KRESLADI Suspension for infusion Ref.[116648] Active ingredients: Marnetegragene autotemcel

Source: FDA, National Drug Code (US) Revision Year: 2026

Product description

KRESLADI (marnetegragene autotemcel) is an autologous hematopoietic stem cell (HSC)-based gene therapy prepared from the patient's HSCs, which are collected via apheresis procedure(s). The autologous cells are enriched for CD34+ cells, then transduced ex vivo with LV-RP-201 overnight in the presence of defined growth factors before harvest and suspended in a cryopreservation solution. LV-RP-201 is a replication-incompetent, self-inactivating lentivirus vector encoding for the CD18 β-subunit of human β2 integrins (ITGB2). The ITGB2 gene is under the control of a human chimeric promoter (a fusion of the FES and CTSG minimal 5'-flanking regions).

The transduced CD34+ cells are washed, formulated into a suspension, and then cryopreserved. KRESLADI is frozen in a patient-specific infusion bag(s) and is thawed prior to intravenous administration [see Dosage and Administration (2.1), How Supplied/Storage and Handling (16)]. The thawed product is a colorless to slightly white suspension of cells. Due to the presence of cells, the solution may be clear to slightly cloudy and may contain visible cell aggregates.

The formulation contains 5% (v/v) dimethyl sulfoxide (DMSO) and dextran.

Dosage Forms and Strengths
KRESLADI is a cell suspension for intravenous infusion. KRESLADI is composed of one or two infusion bags which contain 0.34 to 6.1 × 10⁶ cells/mL (including 0.32 to 6.1 × 10⁶ CD34+ cells/mL) suspended in a cryopreservation solution [see How Supplied/Storage and Handling (16)]. Each infusion bag contains approximately 30 mL of KRESLADI. Up to two drug product lots may be administered to meet the recommended dose. See the Lot Information Sheet for actual strength and dose.

Dosage Forms and Strengths

KRESLADI is a cell suspension for intravenous infusion.

KRESLADI is composed of one or two infusion bags which contain 0.34 to 6.1 × 10⁶ cells/mL (including 0.32 to 6.1 × 10⁶ CD34+ cells/mL) suspended in a cryopreservation solution [see How Supplied/Storage and Handling (16)]. Each infusion bag contains approximately 30 mL of KRESLADI. Up to two drug product lots may be administered to meet the recommended dose.

See the Lot Information Sheet for actual strength and dose.

How Supplied
KRESLADI is supplied in one or two infusion bags containing a frozen suspension of genetically modified autologous cells enriched for CD34+ cells in a cryo-preservative medium containing 5% DMSO and dextran 40. Each infusion bag contains approximately 30 mL and is individually packed within an overwrap in a metal cassette for protection. KRESLADI is shipped from the manufacturing facility to the infusion center in a cryoshipper, which may contain one or two cassettes intended for treatment of a single patient. A Lot Information Sheet is affixed inside the shipper. 50 mL infusion bag and metal cassette (NDC 83537-034-01) Match the identity of the patient with the patient identifiers on the cassette(s) and Lot Information Sheet upon receipt. Manufactured for: Rocket Pharmaceuticals, Inc., 9 Cedarbrook Drive, Cranbury, NJ 08512

How Supplied

KRESLADI is supplied in one or two infusion bags containing a frozen suspension of genetically modified autologous cells enriched for CD34+ cells in a cryo-preservative medium containing 5% DMSO and dextran 40. Each infusion bag contains approximately 30 mL and is individually packed within an overwrap in a metal cassette for protection. KRESLADI is shipped from the manufacturing facility to the infusion center in a cryoshipper, which may contain one or two cassettes intended for treatment of a single patient. A Lot Information Sheet is affixed inside the shipper.

50 mL infusion bag and metal cassette (NDC 83537-034-01)
Match the identity of the patient with the patient identifiers on the cassette(s) and Lot Information Sheet upon receipt.

Manufactured for: Rocket Pharmaceuticals, Inc., 9 Cedarbrook Drive, Cranbury, NJ 08512

Drugs

Drug	Countries
KRESLADI	United States

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.