Octreotide Injection (Teva Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What is OCTREOTIDE INJECTION used for?

OCTREOTIDE INJECTION (octreotide acetate) is used:

• to control symptoms in patients with

  gastroenteropancreatic (GEP) endocrine tumors or with acromegaly.

• for the prevention of complications following

  pancreatic surgery.

• for the emergency treatment of bleeding varices

  (stretched veins) in the esophagus and stomach in patients with liver disease and as protection from rebleeding.

What is a Gastroenteropancreatic (GEP) Endocrine Tumor?

GEP endocrine tumors are growths that have developed from endocrine cells in the gastrointestinal tract (the stomach, intestines, appendix) or the pancreas.

Some symptoms come about because GEP endocrine tumors produce and secrete chemical substances called peptides, i.e. small proteins in excess – overloading the system.

The over-secretion of peptides cause diarrhea and flushing.

Carcinoid tumors (generally occurring in the esophagus, stomach, intestines, appendix, and lungs) and VIPomas (almost always occurring in the pancreas) are the most common type of GEP endocrine tumor.

Diarrhea can cause dehydration, it is therefore very important to control it and replace the loss of water and electrolytes as quickly as possible.

What is Acromegaly?

Acromegaly is a life-time, uncommon, debilitating disease characterized by changes in facial bone structure and specific hormonal abnormalities.

Acromegaly is the result of an overproduction of growth hormone by the pituitary gland (a pea-sized gland located at the base of the brain). Uncontrolled disease may lead to arthritis, cardiac and neurologic problems. Approximately 20% to 30% of acromegalic patients also demonstrate high blood pressure.

What OCTREOTIDE INJECTION (octreotide acetate) Does?

GEP Endocrine Tumors:

OCTREOTIDE INJECTION works to help slow down the release of the peptides that cause the diarrhea and flushing. It also stimulates water absorption.

Acromegaly:

Octreotide acetate has been shown to lower the overproduction of growth hormone by the pituitary gland.

When it should not be used:

OCTREOTIDE INJECTION should not be used if you are allergic to the active ingredient octreotide or to any other ingredient of the formulation.

What the medicinal ingredient is:

Octreotide (as octreotide acetate).

What the important nonmedicinal ingredients are:

The single dose vials also contain some inactive ingredients: Glacial acetic acid, mannitol, sodium acetate trihydrate and water for injection.

The multidose vials also contain some inactive ingredients: Glacial acetic acid, mannitol, phenol liquefied, sodium acetate trihydrate and water for injection.

What dosage forms it comes in:

OCTREOTIDE INJECTION (octreotide acetate) is a solution supplied in:

• 1 mL single dose vials, each containing 50 µg, 100

  µg or 500 µg of octreotide as acetate. OCTREOTIDE INJECTION is available in boxes of 5 vials.

and

• 5 mL multidose vials. Each vial contains 1000 µg

  (200µg/mL) of octreotide as acetate.

WARNINGS AND PRECAUTIONS

BEFORE you use OCTREOTIDE INJECTION talk to your doctor or pharmacist if you:

• have high blood pressure (hypertension),

• have problems with your blood sugar levels, either

  too high or too low (hypoglycaemia).

• have gallstones or have had gallstones in the past,

  as prolonged use of OCTREOTIDE INJECTION may result in gallstone formation,

• have problems with your liver (e.g. liver cirrhosis),
• have problems with your kidneys and require dialysis,

• are pregnant, suspect that you may be pregnant,

• are breast feeding,
• have heart problems.

If you receive long treatment with OCTREOTIDE INJECTION your doctor may wish to check your thyroid function periodically.

There is very little experience with the use of octreotide acetate in children.

Women of child-bearing potential should use an effective contraceptive method during treatment.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with OCTREOTIDE INJECTION include:

• 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)

Please inform your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription.

OCTREOTIDE INJECTION is best injected between meals or on retiring to bed. This may reduce the gastrointestinal side effects of OCTREOTIDE INJECTION.

PROPER USE OF THIS MEDICATION

Usual dose:

Your doctor will tell you how much OCTREOTIDE INJECTION to take each day. OCTREOTIDE INJECTION is to be injected under your skin (subcutaneous injection). The doctor will also tell you how to divide your dosage through the day.

How to Prepare Your Injection of OCTREOTIDE INJECTION?

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

Single Dose 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 vial.
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 correct amount of drug for your dose). Single Dose Vial: Discard any unused portion.

6. 6. Turn the vial 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.

    Important Points to Remember

    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.

Missed Dose:

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

Overdose:

No life-threatening reactions have been reported after overdosage of octreotide acetate.

If you think you have injected more OCTREOTIDE INJECTION than you should, contact your doctor, hospital emergency department or regional Poison Control Centre immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines OCTREOTIDE INJECTION may cause some side effects. If you experience any of these, tell your doctor. Some patients have experienced a burning sensation at the

injection site. For most people, the burning lasts only a few moments. Injecting the drug at room temperature rather than cold from the refrigerator may alleviate the burning sensation.

Serious side effects

• Gallstones, leading to sudden back pain.
• Too much or too little sugar in the blood.

• Underactive thyroid gland (hypothyroidism)

  causing changes in heart rate, appetite or weight; tiredness, feeling cold, or swelling at the front of the neck.

• Changes in thyroid function tests.
• Inflammation of the gallbladder (cholecystitis).
• Impaired glucose tolerance.
• Irregular heart beat (slow or fast).
• Thirst, low urine output, dark urine, dry flushed skin.
• Hypersensitivity (allergic) reactions including skin rash.

• A type of an allergic reaction (anaphylaxis)

  which causes difficulty in breathing, swelling of the face or dizziness.

• Acute inflammation of the pancreas gland causing severe stomach pain (pancreatitis).
• Liver inflammation (hepatitis); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, generally feeling unwell, itching, light-coloured urine.

Other side effects

Side effects listed below are usually mild and tend to disappear as treatment progresses:

• nausea
• vomiting
• stomach pain
• diarrhea
• feeling of fullness in the stomach
• flatulence (wind)
• loss of appetite
• constipation
• headache

• stomach discomfort after meal

• fatty stools
• loose stools
• discoloration of faeces
• dizziness
• change in liver function tests
• hair loss
• shortness of breath

Since gallstones may occasionally form during prolonged use of OCTREOTIDE INJECTION, your doctor may wish to check your gallbladder periodically.

This is not a complete list of side effects. For any unexpected effects while taking OCTREOTIDE INJECTION, contact your doctor or pharmacist

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

---------------------------------------------------------------- $ Report online at

www.healthcanada.gc.ca/medeffect

$ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701C

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

HOW TO STORE IT

For prolonged storage, OCTREOTIDE INJECTION must be refrigerated at 2° to 8°C -- typical refrigerator temperatures. However, you may leave your daily dose of OCTREOTIDE INJECTION single dose vials out at a room temperature of up to 30°C for up to 2 weeks. If the drug is left out at room temperature for longer than 2 weeks, the medication may break down and become ineffective. The single dose vials should be opened just prior to administration and any unused portion discarded.

The multidose vial may be kept at room temperature for up to 2 weeks even after you start using it. If the drug is left out at room temperature for more than 2 weeks the medication can break down and become ineffective.

Protect from light and freezing. Do not use the medication after the expiry date.

Keep in a safe place out of reach of children and pets.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at: 1-800-268-4127 ext. 5005 (English) or 1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

Last revised: March 28, 2014