News & Updates
The Canadian Rheumatology Association has released an updated position statement on biosimilars.
Previously known as Subsequent Entry Biologics (SEBs), biosimilars are drugs demonstrated to be highly similar to a biologic drug that is already authorized for sale (known as the reference biologic drug). It is acknowledged that evidence for the risk/benefit ratio of the use of biosimilars in the management of rheumatic diseases is rapidly accruing. The CRA encourages rheumatologists to provide the best care for individual patients and be fiscally responsible for the benefit of society as a whole. Rheumatologists should consider choosing the most cost-effective product when there is a choice available between an originator biologic and a biosimilar and must be mindful of cost savings. It is imperative that any substitution or transition/change to an approved biosimilar should result in no additional cost to the patient. The CRA recognizes the administrative challenges that patients may experience in accessing a biologic agent and therefore strongly encourages industry to provide and/or maintain patient support programs.
Increased Risk of Serious Depression, Suicidal Ideation or Behaviour, or Self-Injury
The Canadian Rheumatology Association would like to inform its members of the following advisory:
In a recent post-marketing study (BEL115467), depression, suicidal ideation or behaviour, and self-injury were reported more frequently in patients receiving BENLYSTA plus standard therapy, when compared to patients taking placebo plus standard therapy.
Healthcare professionals are advised to:
- Evaluate the risk of depression, suicidal ideation or behaviour, and self-injury before starting and during treatment with BENLYSTA.
- Advise patients and their caregivers to contact a healthcare provider if patients experience new or worsening depression, suicidal ideation or behaviour, or self-injury.
- Evaluate and refer patients experiencing new or worsening depression, suicidal ideation or behaviour, or self-injury to a mental health professional, as needed.
Health Canada is currently working with the manufacturer to update the BENLYSTA Canadian Product Monograph regarding this risk, including data from the post-marketing study (BEL115467).
For more information, please contact GlaxoSmithKline Inc. Medical Information at 1800-387-7374.
Drug Name: Methotrexate Injection (Sandoz), 25 mg/ml, 2 ml vial on backorder due to delay in shipping
Date Shortage Reported: 09/18/2018
Expected Resolution of Shortage: 01/01/2020
Provinces Affected: Ontario; other provinces unconfirmed
- Patients are frequently informed by their retail pharmacist, that all MTXsc is on backorder, which is NOT the case, and may have to ‘inform’ the pharmacist
- The Mayne Pharma Brand of Methotrexate 25mg/mL 2mL vial, which is interchangeable with the Sandoz brand in question, is available: DIN 02182777
- Over the next 6-9mos, it is likely that all formulations may, from time to time be in ‘backorder’
- Use Metoject pre-filled methotrexate. Suggestion is to fax/ call in a new prescription just to be sure that the right product/dose will be dispensed. Also, patient will need to be informed that this is a pre-filled syringe with a different concentration of methotrexate (50mg/mL instead of 25mg/mL).
Note, that Metoject does NOT use the same API (Active Principle Ingredient), and originates in Germany, whereas API for all other brands use the same API sources.
The Canadian Rheumatology Association would like to advise its members of the following reported drug shortage:
Drug Name: Shingrix – Herpes Zoster Vaccine
Expected Resolution of Shortage: December 31, 2018
Provinces Affected: National
Additional Comments: High demand for the drug coupled with the variable timing of supply shipments. Limited supply available of Shingrix 10s.
- January 18, 2019 Update: High demand for the drug coupled with the variable timing of supply shipments. Re-supply is ongoing with current inventory on allocation.
- Supply of Shingrix in the 10 dose package size were released on November 26 and are available under allocation – Read more
- Limited supply of the 1 dose package size is anticipated to be available in mid-December – Read more