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Elahere is a brand name for Mirvetuximab Soravtansine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens (see section 4.2).
Verbatim from this product's EMA label. Tap a section to expand.
ELAHERE must be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection Eligible patients should have FRα tumour status defined as 75% viable tumour cells demonstrating moderate (2+) and/or strong (3+) membrane staining by immunohistochemistry (IHC), assessed by a CE-marked in vitro diagnostic (IVD) with the corresponding intended purpose.
If a CE-marked IVD is not available, an alternative validated test should be used. 3 Posology The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity.
Dosing based on AIBW reduces exposure variability for patients who are either underweight or overweight. 9 kg Pre-medication Pre-medication for infusion related reactions (IRRs), nausea, and vomiting Administer the pre-medications in Table 1 prior to each infusion of ELAHERE to reduce the incidence and severity of IRRs, nausea, and vomiting.
Table 1:
Pre-medication prior to each ELAHERE infusion Pre-medication Route of administration Examples (or equivalent) Administration time prior to ELAHERE infusion Corticosteroid intravenous dexamethasone 10 mg at least 30 minutes prior Antihistamine oral or intravenous diphenhydramine 25 mg to 50 mg Antipyretic oral or intravenous acetaminophen or paracetamol 325 mg to 650 mg Antiemetic oral or intravenous 5-HT3 serotonin receptor antagonist or appropriate alternatives before each dose and following the administration of other premedication For patients experiencing nausea and/or vomiting, additional antiemetics may be considered thereafter as needed.
For patients who experience an IRR Grade ≥2, additional pre-medication with dexamethasone 8 mg two times a day (BID) (or equivalent) the day before ELAHERE administration should be considered.
Ophthalmic exam and pre-medication Ophthalmic exam:
An ophthalmic exam including visual acuity and slit lamp exam should be conducted before the initiation of ELAHERE and if a patient develops any new or worsening ocular symptoms prior to the next dose. In patients with ≥ Grade 2 ocular adverse reactions, additional ophthalmic exams should be conducted at a minimum of every other cycle and as clinically indicated until resolution or return to baseline.
Summary of safety profile The most common adverse reactions with mirvetuximab soravtansine were blurred vision (43%), nausea (41%), diarrhoea (39%), fatigue (35%), abdominal pain (30%), keratopathy (29%), dry eye (27%), constipation (26%), vomiting (23%), decreased appetite (22%), peripheral neuropathy (20%), headache (19%), asthenia (18%), AST increased (16%), and arthralgia (16%).
The most commonly reported serious adverse reactions were pneumonitis (4%), small intestinal obstruction (3%), intestinal obstruction (3%), pleural effusion (2%), abdominal pain (2%), dehydration (1%), constipation (1%), nausea (1%), ascites (1%) and thrombocytopenia (<1%).
Adverse reactions that most commonly led to dose reduction or dose delay were blurred vision (17%), keratopathy (10%), dry eye (5%), neutropenia (5%), keratitis (4%), cataract (3%), visual acuity reduced (3%), thrombocytopenia (3%), peripheral neuropathy (3%), and pneumonitis (3%).
Permanent discontinuation due to an adverse reaction occurred in 12% of patients who received mirvetuximab soravtansine, including most commonly, gastrointestinal disorders (4%), respiratory, thoracic, and mediastinal disorders (3%), blood and lymphatic system disorders (1%), nervous system disorders (1%), and eye disorders (1%).
Tabulated list of adverse reactions The frequencies of adverse reactions are based on pooled data from 4 clinical studies which included 682 patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively referenced as Epithelial Ovarian Cancer (EOC) treated with mirvetuximab soravtansine 6 mg/kg AIBW administered once every 3 weeks.
1 weeks (range: 3, 132 weeks). The adverse reaction frequencies from clinical studies are based on all-cause adverse event frequencies, 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. 8). Patients should be referred to an eye care professional for an ophthalmic exam before initiation of mirvetuximab soravtansine.
Before the start of each cycle, the patient should be advised to report any new or worsening ocular symptoms to the treating physician or qualified individual. 2). 7 Use of lubricating eye drops during treatment with mirvetuximab soravtansine is recommended.
2). 2). Patients should be advised to avoid use of contact lenses during treatment with mirvetuximab soravtansine unless directed by a healthcare professional. 8). Patients should be monitored for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnoea, or interstitial infiltrates on radiologic exams.
Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Mirvetuximab soravtansine treatment should be withheld for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤Grade 1 and dose reduction should be considered.
2). Patients who are asymptomatic may continue dosing of mirvetuximab soravtansine with close monitoring. 8). Patients should be monitored for signs and symptoms of neuropathy, such as paraesthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia.
2). Embryo-foetal toxicity Based on its mechanism of action, mirvetuximab soravtansine could cause embryo-foetal harm when administered to a pregnant patient because it contains a genotoxic compound (DM4) and affects actively dividing cells.
6). Excipients with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. 11 mg of polysorbate 20 in each vial. 8
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ophthalmic topical steroids:
For patients found to have signs of Grade 2 corneal adverse reactions (keratopathy) on slit lamp examination, secondary prophylaxis with ophthalmic topical steroids is recommended for subsequent cycles of ELAHERE, unless the patient’s eye care professional determines that the risks outweigh the benefits of such therapy.
4 • Patients should be instructed to use steroid eye drops on the day of infusion and through the next 7 days of each subsequent cycle of ELAHERE (see Table 3). • Patients should be advised to wait at least 15 minutes after ophthalmic topical steroid administration before instilling lubricating eye drops.
