Synagis® (palivizumab) is a humanized monoclonal antibody (IgG1k) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis® is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human lightchain sequence was derived from the constant domain of Ck and the variable framework regions of the VL gene K104 withJk-4 (3). The murine sequences were derived from a murine monoclonal antibody, Mab 1129 (4), in a process that involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Synagis® is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons.

Synagis® is available in two formulations: a lyophilized powder and a liquid solution.

Lyophilized Powder: Synagis® is supplied as a sterile lyophilized product for reconstitution with sterile water for injection. Reconstituted Synagis® (100 mg/mL) is to be administered by intramuscular injection (IM) only. The reconstituted solution should appear clear or slightly opalescent with a pH of 6.0.

Each 100 mg single-use vial of Synagis® lyophilized powder is formulated in 67.5 mg of mannitol, 8.7 mg histidine and 0.3 mg of glycine and is designed to deliver 100 mg of Synagis® in 1.0 mL when reconstituted with 1.0 mL of sterile water for injection.

Each 50 mg single-use vial of Synagis® lyophilized powder is formulated in 40.5 mg mannitol, 5.2 mg of histidine and 0.2 mg of glycine and is designed to deliver 50 mg of Synagis® in 0.5 mL when reconstituted with 0.6 mL of sterile water for injection.

Liquid Solution: Synagis® (100 mg/mL) is supplied as a sterile, preservative-free solution to be administered by intramuscular injection (IM) only. The solution should appear clear or slightly opalescent with a pH of 6.0.

Each 100 mg single-use vial of Synagis® liquid solution is formulated in 4.7 mg of histidine and 0.1 mg of glycine in a volume of 1.2 mL and is designed to deliver 100 mg of Synagis® in 1.0 mL.

Each 50 mg single-use vial of Synagis® liquid solution is formulated in 2.7 mg of histidine and 0.08 mg of glycine in a volume of 0.7 mL and is designed to deliver 50 mg of Synagis® in 0.5 mL.

REFERENCES

1. Press E, and Hogg N. The Amino Acid Sequences of the Fd Fragments of Two Human Gamma-1 Heavy Chains. Biochem. J. 1970; 117:641-660.

2. Takahashi N, Noma T, and Honjo T. Rearranged Immunoglobulin Heavy Chain Variable Region (VH) Pseudogene That Deletes the Second Complementarity-Determining Region. Proc. Nat. Acad. Sci. USA 1984; 81:5194-5198.

3. Bentley D, and Rabbitts T. Human Immunoglobulin Variable Region Genes - DNA Sequences of Two Vk Genes and a Pseudogene. Nature 1980; 288:730-733.

4. Beeler JA, and Van Wyke Coelingh K. Neutralization Epitopes of the F Protein of Respiratory Syncytial Virus: Effect of Mutation Upon Fusion Function. J. Virology 1989; 63:2941-2950.

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