rituximab


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rituximab

 [rĭ-tuk´sĭ-mab]
a monoclonal antibody that binds CD20 antigen; used as an antineoplastic agent in treatment of B-cell non-Hodgkin's lymphoma positive for that antigen, administered intravenously.

rituximab

MabThera (UK), Rituxan

Pharmacologic class: Murine/human monoclonal antibody

Therapeutic class: Antineoplastic

Pregnancy risk category C

FDA Box Warning

• Deaths from infusion reactions have occurred within 24 hours of rituximab infusion. Approximately 80% of fatal reactions were linked to first infusion. If severe infusion reaction develops, discontinue infusion and intervene appropriately.

• Acute renal failure requiring dialysis, severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy have been reported.

Action

Binds to CD20 antigen on malignant B lymphocytes; recruits immune effector functions to mediate B-cell lysis (possibly through complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity)

Availability

Injection: 10 mg/ml in 10-ml (100-mg) and 50-ml (500-mg) vials

Indications and dosages

Non Hodgkin's lymphoma (NHL)

Adults: 375 mg/m2 by I.V. infusion according to the following schedules:

Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL: Give weekly for four or eight doses.

Retreatment for relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL: Give weekly for four doses.

Previously untreated, follicular, CD20-positive, B-cell NHL: Give on day 1 of each cycle of cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy, for up to eight doses.

Non-progressing, low-grade, CD20-positive B-cell NHL, after first line CVP chemotherapy: Following completion of six to eight cycles of CVP chemotherapy, give weekly for four doses at 6-month intervals to a maximum of 16 doses.

Diffuse large B-cell NHL: Give on day 1 of each cycle of chemotherapy for up to eight infusions.

Dosage in combination with ibritumomab: On day 1, rituximab 250 mg/m2 by I.V. infusion. Within 4 hours after rituximab infusion, give 5 mCi In-111 ibritumomab I.V. On days 7, 8, and 9, give rituximab 250 mg/m2 by I.V. infusion and platelet-count-dependent dose of Y-90 ibritumomab I.V.

Moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more tumor necrosis factor antagonist

Adults: Two 1,000 mg I.V. infusions separated by 2 weeks in combination with methotrexate. Give subsequent courses every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks.

Chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC)

Adults: 375 mg/m2 I.V. day before start of FC chemotherapy; then 500 mg/m2 on day 1 of cycles 2 to 6 (every 28 days).

Off-label uses

• Waldenström's macroglobulinemia

Contraindications

• Hypersensitivity to drug, its components, or murine products

Precautions

Use cautiously in:

• history of drug allergy or sensitivity

• previous exposure to murine-based monoclonal antibodies

• high level of circulating malignant cells

• cardiac or pulmonary conditions

• pregnant or breastfeeding patients

• children.

Administration

• Follow facility policy regarding handling, administration, and disposal of chemotherapeutic drugs.

• Know that Pneumocystis jiroveci pneumonia and antiherpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment, as appropriate.

• To reduce the incidence and severity of infusion reactions, premedicate patient with diphenhydramine and acetaminophen, as prescribed. In addition, for patients with rheumatoid arthritis, give I.V. methylprednisolone (or its equivalent) 30 minutes before each infusion.

• Consider withholding antihypertensive agents 12 hours before giving drug to help prevent hypotension.

• Give drug as I.V. infusion.

Never give as I.V. bolus or I.V. push.

• Don't mix or dilute with other drugs.

• Dilute in dextrose 5% in water (D5W) or normal saline solution to a concentration of 1 to 4 mg/ml. Invert bag gently to mix solution.

• Administer the first infusion at an initial rate of 50 mg/hr. If no infusion reaction occurs, increase the infusion rate in 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.

• If the patient tolerates the first infusion well, administer subsequent infusions at an initial rate of 100 mg/hr and increase by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr, as tolerated.

Be aware that a severe infusion reaction may occur usually after first infusion. This reaction consists of a complex of hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, M.I., ventricular fibrillation, or cardiogenic shock. If such a reaction occurs, stop infusion immediately and treat appropriately.

• If hypersensitivity reaction (non-IgE-mediated) or infusion reaction that is not severe occurs, interrupt or temporarily slow infusion. When symptoms improve, infusion can continue at half of previous rate.

