Drugs Similar to HERCEPTIN

Trastuzumab-pkrb is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-pkrb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. HERZUMA (trastuzumab-pkrb) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of HERZUMA delivers 420 mg trastuzumab-pkrb, 839 mg α,α-trehalose dihydrate, 9.5 mg L-histidine HCl, 6.1 mg L-histidine, and 1.7 mg polysorbate 20. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-pkrb that delivers 20 mL (420 mg trastuzumab-pkrb), at a pH of approximately 6. If HERZUMA is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of HERZUMA delivers 150 mg trastuzumab-pkrb, 299.6 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-pkrb that delivers 7.15 mL (150 mg trastuzumab-pkrb), at a pH of approximately 6.

Trastuzumab-dttb is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dttb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ontruzant (trastuzumab-dttb) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of Ontruzant delivers 420 mg trastuzumab-dttb, 381.4 mg α,α-trehalose dihydrate, 9.4 mg L-histidine HCl monohydrate, 6.1 mg L-histidine, and 1.7 mg polysorbate 20. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dttb at a pH of approximately 6. If Ontruzant is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ontruzant delivers 150 mg trastuzumab-dttb, 136.2 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl monohydrate, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dttb that delivers 7.15 mL (150 mg trastuzumab-dttb), at a pH of approximately 6.

HERCEPTIN HYLECTA is a combination of trastuzumab and hyaluronidase. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. HERCEPTIN HYLECTA (trastuzumab and hyaluronidase) injection is a sterile, preservative-free, colorless to yellowish, clear to opalescent solution supplied in single-dose vials for subcutaneous administration. HERCEPTIN HYLECTA is supplied as 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL in single-dose vials. Each mL of solution contains trastuzumab (120 mg), hyaluronidase (2,000 units), L-histidine (0.39 mg), L-histidine hydrochloride monohydrate (3.67 mg), L-methionine (1.49 mg), polysorbate 20 (0.4 mg), α,α-trehalose dihydrate (79.45 mg), and Water for Injection.

Trastuzumab-pkrb is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-pkrb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. HERZUMA (trastuzumab-pkrb) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of HERZUMA delivers 420 mg trastuzumab-pkrb, 839 mg α,α-trehalose dihydrate, 9.5 mg L-histidine HCl, 6.1 mg L-histidine, and 1.7 mg polysorbate 20. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-pkrb that delivers 20 mL (420 mg trastuzumab-pkrb), at a pH of approximately 6. If HERZUMA is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of HERZUMA delivers 150 mg trastuzumab-pkrb, 299.6 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-pkrb that delivers 7.15 mL (150 mg trastuzumab-pkrb), at a pH of approximately 6.

Trastuzumab-anns is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-anns is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture containing the antibiotic geneticin. Geneticin is not detectable in the final product. KANJINTI (trastuzumab-anns) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of KANJINTI delivers 420 mg trastuzumab-anns, 381.8 mg α,α-trehalose dihydrate, 9.5 mg L-histidine HCl monohydrate, 6.1 mg L-histidine, and 1.7 mg polysorbate 20. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-anns that delivers 20 mL (420 mg trastuzumab-anns), at a pH of approximately 6. If KANJINTI is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of KANJINTI delivers 150 mg trastuzumab-anns, 136.2 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl monohydrate, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of Sterile Water for Injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-anns that delivers 7.15 mL (150 mg trastuzumab-anns), at a pH of approximately 6.

Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6.

Trastuzumab-dttb is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dttb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ontruzant (trastuzumab-dttb) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of Ontruzant delivers 420 mg trastuzumab-dttb, 381.4 mg α,α-trehalose dihydrate, 9.4 mg L-histidine HCl monohydrate, 6.1 mg L-histidine, and 1.7 mg polysorbate 20. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dttb at a pH of approximately 6. If Ontruzant is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ontruzant delivers 150 mg trastuzumab-dttb, 136.2 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl monohydrate, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dttb that delivers 7.15 mL (150 mg trastuzumab-dttb), at a pH of approximately 6.

PHESGO is a combination of pertuzumab, trastuzumab, and hyaluronidase. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Pertuzumab has an approximate molecular weight of 148 kDa. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection is a sterile, preservative-free, clear to opalescent, and colorless to slightly brownish solution supplied in single-dose vials for subcutaneous administration. PHESGO injection is supplied as two different configurations: PHESGO is supplied in a 15 mL single-dose vial containing 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (6.75 mg), L-histidine hydrochloric monohydrate (53.7 mg), L-methionine (22.4 mg), polysorbate 20 (6 mg), and sucrose (685 mg) with a pH of 5.5. PHESGO is supplied in a 10 mL single-dose vial containing 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase, and α,α-trehalose (397 mg), L-histidine (4.4 mg), L-histidine hydrochloric monohydrate (36.1 mg), L-methionine (14.9 mg), polysorbate 20 (4 mg), and sucrose (342 mg) with a pH of 5.5.

Trastuzumab-qyyp is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-qyyp is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. TRAZIMERA (trastuzumab-qyyp) for injection is a sterile, white, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of TRAZIMERA delivers 420 mg trastuzumab-qyyp, 7.9 mg L-histidine, 9.5 mg L-histidine HCl monohydrate, 1.7 mg polysorbate 20, and 386 mg sucrose. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-qyyp that delivers 20 mL (420 mg trastuzumab-qyyp), at a pH of approximately 6. If TRAZIMERA is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of TRAZIMERA delivers 150 mg trastuzumab-qyyp, 2.8 mg L-histidine, 3.4 mg L-histidine HCl monohydrate, 0.6 mg polysorbate 20, and 138 mg sucrose. Reconstitution with 7.4 mL of SWFI yields a solution containing 21 mg/mL trastuzumab-qyyp that delivers 7.15 mL (150 mg trastuzumab-qyyp), at a pH of approximately 6.