During treatment with ophthalmic topical steroids the measurement of intraocular pressure and an examination with slit lamp should be carried out regularly.
Lubricating eye drops:
It is recommended to instruct patients to use lubricating eye drops throughout treatment with ELAHERE. Dose modifications Before the start of each cycle, the patient should be advised to report any new or worsening symptoms to the treating physician or qualified individual.
In patients who develop new or worsening ocular symptoms, an ophthalmic exam should be conducted before dosing. The treating physician should review the patient’s ophthalmic examination report before dosing and determine the dose of ELAHERE based on the severity of findings in the most severely affected eye.
Table 2 and Table 3 provide dose reductions and modifications for adverse reactions. The schedule of administration should be maintained at a 3-week interval between the doses.
Table 2:
Dose reduction schedule ELAHERE dose levels Starting dose 6 mg/kg AIBW First dose reduction 5 mg/kg AIBW Second dose reduction 4 mg/kg AIBW* * Permanently discontinue in patients who cannot tolerate 4 mg/kg AIBW. 8) Non-confluent superficial keratitis/keratopathy Monitor Confluent superficial keratitis/keratopathy, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuity Withhold dose until improved to nonconfluent superficial keratitis/keratopathy or better or resolved, then maintain at same dose level.
Consider dose reduction for patients with recurrent confluent keratitis/keratopathy despite best supportive care or in patients with ocular toxicity lasting longer than 14 days. Corneal ulcer or stromal opacity or best corrected distance visual acuity 6/60 or worse Withhold dose until improved to nonconfluent superficial keratitis/keratopathy or better or resolved, then reduce by one dose level.
8) Grade 1 Monitor Grade 2 Withhold dose until Grade 1 or less, then maintain at same dose level or consider dose reduction if recurrent, lasts longer than 28 days, or at physician discretion. 8) Grade 2 Withhold dose until Grade 1 or less, then reduce by one dose level.
Grade 3 or 4 Permanently discontinue […]
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). Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness.
Table 4:
Tabulated list of all grade adverse reactions in patients treated with mirvetuximab soravtansine in clinical studies System Organ Class Frequency category Adverse reactions Infections and infestations Very common Urinary tract infection Blood and lymphatic system disorders Very common Anaemia, thrombocytopenia Common Neutropenia Metabolism and nutrition disorders Very common Decreased appetite, hypomagnesaemia Common Hypokalaemia, dehydration Psychiatric disorders Common Insomnia Nervous system disorders Very common Peripheral neuropathy1, headache, Common Dysgeusia, dizziness Eye disorders Very common Keratopathy2, cataract3, blurred vision event4, photophobia, eye pain, dry eye5 Common Ocular discomfort6 Vascular disorders Common Hypertension Respiratory, thoracic and mediastinal disorders Very common Pneumonitis7, dyspnoea, cough 10 System Organ Class Frequency category Adverse reactions Gastrointestinal disorders Very common Diarrhoea, abdominal pain8, constipation, abdominal distension, vomiting, nausea Common Ascites, gastro-oesophageal reflux disease, stomatitis, dyspepsia Hepatobiliary disorders Common Hyperbilirubinaemia Skin and subcutaneous tissue disorders Common Pruritus Musculoskeletal and connective tissue disorders Very common Arthralgia Common Myalgia, back pain, pain in extremity, muscle spasms General disorders and administration site conditions Very common Fatigue Common Pyrexia Investigations Very common Aspartate aminotransferase increased, alanine aminotransferase increased Common Blood alkaline phosphatase increased, gamma-glutamyl transferase increased, weight decreased Injury, poisoning and procedural complication Common Infusion related reaction/hypersensitivity9 1 Peripheral neuropathy grouped term includes hypoaesthesia, neuropathy peripheral, neurotoxicity, paraesthesia, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, and polyneuropathy (see section Description of selected adverse reactions).
2 Keratopathy group term includes corneal cyst, corneal deposits, corneal disorder, corneal epithelial microcysts, corneal epithelium defect, corneal erosion, corneal opacity, corneal pigmentation, keratitis, keratitis interstitial, keratopathy, limbal stem cell deficiency, and punctate keratitis (see section Description of selected adverse reactions).
3 Cataract grouped term includes cataract, cataract cortical, and cataract nuclear (see section Description of selected adverse reactions). 4 Blurred vision event grouped term includes accommodation disorder, diplopia, hypermetropia, presbyopia, refraction disorder, vision blurred, visual impairment, visual acuity reduced, and vitreous floaters (see section Description of selected adverse reactions).
5 Dry eye grouped term includes dry eye and lacrimation decreased (see section Description of selected adverse reactions). 6 Ocular discomfort grouped term includes eye irritation, eye pruritus, foreign body sensation in eye, and ocular discomfort (see section Description of selected adverse reactions).
7 Pneumonitis group term includes interstitial lung disease, organising pneumonia, pneumonitis, pulmonary fibrosis, and respiratory failure (see section Description of selected adverse reactions). 8 Abdominal pain grouped term includes abdominal discomfort, abdominal pain, abdominal pain lower, and abdominal pain upper.
9 Infusion related reaction/hypersensitivity grouped term includes SMQ Hypersensitivity narrow and flushing, erythema, erythema of eyelid. Description of selected adverse reactions Ocular disorders Ocular adverse reactions (grouped terms) occurred in 59% of patients with EOC treated with mirvetuximab soravtansine.
Eleven […]