• Relapsed or refractory follicular lymphoma (as monotherapy).
• Previously untreated follicular lymphoma 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 follicular lymphoma following treatment with cyclophosphamide, vincristine, and prednisone (as monotherapy).
• Previously untreated diffuse large B-cell lymphoma (in combination with CHOP or another anthracycline-based chemotherapy regimen).
• Previously untreated chronic lymphocytic leukemia (CLL) (in combination with fludarabine and cyclophosphamide).

Contraindicated in:

• Hypersensitivity to murine (mouse) proteins
• OB: Can pass placental barrier potentially causing fetal B-cell depletion. Give only if clearly needed during pregnancy
• Lactation: Lactation (potential for immunosuppression in infant).

Use Cautiously in:

• Hepatitis B infection (may reactivate infection during and for several mo after treatment)
• Underlying cardiac or pulmonary disease, history of cardiopulmonary reaction to rituximab, or high numbers of circulating malignant cells (25,000/mm³)
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: ARRHYTHMIAS, CARDIOGENIC SHOCK, MI, chest pain, hypertension, peripheral edema.

Derm: MUCOCUTANEOUS SKIN REACTIONS, alopecia, pruritus.

GI: BOWEL OBSTRUCTION/PERFORATION, HEPATITIS B REACTIVATION, abdominal pain, constipation, diarrhea, nausea, vomiting, ↓ appetite, dyspepsia, stomatitis.

GU: RENAL FAILURE.

Hemat: neutropenia, anemia, thrombocytopenia, leukopenia, lymphopenia.

Local: injection site reactions.

Metab: ↓weight.

MS: arthralgia, muscle spasms, myalgia.

Neuro: peripheral neuropathy , PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY, headache, dizziness, insomnia.

Resp: cough, dyspnea.

Misc: infection, infusion reactions, CYTOKINE RELEASE SYNDROME, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), TUMOR LYSIS SYNDROME, fatigue, fever.

Drug-Drug:

• May ↓ antibody response to and ↑ risk of adverse reactions from live vaccines; avoid use during therapy.

• Solution for injection: rituximab 120 mg and hyaluronidase 2,000 units/mL;

Follicular Lymphoma

All patients must receive 1 full dose of rituximab by IV infusion before starting treatment with subcutaneous product.

• SC (Adults): Relapsed or refractory disease — rituximab 1,400 mg/hyaluronidase 23,400 units once weekly starting Week 2 (one wk after receiving treatment with full dose of IV rituximab) for 3 or 7 wk (4 or 8 wk, respectively, of total therapy including IV rituximab); Retreatment for relapsed or refractory disease — rituximab 1,400 mg/hyaluronidase 23,400 units once weekly starting Week 2 (one wk after receiving treatment with full dose of IV rituximab) for 3 wk (4 wk of total therapy including IV rituximab); Previously untreated disease — rituximab 1,400 mg/hyaluronidase 23,400 units on Day 1 of Cycles 2–8 of chemotherapy (every 21 days) for up to 7 cycles following treatment with full dose of IV rituximab (given on Day 1 of Cycle 1 of chemotherapy) (total of 8 cycles including IV rituximab); if complete or partial response achieved, give rituximab 1,400 mg/hyaluronidase 23,400 units (as monotherapy) every 8 wk for 12 doses (initiate 8 wk after completion of combination treatment with chemotherapy); Non-progressing disease after first–line CVP chemotherapy — rituximab 1,400 mg/hyaluronidase 23,400 units once weekly for 3 wk following completion of 6–8 cycles of CVP chemotherapy and a full dose of IV rituximab at Week 1; administer at 6 month intervals to a maximum of 16 doses.

Diffuse Large B-Cell Lymphoma

All patients must receive 1 full dose of rituximab by IV infusion in combination with CHOP chemotherapy before starting treatment with subcutaneous product.

• SC (Adults): Rituximab 1,400 mg/hyaluronidase 23,400 units on Day 1 of Cycles 2–8 of CHOP chemotherapy for up to 7 cycles; full dose of IV rituximab should be administered on Day 1 of Cycle 1 of CHOP chemotherapy.

CLL

All patients must receive 1 full dose of rituximab by IV infusion in combination with fludarabine and cyclophosphamide chemotherapy before starting treatment with subcutaneous product.

• SC (Adults): Rituximab 1,600 mg/hyaluronidase 26,800 units on Day 1 of Cycles 2–6 (every 28 days) for a total of 5 cycles; full dose of IV rituximab should be administered on Day 1 of Cycle 1 of fludarabine/cyclophosphamide chemotherapy.

Rituxan Hycela

• Rituximab — Binds to the CD20 antigen on the surface of lymphoma cells, preventing the activation process for cell cycle initiation and differentiation; hyaluronidase — acts locally by depolymerizing hyalyonan, which increases permeability of the subcutaneous tissue.

• Death of lymphoma and leukemia cells.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Absorption: 64% absorbed following subcutaneous administration.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: 32–34 hr.

Rituxan SC

(B-cell depletion)

• Explain purpose of medication to patient. Advise patient to read Medication Guide prior to starting therapy and before each injection in case of changes.
• Advise patient to report signs or symptoms of hypersensitivity reactions immediately.
• Instruct patient to notify health care professional promptly if fever; chills; cough; hoarseness; sore throat; signs of infection; lower back or side pain; painful or difficult urination; bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; increased fatigue; dyspnea; orthostatic hypotension; or painful ulcers or sores on skin, lips, or in mouth, blisters, peeling skin, rash, pustule occurs.
• Advise patient to live vaccines during therapy.
• Discuss with patient the possibility of hair loss. Explore methods of coping.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
• Rep: Instruct females of reproductive potential to use effective contraception during therapy and for 12 mo following last dose, and to avoid breast feeding for at least 6 mo after last dose. Advise patient to notify health care professional if pregnancy is suspected.

ri-TUX-i-mab/hye-al-yoor-ON-i-dase

NDC Code^*

• 50242- Genentech, Inc.
  • 50242-108- Rituxan Hycela
    • 50242-108-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-01) > 11.7 mL in 1 VIAL, SINGLE-DOSE

• 50242- Genentech, Inc.
  • 50242-108- Rituxan Hycela
    • 50242-108-86- 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-86) > 11.7 mL in 1 VIAL, SINGLE-DOSE

• 50242- Genentech, Inc.
  • 50242-109- Rituxan Hycela
    • 50242-109-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-109-01) > 13.4 mL in 1 VIAL, SINGLE-DOSE