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Tecvayli is a brand name for Teclistamab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TECVAYLI is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three 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 TECVAYLI should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. 4). 3 Posology Pre-treatment medicinal products should be administered prior to each dose of TECVAYLI in the step-up dosing schedule (see below).
4). Recommended dosing schedule The recommended dosing schedule for TECVAYLI is provided in Table 1. 3 mg/kg. 1). Treatment with TECVAYLI should be initiated according to the step-up dosing schedule in Table 1 to reduce the incidence and severity of cytokine release syndrome.
4). 4). 5 mg/kg SC every two weeks a Dose is based on actual body weight and should be administered subcutaneously. b See Table 2 for recommendations on restarting TECVAYLI after dose delays. c Step-up dose 2 may be given between two to seven days after Step-up dose 1.
d First maintenance dose may be given between two to seven days after Step-up dose 2. 5 mg/kg). e Maintain a minimum of five days between weekly maintenance doses. 6). Duration of treatment Patients should be treated with TECVAYLI until disease progression or unacceptable toxicity.
8). Corticosteroid (oral or intravenous dexamethasone 16 mg) Antihistamine (oral or intravenous diphenhydramine 50 mg, or equivalent) Antipyretics (oral or intravenous acetaminophen 650 to 1 000 mg, or equivalent) Administration of pre-treatment medicinal products may also be required prior to administration of subsequent doses of TECVAYLI for the following patients: Patients who repeat doses within the TECVAYLI step-up dosing schedule due to dose delays (Table 2), or Patients who experienced CRS following the previous dose (Table 3).
Prevention of herpes zoster reactivation Prior to starting treatment with TECVAYLI, antiviral prophylaxis should be considered for the prevention of herpes zoster virus reactivation, per local institutional guidelines. Restarting TECVAYLI after dose delay If a dose of TECVAYLI is delayed, therapy should be restarted based on the recommendations listed in Table 2 and TECVAYLI resumed according to the dosing schedule (see Table 1).
Pre-treatment medicinal products should be administered as indicated in Table 2. 2). 06 mg/kg)a. 3 mg/kg)a and continue TECVAYLI step-up dosing schedule. 06 mg/kg)a. 5 mg/kg every two weeks). 3 mg/kg)a. 06 mg/kg)a. a Pre-treatment medicinal products should be administered prior to TECVAYLI dose and patients monitored accordingly.
The most frequent adverse reactions of any grade in patients were hypogammaglobulinaemia (75%), cytokine release syndrome (72%), neutropenia (71%), anaemia (55%), musculoskeletal pain (52%), fatigue (41%), thrombocytopenia (40%), injection site reaction (38%), upper respiratory tract infection (37%), lymphopenia (35%), diarrhoea (28%), pneumonia (28%), nausea (27%), pyrexia (27%), headache (24%), cough (24%), constipation (21%) and pain (21%).
4%). Tabulated list of adverse reactions The safety data of TECVAYLI was evaluated in MajesTEC-1, which included 165 adult patients with multiple myeloma who received the recommended dosing regimen of TECVAYLI as monotherapy. 4) months.
Table 6 summarises adverse reactions reported in patients who received TECVAYLI. The safety data of TECVAYLI was also evaluated in the all treated population (N=302) 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 (≥1/1 000 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.
Note:
The output includes the diagnosis of CRS and ICANS; the symptoms of CRS or ICANS are excluded. 1 Pneumonia includes Enterobacter pneumonia, lower respiratory tract infection, lower respiratory tract infection viral, Metapneumovirus pneumonia, Pneumocystis jirovecii pneumonia, pneumonia, Pneumonia adenoviral, Pneumonia bacterial, Pneumonia klebsiella, Pneumonia moraxella, Pneumonia pneumococcal, Pneumonia pseudomonal, Pneumonia respiratory syncytial viral, Pneumonia staphylococcal and Pneumonia viral.
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. Cytokine release syndrome (CRS) Cytokine release syndrome, including life-threatening or fatal reactions, may occur in patients receiving TECVAYLI.
Clinical signs and symptoms of CRS may include but are not limited to fever, hypoxia, chills, hypotension, tachycardia, headache, and elevated liver enzymes. Potentially life-threatening complications of CRS may include cardiac dysfunction, adult respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).
Treatment should be initiated with TECVAYLI according to the step-up dosing schedule to reduce risk of CRS. 2). The following patients should be instructed to remain within proximity of a healthcare facility and monitored daily for 48 hours: If the patient has received any dose within the TECVAYLI step-up dosing schedule (for CRS).
