LOQTORZI Solution for injection Ref.[107258] Active ingredients: Toripalimab

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

Toripalimab-tpzi is a programmed death receptor-1 (PD-1) blocking antibody. Toripalimab-tpzi is a humanized immunoglobulin G4 (IgG4) kappa immunoglobulin that has a predicted molecular weight of approximately 150 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) mammalian cell expression system.

LOQTORZI (toripalimab-tpzi) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous use supplied in a singledose vial. Each vial contains 240 mg of LOQTORZI in 6 mL of solution. Each mL of solution contains 40 mg toripalimab-tpzi, citric acid monohydrate (0.51 mg), mannitol (25 mg), polysorbate 80 (0.20 mg), sodium chloride (2.92 mg), sodium citrate (4.65 mg), and Water for Injection, USP, at pH 6.0.

Dosage Forms and Strengths

Injection: 240 mg/6 mL (40 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.

How Supplied

LOQTORZI (toripalimab-tpzi), injection is a clear to slightly opalescent, colorless to slightly yellow solution supplied in a carton containing one 240 mg/6 mL (40 mg/mL) single-dose vial (NDC 70114-340-01).

Manufactured and Distributed by: Coherus BioSciences, Inc., 333 Twin Dolphin Drive, Suite 600, Redwood City, CA 94065, USA, U.S. License No. 2023

Drugs

Drug Countries
LOQTORZI United States

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