Mabthera 1400 mg/11.7 ml (SC Injection)

1400 mg vial: ৳ 75,278.00

Medicine Details

Category Details
Generic Rituximab
Company Roche bangladesh ltd
Also available as
Mabthera 10 mg injection

Indications

  • Low-grade or follicular, CD20-positive, B-cell NHL as a single agent
  • Pediatric patients aged 6 months and older with previously untreated mature B-cell NHL/B-AL
  • Treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies
  • Treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
  • Treatment of adult patients with moderate to severe pemphigus vulgaris
  • Combined treatment with chemotherapy for relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL
  • Combination with fludarabine and cyclophosphamide (FC) for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL

Pharmacology

  • Genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen
  • Approximate molecular weight of 145 kD
  • Binding affinity for the CD20 antigen of approximately 8.0 nM

Dosage and administration

  • Intravenous infusion administration only
  • Standard infusion initiation rate of 50-400 mg/hr
  • Pediatric patients with mature B-cell NHL/B-AL initiation rate of 0.5 mg/kg/hr
  • Subsequent infusions initiation rate of 100-400 mg/hr
  • Recommended dose of 375 mg/m2 for various NHL conditions
  • Recommended dose of 375 mg/m2 and 500 mg/m2 for CLL
  • Recommended dose of two-1,000 mg intravenous infusions for RA, GPA, MPA, and PV
  • Maintenance treatment and treatment of relapse guidelines

Interaction

  • Formal drug interaction studies not performed
  • Mabthera did not alter systemic exposure to fludarabine or cyclophosphamide in patients with CLL

Contraindications

  • Known hypersensitivity to Rituximab or any other components of this product

Side effects

  • Reactivation of hepatitis B virus
  • Infusion-related reactions such as fever, rigors, pruritus, skin rashes, dyspnea, bronchospasm, etc.
  • Exacerbation of heart failure and angina pectoris
  • Reversible interstitial pneumonia and interstitial fibrosis
  • Depletion of immunoglobulin concentrations

Pregnancy and lactation

  • Can cause fetal harm when administered to a pregnant woman
  • Can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to Rituximab in-utero
  • Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications
  • Limited data on presence in human milk and its effect on the breastfed child
  • Reported to be excreted at low concentrations in human breast milk
  • Women advised not to breastfeed during treatment and for 6 months after the last dose

Precautions and warnings

  • Can cause severe, including fatal, infusion-related reactions
  • Severe mucocutaneous reactions
  • Progressive Multifocal Leukoencephalopathy (PML)
  • Tumor Lysis Syndrome (TLS)
  • Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur
  • Not recommended for use in patients with severe, active infections

Therapeutic class

  • Cytotoxic immunosuppressants

Storage conditions

  • Store the vial in original carton at 2°C-8°C in a refrigerator
  • Do not freeze
  • Protect from light
  • Keep out of the reach of children

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