diluent solution for reconstitution.
Do not use SIGNIFOR LAR if:
- you are allergic to pasireotide or to any other ingredient in SIGNIFOR LAR or its container
- you have moderate or severe liver problems
- you have uncontrolled diabetes
have the following heart problems:
- heart failure
- cardiogenic shock (a condition that occurs when the heart can't pump enough blood to the body's organs)
- heart rhythm problems. Unless you have a functioning pacemaker
- extremely low heart rate
- congenital long QT syndrome
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SIGNIFOR LAR. Talk about any health conditions or problems you may have, including if you:
- have problems with your blood sugar levels, either too high (hyperglycemia) or too low (hypoglycemia).
- have diabetes.
- have problems with your liver.
- have severe kidney problems.
- have or have had heart problems including ischemic heart disease, or congestive heart failure, an abnormal heart rate or rhythm, or problems with the electrical system of your heart called QT prolongation.
- have low levels of potassium, calcium or magnesium in your blood.
- have conditions such as severe vomiting, diarrhea, dehydration.
- have a history of fainting or near fainting spells.
- have gallstones (cholelithiasis).
- have low levels of pituitary hormones.
- are 65 years or older female who is at risk of developing torsades de pointes
Other warnings you should know about:
Monitoring and tests:
Before you start and during your treatment, your healthcare professional may complete the following tests:
- Electrocardiogram, to measure the electrical activity of the heart
- Electrolytes level tests
- Blood test to check your fasting blood sugar and hemoglobin A1c levels. You may need to start taking medicines to control your blood sugar levels or your healthcare professional may adjust the medicines you are now taking to control your blood sugar levels
- Pituitary hormone test
- Liver function tests
- Gallbladder ultrasound
Female Patients:
Speak to your healthcare professional if you are pregnant, may be pregnant, or thinking of becoming pregnant. You should not use SIGNIFOR LAR while pregnant. It is not known if SIGNIFOR LAR will harm your unborn baby.
- If you are able to get pregnant, you should use effective methods of birth control during your treatment. Your ability to get pregnant can change because you are taking SIGNIFOR LAR. If you wish to get pregnant, you must wait two months after stopping SIGNIFOR LAR.
- Speak to your healthcare professional if you are breastfeeding. It is not known if SIGNIFOR LAR passes into breast milk.
Driving and Using Machines: Before you perform tasks which may require special attention, wait until you know how you respond to SIGNIFOR LAR as fatigue, headache, or dizziness can occur.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with SIGNIFOR LAR:
- Anti-arrhythmics used to treat irregular heart beat such as amiodarone, disopyramide, procainamide, quinidine, sotalol, ibutilide, dronedarone, flecainide, propafenone
Medicines that affect the way the electrical system of your heart works (QT prolongation) such as:
- Antipsychotics (e.g., haloperidol, pimozide, droperidol, ziprasidone, chlorpromazine)
- Antidepressants (e.g., imipramine, citalopram, amitriptyline, maprotiline, venlafaxine)
- Methadone
- Antibiotics (e.g., clarithromycin, moxifloxacin, erythromycin, azithromycin, tacrolimus, levofloxacin, ciprofloxacin)
- Antimalarials (e.g., chloroquine, quinine)
- Antifungals (e.g., ketoconazole, fluconazole, voriconazole)
- Dopamine receptor antagonists (e.g. domperidone)
- Antiemetics (e.g., intravenous ondansetron)
- Cancer drugs (e.g., sunitinib, nilotinib, vandetanib, lapatinib, vorinostat)
- Asthma drugs (e.g., formoterol, salmeterol)
- Diuretics (water pills)
- Laxatives and enemas
- Amphotericin B
- High dose corticosteroids
Medicines that decrease heart rate and prolong the PR interval
- Drugs to treat high blood pressure (e.g., beta-blockers or calcium channel blockers, atenolol, diltiazem, verapamil, clonidine)
- Drugs to treat heart failure (e.g., digoxin)
- Drugs to treat multiple sclerosis (e.g., fingolimod)
- Drugs to treat HIV infection (e.g., atazanavir)
- cyclosporine
- bromocriptine
- Medicines that work to prevent blood clots (anticoagulants)
- Antidiabetic drugs, including insulin
How to take SIGNIFOR LAR:
- See the Instructions for Use leaflet for detailed directions on how to take SIGNIFOR LAR.
