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

Condition(s) studied

Investigational drug(s) / intervention(s)

Fremanezumab 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.

Study summary

To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected.

Eligibility

Primary outcome measure(s)

• Safety information (Adverse Event) — 2 years from the start date of treatment
  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.
• Number of Special Situations — 2 years from the start date of treatment
  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
• Number of off-Label Use — 2 years from the start date of treatment
  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.
• Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening) — 2 years from the start date of treatment
  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.
• Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event) — 2 years from the start date of treatment
  Collecting the number of non-serious Adverse Events

Trial sites (1)

More Otsuka Pharmaceutical Co., Ltd. trials in Japan