Consumer Information for: SYNACTHEN DEPOT

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for
  • in the treatment of certain conditions that are responsive to corticoids, and
  • in the test to find out if the adrenal glands, small glands next to the kidneys, are working as well as they should.

What it does

SYNACTHEN DEPOT belongs to a group of medicines called pituitary hormones and analogues.

SYNACTHEN DEPOT works by stimulating the adrenal glands to increase the production of natural “steroid” hormones.

When it should not be used

This product should be given under medical supervision

You should not be given SYNACTHEN DEPOT:

  • In premature babies and neonates (less than one month)
  • If you are allergic (hypersensitive) to tetracosactide (also known as cosyntropin), or a corticotrophin (ACTH), or any of the other ingredients of SYNACTHEN DEPOT listed under the heading "What the important nonmedicinal ingredients are;"
  • If you have any untreated infectious disease.
  • If you have an acute mental illness (acute psychosis).
  • If you have or have had a duodenal or stomach ulcer.
  • If you have a heart disease.
  • If you have Cushing’s syndrome, a condition of the adrenal glands causing weight gain, rounded face and high blood pressure.
  • If your adrenal glands not working properly (adrenocortical insufficiency, or adrenogenital syndrome)

Do not use SYNACTHEN DEPOT in premature babies and children up to 3 years old. Since SYNACTHEN DEPOT contains benzyl alcohol as a preservative which can cause Gasping Syndrome and may result in death.

Do not use SYNACTHEN DEPOT to treat asthma or other allergic conditions as this may result in anaphylactic reactions (very serious allergic reactions.)

If any of these conditions apply to you, tell your doctor as you should not be treated with SYNACTHEN DEPOT.

What the medicinal ingredient is

Tetracosactide (also known as cosyntropin)

What the non-medicinal ingredients are

Benzyl alcohol (10 mg), sodium chloride, sodium hydroxide, sodium phosphate, sterile water for injection.

What dosage form it comes in

SYNACTHEN DEPOT is supplied as a suspension in a 1 mL ampoule for injection into a muscle (intramuscular injection). One 1 ml ampoule contains 1 mg of tetracosactide in the form of a tetracosactide/zinc complex.

Warnings and precautions

SYNACTHEN DEPOT is not recommended for use in children less than 3 years old, since it contains benzyl alcohol, which can cause toxic reactions and allergic reactions (gasping syndrome). SYNACTHEN DEPOT can cause salt and water retention; you may need a low-salt diet during the treatment.

BEFORE you use SYNACTHEN DEPOT talk to your doctor or pharmacist if you have any of the following conditions:

  • underactive thyroid gland (hypothyroidism);
  • severe liver disease (cirrhosis);
  • kidney problems;
  • high blood pressure;
  • inflammation of the bowel (e.g. ulcerative colitis or diverticulitis);
  • blood clotting problems (thromboembolism);
  • thinning of the bones (osteoporosis);
  • extreme muscle weakness (myasthenia gravis);
  • pregnancy or breast-feeding;

You should also tell your doctor if you are going to have a surgery or to receive a vaccine.

Interactions with this medication

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. These include the following medicines:

  • medicines to treat seizure such as valproate, phenytoin, clonazepam, primidone, phenobartbital;
  • hormonal birth control pills.

Proper use of this medication

Usual Dose

Adult

Starting dose: 1 mg is given once daily as an injection into a muscle.

Maintenance dose: 0.5 mg to 1 mg twice a week depending on how you respond to the treatment.

The treatment should be stopped gradually to help maintain the normal function of adrenal glands.

For diagnostic test use: 1 mg is given as a single injection into a muscle, before one or more blood samples are taken. These blood samples will show whether your adrenal glands are functioning as well as they should.

Children

The starting dose for children depends on the age of the child. 3 to 6 years old:
Starting dose: 0.25mg to 0.5 mg is given once daily as an injection in a muscle.
Maintenance dose is 0.25mg to 0.5mg every 2-8 days depending on how the child responds to the treatment.

7 to 15 years old:
Starting dose: 0.25mg to 1 mg is given once daily as an injection in a muscle.
Maintenance dose is 0.25mg to 1 mg every 2-8 days depending on how the child responds to the treatment.

Overdose

In case of a suspected drug overdose, contact your doctor, or nurse, or regional Poison Control Centre immediately, even if there are no symptoms..

Missed Dose

If you miss your scheduled dose, call your doctor or nurse immediately

Side effects and what to do about them

SYNACTHEN DEPOT may cause the following side effects:

  • Endocrine disorders: menstrual (period) problems, Cushings’ syndrome (a condition of the adrenal glands causing weight gain, rounded face and high blood pressure), dysfunction of the adrenal glands (adrenocortical problem), increased blood sugar levels, increased body and facial hair.
  • Fluid and metabolic disturbances: low calcium level in the blood (hypocalcaemia), low potassium level in the blood (hypokalaemia), high sodium level in the blood (hypernatraemia), swelling of hands, ankles or feet (fluid build-up in the body).
  • Neurological disorders: mood changes, fits, headache, dizziness.
  • Ophthalmic disorders: decreased or blurred vision, glaucoma (a condition in which the pressure of fluid in the eye is high), exophthalmus (protruding eyeballs).
  • Cardiac and vascular disorders: high blood pressure, heart disease involving shortness of breath, swelling of the feet or legs due to fluid build-up in the body (oedema due to heart failure), reversible enlargement of the heart muscle, blockage of a blood vessel by a clot (thromboembolism), necrotising vasculitis.
  • Gastrointestinal disorders: ulcer in stomach or duodenum, inflammation of the pancreas (pancreatitis), inflammation of the oesophagus (food pipe), stomach or abdominal pain or discomfort.
  • Skin disorders: allergic reaction (see above also section “Some effects could be serious”), thinning of the skin, red or purple flat, pinhead spots under the skin, bruising, redness of the skin, acne.
  • Muscle and bone disorders: muscle cramps or pain, muscle weakness, thinning of the bones (osteoporosis), destruction of bone tissue (aseptic necrosis of femoral and humeral heads), tendon rupture.
  • Others: breathlessness, increased susceptibility to infection, excessive sweating, weight gain, growth retardation in children, increased white blood cells.

If any of these side effects persist or are troublesome, tell your doctor

If you notice any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Serious side effects and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Unknown Frequency
If you have an allergic reaction. Symptoms of an allergic reaction may include redness or pain at the injection site, rash, itching, hives or flushing,     ✔
dizziness, nausea or vomiting, difficulty breathing, swelling of the face, lips, tongue or other parts of the body     ✔
If you are bleeding of the adrenal gland, a small gland above the kidneys. Symptoms of bleeding of the adrenal gland are sudden acute abdominal and flank pain.     ✔

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

How to store

If you are storing SYNACTHEN DEPOT at home, keep it in the refrigerator (2-8°C).

Do not use after the expiry date shown on the box.

Store in the original package.

Keep out of the sight and reach of children

Reporting 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 0701E
      Ottawa, Ontario
      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.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Valeo Pharma Inc., at:

Toll-free telephone: 1-855-694-0151

Or by written request at: 16667 Boul. Hymus
        Kirkland, (QC), Canada
        H9H 4R9

Or by e-mail at: info@valeopharma.com

This leaflet was prepared by:
Atnahs Pharma UK Limited
Sovereign House Miles Gray Road
Basildon, SS14 3FR
United Kingdom

Last revised: January 13, 2020

SYNACTHEN is a registered trademark.

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