TECVAYLI

/ Janssen

Pre-treatment medicinal products should be administered prior to each dose in the step-up dosing schedule.
Recommended dosing schedule
The recommended doses are 1.5 mg/kg by subcutaneous injection (SC) weekly, preceded by step-up doses of 0.06 mg/kg and 0.3 mg/kg. In patients who have a complete response or better for a minimum of 6 months, a reduced dosing frequency of 1.5 mg/kg SC every two weeks may be considered
See prescribing information for full details.

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.

Hypersensitivity to the active substance or to any of the excipients

Cytokine release syndrome (CRS)
Cytokine release syndrome, including life-threatening or fatal reactions, may occur. 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 according to the step-up dosing schedule to reduce risk of CRS. Pre-treatment medicinal products (corticosteroids, antihistamine and antipyretics) should be administered prior to each dose of the teclistamab step-up dosing schedule to reduce risk of CRS.
Neurologic toxicities, including ICANS
Serious, life-threatening or fatal neurologic toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) occurred following treatment.
At the first sign of neurologic toxicity, including ICANS, patients should be immediately evaluated and treated based on severity. Patients who experience Grade 2 or higher ICANS or first occurrence of Grade 3 ICANS with the previous dose of teclistamab should be instructed to remain within proximity of a healthcare facility and monitored for signs and symptoms daily for 48 hours.
Due to the potential for ICANS, patients should be advised not to drive or operate heavy machinery during the step-up dosing schedule and for 48 hours after completing the teclistamab step-up dosing schedule and in the event of new onset of any neurological symptoms.
Infections
Severe, life-threatening, or fatal infections have been reported. Patients should be monitored for signs and symptoms of infection prior to and during treatment. Progressive Multifocal Leukoencephalopathy (PML), which can be fatal, has also been reported. If PML is suspected, treatment should be withheld and appropriate diagnostic testing initiated. If PML is confirmed, teclistamab must be discontinued.
Hepatitis B virus reactivation
Hepatitis B virus reactivation can occur in patients treated with medicinal products directed against B cells, and in some cases, may result in fulminant hepatitis, hepatic failure, and death.
Patients with evidence of positive HBV serology should be monitored for clinical and laboratory signs of HBV reactivation while receiving teclistamab, and for at least six months following the end of treatment.
In patients who develop reactivation of HBV while on teclistamab, treatment should be withheld.
Hypogammaglobulinaemia
Hypogammaglobulinaemia has been reported, immunoglobulin levels should be monitored during treatment.
Vaccines
Immune response to vaccines may be reduced. The safety of immunisation with live viral vaccines during or following treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 4 weeks prior to the start of treatment, during treatment and least 4 weeks after treatment.
Neutropenia
Neutropenia and febrile neutropenia have been reported. Complete blood cell counts should be monitored at baseline and periodically during treatment. Patients with neutropenia should be monitored for signs of infection.
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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%).
See prescribing information for full details.

No interaction studies have been conducted.
The initial release of cytokines associated with the start of treatment may suppress CYP450 enzymes. The highest risk of interaction is expected from the initiation of the teclistamab step-up dosing schedule up to seven days after the first maintenance dose or during a CRS event. During this period, toxicity or plasma concentrations of concomitant medicinal products (e.g., cyclosporine) that are CYP450 substrates with a narrow therapeutic index should be monitored. The dose of the concomitant medicinal product should be adjusted as clinically indicated.

Women of child-bearing potential/Contraception in males and females: Pregnancy status for females of child-bearing potential should be verified prior to starting treatment. Women of child-bearing potential should use effective contraception during treatment and for five months after the final dose.
Pregnancy: There are no available data on the use of teclistamab in pregnant women. Therefore, teclistamab, a humanised IgG4-based antibody, has the potential to be transmitted from the mother to the developing foetus. Teclistamab is not recommended for women who are pregnant. Teclistamab is associated with hypogammaglobulinaemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with teclistamab should be considered.
Lactation: It is not known whether teclistamab is excreted in human or animal milk, affects breast-fed infants or affects milk production. Because of the potential for serious adverse reactions in breast-fed infants from teclistamab, patients should be advised not to breast-feed during treatment with teclistamab and for at least five months after the last dose.
See prescribing information for full details.

Major influence on the ability to drive and use machines has been reported in patients receiving teclistamab, due to the potential for ICANS and associated depressed level of consciousness.