Tecvayli (Teclistamab) Administration and Patient Education

Administration Protocol

Teclistamab is administered as a subcutaneous injection following a mandatory step-up dosing schedule to mitigate cytokine release syndrome (CRS), with weekly maintenance dosing that can be safely delivered in an outpatient setting. 1

Step-Up Dosing Schedule

First dose: 0.06 mg/kg subcutaneously 1
Second dose: 0.3 mg/kg subcutaneously, given 2-4 days after the first step-up dose 1
Maintenance dose: 1.5 mg/kg subcutaneously once weekly, starting 2-4 days after the second step-up dose 1
Continue weekly dosing until disease progression or unacceptable toxicity 1

Outpatient Administration Feasibility

Step-up dosing can be safely administered in the outpatient setting in appropriately selected patients 2
Most doses (60%) during step-up require <1 hour of clinic time between administration and checkout 2
Post-step-up maintenance doses require <30 minutes of clinic time for 82% of administrations 2
All patients must receive premedications on the days of teclistamab administration per label recommendations 2

Common Pitfall

Do not attempt to administer teclistamab to patients with active infections—all infections must be resolved before initiating therapy 3

Critical Patient Education Points

Pre-Treatment Requirements

Patients must complete all vaccinations (including COVID-19) and undergo infectious disease screening before starting teclistamab. 3

Mandatory screening: Hepatitis B, hepatitis C, and HIV testing 3
Vaccination status: Ensure up-to-date immunizations, particularly COVID-19 vaccines 3
Active infection exclusion: No teclistamab administration if any active infection is present 3

Expected Side Effects and Monitoring

Cytokine Release Syndrome (CRS)

Occurs in 72% of patients, predominantly grade 1-2 (only 0.6% grade 3; no grade 4 events) 1
Most common during step-up dosing, with median onset at 1.7 months 3
Symptoms to report immediately: Fever ≥39°C, persistent fever >3 days, low blood pressure, difficulty breathing 1
Management: Most cases resolve with supportive care; 18 patients (31.6%) required hospitalization with median 2-day stays 2

Neurotoxicity

Occurs in 14.5% of patients, including immune effector cell-associated neurotoxicity syndrome (ICANS) in 3% 1
All neurotoxicity events were grade 1-2 in the pivotal trial 1
Symptoms to report: Confusion, difficulty speaking, tremors, seizures, altered consciousness 1

Infections (Most Critical Long-Term Risk)

Infections occur in 78.8% of patients, with grade 3-4 infections in 55.2% 1
COVID-19 is the leading cause of infection-related deaths (21 total deaths from infections, 18 from COVID-19) 3
Median time to first infection: 1.7 months for any grade; 4.2 months for grade 3-5 3
Common infection types: Respiratory infections (19.4%), COVID-19 (21.2%), Pneumocystis jirovecii pneumonia (4.2%), viral infections (4.2%) 3

Blood Count Abnormalities

Neutropenia: 71.5% any grade; 65.5% grade 3-4 1
Anemia: 55.2% any grade; 37.6% grade 3-4 1
Thrombocytopenia: 41.8% any grade; 23% grade 3-4 1
Median time to grade ≥3 neutropenia: 2.3 months 3

Mandatory Prophylaxis and Monitoring

Antimicrobial Prophylaxis

Pneumocystis jirovecii pneumonia prophylaxis: Required throughout treatment 3
Herpes simplex/varicella zoster virus prophylaxis: Required throughout treatment 3
Additional antimicrobials: Per institutional guidelines based on local resistance patterns 3

Immunoglobulin Monitoring and Replacement

70.9% of patients develop IgG <400 mg/dL, with median time to low IgG of 1.2 months 3
Monitor IgG levels closely throughout treatment 3
IgG replacement therapy: Administer every 3-6 weeks to maintain IgG ≥400 mg/dL 3
46.1% of patients required ≥1 dose of IgG replacement in clinical trials 3

Growth Factor Support

Consider growth factors for:
- Grade ≥3 neutropenia with infection or fever 3
- Grade 4 neutropenia 3

Ongoing Surveillance Requirements

Frequent Monitoring Schedule

Close monitoring for infections must continue throughout the entire treatment duration 3
Regular blood count monitoring to detect cytopenias early 1
Serial IgG level checks to guide replacement therapy 3
Vigilance for CRS symptoms, particularly during the first 4 months 3

Duration of Treatment

Weekly dosing continues indefinitely until disease progression or unacceptable toxicity 1
Fixed-duration strategies (discontinuation after deep response) are investigational and should only be considered in highly selected patients with ≥VGPR, recognizing potential for earlier progression 4

Special Populations

Renal Impairment

Teclistamab can be administered to patients with severe renal impairment, including those on dialysis, without dose modifications 1

Risk Evaluation and Mitigation Strategy (REMS)

Teclistamab is available only through a restricted REMS program due to risks of CRS and neurotoxicity 5
Prescribers and healthcare facilities must be certified in the REMS program 5

Key Patient Counseling Messages

Educate patients to immediately report:

Fever, chills, or signs of infection 3
Confusion, difficulty speaking, or neurologic changes 1
Unusual bleeding or bruising 1
Severe fatigue or shortness of breath 1

Emphasize the importance of:

Strict adherence to prophylactic antimicrobials 3
Keeping all scheduled monitoring appointments 3
Avoiding exposure to sick contacts, particularly those with COVID-19 3
Reporting any new symptoms promptly rather than waiting for scheduled visits 3

How is Tecvayli (teclistamab) administered to patients and what education should be provided to them?

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