Clinical Pharmacology Details


Rituximab


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Indications & Dose:

Treatment of severe active rheumatoid arthritis in patients whose condition has not responded adequately to other disease-modifying antirheumatic drugs (including one or more tumour necrosis factor inhibitors) or who are intolerant of them (in combination with methotrexate) l



Adult: 1 g, then 1 g after 2 weeks, patients should receive premedication before each infusion (consult product literature for details)


Treatment of previously untreated stage III–IV follicular lymphoma (in combination with other chemotherapy) | Maintenance therapy in patients with follicular non- Hodgkin’s lymphoma that has responded to induction therapy (in combination with other chemotherapy) | Treatment of diffuse large Bcell non-Hodgkin’s lymphoma (in combination with other chemotherapy) | Treatment of chemotherapy-resistant or relapsed stage III– IV follicular non-Hodgkin’s lymphoma | Previously untreated or relapsed chronic lymphocytic leukaemia | Induction of remission in patients with severe, active granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis (in combination with glucocorticoids) l



Adult: Patients should receive premedication before each dose (consult product literature for details) (consult product literature or local protocols)

Contraindications:

Severe heart failure (when used to treat granulomatosis with polyangiitis or microscopic polyangiitis) .  Patients with a known type I hypersensitivity (or anaphylaxis) to mouse proteins. 

Side Effects:

Cautions:

Precautions:

Pregnancy; lactation. Contraception is recommended in women of childbearing potential. The ability to respond immunologically to a vaccination is compromised after therapy; the safety of live virus vaccination is not known. Consider stopping antihypertensive medications on the day of treatment to reduce hypotensive reactions. Cardiac monitoring is recommended only in patients with pre-existing arrhythmias and angina that have worsened during the infusion

Interaction:

Additive hypotension can occur in patients on antihypertensive therapy. There is no inhibition of cytotoxic activity in patients being treated for lymphoma with CHOP chemotherapy. 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Most patients experience an infusion-related symptoms complex with fever, chills, and rigors on the first infusion. Other frequent, acute infusion-related symptoms are nausea (18%), vomiting (10%), angioedema (13%), urticaria or pruritus (10%), and bronchospasm and rhinitis (8%). Hypotension and other acute effects are moderate or severe in 10% of the first doses. Overall, the frequency and severity of all reactions diminishes with subsequent injections. Most first-dose reactions occur within 30 min to 2 hr and resolve with showing of the infusion rate of mild to moderate reactions. Epinephrine is required only occasionally. Myelosuppression (neutropenia and thrombocytopenia) is typically mild and occurs in only 10% of patients, although long-term depletion of B-cells occurs in 70-80%; a minority also have decreased serum immunoglobulins. The frequency of grade 3 infections during the 4-week treatment period is 9% and grade 4 infections generally do not occur. Serious, sometimes fatal, skin reactions (bullous reactions, pemphigus) occur rarely

Patient And Carer Advice: