Ofatumumab


Generic Medicine Info
Indications and Dosage
Intravenous
Chronic lymphocytic leukaemia
Adult: In combination with chlorambucil in previously untreated patients for whom fludarabine-based treatment is inappropriate: Cycle 1: Initially, 300 mg on day 1, followed by 1,000 mg on day 8. Subsequent cycles: 1,000 mg on day 1 every 28 days; continue for at least 3 cycles until best response is achieved or a Max of 12 cycles. In combination with fludarabine and cyclophosphamide in patients with relapsed case: Cycle 1: Initially, 300 mg on day 1, followed by 1,000 mg on day 8. Subsequent cycles: 1,000 mg on day 1 every 28 days; continue for a Max of 6 cycles. For extended treatment of patients who are in complete or partial response following at least 2 lines of therapy for recurrent or progressive case: Initially, 300 mg on day 1, followed by 1,000 mg on day 8, followed by 1,000 mg 7 weeks later; then every 8 weeks thereafter for up to Max of 2 years. Initial doses are infused at 12 mL/hr; subsequent doses at 25 mL/hr. In combination with fludarabine and alemtuzumab in patients with refractory CLL (total of 12 doses): Initially, 300 mg on day 1, followed 1 week later by 2,000 mg once weekly for 7 doses (doses 2-8); followed 4 weeks later by 2,000 mg once every 4 weeks for 4 doses (doses 9-12). 1st and 2nd doses are infused at 12 mL/hr; 3rd through 12th doses at 25 mL/hr. Infusion rates may be adjusted according to safety and tolerability (refer to detailed product guideline). Premedicate with paracetamol, antihistamine, and corticosteroid before each administration. Treatment recommendations may vary among individual products and between countries. Refer to specific product guidelines.

Subcutaneous
Relapsing forms of multiple sclerosis
Adult: Initially, 20 mg once weekly for 3 doses (weeks 0, 1, and 2). Maintenance: 20 mg once a month, starting at week 4. Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Reconstitution
IV infusion: Dilute in 1,000 mL of 0.9% NaCl solution.
Contraindications
Severely immunocompromised, severe active infection, known active malignancy, active hepatitis B virus (HBV) infection (when used for relapsing forms of multiple sclerosis [MS]). Concurrent vaccination with live-attenuated or live vaccines.
Special Precautions
Patient with prior HBV infection, high tumour burden and/or high circulating lymphocyte counts. Pregnancy and lactation.
Adverse Reactions
Significant: Bacterial, fungal, and new or reactivated viral infections. SC: Decreased IgM levels, inj-related reactions (systemic), inj-site reactions (e.g. pain, itching, swelling, erythema). IV: Severe and prolonged cytopenias (e.g. neutropenia, thrombocytopenia, anaemia, pancytopenia, agranulocytosis), tumour lysis syndrome.
Gastrointestinal disorders: Oral herpes, diarrhoea, nausea.
General disorders and administration site conditions: Fatigue, fever.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infections, cough, dyspnoea, pneumonia, bronchitis.
Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Hepatitis B reactivation, progressive multifocal leucoencephalopathy (PML). Neutropenic sepsis, serious infusion reactions (IV).
Monitoring Parameters
Evaluate immune status; perform HBV screening before initiating treatment. Monitor for signs and symptoms of PML. IV: Monitor CBC with differential (during and after therapy), renal function, electrolytes, fluid status. Assess for signs of active hepatitis B infection (during and after therapy), hepatitis, infusion reactions, infection intestinal obstruction. SC: Obtain quantitative serum Ig (at baseline and during therapy as clinically indicated).
Drug Interactions
May alter the effects of inactivated vaccines. Increased risk of infection with other immunosuppressant drugs (including systemic corticosteroids).
Action
Description: Ofatumumab, a fully human anti-CD20 monoclonal antibody (IgG1), specifically binds to the small and large extracellular loops of the CD20 molecule (expressed on normal B lymphocytes and in B-cell CLL). This results in potent complement-dependent cell lysis and antibody-dependent cell-mediated toxicity in cells that overexpress CD20.
Pharmacokinetics:
Absorption: Mainly absorbed via the lymphatic system.
Distribution: Volume of distribution: 6.1 L (IV); 5.4 L (SC).
Metabolism: Undergoes degradation to small peptides and amino acids by proteolytic enzymes.
Excretion: Via target-dependent and target-mediated B-cell binding routes. Elimination half-life: 17.6 days (IV); approx 16 days (SC).
Storage
Store between 2-8°C. Do not freeze. Do not shake. Protect from light.
MIMS Class
Immunosuppressants
ATC Classification
L04AA52 - ofatumumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
L01FA02 - ofatumumab ; Belongs to the class of CD20 (Clusters of Differentiation 20) inhibitors. Used in the treatment of cancer.
References
Anon. Ofatumumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/07/2022.

Arzerra Injection, Solution (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/07/2022.

Bonspri 20 mg Solution for Injection in a Pre-filled Syringe (Novartis Corporation [Malaysia] Sdn. Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/07/2022.

Buckingham R (ed). Ofatumumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/07/2022.

Joint Formulary Committee. Ofatumumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/07/2022.

Kesimpta 20 mg Solution for Injection in Pre-filled Syringe (Novartis Pharmaceuticals UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/07/2022.

Kesimpta Injection, Solution (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/07/2022.

Ofatumumab 20 mg Solution for Injection in Pre-filled Syringe (Novartis Pharmaceuticals [H] Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 01/07/2022.

Disclaimer: This information is independently developed by MIMS based on Ofatumumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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