Details for: TRUMENBA
Company: PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02468751 | TRUMENBA | NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY A; NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY B | 60 MCG / 0.5 ML; 60 MCG / 0.5 ML | SUSPENSION | INTRAMUSCULAR |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Trumenba is a vaccine to prevent invasive meningococcal disease, caused by Neisseria meningitidis serogroup B bacteria, for use in people aged 10 through 25 years. Invasive meningococcal group B disease (also known as meningitis B) is a serious and sometimes life threatening bacterial infection that can result in meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning). Meningitis B can spread from person to person through close contact (such as coughing or kissing) or lengthy contact, especially among people living in the same household.
What it does
Trumenba targets a protein found in over 95% of bacteria that cause meningitis B. It works by helping the body to make antibodies (the body’s natural defences), which protect you or your child against this disease. These antibodies kill the bacteria that cause meningitis B. If a vaccinated person comes into contact with the bacteria that cause this disease, their body is usually ready to destroy them.
When it should not be used
Do not use Trumenba if:
- You or your child are allergic to the active substance or any of the other ingredients of this vaccine.
What the medicinal ingredient is
1 dose (0.5 mL) contains the following active substances:
-
Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086) subfamily A:
60 micrograms
Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086) subfamily B: 60 micrograms
What the non-medicinal ingredients are
aluminum phosphate, histidine, polysorbate 80, sodium chloride, water for injection
What dosage form it comes in
A white suspension for injection, provided in a single-dose, pre-filled syringe.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you or your child receives Trumenba. Talk about any health conditions or problems you or your child may have, including if you or your child:
- Have any problems after any dose of Trumenba such as an allergic reaction or problems with breathing.
- Have any problem that may stop your blood from clotting properly.
- Have a weakened immune system, which may prevent you or your child from getting the full benefit from Trumenba, for example due to complement deficiencies or medicines that suppress the immune system (for example eculizumab).
- Are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Ask your healthcare professional for advice before receiving Trumenba. Your healthcare professional may still recommend that you receive Trumenba if you are at risk of meningococcal disease.
Trumenba has little or no influence on the ability to drive or use machines. However, some of the effects mentioned under the section “What are possible side effects from using Trumenba?” may temporarily affect the ability to drive or use machines.
Other warnings you should know about:
As with any vaccine, Trumenba may not fully protect everyone who is vaccinated.
Tell your healthcare professional about all the medicines you or your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with Trumenba:
If you or your child take medicines or receive therapies that affect your immune system (such as
radiation therapy, eculizumab, steroids or some types of cancer chemotherapies), you or your
child may not get the full benefit of Trumenba, or may remain at increased risk for disease
caused by meningococcal group B bacteria even if you develop antibodies following vaccination
with Trumenba.
Trumenba can be given at the same time as any of the following vaccines: quadrivalent human
papillomavirus vaccine (HPV4), meningococcal serogroups A, C, Y, W conjugate vaccine
(MnACYW) and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
adsorbed (Tdap).
When Trumenba is given at the same time as another vaccine, the vaccines must be given in
different syringes and at separate injection sites.
Proper use of this medication
How Trumenba is given:
Trumenba (0.5 mL) will be given to you or your child by a healthcare professional (doctor, nurse
or pharmacist). It will be injected into the upper arm muscle.
It is important to follow the instructions from the healthcare professional so that you or your
child receives all of the injections.
Usual Dose
Schedule for routine immunization
You or your child will receive two injections of the vaccine. The second injection is given 6
months after the first injection.
Schedule for those at increased risk of invasive meningococcal disease
You or your child will receive two injections of the vaccine given at least 1 month apart and a
third injection at least 4 months after the second injection.
Overdose
Overdose with Trumenba is unlikely as it is supplied as a single-dose pre-filled syringe.
Missed Dose
If you forget to go back to your healthcare professional at the scheduled time for your/your child’s next dose, ask your healthcare professional for advice.
Side effects and what to do about them
Like all vaccines, Trumenba can cause side effects, although not everybody gets them. These are
not all the possible side effects you or your child may feel when receiving Trumenba.
When Trumenba is given to you or your child, the following side effects may occur.
Very common (these may affect more than 1 in 10 people)
- headache
- nausea
- diarrhea
- muscle pain, joint pain
- redness, swelling and pain at injection site
- chills
- fatigue (tiredness)
- vomiting
- fever ≥ 38°C
- allergic reactions
- fainting
How to store
Store in a refrigerator (2°C to 8°C).
Store syringes in the refrigerator horizontally (laying flat on the shelf).
Do not freeze. Discard if the vaccine has been frozen.
Do not use this vaccine after the expiry date which is stated on the label and carton after EXP.
The expiry date refers to the last day of that month.
Keep out of reach and sight 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 three 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
If you want more information about Trumenba:
- 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, the manufacturer’s website www.pfizer.ca, or by calling 1-800-463-6001 (Pfizer Medical Information)
Last Revised MAY-24-2019