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Talvey is a brand name for Talquetamab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TALVEY is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with TALVEY should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. TALVEY should be administered by a healthcare professional with adequately-trained medical personnel and appropriate medical equipment to manage severe reactions, including cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).
3 Posology Pre-treatment medicinal products should be administered prior to each dose of TALVEY during the step-up phase (see below). TALVEY should be administered subcutaneously on a weekly or biweekly (every 2 weeks) dosing schedule according to Table 1.
8 mg/kg body weight biweekly dosing schedule. 8 mg/kg a Based on actual body weight and administered subcutaneously. b Dose may be administered between 2 to 4 days after the previous dose and may be given up to 7 days after the previous dose to allow for resolution of adverse reactions.
c Maintain a minimum of 6 days between weekly doses and a minimum of 12 days between biweekly (every 2 weeks) doses. 4). Duration of treatment Patients should be treated with TALVEY until disease progression or unacceptable toxicity.
4). Corticosteroid (oral or intravenous dexamethasone 16 mg or equivalent) Antihistamine (oral or intravenous diphenhydramine 50 mg or equivalent) Antipyretics (oral or intravenous paracetamol 650 mg to 1 000 mg or equivalent) Pre-treatment medicinal products should be administered prior to subsequent doses for patients who repeat doses within the TALVEY step-up phase due to dose delays (see Table 2) or for patients who experienced CRS (see Table 3).
Prevention of infection Prior to starting treatment with TALVEY, prophylaxis should be considered for the prevention of infections, per local institutional guidelines. Dose delays If a dose of TALVEY is delayed, therapy should be restarted based on recommendations in Table 2, and weekly or biweekly dosing should be resumed accordingly (see Posology above).
Pre-treatment medicinal products should be administered prior to restarting TALVEY, and patients should be monitored accordingly. 01 mg/kg * Administer pretreatment medicinal products prior to restarting TALVEY. 2). 4). See Table 2 for recommendations on restarting TALVEY after a dose delay.
Summary of the safety profile The most frequent adverse reactions were CRS (77%), dysgeusia (72%), hypogammaglobulinaemia (67%), nail disorder (56%), musculoskeletal pain (48%), anaemia (47%), fatigue (43%), weight decreased (40%), rash (39%), skin disorder (37%), dry mouth (36%), neutropenia (35%), pyrexia (33%), xerosis (32%), thrombocytopenia (30%), upper respiratory tract infection (29%), lymphopenia 13 (27%), dysphagia (24%), diarrhoea (25%), pruritus (23%), cough (23%), pain (22%), decreased appetite (22%) and headache (20%).
1%). 9%). Tabulated list of adverse reactions The safety of TALVEY was evaluated in 339 adult patients with relapsed or refractory multiple myeloma, including patients treated with TALVEY at the recommended dosing regimen with or without prior T cell redirection therapy in MonumenTAL-1.
9) months. Table 7 summarises adverse reactions reported in patients who received TALVEY. The safety data of TALVEY was also evaluated in the All Treated population (N=501) with no additional adverse reactions identified. Adverse reactions observed during clinical studies are listed below by frequency category.
Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 0. 03, maximum toxicity grade for dysgeusia is 2 and maximum toxicity grade for dry mouth is 3. * Grouped term # Contains fatal outcome(s) 1 Haemorrhage includes: Conjunctival haemorrhage, Epistaxis, Haematoma, Haematuria, Lower gastrointestinal haemorrhage, Periorbital haemorrhage, Petechiae, Rectal haemorrhage, Subdural haematoma and Vaginal haemorrhage.
2 Hypogammaglobulinaemia includes: hypogammaglobulinaemia and/or subjects with laboratory IgG levels below 500 mg/dL following treatment with talquetamab. 3 Encephalopathy includes: agitation, amnesia, aphasia, bradyphrenia, confusional state, delirium, disorientation, encephalopathy, hallucination, lethargy, memory impairment, restlessness, sleep disorder and somnolence.
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). Clinical signs and symptoms of CRS may include but are not limited to pyrexia, hypotension, chills, hypoxia, headache, tachycardia and elevated transaminases.
Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). TALVEY therapy should be initiated with step-up phase dosing and pre-treatment medicinal products (corticosteroids, antihistamine, and antipyretics) should be administered prior to each dose of TALVEY during the step-up phase to reduce the risk of CRS.