If the patient has received TECVAYLI after experiencing Grade 2 or higher CRS. Patients who experience CRS following their previous dose should be administered pre-treatment medicinal products prior to the next dose of TECVAYLI. 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. Treatment with supportive care, tocilizumab and/or corticosteroids should be instituted, based on severity as indicated in Table 4 below. The use of myeloid growth factors, particularly granulocyte macrophage-colony stimulating factor (GM-CSF), has the potential to worsen CRS symptoms and should be avoided during CRS.
2). Management of cytokine release syndrome CRS should be identified based on clinical presentation. Patients should be evaluated and treated for other causes of fever, hypoxia, and hypotension. If CRS is suspected, TECVAYLI should be withheld until the adverse reaction resolves (see Table 3).
1.
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Dose modifications Treatment with TECVAYLI should be initiated according to the step-up dosing schedule in Table 1. Dose reductions of TECVAYLI are not recommended. 4). Recommendations on restarting TECVAYLI after a dose delay are provided in Table 2.
Recommended actions after adverse reactions following administration of TECVAYLI are listed in Table 3.
Table 3:
Recommended actions taken after […]
2 Sepsis includes bacteraemia, Meningococcal sepsis, neutropenic sepsis, Pseudomonal bacteraemia, Pseudomonal sepsis, sepsis and Staphylococcal bacteraemia. 3 COVID-19 includes asymptomatic COVID-19 and COVID-19. 4 Upper respiratory tract infection includes bronchitis, nasopharyngitis, pharyngitis, respiratory tract infection, respiratory tract infection bacterial, rhinitis, rhinovirus infection, sinusitis, tracheitis, upper respiratory tract infection and viral upper respiratory tract infection.
5 Urinary tract […]
CRS should be managed according to the recommendations in Table 4. ) should be administered as appropriate. Laboratory testing to monitor for disseminated intravascular coagulation (DIC), haematology parameters, as well as pulmonary, cardiac, renal, and hepatic function should be considered.
Table 4:
Recommendations for management of cytokine release syndrome with tocilizumab and corticosteroids Gradee Presenting symptoms Tocilizumaba Corticosteroidsb Grade 1 Temperature ≥38 °Cc May be considered Not applicable Grade 2 Temperature ≥38 °Cc with either: Hypotension responsive to fluids and not requiring vasopressors, or Oxygen requirement of low-flow nasal cannulad or blow-by Administer tocilizumabb 8 mg/kg intravenously over 1 hour (not to exceed 800 mg).
Repeat tocilizumab every 8 hours as needed, if not responsive to intravenous fluids or increasing supplemental oxygen. Limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses. If no improvement within 24 hours of starting tocilizumab, administer methylprednisolone 1 mg/kg intravenously twice daily, or dexamethasone 10 mg intravenously every 6 hours.
Continue corticosteroid use until the event is Grade 1 or less, then taper over 3 days. 9 Grade 3 Temperature ≥38 °Cc with either: Hypotension requiring one vasopressor with or without vasopressin, or Oxygen requirement of high-flow nasal cannulad, facemask, non-rebreather mask, or Venturi mask Administer tocilizumab 8 mg/kg intravenously over 1 hour (not to exceed 800 mg).
Repeat tocilizumab every 8 hours as needed, if not responsive to intravenous fluids or increasing supplemental oxygen. Limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses. If no improvement, administer methylprednisolone 1 mg/kg intravenously twice daily, or dexamethasone 10 mg intravenously every 6 hours.
Continue corticosteroid use until the event is Grade 1 or less, then taper over 3 days. , continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation, and mechanical ventilation) Administer tocilizumab 8 mg/kg intravenously over 1 hour (not to exceed 800 mg).
Repeat tocilizumab every 8 hours as needed if not responsive to intravenous fluids or increasing supplemental oxygen. Limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses. As above, or administer methylprednisolone 1 000 mg intravenously per day for 3 days, per physician discretion.
If no improvement or if condition worsens, consider alternate immunosuppressants b. a Refer to tocilizumab prescribing information for details. b Treat unresponsive CRS per institutional guidelines. c Attributed to CRS. , tocilizumab or corticosteroids).
d Low-flow nasal cannula is ≤6 L/min, and high-flow nasal cannula is >6 L/min. e Based on ASTCT grading for CRS (Lee et al 2019). Neurologic toxicities, including ICANS Serious, life-threatening or fatal neurologic toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) occurred following treatment with TECVAYLI.
Patients should be monitored for signs or symptoms of neurologic toxicities during treatment and treated […]