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Blenrep is a brand name for Belantamab Mafodotin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Blenrep is 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…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Blenrep is initiated and monitored by physicians experienced in the treatment of multiple myeloma. 4). Posology Administration of Blenrep is to be continued according to the recommended schedule until disease progression or unacceptable toxicity.
Blenrep is administered in combination with other treatments (see Table 1). 1 and the respective current Summary of Product Characteristics. 9 mg/kg administered once every 4 weeks a Bortezomib and dexamethasone are administered for the first 8 cycles.
If a planned dose of Blenrep is missed due to reasons other than adverse reactions, it is recommended that Blenrep be resumed with the start of the next planned treatment cycle. If a planned dose of Blenrep is missed due to adverse reactions, it is recommended that Blenrep be resumed with the start of the next planned treatment cycle after recovery of adverse reactions (see Table 3).
Dose modifications Dose modifications are required for nearly all patients to manage safety and tolerability. Dose reduction levels for Blenrep are provided in Table 2. Recommended modifications to manage adverse reactions are provided in Table 3.
4 mg/kg every 8 weeks NA = Not applicable. a There is no reduced dose level 2. Ocular adverse reactions Ocular events were graded based on ophthalmic examination findings that include the combination of corneal examination findings and best corrected visual acuity (BCVA).
The patient’s ophthalmic examination findings should be reviewed by the treating physician before determining the dose of Blenrep. The corneal examination findings may or may not be accompanied by changes in BCVA. Ocular adverse reaction severity is defined by the most severely affected eye as both eyes may not be affected to the same degree.
It is important for physicians to consider not only corneal examination findings but also visual acuity changes and reported symptoms as they evaluate dose delays and reductions. Do not re-escalate dose after a dose reduction is made for ocular adverse reactions.
Re-escalation of dose for non-ocular adverse reactions is to be based on clinical judgement, if applicable. 4) Mild (Grade 1) Corneal examination finding(s) Mild superficial punctate keratopathy with worsening from baseline, with or without symptoms.
Summary of the safety profile The most common adverse reactions (any grade) were corneal examination findings (including keratopathy) (84%), visual acuity reduced (81%), thrombocytopenia (62%), vision blurred (52%), dry eye (36%), foreign body sensation in eyes (32%), photophobia (30%), eye irritation (28%), neutropenia (27%), anaemia (23%), diarrhoea (23%), neuropathies (23%), and eye pain (21%).
The most common serious adverse reactions (any grade) were pneumonia (9%), pyrexia (4%), COVID-19 (3%), COVID-19 pneumonia (3%), and thrombocytopenia (2%). The proportion of subjects with treatment discontinuation due to adverse reactions was 24%.
The most common adverse reaction leading to treatment discontinuation was ocular events (7%). The frequency of dose reduction due to adverse reactions was 63%. The most common adverse reactions leading to dose reduction were ocular events (39%), thrombocytopenia (12%), platelet count 11 decreased (6%), insomnia (5%), peripheral sensory neuropathy (5%), neuropathy peripheral (5%), neutropenia (4%), fatigue (3%), and neutrophil count decreased (2%).
The frequency of dose delay due to adverse reactions was 83%. The most common adverse reactions leading to dose delay were ocular events (67%), thrombocytopenia (16%), COVID-19 (11%), platelet count decreased (8%), neutropenia (8%), upper respiratory tract infection (7%), pneumonia (7%), diarrhoea (4%), pyrexia (4%), neutrophil count decreased (4%), peripheral sensory neuropathy (4%), bronchitis (3%), COVID-19 pneumonia (3%), cataract (3%), neuropathy peripheral (3%), and alanine aminotransferase increased (3%).
Tabulated list of adverse reactions The adverse reaction frequencies are based on all-cause adverse event frequencies, from patients with multiple myeloma exposed to belantamab mafodotin, for which, after thorough assessment, a causal relationship between the medicinal product and the adverse event is at least a reasonable possibility.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. , blurred vision, dry eye, eye irritation, and photophobia) have been reported with the use of Blenrep.
The most commonly reported corneal examination findings include superficial punctuate keratopathy, microcyst-like epithelial changes, and haze, with or without changes in visual acuity or symptoms. 8). 7) and to report any changes in vision promptly.