Patients should be monitored following administration accordingly. 2). Subjects who experienced Grade 3 or higher CRS with any previous T cell redirection therapy were excluded from clinical studies. It cannot be excluded that prior severe CRS with chimeric antigen receptor (CAR) T-cell therapy or other T-cell engagers might impact on the safety of TALVEY.
The potential benefits of treatment should be carefully weighed against the risk of neurologic events, and heightened caution should be exercised when administering TALVEY to these patients. Patients should be counselled to seek medical attention should signs or symptoms of CRS occur.
At the first sign of CRS, patients should be immediately evaluated for hospitalisation and treatment with supportive care, tocilizumab and/or corticosteroids, should be instituted based on severity. The use of myeloid growth factors, particularly granulocyte macrophage-colony stimulating factor (GM-CSF), should be avoided during CRS.
2). 8). 10 ICANS, including fatal reactions, have occurred following treatment with TALVEY. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.
1.
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See Tables 3 and 4 for recommended actions for the management of CRS and ICANS. See Table 6 for recommended dose modifications for other adverse reactions. 4). Other causes of fever, hypoxia, and hypotension should be evaluated and treated.
If CRS is suspected, TALVEY should be withheld until CRS resolves and should be managed according to the recommendations in Table 3. Supportive therapy for CRS should be administered, which may include intensive care for severe or life-threatening CRS.
Laboratory testing should be considered to monitor for disseminated intravascular coagulation (DIC), haematology parameters, as well as pulmonary, cardiac, renal, and hepatic function.
Table 3:
Recommendations for management of CRS CRS Gradea TALVEY actions Tocilizumabb Corticosteroidsc Grade 1 Temperature ≥ 38°Cd Withhold TALVEY until CRS resolves. Administer pre-treatment medicinal product prior to next dose of TALVEY. May be considered.
Not applicable 5 Grade 2 Temperature ≥ 38°Cd with either: Hypotension responsive to fluids and not requiring vasopressors, or Oxygen requirement of low-flow nasal cannulae or blow-by. Withhold TALVEY until CRS resolves. Administer pre-treatment medicinal products prior to next dose of TALVEY.
Monitor patient for 48 hours following the next dose of TALVEY. Instruct patients to remain within proximity of a healthcare facility during monitoring. Administer tocilizumabc 8 mg/kg intravenously over 1 hour (not to exceed 800 mg).
Repeat […]
4 Motor dysfunction includes: dysgraphia, dysphonia, gait disturbance, muscle spasms, muscular weakness and tremor. 5 Sensory neuropathy includes: dysaesthesia, hypoaesthesia, […]
Patients should be monitored for signs and symptoms of neurologic toxicities and treated promptly. Patients should be counselled to seek medical attention should signs or symptoms of neurologic toxicities including ICANS occur. At the first sign of neurologic toxicities including ICANS, the patient should be immediately evaluated and supportive care should be provided based on severity.
Patients who experience Grade 2 or higher ICANS should be instructed to remain within proximity of a healthcare facility and monitored for signs and symptoms for 48 hours following the next dose of TALVEY. 2). There are no data on use of talquetamab in patients with CNS involvement of myeloma or other clinically relevant CNS pathologies as a result of their exclusion from the study due to the potential risk of ICANS.
7). Management of neurologic toxicities At the first sign of neurologic toxicity, including ICANS, neurology evaluation should be considered. Other causes of neurologic symptoms should be ruled out. TALVEY should be withheld until adverse reaction resolves (see Table 4).
Intensive care and supportive therapy should be provided for severe or life-threatening neurologic toxicities. 8). Patients should be monitored for signs and symptoms of oral toxicity. Patients should be counselled to seek medical attention should signs or symptoms of oral toxicity occur, and supportive care should be provided.
Supportive care may include saliva stimulating agents, steroid mouth wash, or consultation with a nutritionist. 2). 8). Weight change should be monitored regularly during therapy. Clinically significant weight loss should be further evaluated.
2). 8). Patients should be monitored for signs and symptoms of infection prior to and during treatment with TALVEY and treated appropriately. Prophylactic antimicrobials should be administered according to local guidelines. TALVEY should not be administered in patients with active serious infection.
2). Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. 8). Immunoglobulin levels should be monitored during treatment […]