Rituximab instructions

1. Indications and Usage

Rituximab is a CD20 directed cytolytic antibody used to treat :

1.Adult patients with non-Hodgkin lymphoma (NHL).

Monotherapy for relapsed or refractory, low-grade or follicular CD20positiveB cell non-Hodgkin lymphoma.

Previously untreated follicularCD20positiveBcellsNHL in combination with first-line chemotherapy, and as single-agent maintenance therapy in patients who have achieved a complete or partial response to a rituximab product in combination with chemotherapy.

First-line cyclophosphamide, vincristine, and prednisone(CVP)Non-progressive after chemotherapy(Including stable phase)Low levelCD20PositiveB cellsNHL.

Previously untreated diffuse largeB cell, CD20positiveNHL combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

2.Previously untreated and previously treated with a combination of fludarabine and cyclophosphamide (FC)CD20positiveCLL.

3.Rituximab in combination with methotrexate for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA) who have failed to respond to one or more tumor necrosis factor antagonists.

4.Granulomatosis with polyangiitis in adults (GPA) (Wegener's granulomatosis) and microscopic polyangiitis (MPA) with glucocorticoids.

2. Dosage and usage

Administer as intravenous infusion only. Do not give by intravenous push or bolus injection.

Rituximab should be taken only by a healthcare professional with appropriate medical support to manage serious infusion-related reactions, which may be fatal if adverse reactions occur.

The dose for adultsBcell non-Hodgkin lymphoma is 375mg/m²2 .

The dose of CLL is 375mg/m22 in the first cycle and 500mg/ cubic meter2In combination with FC in cycles 2-6, administered once every 28 days.

The dose of RAcombined with methotrexate is intravenous infusion 2-1, 000 every 24 weeks or 2 weeks apart according to clinical evaluation. mg (one course of treatment), but not earlier than every 16 weeks. It is recommended that intravenous administration of methylprednisolone 100 mg or equivalent glucocorticoid 30 minutes before each infusion.

In adults with active GPA and MPA the induction dose of combined glucocorticoids is 375 mg/m2 once weekly for 4 weeks. Adult patients with GPA and MPA achieved disease control with induction therapy combined with glucocorticoids with two follow-up doses of 500 mgIntravenous infusion 500 mg every 6 months thereafter based on clinical assessment.

Three. Dosage form and strength

Injection: 100mg/10ml in a single-dose vial (10mg/ ml) and 500mg/50ml (10mg/ml) solution.

Four. Contraindications

None

Five. Warnings and Precautions

Tumor lysis syndrome:Give aggressive intravenous hydration, anti-hyperuricemia drugs, and monitor renal function.

Infection: Discontinue rituximab and initiate appropriate anti-infective treatment.

Adverse Cardiac Reactions: If a serious or life-threatening event occurs, stop the infusion.

Nephrotoxicity: Patients with elevated serum creatinine or oliguria should stop taking the drug.

Intestinal obstruction and perforation: Consider and evaluate abdominal pain, vomiting, or related symptoms.

Immunization: Live virus vaccines are not recommended before or duringrituximab treatment.

Embryo-Fetal Toxicity:Can cause fetal harm. Inform women of the potential risks to the fetus and the use of effective contraception.

6. Adverse reactions

The most common adverse reactions in clinical trials are:

NHL (greater than or equal to 25%):Infusion-related reactions, fever, lymphopenia, chills, infection, and fatigue (6.1).

CLL (greater than or equal to 25%):Infusion-related reactions and neutropenia.

RA(greater than or equal to 10%):Upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events).

GPA and MPA (greater than or equal to 15%):Infection, nausea, diarrhea, headache, muscle cramps, anemia, peripheral edema, infusion-related reactions.

7. Drug interactions

Nephrotoxicity when used in combination with cisplatin.

8. Use among specific groups of people

Breastfeeding: Breastfeeding is not recommended.

Geriatric Use:In CLL patients 70 years and older, an exploratory analysis showed no benefit from adding rituximab to FC.

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