Belantamab mafodotin parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of belantamab mafodotin.
Drugs List
Therapeutic Indications
Uses
Multiple myeloma - refractory
Monotherapy for the treatment of multiple myeloma in adults patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, who have demonstrated disease progression on the last therapy.
Dosage
Adults
2.5mg/kg once every 3 weeks.
Additional Dosage Information
Dose modifications for adverse reactions
Corneal adverse reactions
Mild (Mild superficial keratopathy, Decline from baseline of 1 line on Snellen Visual Acuity): Continue treatment at current dose
Moderate (Moderate superficial keratopathy, Decline from baseline of 2 or 3 lines (and Snellen Visual Acuity not worse than 20/200)): Withhold treatment until improvement to mild severity or better. Consider resuming treatment at a reduced dose of 1.9mg/kg.
Severe (Severe superficial keratopathy, Decline from baseline of more than 3 lines): Withhold treatment until improvement to mild severity or better. For worsening symptoms that are unresponsive to management, consider discontinuing treatment.
Other adverse reactions
Thrombocytopenia
Grade 2-3 (Platelet count 25,000 to less than 75,000/microlitres): Consider withholding and/or reducing the dose to 1.9mg/kg.
Grade 4 (Platelet count less than 25,000/microlitres): Withhold until platelet count improves to Grade 3 or better. Consider resuming at reduced dose of 1.9mg/kg.
Infusion-related reactions
Grade 2 (moderate): Interrupt infusion and provide supportive treatment. Once symptoms have resolved, resume at lower infusion rate by at least 50%.
Grade 3 or 4 (severe): Interrupt infusion and provide supportive treatment. Once symptoms have resolved, resume at lower infusion rate by at least 50%. If anaphylactic or life-threatening infusion reaction occurs, permanently discontinue and provide appropriate emergency care.
Administration
For intravenous infusion only.
Contraindications
Children under 18 years
Weight above 130kg
Weight below 40kg
Breastfeeding
Moderate hepatic impairment
Pregnancy
Severe renal impairment
Precautions and Warnings
Dry eyes
Severe thrombocytopenia
Advise ability to drive/operate machinery may be affected by side effects
Give pre-treatment counselling and consideration of oocyte cryopreservation
Give pre-treatment counselling and consideration of sperm cryopreservation
Premedicate all patients with prior infusion related reactions
Treatment to be initiated and supervised by a specialist
Contains polysorbate
Advise patient to administer PF artificial tears 4 times a day
Consult local policy on the safe use of anti-cancer drugs
Record name and batch number of administered product
Staff: Not to be handled by pregnant staff
Exclude pregnancy prior to initiation of treatment
Monitor full blood count regularly
Monitor ophthalmic function
Consider discontinuing treatment/dose modification if keratopathy occurs
Consider withholding/reducing dose if grade 2 thrombocytopenia occurs
Discontinue / interrupt treatment if ulcerative keratitis develops
Interrupt/reduce infusion rate by 50% if grade 2 infusion reaction occurs
Discontinue if anaphylactoid reaction occurs
Discontinue permanently if life threatening infusion reactions occur
Interrupt treatment if severe infusion reaction occurs
Suspend treatment and/or reduce dose if grade 4 thrombocytopenia
May cause impaired fertility
Female: Contraception required during and for 4 months after treatment
Male: Contraception required during and for 6 months after treatment
Breastfeeding: Do not breastfeed during & for 3 months after treatment
Contact lenses should not be worn during treatment
Ophthalmic examination should be performed by an eye care specialist at baseline, before the subsequent 3 treatment cycles and as clinically indicated during treatment.
Pregnancy and Lactation
Pregnancy
Belantamab mafodotin is contraindicated during pregnancy.
The manufacturer recommends that belantamab mafodotin should not be used during pregnancy unless the benefit to the mother outweighs the potential risk to the foetus. There are no data from the use of belantamab mafodotin in pregnant women. Based on the mechanism of action of the cytotoxic component, belantamab mafodotin can cause embryo-foetal harm. Human immunoglobulin G (IgG) is also known to cross the placenta, therefore there is the potential for belantamab mafodotin to be transmitted from the mother to the foetus.
Lactation
Belantamab mafodotin is contraindicated during breastfeeding.
The manufacturer recommends that women should be advised to discontinue breastfeeding prior to initiating treatment with belantamab mafodotin and for 3 months after the last dose. It is not known whether belantamab mafodotin is excreted into human breast milk. Immunoglobulin G (IgG) is present in breast milk in small amounts, so based on the mechanism of action belantamab mafodotin may cause serious adverse reactions in breastfed infants.
Side Effects
Anaemia
Aspartate aminotransferase increased
Asthenia
Blurred vision
Chills
Creatine phosphokinase increased
Diarrhoea
Diplopia
Dry eyes
Eye irritation
Eye pruritus
Fatigue
Gamma glutamyl transferase (GGT) increased
Hypertension
Impaired vision
Infective keratitis
Infusion related reaction
Keratopathy
Lethargy
Leukopenia
Lymphopenia
Nausea
Neutropenia
Ocular discomfort
Photophobia
Pneumonia
Pyrexia
Reduced visual acuity
Tachycardia
Thrombocytopenia
Ulcerative keratitis
Upper respiratory tract infection
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2021
Reference Sources
Summary of Product Characteristics: Blenrep 100 mg powder for concentrate for solution for infusion. GlaxoSmithKline UK. Revised January 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.