Adverse reactions

CNS: dizziness, headache, nervousness, hypertonia, hyperesthesia, insomnia, agitation, malaise, paresthesia, asthenia, fatigue, tremor, rigors

CV: hypotension, hypertension, peripheral edema, chest pain, tachycardia, bradycardia, angina, arrhythmias

EENT: conjunctivitis, lacrimation disorders, rhinitis, sinusitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, anorexia

GU: renal toxicity

Hematologic: anemia, neutropenia, leukopenia, thrombocytopenia

Metabolic: hyperglycemia, hypocalcemia

Musculoskeletal: myalgia, back pain

Respiratory: dyspnea, cough, bronchitis, bronchospasm

Skin: pruritus, rash, urticaria, flushing, dermatitis, angioedema, toxic epidermal necrolysis, Stevens-Johnson syndrome

Other: altered taste, fever, chills, pain at injection site, hypersensitivity reactions including sepsis, severe infusion reaction

Interactions

Drug-drug. Cisplatin: increased risk of renal failure

Live-virus vaccines: increased risk of infection from vaccine

Drug-diagnostic tests. Calcium, hemoglobin, neutrophils, platelets, white blood cells: decreased values

Glucose, lactate dehydrogenase: increased levels

Patient monitoring

• Monitor closely for signs and symptoms of hypersensitivity reaction.

Stop drug immediately and notify prescriber if patient develops signs or symptoms of Stevens-Johnson syndrome or other severe mucocutaneous reactions (including severe rash).

Monitor pulse and blood pressure throughout I.V. infusion. Stop infusion if hypotension, bronchospasm, or angioedema occurs. Then consult prescriber about restarting infusion at half of previous rate.

Monitor ECG throughout infusion. Stop infusion if serious arrhythmia develops.

• Monitor CBC, blood glucose, and electrolyte levels.

• Assess for signs and symptoms of infection, including fever.

Patient teaching

Tell patient to immediately report signs and symptoms of hypersensitivity reaction or severe skin reaction.

Instruct patient to take his temperature daily and immediately report fever and other signs or symptoms of infection.

Instruct patient to immediately report unusual bleeding or bruising.

• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

rituximab

(rĭ-tŭk′sĭ-măb′)
n.
A chimeric monoclonal antibody used to treat certain types of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and refractory rheumatoid arthritis.

rituximab

A MONOCLONAL ANTIBODY anticancer drug used to treat non-Hodgkin's lymphomas. A brand name is Mabthera.
References in periodicals archive ?
the widespread introduction of rituximab, a chimeric antiCD20 antibody, and improvement in autologous stem cell transplantation (ASCT).
its purpose is the provision of rituximab (atc code l01xc02) intravenously and includes 2 positions: - item 1: rituximab in 100 mg / 10 ml dosage (concentrate for solution for infusion), - item 2: rituximab in 500 mg / 50 ml dosage (concentrate for solution for infusion).
Despite the high unmet demand for effective cancer therapies in China, the adoption rate of rituximab is low due to low affordability, the companies said.
To satisfy requirements of the conditional authorization, a further Phase III clinical study, PIX306, was completed to provide additional efficacy data to confirm the benefit of Pixuvri in patients that had received prior treatment regimens containing rituximab.
Food and Drug Administration (FDA) approved REVLIMID[R] (lenalidomide) in combination with a rituximab product (R (2)) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation.
The combination of lenalidomide and rituximab therapy for elderly patients showed high and continuous CR, according to Zinzani et al .'s trial.[15] Twenty-three elderly patients with R/R DLBCL were enrolled and given lenalidomide and rituximab as induction treatment, and ORR was 35% ( n = 8).
Rituximab (Rituxan), which was under priority review by the Food and Drug Administration for treating moderate to severe pemphigus vulgaris, was approved for this indication in June, shortly after the meeting, where she presented a review of off-label rituximab outcomes in 113 patients.
Recibio tratamiento con pulsos de metilprednisolona 500 mg/dia por 3 dias, y dada la edad avanzada y el estado critico de la paciente, se decidio manejo con rituximab 375 mg/m2 semanal por 4 dosis y soporte con hemodialisis.
A suggestive chimeric anti-CD20 monoclonal antibody, rituximab (RTX), has been found to suppress immune response with a better efcacy and less toxicity than the standard treatment (10-19).
Biotechnology company Genmab A/S (CPH:GEN) reported on Thursday that topline results from the phase III study of Arzerra (ofatumumab) plus bendamustine did not meet the primary endpoint of improved progression-free survival (PFS) in patients with indolent B-cell non-Hodgkin's lymphoma (iNHL) who were unresponsive to rituximab or a rituximab-containing regimen, as compared to those given bendamustine alone.