Octreotide Injection (Mont-Pharma): Uses, Side Effects and Dosage

What is OCTREOTIDE INJECTION used for?

OCTREOTIDE INJECTION (octreotide acetate) is used in adults:

• to control symptoms in patients with:

  • metastatic carcinoid tumours. OCTREOTIDE INJECTION prevents severe diarrhoea and flushing caused by metastatic carcinoid tumours.
  • vasoactive intestinal peptide-secreting tumours (VIPomas). OCTREOTIDE INJECTION treats excessive watery diarrhoea caused by these tumours.
  • acromegaly. Acromegaly is a condition where there is an overproduction of growth hormones by a gland in the brain.
• to prevent problems following pancreatic surgery.
• for the emergency treatment of bleeding in the oesophagus and stomach in patients with liver disease., OCTREOTIDE INJECTION used with other interventions, provides better control of bleeding and early re-bleeding.

How does OCTREOTIDE INJECTION (octreotide acetate) work?

OCTREOTIDE INJECTION is believed to reduce symptoms by:

• reducing the overproduction of growth hormones made by the pituitary gland (a pea-sized gland located at the base of the brain). Too much growth hormone leads to an increase in the growth of tumours.
• slowing down the overproduction of some specific hormones and other related substances made by the stomach, bowels, or pancreas. This overproduction in hormones can cause flushing and diarrhoea.
• increasing water absorption in the body.

What are the ingredients in OCTREOTIDE INJECTION?

Medicinal ingredient: octreotide as octreotide acetate

Non-medicinal ingredients

Single dose vials: glacial acetic acid, sodium acetate trihydrate, sodium chloride and water for injection

Multidose vials: glacial acetic acid, sodium acetate trihydrate, sodium chloride, phenol and water for injection.

OCTREOTIDE INJECTION comes in the following dosage forms:

• 1 mL single-use vials, each containing 50 mcg, 100 mcg or 500 mcg of octreotide as acetate. OCTREOTIDE INJECTION is available in boxes of 5 vials.
• 5 mL multidose vials. Each vial contains 1000 mcg of octreotide as acetate (200 mcg/mL). OCTREOTIDE INJECTION is available in boxes of 1 vial.

Do not use OCTREOTIDE INJECTION if you:

• Are allergic to octreotide acetate or to any other ingredients of OCTREOTIDE INJECTION.

To help avoid side effects and ensure proper use, talk to your health professional before you take OCTREOTIDE INJECTION. Talk about any health conditions or problems you may have, including if you:

• have high blood pressure (hypertension),
• have problems with your blood sugar levels, either too high (hyperglycaemia) or too low (hypoglycaemia), Taking OCTREOTIDE INJECTION can also result in diabetes. Your doctor will monitor your blood sugar levels at the beginning of your treatment or when your dosage is changed.
• have or had gallstones or other biliary problems. Long-term use of OCTREOTIDE INJECTION may result in gallstones or other related problems.
• have or had pancreas problems
• have problems with your liver (e.g. liver cirrhosis),
• have problems with your kidneys and require dialysis,
• have heart problems. Abnormal heart rate and rhythm have been reported during treatment OCTREOTIDE INJECTION. If you are taking any blood pressure medications, your doctor may adjust your dosage while on OCTREOTIDE INJECTION.

Other warnings you should know about:

If you take OCTREOTIDE INJECTION , you may experience the following:

• Growth of tumours. This can cause serious complications (i.e. vision problems). Your doctor will monitor your condition and may provide other treatments.
• Hypothyroidism (low thyroid hormone). If you receive long treatment with OCTREOTIDE INJECTION your doctor may wish to check your thyroid function periodically.

Pregnancy and breastfeeding

If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your doctor.

• Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with OCTREOTIDE INJECTION.
• Effective birth control methods should be used during treatment with OCTREOTIDE INJECTION. Talk to your doctor about birth control methods that may be right for you.

• If you are taking OCTREOTIDE INJECTION to treat acromegaly, there is an increase in risk of you developing the following conditions:

  • Diabetes during pregnancy
  • High blood pressure
  • Worsening of heart disease
• If you are breastfeeding or plan to breastfeed. It is not known if OCTREOTIDE INJECTION passes into your breast milk. Do not breastfeed during your treatment with OCTREOTIDE INJECTION.

Nutrition

Taking OCTREOTIDE INJECTION may alter your ability to absorb vitamin B12 and dietary fat. If you are receiving an intravenous nutritional feeding, zinc levels in your body may also increase. Your doctor will monitor your levels of dietary fat, vitamin B12 and zinc during your treatment.

Tell your health professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with OCTREOTIDE INJECTION:

• drugs to control blood pressure (e.g. beta blockers, calcium channel blockers),
• drugs to control blood sugar (e.g. sulfonylureas, insulin, and diazoxide),
• cimetidine,
• cyclosporine,
• bromocriptine.
• anti-diarrheal agents (affect fluid and electrolytes)
• lutetium (177Lu) oxodotreotide (LUTATHERATM), a radiopharmaceutical drug. If you are going to get LUTATHERA treatment, your doctor may stop and/or change your treatment with OCTREOTIDE INJECTION.

How to take OCTREOTIDE INJECTION:

Usual dose:

• Your doctor will tell you how much OCTREOTIDE INJECTION to take each day. The doctor will also tell you how to divide your dosage through the day.
• OCTREOTIDE INJECTION is to be injected under your skin (subcutaneous injection).
• Pay close attention to the amount of drug you are taking into the syringe for injection. Make sure it is the amount your doctor has prescribed for you.