Regular ophthalmologic monitoring is recommended. Physicians should also encourage patients to inform them of any ocular symptoms. Ophthalmic examinations, including assessment of visual acuity and slit lamp examination, should be performed before each of the first 4 doses of Blenrep 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 (see Table 3).
8). These should be managed promptly and as clinically indicated by an eye care professional. Treatment with Blenrep should be interrupted until the corneal ulcer has healed (see Table 3). Thrombocytopenia Thrombocytopenic events (thrombocytopenia and platelet count decreased) have been reported with the use of Blenrep.
8). Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment. 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 (see Table 3).
1.
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Change in BCVA Decline from baseline of 1 line on snellen equivalent visual acuity. Treatment should be continued at the current dose. 5 Adverse reaction Severitya Recommended dose modifications Moderate (Grade 2) Corneal examination finding(s) Moderate superficial punctate keratopathy, patchy microcyst-like deposits, peripheral sub-epithelial haze, or a new peripheral stromal opacity.
Change in BCVA Decline from baseline of 2 lines (and snellen equivalent visual acuity not worse than 20/200). Or Severe (Grade 3) Corneal examination finding(s) Severe superficial punctate keratopathy, diffuse microcyst-like deposits involving the central cornea, central sub-epithelial haze, or a new central stromal opacity.
Change in BCVA Decline from baseline of 3 or more lines (and snellen equivalent visual acuity not worse than 20/200). Withhold treatment until improvement in both corneal examination findings and BCVA to mild severity or better. Resume treatment at reduced dose level 1 as per Table 2.
9 mg/kg every 4 weeks for cycle 2 and all subsequent cycles. b Change in BCVA Decline to snellen equivalent visual acuity of worse than 20/200. Withhold until improvement in both corneal examination findings and BCVA to mild severity or better.
Resume treatment at reduced dose level 1 for BVd and reduced dose level 2 for BPd as per Table 2, if applicable. For worsening symptoms that are unresponsive to appropriate management, consider permanent discontinuation. 9 mg/kg. For BVd, may consider reverting to previous dose, if appropriate once thrombocytopenia recovers to Grade 2 or better.
9 mg/kg or lower, continue at same dose. With bleeding: • Withhold Blenrep until improvement to Grade 2 or better. 9 mg/kg. 9 mg/kg or lower, resume at same dose. , transfusion), as clinically indicated and per local practice. Grade 4 Withhold the dose.
Consider restarting if recovered […]
The safety of belantamab mafodotin has been evaluated in more than 7500 patients with multiple myeloma, including 516 patients who received belantamab mafodotin in triplet combinations as part of the DREAMM-6 (a Phase 1/2, open-label dose exploration study), DREAMM-7, and DREAMM-8 studies, 312 patients who received belantamab mafodotin as monotherapy in the DREAMM-2 and DREAMM-3 studies, and including patients from the post-marketing setting.
