Blenrep 100 mg

/ GSK

The dosage should be individualised for each patient.
Administration is to be continued according to the recommended schedule until disease progression or unacceptable toxicity. The drug is administered in combination with other treatments.
Combination with bortezomib and dexamethasone
When combined with bortezomib and dexamethasone, administer as a 30-minute infusion, once every 3 weeks with a starting dose of 2.5 mg/kg. Administer from Cycle 1 until completion of treatment, while bortezomib and dexamethasone are administered for the first 8 Cycles. Each 21-day period is considered one treatment Cycle.
Combination with pomalidomide and dexamethasone
When combined with pomalidomide and dexamethasone, administer as a 30-minute infusion, once every 4 weeks with a starting dose of 2.5 mg/kg given once in Cycle 1. From Cycle 2 and onwards, the drug is dosed at 1.9 mg/kg. Each 28-day period is considered one treatment Cycle.
Recommended supportive care
Patients should have an ophthalmic examination (including visual acuity and slit lamp examination) performed by an eye care professional before each of the first 4 doses, and as clinically indicated thereafter.
Preservative-free artificial tears at least 4 times a day beginning on the first day of infusion and continuing until completion of treatment as this may reduce ocular symptoms
See prescribing information for full details.

Indicated in adults for the treatment of relapsed or refractory multiple myeloma:
• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
• in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.

Hypersensitivity to the active substance or to any of the excipients.

Ocular adverse reactions
Ocular adverse reactions (e.g., blurred vision, dry eye, eye irritation, and photophobia) have been reported with the use of belantamab. The most commonly reported corneal examination findings include superficial punctuate keratopathy, microcyst-like epithelial changes, and haze, with or without changes in visual acuity. Clinically relevant changes in visual acuity may be associated with difficulty in driving or operating machinery.
Ophthalmic examinations, including assessment of visual acuity and slit lamp examination, should be performed before each of the first 4 doses and during treatment as clinically indicated.
Patients should be advised to administer preservative-free artificial tears at least 4 times a day during treatment. Patients should avoid using contact lenses until the end of treatment. Bandage contact lenses may be used under the direction of an ophthalmologist.
Patients experiencing corneal examination findings (keratopathies such as superficial punctate keratopathy or microcyst-like deposits) with or without changes in visual acuity may require a dose modification (delay and/or reduction) or treatment discontinuation based on severity of findings.
Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. These should be managed promptly and as clinically indicated by an eye care professional. Treatment should be interrupted until the corneal ulcer has healed.
Thrombocytopenia
Thrombocytopenic events (thrombocytopenia and platelet count decreased) have been reported with the use of belantamab. Thrombocytopenia may lead to serious bleeding events, including gastrointestinal and intracranial bleeding.
Complete blood counts are to be obtained at baseline and monitored during treatment, as clinically indicated. Patients experiencing Grade 3 or 4 thrombocytopenia or those on concomitant anticoagulant treatments may require more frequent monitoring and may be managed with a dose delay or dose reduction. Supportive therapy (e.g., platelet transfusions) may be provided according to standard medical practice.
Infusion-Related Reactions
Infusion-related reactions (IRRs) have been reported with the use of belantamab. Most IRRs were Grade 1 or 2 and resolved within the same day. Patients experiencing IRR may require a dose modification (delay and/or reduction) or treatment discontinuation based on severity of findings.
Pneumonitis
Cases of pneumonitis, including fatal events, have been observed with belantamab, although a causal association has not been established. Evaluation of patients with new or worsening unexplained pulmonary symptoms (e.g., cough, dyspnoea) must be performed to exclude possible pneumonitis. In case of suspected Grade 3 or higher pneumonitis, it is recommended that treatment is withheld and appropriate treatment initiated . Treatment should only be resumed after an evaluation of the benefit and risk.
Hepatitis B virus reactivation
Hepatitis B virus (HBV) reactivation can occur in patients treated with medicinal products directed against B cells, including belantamab. Patients with evidence of positive HBV serology must be monitored for clinical and laboratory signs of HBV reactivation. If reactivation of HBV occurs while treated, patients must be treated according to clinical guidelines.
See prescribing information for full details

In combination with bortezomib and dexamethasone
The most frequent adverse reactions (≥20%) in BVd included reduced visual acuity (89%), thrombocytopenia (87%), corneal examination findings (86%), blurred vision (66%), dry eye (51%), photophobia (47%), foreign body sensation in eyes (44%), eye irritation (43%), eye pain (32%), diarrhoea (32%), and upper respiratory tract infection (20%).
In combination with pomalidomide and dexamethasone
The most frequent adverse reactions (≥20%) in BPd included reduced visual acuity (91%), corneal examination findings (87%), blurred vision (79%), neutropenia (63%), foreign body sensation in eyes (61%), dry eye (61%), thrombocytopenia (55%), eye irritation (50%), photophobia (44%), eye pain (33%), fatigue (27%), upper respiratory tract infection (27%), pneumonia (24%), anaemia (23%), and diarrhoea (23%).
See prescribing information for full details

No drug interaction studies have been performed. Based on available in vitro and clinical data, there is a low risk of pharmacokinetic or pharmacodynamic drug interactions.

Pregnancy: There are no data from the use of belantamab mafodotin in pregnant women. Based on the mechanism of action of the cytotoxic component monomethyl auristatin F (MMAF), belantamab mafodotin can cause embryo-foetal harm when administered to a pregnant woman. Human immunoglobulins (IgG) are known to cross the placental barrier, and therefore, being an IgG, belantamab mafodotin has the potential to be transmitted from the mother to the developing foetus.
Use is not recommended during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus. If a pregnant woman needs to be treated she must be clearly advised on the potential risk to the foetus.
Lactation: It is unknown whether belantamab mafodotin is excreted into human milk. Immunoglobulin G (IgG) is present in human milk in small amounts. Since belantamab mafodotin is a humanised IgG monoclonal antibody, and based on the mechanism of action, it may potentially cause serious adverse reactions in breastfed children. Breast-feeding should be discontinued prior to initiating treatment and for at least 3 months after the last dose of the drug.

There is no known specific antidote for belantamab mafodotin overdose. If overdose is suspected, patients must be monitored for any signs or symptoms of adverse effects and appropriate supportive treatment instituted.

Effects on ability to drive and use machines
Changes in visual acuity may be associated with difficulty for driving and reading.