|
Chỉ định và Liều dùng
Intravenous
Multiple myeloma Adult: As monotherapy in patients who have received at least 4 previous treatments including proteasome inhibitor, immunomodulatory agent, and an anti-CD38 monoclonal antibody: 2.5 mg/kg via IV infusion over 30 minutes every 3 weeks. Dose reduction or dosing interruption may be required according to individual safety and tolerability (refer to specific product guidelines).
|
|
Hướng dẫn pha thuốc
Before reconstitution, allow the vial to stand at room temperature for approx 10 minutes. Reconstitute vials labelled as 100 mg with 2 mL of sterile water for inj to obtain a concentration of 50 mg/mL. Gently swirl; do not shake. Further dilute the reconstituted solution by withdrawing the necessary dose volume (do not round down for partial vials) from the vial(s) and add it to an infusion bag containing 250 mL 0.9% NaCl to obtain a final concentration of between 0.2-2 mg/mL. Gently invert the bag to mix; do not shake.
|
|
Chống chỉ định
Pregnancy and lactation.
|
|
Thận trọng
Patient with history of dry eyes.
|
|
Tác dụng không mong muốn
Significant: Ocular toxicity (e.g. severe vision loss, corneal ulcer), blurred vision, dry eye syndrome, epithelial keratopathy, decreased visual acuity; bone marrow suppression (e.g. thrombocytopenia, decreased neutrophils); infusion-related reactions.
Blood and lymphatic system disorders: Anaemia, lymphopenia, leucopenia, neutropenia. Eye disorders: Eye irritation, photophobia. Gastrointestinal disorders: Diarrhoea, nausea, vomiting. General disorders and administration site conditions: Fatigue, pyrexia. Investigations: Increased aspartate aminotransferase, gamma-glutamyl transferase, creatine phosphokinase. Respiratory, thoracic and mediastinal disorders: Pneumonia, upper respiratory tract infection. Potentially Fatal: Rarely, cerebral haemorrhage. |
|
IV: Z (Avoid)
|
|
Thông tin tư vấn bệnh nhân
This drug may cause changes in visual acuity, if affected, do not drive or operate machinery. Avoid use of contact lenses during treatment.
|
|
Chỉ số theo dõi
Perform ophthalmic examinations (e.g. visual acuity, slit lamp) at baseline, before the 1st 3 treatment cycles, and as necessary during treatment (particularly for worsening ocular symptoms). Monitor CBC at baseline and as necessary during treatment. Assess pregnancy status before treatment initiation. Monitor for bleeding events and infusion-related reactions.
|
|
Tác dụng
Description:
Mechanism of Action: Belantamab mafodotin is an afucosylated, humanised IgG1 monoclonal antibody that is directed against the B-cell maturation antigen (BCMA) conjugated with maleimidocaproyl monomethyl auristatin F (mcMMAF), a cytotoxic microtubule inhibitor. It binds to cell surface BCMA where it is then internalised and mcMMAF is released via proteolytic cleavage leading to eventual cell cycle arrest and apoptosis. It also causes tumour cell lysis through antibody-dependent cellular toxicity and phagocytosis. Onset: 1.4 months (median time to first response). Duration: ≥6 months. Pharmacokinetics: Absorption: Time to peak plasma concentration: Shortly after the end of the infusion. Distribution: Volume of distribution: 11 L. Metabolism: Metabolised via proteolysis by ubiquitous proteolytic enzymes into small peptides and individual amino acids. Excretion: Elimination half-life: 12 days (after the 1st dose); 14 days (steady state). |
|
Bảo quản
Intact vials: Store between 2-8°C. Diluted solutions: Storage recommendation varies per country, refer to detailed product guideline. Follow applicable procedures for receiving, handling, administration, and disposal.
|
|
Phân loại MIMS
|
|
Phân loại ATC
L01FX15 - belantamab mafodotin ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
|
|
Tài liệu tham khảo
Anon. Belantamab Mafodotin-blmf. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/06/2022. Anon. Belantamab Mafodotin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/06/2022. Blenrep 100 mg Powder for Concentrate for Solution for Infusion (GlaxoSmithKline Limited [HK]). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 02/06/2022. Blenrep 100 mg Powder for Concentrate for Solution for Infusion (GlaxoSmithKline UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/06/2022. Blenrep Injection, Powder, Lyophilized, for Solution (GlaxoSmithKline LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/06/2022. Joint Formulary Committee. Belantamab Mafodotin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2022.
|
Đăng xuất
