LUPKYNIS Drug-use Results Survey

Browse trials for

• Lupus Nephritis 330

Study population

Interventions

• DrugVoclosporin (LUPKYNIS)

  In general, for adults, voclosporin should be administered orally at a dose of 23.7 mg BID. The dosage may be appropriately reduced depending on the patient's condition. In principle, at the start of treatment with voclosporin, it should be used in combination with corticosteroids and mycophenolate mofetil.

Primary outcomes

1. Safety Information (Number of 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 (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 (LUPKYNIS), whether or not it is considered causally related to the Medicinal Product.

   Time frame: 3 years from the initiation of LUPKYNIS treatment

2. Safety Information (Types of Special Situations and the Number of Corresponding Cases)

   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: 3 years from the initiation of LUPKYNIS treatment

3. Safety Information (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: 3 years from the initiation of LUPKYNIS treatment

4. Safety Information (Number of Serious Adverse Event)

   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: 3 years from the initiation of LUPKYNIS treatment

5. Safety Information (Number of Non-serious Adverse Events)

   All Adverse Events that do not meet the definition of a serious Adverse Event are considered non-serious Adverse Events.

   Time frame: 3 years from the initiation of LUPKYNIS treatment