How to Prepare Your Injection of OCTREOTIDE INJECTION ?

You will receive your supply of OCTREOTIDE INJECTION either in single-use or multidose vials. The single-use or multidose vials should be visually inspected and not used in the presence of floating particles or discoloration.

Injecting the drug at room temperature, rather than cold from the refrigerator, may lessen the burning sensation that some patients may experience at the injection site.

Single-use and Multidose Vials

1. 1. Peel off the aluminum seal.
2. 2. Wipe the top of the vial with an alcohol swab.
3. 3. Remove the cap from the needle and insert the needle into the vial through the rubber stopper.
4. 4. Leave the needle in the bottle.
5. 5. Turn the vial and the syringe upside down. Keep the needle tip within the liquid. Pull the plunger and carefully withdraw the prescribed amount of OCTREOTIDE INJECTION (your doctor or nurse will tell you how to read the markings on the syringe so that you fill it with the correct amount of drug for your dose).
6. 6. Turn the bottle and syringe back upright.
7. 7. Withdraw the needle from the vial.
8. 8. Check to see if there are any air bubbles in the syringe. If bubbles do appear, hold the syringe upright (with the needle pointed up) and lightly tap the barrel. This should make the bubbles rise to the top of the syringe. Then gently press the plunger to push the bubbles out.

How to Inject Your Dose of OCTREOTIDE INJECTION

1. 1. Choose the area of your hip, thigh, or abdomen where you want to make your injection.
2. 2. Clean the site with a fresh alcohol wipe, and keep it nearby.
3. 3. Hold the syringe like a pencil, and remove the needle cap.
4. 4. Use the thumb and forefinger of your other hand to gently pinch up a fold of skin at the place you want to inject. This will lift the subcutaneous tissue away from the muscle underneath.
5. 5. Hold the syringe at a 45° angle, and insert the entire length of the needle into the fold of skin in one quick motion.
6. 6. Once the needle is inserted, let go of the skin.
7. 7. Using your free hand, pull back on the plunger slightly to check whether you have placed the needle in a blood vessel. (You don't want to.) If any blood appears in the syringe, this is not a proper site for your injection. You will have to remove and discard the syringe and needle and start over.
8. 8. Once the needle is inserted properly, slowly inject all of the medication.
9. 9. When you are finished injecting the medicine, place your alcohol wipe where the needle enters the skin. Press lightly.
10. 10. Withdraw the needle at the same angle it is inserted.
11. 11. Gently hold the wipe on your skin for about five seconds.
12. 12. Put the cap back on the needle and dispose of the syringe and needle safely. Do not reuse the syringe and needle. Single-use syringes and needles are used to reduce the chance of infection. Collect your used needles and syringes in a metal container, such as a coffee can, and then dispose of them in a covered garbage can. This will keep others (especially children) from injuring themselves.

Overdose:

Missed Dose:

If you forget to take a scheduled injection, check with your doctor. Do not double your dose at the next injection.

What are possible side effects from using OCTREOTIDE INJECTION ?

• arm and leg feel heavy
• arthritis
• •

If you think you, or a person you are caring for, have injected too much OCTREOTIDE ACETATE OMEGA, contact a health professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

• behaviour changes

  • anxiety, sadness, moody, bad temper
• congested nose
• constipation
• diarrhoea
• dizziness
• dry mouth
• fainting
• fatty stools, loose stools, discolouration of stools
• feeling of fullness in the stomach
• fever
• flatulence (wind)
• flu and cold-like symptoms
• flushing or hot flashes
• foot, back, joint and leg pain
• headache
• haemorrhoids
• hair loss
• leg cramps
• loss of appetite
• nausea
• nose bleeds
• ringing, buzzing, clicking or hissing in the ears
• sore throat

• stomach pain, stomach discomfort after meal

• swelling, pain, rash, burning sensation or bruising at injection site
• tiredness or inability to sleep
• unusual swelling of the arms, hands, legs, feet and ankles, face
• vomiting
• weakness or lack of energy
• weight gain

Treatment with OCTREOTIDE INJECTION may cause a change in thyroid function tests and liver function tests.

These are not all the possible side effects; you may have when taking OCTREOTIDE INJECTION. If you experience any side effects not listed here, tell your healthcare professional.

SERIOUS SIDE EFFECTS, AND WHAT TO DO ABOUT THEM

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 health professional.

REPORTING SIDE EFFECTS

STORAGE:

OCTREOTIDE INJECTION must be stored at 2° to 8°C (in a refrigerator). However, you may leave your daily dose of OCTREOTIDE INJECTION (single-use or multidose vials) out at a room temperature (15°C to 30°C) for up to 2 weeks. The single-use vials should be opened just prior to administration and any unused portion discarded.

Keep the container in the outer carton in order to protect from light. Do not freeze.

Do not use OCTREOTIDE INJECTION (single-use or multidose vials) after the expiry date.

Keep out of reach and sight of children and pets.

If you want more information about OCTREOTIDE INJECTION :

• Talk to your health professional
• Find the full product monograph that is prepared for health 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); by contacting the sponsor, Mont-Pharma Inc, at:

Montreal: (514) 342- 5353

By mail: Mont-Pharma Inc.

2379 Guenette street

Montreal, QC H4R2E9

Last revised: MAR 2, 2023