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Rituxan Hycela

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Overview

What is Rituxan Hycela?

RITUXAN HYCELA is a combination of rituximab and hyaluronidase human. Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM. Rituximab is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium that may contain the antibiotic gentamicin. Gentamicin is not detectable in the final product.

Recombinant human hyaluronidase is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). It is a glycosylated single-chain protein with an approximate molecular weight of 61 kD.

RITUXAN HYCELA (rituximab and hyaluronidase human) Injection is a colorless to yellowish, clear to opalescent solution supplied in sterile, preservative-free, single-dose vials for subcutaneous administration.

RITUXAN HYCELA is supplied as 1,400 mg rituximab and 23,400 Units hyaluronidase human per 11.7 mL in single-dose vials or 1,600 mg rituximab and 26,800 Units hyaluronidase human per 13.4 mL in single-dose vials. Each mL of solution contains rituximab (120 mg), hyaluronidase human (2,000 Units), L-histidine (0.53 mg), L-histidine hydrochloride monohydrate (3.47 mg), L-methionine (1.49 mg), polysorbate 80 (0.6 mg), α,α-trehalose dihydrate (79.45 mg), and Water for Injection.



What does Rituxan Hycela look like?



What are the available doses of Rituxan Hycela?

Injection: ()

What should I talk to my health care provider before I take Rituxan Hycela?

How should I use Rituxan Hycela?

RITUXAN HYCELA is indicated for the treatment of adult patients with:

RITUXAN HYCELA is for subcutaneous use only.

All patients must first receive at least one full dose of a rituximab product by intravenous infusion without experiencing severe adverse reactions before starting treatment with RITUXAN HYCELA. If patients are not able to receive one full dose by intravenous infusion, they should continue subsequent cycles with a rituximab product by intravenous infusion and not switch to RITUXAN HYCELA until a full intravenous dose is successfully administered

Refer to the prescribing information for a rituximab product for intravenous infusion for additional information.

Premedicate before each dose of RITUXAN HYCELA .

Dose reductions of RITUXAN HYCELA are not recommended. When RITUXAN HYCELA is given in combination with chemotherapy dose, reduce the chemotherapeutic drugs to manage adverse reactions.


What interacts with Rituxan Hycela?

Sorry No Records found


What are the warnings of Rituxan Hycela?

Sorry No Records found


What are the precautions of Rituxan Hycela?

Sorry No Records found


What are the side effects of Rituxan Hycela?

Sorry No records found


What should I look out for while using Rituxan Hycela?

None


What might happen if I take too much Rituxan Hycela?

Sorry No Records found


How should I store and handle Rituxan Hycela?

TabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).TabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).TabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).RITUXAN HYCELA (rituximab and hyaluronidase human) Injection formulated for subcutaneous injection is supplied as a sterile preservative-free liquid solution in a single-dose vial. The following configurations are available:Individually packaged single-dose vials:RITUXAN HYCELA (rituximab and hyaluronidase human) Injection formulated for subcutaneous injection is supplied as a sterile preservative-free liquid solution in a single-dose vial. The following configurations are available:Individually packaged single-dose vials: