Leukemias, lymphomas, and other hematologic cancers:

Indications for: RITUXAN HYCELA

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.

Adult Dosage:

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 Dosage:

Not established.

Boxed Warning:

Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.

RITUXAN HYCELA 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 12months after the last dose. Pregnancy: exclude status prior to initiation. Newborns/infants: monitor for infection. Nursing mothers: not recommended (during and for 6months after the last dose).

RITUXAN HYCELA Classification:

CD20-directed cytolytic monoclonal antibody + endoglycosidase.

RITUXAN HYCELA Interactions:

Concomitant live virus vaccines: not recommended. Renal toxicity with concomitant cisplatin.

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).

Generic Drug Availability:


How Supplied:

Single-dose vial—1