What Synagis is used for and how to use it
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Synagis - Consumer Medicine Information

Manufacture: AbbVie
Country: Canada
Condition: Respiratory Syncytial Virus
Class: Immune globulins
Form: Liquid solution, Intramuscular (IM), Powder
Ingredients: palivizumab, glycine, histidine, mannitol

SYNAGIS (Lyophilized Powder)

palivizumab

About this Medication

What the medication is used for

  • The prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease.

SYNAGIS is not used to treat the symptoms of RSV disease once a child already has it. It is only used to prevent RSV disease.

SYNAGIS is not for adults or for children older than 24 months of age at the start of dosing.

What it does

SYNAGIS contains man-made, disease-fighting proteins called antibodies. These antibodies help prevent RSV disease. Children at high risk for severe RSV disease often do not have enough of their own antibodies. SYNAGIS is used in certain groups of children to help prevent severe RSV disease by increasing protective RSV antibodies.

When it should not be used

SYNAGIS is contraindicated in patients with known hypersensitivity to palivizumab or to any of its ingredients. It is also contraindicated in patients with known hypersensitivity to other humanized monoclonal antibodies.

Signs and symptoms of a severe allergic reaction can include:

  • Severe rash, hives, or itching skin
  • Swelling of the lips, tongue, or face
  • Closing of the throat, difficult swallowing
  • Difficult, rapid, or irregular breathing
  • Bluish colour of skin, lips, or under fingernails
  • Muscle weakness or floppiness
  • A drop in blood pressure
  • Unresponsiveness

What the medicinal ingredient is

palivizumab

What the important non-medicinal ingredients are

SYNAGIS also contains glycine, histidine, and mannitol.

For a full listing of non-medicinal ingredients see PART I of the Product Monograph.

What dosage form it comes in

SYNAGIS is available as a lyophilized powder or as a solution for injection, in a single-use vial containing either:

  • 50 mg of lyophilized powder. Once reconstituted, the vial contains a solution of 50 mg/0.5 mL.
  • 100 mg of lyophilized powder. Once reconstituted, the vial contains a solution of 100 mg/mL.
  • 0.5 mL of solution for injection with a concentration of 100 mg/mL.
  • 1 mL of solution for injection with a concentration of 100 mg/mL.

Warnings and Precautions

BEFORE you use SYNAGIS talk to your doctor or pharmacist if:

  • your child is unwell, as the use of SYNAGIS may need to be delayed.
  • your child has any bleeding disorder, as SYNAGIS is usually injected into the thigh.

Interactions with this Medication

Drugs that may interact with SYNAGIS include:

  • The monoclonal antibody is specific for RSV. SYNAGIS is not expected to interfere with the immune response to vaccines, including live viral vaccines.

You should inform your doctor of all medicines your child is currently taking, especially blood thinner medicine, before starting SYNAGIS.

Proper Use of this Medication

Usual Dose

The recommended dose of SYNAGIS is 15 mg/kg of body weight, INTRAMUSCULAR INJECTION ONLY, given once a month during anticipated periods of RSV risk in the community.

Overdose

From the post-marketing experience, overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose.

If you think your child has received too much SYNAGIS, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose

If your child misses an injection, you should contact your doctor as soon as possible. Each injection of SYNAGIS can only help protect your child for about one month before another injection is needed.

Side Effects and what to do about them

Like all medicines, SYNAGIS can cause side effects.

Some of the very common side effects that your child may have while on SYNAGIS include fever and rash. Some of the common side effects include nervousness, redness or swelling at the injection site. A pause in breathing or other breathing difficulties may also be common. Less common side effects include colds, coughs, runny nose, wheeze, vomiting, diarrhea, pain, viral infections and increase in liver function tests. Severe allergic reactions may occur after any dose of SYNAGIS. Such reactions may be life threatening or cause death. Severe allergic reactions may occur very rarely.

If a child shows ANY side effects after receiving SYNAGIS you should contact your doctor. You should also notify your doctor of any side effects experienced that are not mentioned in this section.

Serious Side Effects, how often they Happen and what to do about them

Symptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Very
Common
Fever
Rash
Common Nervousness
Redness or
swelling at the
injection site
A pause in
breathing or any
other breathing
difficulties
Uncommon Colds
Coughs
Runny nose
Wheeze
Vomiting
Diarrhea
Pain
Viral infection
Increase in liver
function tests
Very rare Severe allergic
reaction

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

How to Store it

Upon receipt and until reconstitution for use, SYNAGIS should be stored between 2 and 8°C in its original container. Do not freeze. Do not use beyond the expiration date.

Reconstituted SYNAGIS lyophilized powder is stable for up to 6 hours when left at room temperature. However, since the single-use vial of SYNAGIS lyophilized powder does not contain a preservative, unless it is reconstituted under controlled and validated aseptic conditions, the product should be administered as soon as possible, preferably within 3 hours of reconstitution.

Reporting Suspected Side Effects

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect (www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, ON
      K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

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.

More Information

The most recent version of this document plus the full Product Monograph, prepared for health professionals can be found at:

www.abbvie.ca

or by contacting the sponsor, AbbVie Corporation, Saint-Laurent, Qc H4S 1Z1 at: 1-888-704-8271