Mabthera Injection
Rituximab
1600mg/13.4ml
F. Hoffmann-La Roche Ltd.
| Pack size | 20ml Glass Vial |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 11711.00 AED |
Available as:
Indications
Mabthera Injection is used for:
Non-Hodgkin's lymphoma; follicular lymphoma
Adult Dose
Intravenous
Non-Hodgkin Lymphoma
Recommended dose for NHL
375 mg/m² IV infusion according to the following schedules
Relapsed or refractory low-grade or follicular, CD20-positive, B-cell NHL: Once weekly x4-8 doses
Retreatment for relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL: Once weekly x4 doses
Previously untreated, follicular, CD20-positive, B-cell NHL: Administer on Day 1 of each chemotherapy cycle for up to 8 doses; with complete or partial response, initiate maintenance 8 weeks following completion of combination chemotherapy as a single-agent q8weeks for 12 doses
Nonprogressing, low-grade, CD20-positive, B-cell NHL, after first-line CVP chemotherapy: Following completion of 6-8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses
Diffuse large B-cell NHL: Administer on Day 1 of each cycle of chemotherapy for up to 8 infusions
Chronic Lymphocytic Leukemia
Indicated for untreated and previously treated CD20-positive CLL; combined therapy with fludarabine and cyclophosphamide (FC)
375 mg/m² IV infusion on day 1 of 1st cycle (for 1st cycle, administer 1 day before chemotherapy with FC), THEN
500 mg/m² IV on day 1 of subsequent cycles (administer on same day as chemotherapy with FC)
Repeat q28 days x6 cycles
Fludarabine & cyclophosphamide dosage
Fludarabine: 25 mg/m² IV qDay x 3 days
Cyclophosphamide: 250 mg/m² IV qDay x3 days
Repeat q28 days x 6 cycles
Rheumatoid Arthritis
1000 mg IV infusion, repeat after 2 week (2 infusions separated by 2 week is 1 course)
Repeat course q24weeks or based on clinical evaluation (but no sooner than 16 weeks)
Used in combo with methotrexate
Premedicate with glucocorticoids 30 minutes before infusion to reduce infusion rxn
Not to exceed 1000 mg/dose
Child Dose
Safety and efficacy not established
Renal Dose
Administration
Reconstitution: Dilute the appropriate dose w/ sodium chloride 0.9% or glucose 5% to a final concentration of between 1 and 4 mg/mL.
IV Administration
Consider premedication (ie, paracetamol and diphenhydramine, or glucocorticoids for RA) before each infusion
Administer by slow IV infusion only; do not administer as an IV
First IV infusion rate: Start 50 mg/hr; increase by 50 mg/hr q30min, not to exceed 400 mg/hr
Subsequent IV infusions (90 minutes)
Standard IV infusions: Start 100 mg/hr, increase by 100 mg/hr q30min, not to exceed 400 mg/hr; institutional protocols may allow faster increments
Contra Indications
Lactation. Type I hypersensitivity or anaphylactic reactions to murine proteins or component of the formulation.
Precautions
Extensive tumor burden, pulmonary tumor infiltration or pulmonary insufficiency; history of cardiac disease; effective contraception during and up to 12 mth after treatment; pregnancy. Monitor CBC and platelet counts regularly. Premedication with analgesics, antihistamines and corticosteroids may be recommended. Monitor for signs of active infection or hepatitis in hepatitis B carriers. Discontinue treatment if viral hepatitis develops.
Lactation: not known if excreted in breast milk, do not nurse
Pregnancy-Lactation
Pregnancy
Limited available data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
Use with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery; anticoagulant effect cannot be reliably monitored with standard laboratory testing
Consider benefits and risks for the mother and possible risks to the fetus when prescribing to a pregnant woman
Females of reproductive potential requiring anticoagulation should discuss pregnancy planning
Clinical considerations
Pregnancy is a risk factor for VTE and risk increases in women with inherited or acquired thrombophilias; pregnant women with thromboembolic disease have an increased risk of maternal complications (eg, pre-eclampsia); maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption, and early and late pregnancy loss
Based on pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate
All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery; risk of bleeding should be balanced with the risk of thrombotic events when considering the use in this setting
Lactation
Drug detected in human milk
Insufficient data available to determine effects on breastfed child or on milk production; drug and/or its metabolites were present in milk of rats
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Interactions
Increased risk of renal toxicity w/ cisplatin.
Potentially Fatal: May decrease the efficacy of vaccines and increase the risk of infections in patients immunised w/ live vaccines.
Adverse Effects
Side effects of Rituximab :
>10%
NHL
Angioedema (11%), hypotension (10%), Asthenia (26%), chills (33%), dizziness (10%), fever (53%), headache (19%)
Pruritus (14%), rash (15%), Abdominal pain (14%), diarrhea (10%), nausea (23%), vomiting (10%)
Leukopenia (14%), lymphopenia (48%), neutropenia (14%), thrombocytopenia (12%), Back pain (10%), myalgia (10%)
Cough (13%), rhinitis (12%), Infection (31%), night sweats (15%)
1-10%
NHL
Edema, Flushing, Hypertension, Anxiety, Anemia, Elevated LDH, Hyperglycemia, Bronchospasm, dyspnea, sinusitis, throat irritation, urticaria, RA (Rituximab+Methotrexate vs Methotrexate Alone)
Hypertension, Anxiety, asthenia, chills, migraine, paresthesia, pyrexia, Pruritus, urticaria, Dyspepsia, nausea, upper abd pain, Hypercholesterolemia, Arthralgia, Rhinitis, throat irritation, URI
Frequency Not Defined
Tumor lysis syndrome, Lymphoid malignancies, Hypogammaglobulinemia
Potentially Fatal: Pulmonary or cardiac toxicity during infusion; severe mucocutaneous reactions; severe cytokine release syndrome associated with tumor lysis syndrome. Toxic epidermal necrolysis.
Mechanism of Action
Rituximab is a chimeric monoclonal antibody to CD20 antigen which regulates cell cycle initiation. It binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity.
Note
Mabthera 1600mg/13.4ml Injection manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Rituximab. Mabthera is availble in United Arab Emirates.
Farmaco UAE drug index information on Mabthera Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.