Patient Medication Information: uses, side effects, how to take - Immunine Vh
What is IMMUNINE VH used for?
- IMMUNINE VH is a Factor IX protein used for therapeutic and prophylactic (preventative) use in patients suffering from congenital (haemophilia B) or acquired factor IX deficiency.
How does IMMUNINE VH work?
IMMUNINE VH is administered by intravenous (IV) therapy and provides an increase in plasma levels of factor IX. IMMUNINE VH can temporarily correct the coagulation defect of patients with factor IX deficiency and therefore stop the bleeding episodes.
What are the ingredients in IMMUNINE VH?
Medicinal ingredients: Freeze dried Factor IX concentrate of high purity containing traces of Factors II, VII and X (<0.02 IU / 1 IU factor IX)
Non-medicinal ingredients: Factor II, VII and X (<0.02 IU / 1 IU factor IX), Sodium Chloride, Sodium Citrate and Sterile Water for Injection, Tween 80
IMMUNINE VH comes in the following dosage forms:
IMMUNINE VH is a sterile freeze-dried powder and supplied in a single dose vial accompanied by a vial of Sterile Water for Injection, EP as diluent, a sterile transfer needle, and a sterile filter needle. It is available in the following package sizes:
IMMUNINE VH (IU) | Sterile Water for Injection EP (mL) |
|---|---|
| 480 to 720 | 5 |
The number of IU Factor IX is stated on the label of each vial.
Do not use IMMUNINE VH if:
- You suffer from DIC and/or hyperfibrinolysis; or
- You have a known allergy to heparin or history of heparin induced thrombocytopenia; or
- You experience hypersensitive reactions occurs during administration of IMMUNINE VH; or
You are pregnant or nursing mothers (only use if clearly needed); or
- You have had a recent myocardial infarction, stroke or thromboembolic events
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IMMUNINE VH. Talk about any health conditions or problems you may have, including if you:
- You have known allergies to this drug, to heparin, or to any ingredient in the formulation or component of the product
- You have thromboembolism, DIC, or fibrinolysis
- You are pregnant or may be pregnant
- You are a nursing mother
Other warnings you should know about:
Because IMMUNINE VH is made from human plasma, a risk of transmitting infectious agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The use of IMMUNINE VH may lead to hypersensitivity reactions. Hypersensitivity reactions refer to undesirable reactions produced by the normal immune system such as allergies. At first signs or symptoms of hypersensitivity reactions, IMMUNINE VH treatment should be stopped and medical care should be started as appropriate.
Your body may form inhibitors to factor IX. An inhibitor is an antibody (part of your body’s normal immune defenses) that forms in response to infusions of factor IX that prevents the factor IX from working properly. These inhibitors can lead to a reduced response or to no response to factor IX therapy. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors.
The use of factor IX may lead to the development of blood clots in your veins. This is particularly dangerous if you have disseminated intravascular coagulation (DIC) or fibrinolysis. If you have DIC or are at risk of DIC, please discuss with your doctor whether the use of IMMUNINE VH is right for you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with IMMUNINE VH:
- No interactions with other drugs are currently known. IMMUNINE VH should not be mixed with other drugs
How to take IMMUNINE VH:
- See Usual dose
Usual dose:
The dose of the treatment depends on the severity of factor IX deficiency, the location and extent of the bleeding, and the patient’s clinical condition. The treatment should be carried out by a doctor who is familiar with the treatment of haemophilia.
Overdose:
Overdosage may increase your risk of myocardial infarction, DIC, venous thrombosis, and pulmonary embolism.
IMMUNINE VH, should not be administered at a rate exceeding 2 mL/min.
| If you think you, or a person you are caring for, have taken too much IMMUNINE VH, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
Patients should be advised to proceed immediately with a regular administration of IMMUNINE VH and to continue treatment at regular intervals as required.
What are possible side effects from using IMMUNINE VH?
These are not all the possible side effects you may have when taking IMMUNINE VH. If you experience any side effects not listed here, tell your healthcare professional.
- Although rare, severe allergic reactions may occur.
- If you develop fever, skin rashes, hives, tingling, nausea, retching, shortness of breath, a drop in blood pressure or shock you should stop the use of IMMUNINE VH and contact your doctor or visit the Emergency Department immediately.
- Mild allergic reactions may be managed with antihistamine.
- Burning and stinging at the infusion site
The following side effects have been reported:
- Allergic reaction
- Headache
- Myocardial Infarction, Tachycardia
- Flushing
- Shortness of Breath
- Skin rashes
- Chills
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:
IMMUNINE VH should be stored in the refrigerator at a temperature between 2°C and 8°C.
IMMUNINE VH may be temporarily stored at room temperature (up to +25°C) for a period of up to 3 months. Record the period of storage at room temperature below the expiration date indicated on the package label. Dispose of the product if stored at room temperature for three months or longer.
IMMUNINE VH must not be used beyond the expiration date indicated on each pack.
The reconstituted solution contains no preservatives and should be used immediately after preparation. Dispose of any unused portion. Do not refrigerate any unused portion.
Keep out of reach and sight of children.
If you want more information about IMMUNINE VH:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare 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 www.takeda.com/en-ca, or by calling 1-800-268-2772.
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Last Revised April 18, 2023
IMMUNINE® is a registered trademark of Baxalta Incorporated. Takeda® and the Takeda Logo® are trademarks of Takeda Pharmaceutical Company Limited, used under license.