Adverse reactions are listed in Table 4 by system organ class and by frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Frequencies are defined as:
Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1 000 to <1/100 Rare: ≥1/10 000 to <1/1 000 Very rare: <1/10 000 Not known: frequency cannot be estimated from the available data Table 4: Adverse reactions in multiple myeloma patients treated with belantamab mafodotin in clinical trials and post-marketing System organ class (SOC) Adverse reaction Frequency Incidence (%) Any grade Grade 3-4 Infections and infestations COVID-19 Very common 18 3 Upper respiratory tract infection Very common 15 <1 Pneumonia Very common 13 7 Urinary tract infection Common 9 2 Bronchitis Common 5 ˂1 COVID-19 pneumonia Common 3 2 Hepatitis B reactivation Uncommon <1 <1 Blood and lymphatic system disorders Thrombocytopeniaa Very common 62 47 Neutropeniab Very common 27 22 Anaemia Very common 23 12 Lymphopeniac Very common 10 7 Leukopeniad Common 9 4 Febrile neutropenia Common 1 1 12 System organ class (SOC) Adverse reaction Frequency Incidence (%) Any grade Grade 3-4 Immune system disorders Hypogammaglobulinemia Common 2 ˂1 Metabolism and nutrition disorders Decreased appetite Common 8 <1 Psychiatric disorders Insomnia Very Common 13 1 Nervous system disorders Neuropathiese Very common 23 2 Eye disorders Corneal examination findings (including keratopathy)f,g Very common 84 62 Visual acuity reducedf Very common 81 50 Vision blurred Very common 52 13 Dry eye Very common 36 5 Foreign body sensation in eyes Very common 32 2 Photophobia Very common 30 1 Eye irritation Very common 28 3 Eye pain Very common 21 <1 Cataract Very common 13 4 Visual impairment Common 8 5 Lacrimation increased Common 5 <1 Diplopia Common 3 <1 Eye pruritus Common 2 <1 Ocular discomfort Common 1 <1 Corneal ulcerh Common 1 <1 Corneal hypoesthesia Not known - - Respiratory, thoracic and mediastinal disorders Cough Very common 11 ˂1 Dyspnoea Common 9 1 Pneumonitis Uncommon <1 <1 Gastrointestinal disorders Diarrhoea Very common 23 2 Nausea Very common 17 <1 Constipation Very common 15 <1 Vomiting Common 7 <1 Hepatobiliary Disorders Increased aspartate aminotransferase Very common 15 2 Increased alanine aminotransferase Very common 13 3 Increased gamma glutamyltransferase Very common 11 5 Porto-sinusoidal vascular disorderi Uncommon <1 <1 Skin and subcutaneous tissue disorders Rash Common 4 <1 Musculoskeletal Arthralgia Very common 11 <1 13 System organ class (SOC) Adverse reaction Frequency Incidence (%) Any grade Grade 3-4 and connective tissue disorders Back pain Very common 11 1 Increased creatine phosphokinase Common 3 1 Renal and urinary disorders Albuminuriaj Common 3 <1 General disorders and administration site conditions Fatigue Very common 19 3 Pyrexia Very common 18 <1 Asthenia Common 6 1 Injury, poisoning and procedural complications Infusion-related reactionsk Very Common 11 <1 a Includes thrombocytopenia and platelet count decreased.
b Includes neutropenia and neutrophil count decreased. c Includes lymphopenia and lymphocyte count decreased. d Includes leukopenia and white blood cell count decreased. e Includes peripheral sensory neuropathy, neuropathy peripheral, neuralgia, polyneuropathy, peripheral motor neuropathy, sensory loss, peripheral sensorimotor neuropathy.
f Based on ophthalmic examination findings. g Includes superficial punctate keratopathy, microcyst-like epithelial changes, stippled vortex staining pattern, sub-epithelial haze, corneal epithelial […]
, platelet transfusions) may be provided according to standard medical practice. 9 Infusion-related reactions Infusion-related reactions (IRRs) have been reported with the use of Blenrep. 8). If a Grade 2 or higher infusion- related reaction occurs during administration, reduce the infusion rate, or stop the infusion depending on the severity of the symptoms.
Institute appropriate medical treatment and restart infusion at a slower rate if the patient’s condition is stable. If Grade 2 or higher IRR occurs, consider premedication for subsequent infusions (see Table 3). Pneumonitis Cases of pneumonitis, including fatal events, have been observed with Blenrep.
, cough, dyspnoea) must be performed to exclude possible pneumonitis. In case of suspected or confirmed Grade 3 or higher pneumonitis, it is recommended that Blenrep is discontinued and appropriate treatment initiated. Hepatitis B virus reactivation Hepatitis B virus (HBV) reactivation can occur in patients treated with medicinal products directed against B cells, including Blenrep, and in some cases, may result in fulminant hepatitis, hepatic failure, and death.
Patients with evidence of positive HBV serology must be monitored for clinical and laboratory signs of HBV reactivation as per clinical guidelines. In patients who develop reactivation of HBV while on Blenrep, treatment with Blenrep must be withheld and patients must be treated according to clinical guidelines.
Excipients with known effect Polysorbate 80 This medicinal product contains polysorbate 80 (E433), which may cause allergic reactions. 4 mg of polysorbate 80 (E433) in 2 mL of withdrawable reconstituted solution. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.