Patient Medication Information: uses, side effects, how to take - Cytogam
Serious warnings and precautions box
What CYTOGAM is used for:
It is used to prevent cytomegalovirus (CMV) disease after Kidney transplant.
How CYTOGAM works:
Cytogam can raise the relevant antibodies to levels sufficient to attenuate or reduce the incidence of serious CMV disease.
The ingredients in CYTOGAM are:
Medicinal ingredient(s): Cytomegalovirus immunoglobulin (Human)
Non-medicinal ingredients: Albumin (Human), Sucrose, and Monosodium phosphate.
CYTOGAM comes in the following dosage form(s):
CYTOGAM is a sterile liquid supplied in single-use vials containing 2500 mg ± 500 mg of Cytomegalovirus immunoglobulin (Human).
Do not use CYTOGAM if:
- CYTOGAM is made from human plasma which may contain the causative agents of viral diseases. The risk of getting a disease from this product has been reduced by screening plasma donors, testing for the presence of certain viruses and by inactivating and removing certain viruses during manufacturing. However, there is still a possibility that plasma products could transmit disease.
- Allergic or anaphylactic reactions are rare. These reactions can occur in patients with a history of allergy to blood products or in patients lacking the IgA blood protein.
- Before using CYTOGAM, discuss the risks and benefits with your doctor.
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You have a history of allergic reactions to blood products, or to any of the ingredients in CYTOGAM.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CYTOGAM. Talk about any health conditions or problems you may have, including if you:
- Have experienced allergic reactions to blood products in the past.
- Are receiving high doses of other immunoglobulins.
- Have any bleeding disorders or take medication for bleeding disorders.
- Have a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity.
- Are predisposed to acute renal failure include any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or receive known nephrotoxic drugs.
- Have a noncardiogenic pulmonary edema, Transfusion-Related Acute Lung Injury (TRALI).
- Have any immune deficiencies which cause you to be deficient in certain antibodies.
- Have recently (within the last 3 months) received live attenuated virus vaccine(s).
Are pregnant or nursing.
Other warnings you should know about:
- CYTOGAM administration may interfere with other vaccines. It is important to avoid immunization with other live vaccines for 3 months after CYTOGAM administration.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions:
Serious drug interactions with CYTOGAM include:
Administration of other vaccines
How to take CYTOGAM:
- CYTOGAM should be administered by a healthcare professional provider only.
Usual dose:
The maximum recommended total dosage per infusion of CYTOGAM is 150 mg Ig/kg, administered according to the following schedule:
Within 72 hours of transplant: 150 mg/kg
2 weeks post transplant: 100 mg/kg
4 weeks post transplant: 100 mg/kg
6 weeks post transplant: 100 mg/kg
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8 weeks post transplant: 100 mg/kg
12 weeks post transplant: 50 mg/kg
16 weeks post transplant: 50 mg/kg
Overdose:
If you think you, or a person you are caring for, have taken too much CYTOGAM, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Possible side effects from using CYTOGAM:
These are not all the possible side effects you may have when taking CYTOGAM. If you experience any side effects not listed here, tell your healthcare professional.
The most frequent side effects occurring with CYTOGAM included minor reactions such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking the/this drug (if applicable) and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| Rare | ||
| Allergic Reaction | ||
| ✓ | ✓ | |
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.
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Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Cytogam should be stored between 2-8°C (36-46°F).
Keep out of reach and sight of children.
If you want more information about CYTOGAM:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling KI BioPharma LLC at 1-866-916-0077.
Date of Authorization: 2026-05-07