Mabthera® (rituximab) Prescribing Information Summary
Please refer to the MabThera Summary of Product Characteristics for full product information.
MabThera 100 or 500 mg concentrate for solution for infusion. Each single-use vial contains 10 mg/ml of rituximab. Excipients: Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.
Indication: MabThera, in combination with methotrexate, is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other DMARDs including one or more TNF inhibitor therapies.
Dosage and Administration: A course of MabThera consists of two infusions: 1000mg by iv infusion followed by a second 1000mg iv infusion two weeks later. Administer through a dedicated line, with full resuscitation facilities immediately available. Premedication should be given. Monitor for onset of cytokine release syndrome. Severe reactions e.g. severe dyspnoea, bronchospasm or hypoxia require immediate interruption of infusion. First Infusion: Recommended initial infusion rate is 50mg/hr. Second Infusion: Initial rate of 100mg/hr.
Dose adjustments: No dose adjustment is required in elderly patients.
Contraindications: Hypersensitivity to this product or to murine proteins; active, severe infections; patients in a severely immunocompromised state, severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease.
Precautions: Infusion reactions: Anaphylactic and other hypersensitivity reactions. Premedication with IV glucocorticoid is recommended. Treatments for hypersensitivity reactions should be immediately available. Presence of HACA may be associated with worsening infusion reactions. Consider carefully patients with cardiac history and monitor during administration. Hypotension may occur, consider withholding antihypertensive medications. Infections: Do not give to patients with an active and/or severe infection, or severely immunocompromised patients. Exercise caution in patients with recurring/chronic infections. Treat and evaluate promptly and appropriately. Before giving subsequent courses, re-evaluate patients for infection risk. Use of MabThera may be associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML) which may be fatal, reactivation of hepatitis B infection may occur. Immunisation: Safety or efficacy of vaccination – consult Product Information. Concomitant/sequential use of other DMARDs: The concomitant use of MabThera and antirheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended. Initial data suggest that the rate of clinically relevant infection is unchanged. Malignancy: Limited experience in RA patients, cannot exclude a possible risk for the development of solid tumours.
Pregnancy and Lactation: Women should not become pregnant and should not breastfeed during, and for 12 months following treatment. Contraception should be used during, and for 12 months following treatment.
Undesirable effects: Prescribers should consult the Product Information for full details of side-effects. Very common: infusion reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, rhinitis, throat irritation, hot flush, hypotension, chills) urinary tract infections, upper respiratory tract infections. Common: Infections, including bronchitis, sinusitis, gastroenteritis, dyspepsia and other gastrointestinal disorders, hypercholesterolaemia, arthralgia/musculoskeletal pain, osteoarthritis, paraesthesia, migraine. Uncommon: infusion related reactions (generalised oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritus, anaphylaxis, anaphylactoid reaction.) Very rare: PML, serum sickness-like reaction. Medically significant events: Acute infusion reactions, incidence of clinically significant infection, some of which were fatal, was 0.05 per patient year. Very rare cases of PML have been reported. Serious cardiac events reported equally in 2% of MabThera and placebo treated patients.