Teclistamab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026🚩 Report this page

Teclistamab

Other Monoclonal Antibodies and Antibody Drug Conjugates

Sold as Tecvayli

GB MHRAEU EMACA Health Canada

Drug class: Other Monoclonal Antibodies and Antibody Drug Conjugates
Availability: See label
Routes: Subcutaneous
Markets covered: 3
Products on record: 7

L01FXOther Monoclonal Antibodies and Antibody Drug Conjugates

Overview

Teclistamab is an active pharmaceutical ingredient in the Other Monoclonal Antibodies and Antibody Drug Conjugates group (L01FX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	4	May 22, 2026
EU European Union	EMA	1	October 8, 2025
CA Canada	Health Canada	2	July 30, 2025

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised May 22, 2026[1]

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.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised October 8, 2025[2]

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.

How to take

CACanada· Health Canada

2 products

2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

TECVAYLIJANSSEN INC

Sources & citations

[1]MHRA (UK) · PLGB002420751 · revised May 22, 2026
[2]European Medicines Agency · EMEA/H/C/005865 · revised October 8, 2025
[3]Health Canada (DPD) · 02539756 · revised July 30, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment with TECVAYLI should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. 4). 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.
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 adverse […]

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]

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.
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 […]

GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]

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).
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.

This is not medical advice. Consult a qualified healthcare professional.

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.
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 […]

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised October 8, 2025[2]

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.
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 […]

EUOfficial regulatory label· Warnings and precautions· revised October 8, 2025[2]

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).
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.

This is not medical advice. Consult a qualified healthcare professional.