Product Details

Takhzyro

Lanadelumab
300 mg/2 mL
Solution for Subcutaneous Injection
Single-Use 2-mL Pre-Filled Syringe (Preservative-Free)

DIN/PIN/NPN

02505614

Manufacturer

Takeda Canada Inc.

Formulary Listing Date

2022-01-14  

Unit Price

68.4600

Amount MOH Pays

68.4600

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

B06AC05

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Blood Modifiers

Lanadelumab

  • Brand(s): Takhzyro
  • Dosage Form/Strength: 300 mg/2mL inj and 300 mg/2mL Prefilled Syringe
  • Effective date: February 2, 2021, Updated January 14, 2022

Initiation Criteria: 

For the routine prevention of attacks of hereditary angioedema (HAE) in patients meeting ALL the following criteria: 

  1. Is at least 12 years of age; AND

  2. Has HAE type I or II; AND

  3. Has experienced at least three HAE attacks within any four-week period requiring treatment with an acute injectable therapy (e.g., Icatibant, C1-INH); AND

  4. Must be prescribed by physicians (e.g., immunologists, allergists or hematologists) with experience in the diagnosis and management of HAE.

Note: For patients who are already on long-term prophylactic treatment of angioedema (e.g., C1-INH) and intend to transition to lanadelumab, please provide historical HAE attack rates and treatment details. 

Discontinuation Criteria: 

Reimbursement will be discontinued in patients who either respond inadequately or exhibit loss of response, defined as follows: 

  • Inadequate response: No reduction in the number of HAE attacks that require treatment with an acute injectable therapy during the first three months of treatment with Takhzyro. 

  • Loss of response: An increase in the observed number of HAE attacks requiring acute injectable treatment compared to the number before initiating treatment with lanadelumab.

Exclusion Criteria:
Patient is using lanadelumab with other medications used for the long- term prophylactic treatment of angioedema (e.g., C1-INH). 

Renewal Criteria:
Renewals will be considered in patients who do not meet the discontinuation criteria. 

Note(s): 

  • An assessment of a response to treatment should be conducted three months after initiating treatment with lanadelumab. 

  • Following the initial three-month assessment, patients should be assessed for continued response to lanadelumab every six months. 

Recommended dose:
300 mg administered subcutaneously (SC) every 2 weeks. The dose should not be escalated to more than 300 mg every two weeks in cases of inadequate response or loss of response.
Dosing interval of 300 mg SC every 4 weeks may be considered if the patient is well-controlled (e.g., attack free) for more than six months. 

Approval duration of initials and renewals: 4 months initial, 6 months first renewal, 12 months subsequent renewals 

Case by Case Consideration: For patients not meeting the requirement of 3 HAE attacks in the initiation criteria but with HAE attacks associated with significant functional impairment and risk of mortality (e.g., laryngeal attacks).

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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