- SIGNIFOR LAR should be administered by a trained healthcare professional. Your healthcare provider will mix and examine SIGNIFOR LAR before the injection.
SIGNIFOR LAR is injected:
- Deep into the muscle of the buttocks
- Every 4 weeks
- Alternately into the left and right buttocks
Usual dose:
Your healthcare professional will:
- Decide your dose as it depends on your test results or how you feel
- tell you when you will receive your dose of SIGNIFOR LAR.
- tell you how long you need to receive SIGNIFOR LAR and when you may need to stop taking it temporarily or permanently
Overdose:
| If you think that you or a person you are caring for have taken too much SIGNIFOR LAR, contact your healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
If you miss your injection, contact your healthcare professional as soon as possible.
Possible side effects from using SIGNIFOR LAR:
These are not all the possible side effects you may have when taking SIGNIFOR LAR. If you have any side effects not listed here, tell your healthcare professional.
Side effects include:
- Altered sense of taste
- Back pain
- Chest pain
- Diarrhea, nausea, abdominal pain, abdominal discomfort, bloating, vomiting, loss of appetite, constipation, gas, indigestion, frequent bowel movements
- Dry, peeling, itchy or flaky skin
- Eye irritation, blurred vision
- Fainting
- Fatigue, weakness, inactivity
- Hair loss
- Headache, dizziness
- High blood pressure
- Insomnia
- Limb swelling
- Muscle pain, muscle spasm, joint pain
- Pain, discomfort, itch and swelling at the injection site
SIGNIFOR LAR can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Very common | |||
| Hyperglycemia (High level of sugar in the blood) or Diabetes: Excessive thirst, high urine output, increased appetite with weight loss, tiredness, nausea, vomiting, abdominal pain | √ | ||
| Cholelithiasis (Gallstones): Sudden back pain or pain on the right side of your abdomen, sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin and whites of your eyes, fever with chills, nausea | √ | ||
| Common | |||
| Hypocortisolism (low cortisol levels): extreme weakness, weight loss, nausea, vomiting, low blood pressure | √ | ||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness | √ | ||
| Bradycardia (abnormally slow heartbeat): Weakness, tiredness, shortness of breath, light-headedness, fainting or near fainting | √ | ||
| Prolonged QT interval (Changes in the electrical system of your heart): dizziness, palpitations, fainting or near fainting, seizures | √ | ||
| Liver Disorder: Itching, yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | √ | ||
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heart beat, nausea, vomiting, tenderness when touching the abdomen, indigestion, diarrhea, bloating | √ | ||
| Change in blood coagulation parameters: severe bruising or unusual bleeding from the skin or other areas | √ | ||
| Cholecystitis (Inflammation of the gallbladder): fever, nausea, pain that radiates to your shoulder or back, severe pain in your upper right abdomen, vomiting | √ | ||
| Unknown | |||
| Diabetic ketoacidosis (High amounts of ketones in your urine or blood): fruity scented breath, trouble breathing, confusion | √ | ||
| Steatorrhea (high amounts of fat in stool) and body unable to absorb fats from food: new or worsening symptoms of oily stools, stool discoloration, loose stools, abdominal bloating, and weight loss | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Keep out of the reach and sight of children.
- Do not use SIGNIFOR LAR after the expiry date, which is stated on the carton box.
- Store at 2 to 8°C.
- Do not freeze.
- Medicines should not be thrown away in household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
If you want more information about SIGNIFOR LAR:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.recordatirarediseases.com/ca), or by calling 1-877-827-1306.
Date of Authorization: 2025-05-09
SIGNIFOR and LAR are registered trademarks.