Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use

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• Migraine Disorders 1,520

Study population

Groups and cohorts

• Drug

  Ajovy syringe for SC injection 225 mg.

  Drug: Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution

Interventions

• DrugFremanezumab 225 Mg/1.5 mL Subcutaneous Solution

  The usual adult dose is 225 mg of fremanezumab (genetical recombination) administered subcutaneously as a single dose once every 4 weeks or 675 mg administered subcutaneously as a single dose once every 12 weeks.

Primary outcomes

1. Safety information (Adverse Event)

   Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (see Annex Ⅳ, ICH-E2A Guideline). An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product, whether or not it is considered causally related to the Medicinal Product.

   Time frame: 2 years from the start date of treatment

2. Number of Special Situations

   Collecting any Situations related to the use of an Otsuka product which may or may not be associated with an adverse event: * Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure; * Exposure during breastfeeding; * Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products); * Medication errors (e.g. patient took wrong dose); * Lack of therapeutic efficacy (e.g. the product doesn't work); * Occupational exposure (e.g.: nurse administering the product is exposed); * Cases of suspected transmission of infectious agents; * Use of suspected or confirmed falsified product(s) or quality defect of the product(s); * Withdrawal reactions; * Accidental exposure (e.g.: child takes parent's product); * Drug-drug/drug-food interactions; * Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population); * Disease progression/exacerbation of existing disease

   Time frame: 2 years from the start date of treatment

3. Number of off-Label Use

   Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.

   Time frame: 2 years from the start date of treatment

4. Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)

   Collecting the number of any adverse drug experience/event occurring at any dose which * results in death * is life-threatening * requires inpatient hospitalization or prolonged of existing hospitalization * results in persistent or significant disability or incapacity * is a congenital anomaly/birth defect * is medically significant.

   Time frame: 2 years from the start date of treatment

5. Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)

   Collecting the number of non-serious Adverse Events

   Time frame: 2 years from the start date of treatment