Generic Name
RiTUXimab
Brand Names
Rituxan Hycela, Ruxience, Riabni, Truxima, Rituxan
FDA approval date: November 26, 1997
Classification: Endoglycosidase
Form: Injection
What is Rituxan Hycela (RiTUXimab)?
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma .
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Brand Information
Rituxan Hycela (rituximab and hyaluronidase)
1DOSAGE FORMS AND STRENGTHS
RITUXAN HYCELA is a colorless to yellowish, clear to opalescent solution for subcutaneous injection:
- Injection: 1,400 mg rituximab and 23,400 Units hyaluronidase human per 11.7 mL (120 mg/2,000 Units per mL) in a single-dose vial.
- Injection: 1,600 mg rituximab and 26,800 Units hyaluronidase human per 13.4 mL (120 mg/2,000 Units per mL) in a single-dose vial.
2CONTRAINDICATIONS
None
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Mucocutaneous reactions
- Hepatitis B reactivation including fulminant hepatitis
- Progressive multifocal leukoencephalopathy
- Hypersensitivity and other administration reactions
- Tumor lysis syndrome
- Infections
- Cardiac arrhythmias
- Renal toxicity
- Bowel obstruction and perforation
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to RITUXAN HYCELA in 892 patients in four controlled trials with exposures ranging from a single injection up to 27 months of treatment.
The population included 382 patients with follicular lymphoma (FL), 369 patients with diffuse large B-cell lymphoma (DLBCL), and 141 patients with chronic lymphocytic leukemia (CLL). The median age was 60 years (range: 18–85 years, 53% were male, and 84% were White. In the SABRINA study patients with FL received a full dose of a rituximab product by intravenous infusion, followed by RITUXAN HYCELA (1,400 mg rituximab/23,400 Units hyaluronidase human), in combination with chemotherapy for up to 7 doses (i.e., total of 8 doses in combination with chemotherapy), or as monotherapy for up to 12 doses (maintenance treatment). In the MabEase study patients with DLBCL received a full dose of a rituximab product by intravenous infusion, followed by RITUXAN HYCELA (1,400 mg rituximab/23,400 Units hyaluronidase human), given in combination with chemotherapy for up to 7 doses (i.e., up to a total of 8 doses). In the SAWYER study patients with CLL on part 2 received a full dose of a rituximab product by intravenous infusion, followed by RITUXAN HYCELA (1,600 mg rituximab/26,800 Units hyaluronidase human) for up to 5 doses, in combination with fludarabine and cyclophosphamide (i.e., total of 6 doses).
The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with FL on the SABRINA study were: infections, neutropenia, nausea, constipation, cough, and fatigue.
The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with DLBCL on the MabEase study were: infections, neutropenia, alopecia, nausea, and anemia.
The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with CLL on part 2 of the SAWYER study were: infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and injection site erythema.
3.2Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to RITUXAN HYCELA and rituximab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
In the SABRINA study, where previously untreated patients with follicular lymphoma were treated with RITUXAN HYCELA or rituximab in combination with CVP or CHOP, the incidence of treatment-induced/enhanced anti-rituximab antibodies in the RITUXAN HYCELA group was similar to that observed in the rituximab group (2.0% RITUXAN HYCELA vs. 1.9% rituximab). The incidence of treatment-induced/enhanced anti-recombinant human hyaluronidase antibodies was 15% in the RITUXAN HYCELA group compared with 8% in the rituximab group, and the overall proportion of patients found to have anti-recombinant human hyaluronidase antibodies remained generally constant over the follow-up period in both cohorts. All patients who tested positive for anti-recombinant human hyaluronidase antibodies at any point during the study were negative for neutralizing antibodies.
In the SAWYER study, where previously untreated patients with CLL were treated with RITUXAN HYCELA or rituximab in combination with FC, the incidence of treatment-induced/enhanced anti-rituximab antibodies was 12% in the RITUXAN HYCELA group and 15% in the rituximab group. The incidence of treatment-induced/enhanced anti-recombinant human hyaluronidase antibodies was 11% in the RITUXAN HYCELA treatment arm. None of the patients who tested positive for anti-recombinant human hyaluronidase antibodies tested positive for neutralizing antibodies.
The clinical relevance of the development of anti-rituximab or anti-recombinant human hyaluronidase antibodies after treatment with RITUXAN HYCELA is not known.
3.3Postmarketing Experience
The following adverse reactions have been identified during post-approval use of rituximab-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Hematologic: prolonged pancytopenia, marrow hypoplasia, Grade 3–4 prolonged or late-onset neutropenia, hyperviscosity syndrome in Waldenstrom's macroglobulinemia, prolonged hypogammaglobulinemia
- Cardiac: fatal cardiac failure
- Immune/Autoimmune Events: uveitis, optic neuritis, systemic vasculitis, pleuritis, lupus-like syndrome, serum sickness, polyarticular arthritis, and vasculitis with rash.
- Infection: viral infections, including progressive multifocal leukoencephalopathy (PML), increase in fatal infections in HIV-associated lymphoma, and a reported increased incidence of Grade 3 and 4 infections
- Neoplasia: disease progression of Kaposi's sarcoma.
- Skin: severe mucocutaneous reactions, pyoderma gangrenosum (including genital presentation).
- Gastrointestinal: bowel obstruction and perforation.
- Pulmonary: fatal bronchiolitis obliterans and fatal interstitial lung disease.
4DESCRIPTION
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.
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 use.
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.
5HOW SUPPLIED/STORAGE AND HANDLING
RITUXAN HYCELA (rituximab and hyaluronidase human) injection, for subcutaneous use 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 1,400 mg/23,400 Units (NDC 50242-108-01) providing 1,400 mg rituximab and 23,400 Units hyaluronidase human per 11.7 mL
- RITUXAN HYCELA 1,600 mg/26,800 Units (NDC 50242-109-01) providing 1,600 mg rituximab and 26,800 Units hyaluronidase human per 13.4 mL
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
7PRINCIPAL DISPLAY PANEL - 11.7 mL Vial Carton
Rx only
NDC 50242-108-01
Rituxan Hycela
1,400 mg and
For Subcutaneous Use Only.
Single-Dose Vial.
Attention Pharmacist: Dispense the
1 vial
Genentech | Biogen
10214985
8PRINCIPAL DISPLAY PANEL - 13.4 mL Vial Carton
Rx only
NDC 50242-109-01
Rituxan Hycela
1,600 mg and
For Subcutaneous Use Only.
Single-Dose Vial.
Attention Pharmacist: Dispense the
1 vial
Genentech | Biogen
10214988
