Patient Medication Information: uses, side effects, how to take - Octreotide for Injectable Suspension
What is OCTREOTIDE for INJECTABLE SUSPENSION used for?
OCTREOTIDE for INJECTABLE SUSPENSION is used in adults who are adequately being treated with octreotide acetate injection for:
- metastatic carcinoid tumours. OCTREOTIDE for INJECTABLE SUSPENSION treats severe diarrhea and flushing caused by metastatic carcinoid tumours
- vasoactive intestinal peptide-secreting tumours (VIPomas). OCTREOTIDE for INJECTABLE SUSPENSION treats excessive watery diarrhea caused by these tumours.
acromegaly. Acromegaly is a condition where there is an overproduction of growth hormones by a gland in the brain. OCTREOTIDE for INJECTABLE SUSPENSION is used to treat people with acromegaly:
- when other types of treatment for acromegaly (surgery or radiotherapy) are not suitable or haven’t worked;
- to cover the interim period until the radiotherapy becomes fully effective.
How does OCTREOTIDE for INJECTABLE SUSPENSION work?
OCTREOTIDE for INJECTABLE SUSPENSION is believed to provide treatment 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 diarrhea.
- increasing water absorption in the body.
What are the ingredients in OCTREOTIDE for INJECTABLE SUSPENSION?
Medicinal ingredient: octreotide as octreotide acetate.
Non-medicinal ingredients
Powder (in vial): poly (DL-lactide-co-glycolide) and mannitol.
Diluent (in prefilled syringe): carboxymethylcellulose sodium, mannitol, poloxamer 188 and sterile water.
OCTREOTIDE for INJECTABLE SUSPENSION comes in the following dosage forms:
OCTREOTIDE for INJECTABLE SUSPENSION is supplied in a kit which includes:
One glass vial
- Powder for suspension (8 mL glass vial): 10 mg, 20 mg or 30 mg of octreotide (as acetate);
- A pre-filled glass syringe containing 2 mL of diluent to be used for suspending the powder;
- One vial adapter to be used for delivering the diluent from the pre-filled syringe to the vial, without a needle;
- One 19G x 1.5” safety injection needle;
- A package insert for detailed directions for use.
Do not use OCTREOTIDE for INJECTABLE SUSPENSION if you:
- Are allergic to octreotide acetate or any other ingredients in OCTREOTIDE for INJECTABLE SUSPENSION and its package.
To help avoid side effects and ensure proper use, talk to your health professional before
you take OCTREOTIDE for INJECTABLE SUSPENSION. 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 (hyperglycemia) or too low (hypoglycemia). Taking OCTREOTIDE for INJECTABLE SUSPENSION 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 for INJECTABLE SUSPENSION may result in gallstones and 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 with OCTREOTIDE for INJECTABLE SUSPENSION. If you are taking any blood pressure medications, your doctor may adjust your dosage while on OCTREOTIDE for INJECTABLE SUSPENSION.
Other warnings you should know about:
If you take OCTREOTIDE for INJECTABLE SUSPENSION, 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-term treatment with OCTREOTIDE for INJECTABLE SUSPENSION 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 for INJECTABLE SUSPENSION
- Effective birth control methods should be used during treatment with OCTREOTIDE for INJECTABLE SUSPENSION. Talk to your doctor about birth control methods that may be right for you.
If you are taking OCTREOTIDE for INJECTABLE SUSPENSION 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 for INJECTABLE SUSPENSION passes into your breast milk. Do not breastfeed during your treatment with OCTREOTIDE for INJECTABLE SUSPENSION.
Nutrition
Taking OCTREOTIDE for INJECTABLE SUSPENSION 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 for INJECTABLE SUSPENSION:
- 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 for INJECTABLE SUSPENSION.
How to take OCTREOTIDE for INJECTABLE SUSPENSION:
- Your doctor or nurse will give you your injection of OCTREOTIDE for INJECTABLE SUSPENSION.
OCTREOTIDE for INJECTABLE SUSPENSION is injected into the muscles of your buttocks. For each injection, the doctor or nurse should alternate between the left and right
- buttocks.
- The vials should be examined before use. Do not use if the vial is damaged, the powder is discoloured, or contains unusual particulate matter.
Usual dose
Dose: One vial every 4 weeks
Usual starting dose: 20 mg every 4 weeks. The dose may be changed later depending on your condition.
Overdose:
| If you think you, or a person you are caring for, have been given too much OCTREOTIDE for INJECTABLE SUSPENSION, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss your injection, please contact your doctor as soon as possible.
What are possible side effects from using OCTREOTIDE for INJECTABLE SUSPENSION?
These are not all the possible side effects you may have when taking OCTREOTIDE for INJECTABLE SUSPENSION. If you experience any side effects not listed here, tell your health professional.
behaviour changes
- anxiety, sadness, moody, nervous, inability to sleep
- breast pain
cold
- runny or stuffy nose, sore throat, cough, sinus congestion, body aches, sneezing
- constipation
- cramps
- diarrhea
- discoloration of stools
- dizziness
- fainting
- fatty stools
- feeling of fullness in the stomach
- fever
- flatulence (wind)
- flu-like symptoms
- hair loss
- having the urge to empty your bowels
- headache
- hot flashes
- increased sweating
- indigestion
- joint, leg(s), muscle, or back pain
- loss of appetite
- nausea
- nose bleeds
- pain, swelling and/or rash at injection site
- rash or itchy skin
stomach discomfort after meal
- stomach pain
- tiredness
- unusual swelling of the arms, hands, legs, feet and ankles, face
- vomiting
- weakness or lack of energy
Treatment with OCTREOTIDE for INJECTABLE SUSPENSION may cause a change in thyroid function tests and liver function tests.
Serious side effects and what to do about them
| Symptom / effect | Talk to your health professional | Stop taking drug and get immediate medical help | |||||
|---|---|---|---|---|---|---|---|
| Only if severe | In all cases | ||||||
| COMMON | |||||||
| Formation of gallstones in the gallbladder (cholelithiasis), inflammation of the gallbladder (cholecystitis) and inflammation of the bile ducts (cholangitis) (severe pain in the upper right abdomen which may last for several hours, particularly after a fatty meal, possible nausea or vomiting, fever) | √√ √ | ||||||
| Anaemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | √ | ||||||
| Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine | √ | ||||||
| Slow heartbeat (bradycardia) | √ | ||||||
| UNCOMMON | |||||||
| Acute pancreatitis (inflammation of the pancreas gland causing severe stomach pain) | √ | ||||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your health professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Low blood sugar (hypoglycemia): feeling hungry, dizziness, fast heartbeat, tingling, trembling, nervousness, sweating, feeling tired | √ | ||
| Diabetes, worsening of diabetes, or high blood sugar: unusual thirst, frequent urination, fatigue, blurred vision | √ | ||
| Underactive thyroid gland (hypothyroidism) causing changes in heart rate, appetite or weight; tiredness, feeling cold, or swelling at the front of the neck. | √ | ||
| 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. | √ | ||
| Fast heartbeat (tachycardia) | √ | ||
| RARE | |||
| Allergic skin reactions: rash, hives, itching, redness | √ | ||
| UNKNOWN | |||
| Low level of platelet in blood (thrombocytopenia); increased bleeding or bruising, fatigue, weakness | √ | ||
| Allergic reaction (anaphylaxis) (difficulty in swallowing or breathing, rash, hives, swelling of the face, lips, tongue or throat, tingling, possibly with a drop in blood pressure with dizziness or loss of consciousness) | √ | ||
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:
The OCTREOTIDE for INJECTABLE SUSPENSION powder and diluent should be stored at 2°C to 8°C (in a refrigerator). Do not freeze. Keep the vial in the outer carton in order to protect it from light. The vials should be allowed to reach room temperature on the day of the injection, but must be protected from light. However, the suspension must only be prepared immediately before injection. Once removed from the refrigerator, the vials will usually reach room temperature within 30 to 60 minutes.
Do not use OCTREOTIDE for INJECTABLE SUSPENSION after the expiry date.
Keep in a safe place out of reach and sight of children and pets.
If you want more information about OCTREOTIDE for INJECTABLE SUSPENSION:
- Talk to your healthcare 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); the manufacturer’s website http://wwww.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada
M1B 2K9