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Rituxan Hycela Generic Name & Formulations
Legal Class
Rx
General Description
Rituximab, hyaluronidase human 1400mg/23400 Units, 1600mg/26800 Units; soln for SC inj; preservative-free.
Pharmacological Class
CD20-directed cytolytic monoclonal antibody + endoglycosidase.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Rituxan Hycela Indications
Indications
Relapsed or refractory, follicular lymphoma (FL) as a single agent. Previously untreated FL in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease) FL as a single agent after first-line CVP chemotherapy. Previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with CHOP or other anthracycline-based chemotherapy regimens. Chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide.
Limitations of Use
Start treatment only after receiving at least 1 full dose of a rituximab product by IV infusion. Not for treating non-malignant conditions.
Rituxan Hycela Dosage and Administration
Adult
Give by SC inj into abdomen. Premedicate with an antihistamine and acetaminophen prior to each dose; may consider glucocorticoids. Monitor for at least 15mins after each dose. Relapsed or refractory FL: 1400mg/23400 Units over 5mins once weekly for 3 or 7 weeks following a full dose of IV rituximab at Week 1. May give retreatment once weekly for 3 weeks following a full dose of IV rituximab at Week 1. Previously untreated FL: 1400mg/23400 Units over 5mins on Day 1 of Cycles 2–8 of chemotherapy (every 21 days) for up to 7 cycles following a full dose of IV rituximab on Day 1 of Cycle 1; if complete or partial response, initiate Rituxan Hycela maintenance 8 weeks following completion of Rituxan Hycela in combination with chemotherapy. Administer Rituxan Hycela as a single-agent every 8 weeks for 12 doses. Non-progressing FL after first-line CVP chemotherapy: 1400mg/23400 Units over 5mins once weekly for 3 weeks at 6-month intervals following completion of 6–8 cycles of CVP and a full dose of IV rituximab at Week 1; max 16 doses. DLBCL: 1400mg/23400 Units over 5mins on Day 1 of Cycles 2–8 of CHOP chemotherapy for up to 7 cycles following a full dose of IV rituximab on Day 1 of Cycle 1. CLL: 1600mg/26800 Units over 7mins on Day 1 of Cycles 2–6 (every 28 days) for 5 cycles following a full dose of IV rituximab on Day 1 of Cycle 1. Give PCP and antiherpetic viral prophylaxis during and up to 12 months after CLL therapy.
Children
Not established.
Rituxan Hycela Contraindications
Not Applicable
Rituxan Hycela Boxed Warnings
Boxed Warning
Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.
Rituxan Hycela Warnings/Precautions
Warnings/Precautions
Discontinue if severe injection or mucocutaneous reactions occur (eg, urticaria, hypotension, angioedema, hypoxia, pulmonary infiltrates, acute respiratory failure, paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid or vesiculobullous dermatitis, toxic epidermal necrolysis). Increased risk of HBV reactivation. Test/treat HBV infection prior to initiating therapy. Monitor for signs of hepatitis or HBV reactivation during and for several months after therapy; discontinue if HBV reactivation occurs. Tumor lysis syndrome (esp. with high tumor burden); monitor renal function, fluid balance, electrolyte abnormalities (correct if occurs); discontinue if SCr rises or oliguria occurs. Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Discontinue and treat if serious infections (eg, bacterial, fungal, viral) occur. Pre-existing cardiac or pulmonary conditions, prior cardiopulmonary adverse events, high malignant cell count; monitor during and after treatment. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 12 months after the last dose. Pregnancy: exclude status prior to initiation. Newborns/infants: monitor for infection. Nursing mothers: not recommended (during and for 6 months after the last dose).
Rituxan Hycela Pharmacokinetics
See Literature
Rituxan Hycela Interactions
Interactions
Concomitant live virus vaccines: not recommended. Renal toxicity with concomitant cisplatin.
Rituxan Hycela Adverse Reactions
Adverse Reactions
Infections, neutropenia, nausea, constipation, cough, fatigue, alopecia, anemia, thrombocytopenia, pyrexia, vomiting, injection site erythema, mucocutaneous reactions (may be fatal), hypersensitivity, PML, tumor lysis syndrome, renal toxicity, bowel obstruction/perforation (when concomitant chemotherapy), HBV reactivation, arrhythmias (discontinue if serious).
Rituxan Hycela Clinical Trials
See Literature
Rituxan Hycela Note
Not Applicable
Rituxan Hycela Patient Counseling
See Literature
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