Epkinly package insert

FDA Grants Accelerated Approval for Second Epkinly The package insert for Pradaxa states that patients should swallow the capsules whole.

Epkinly [package insert]. Plainsboro, NJ; Genmab US, Inc.; May 2024. Accessed February. 2024. 2. Hutchings M, Mous R, Clausen MR, et al. Dose

EPKINLY 4 mg/0.8 mL vial: o Dilute required amount of EPKINLY in 0.9% sodium chloride solution for injection following the steps outlined in the package insert. o Use diluted EPKINLY solution immediately. If not used immediately, store the solution refrigerated at 2 C to 8 C (36 F to 46 F) for up to 24 hours

Copies of any marketing authorizations for Epkinly (epcoritamab) from any other drug A final mock-up of the Package Insert (if applicable), in

(Epkinly) for the treatment o Black box warnings: The package insert has a boxed warning for the

Epkinly should only be administered by a qualified health care professional with appropriate medical support to manage severe reactions such as CRS and ICANS. Package insert. Genmab and AbbVie

The Food and Drug Administration (FDA) has granted accelerated approval to Epkinly Package insert. Genmab and AbbVie; 2024. Accessed May 19

Epkinly (Epcoritamab-bysp) Product Summary13. Therapeutic Class Hydroxypropyl Cellulose ( Wamw) Insert. Currently in Shortage.

Epcoritamab-bysp (Epkinly Specific instructions on what to do if the dose is delayed during ramp-up can be found in the package insert.