Tecvayli Dosage/Direction for Use

Treatment with TECVAYLI should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.
TECVAYLI 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) (see Precautions).
Posology: Pre-treatment medicinal products should be administered prior to each dose of TECVAYLI in the step-up dosing schedule (see as follows).
TECVAYLI step-up dosing schedule should not be administered in patients with active infection (see Table 5 and Precautions).
Recommended dosing schedule: The recommended dosing schedule for TECVAYLI is provided in Table 3. The recommended doses of TECVAYLI 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 Pharmacology: Pharmacodynamics under Actions).
Treatment with TECVAYLI should be initiated according to the step-up dosing schedule in Table 3 to reduce the incidence and severity of cytokine release syndrome. Due to the risk of cytokine release syndrome, patients should be instructed to remain within proximity of a healthcare facility, and monitored for signs and symptoms daily for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule (see Precautions).
Failure to follow the recommended doses or dosing schedule for initiation of therapy, or re-initiation of therapy after dose delays, may result in increased frequency and severity of adverse reactions related to mechanism of action, particularly cytokine release syndrome (see Precautions). (See Table 3.)

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Duration of treatment: Patients should be treated with TECVAYLI until disease progression or unacceptable toxicity.
Pre-treatment medicinal products: The following pre-treatment medicinal products must be administered 1 to 3 hours before each dose of the TECVAYLI step-up dosing schedule (see Table 3) to reduce the risk of cytokine release syndrome (see Precautions and Adverse Reactions): Corticosteroid (oral or intravenous dexamethasone 16 mg); Antihistamine (oral or intravenous diphenhydramine 50 mg, or equivalent); Antipyretics (oral or intravenous acetaminophen 650 to 1000 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 4); or Patients who experienced CRS following the previous dose (Table 5).
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 4 and TECVAYLI resumed according to the dosing schedule (see Table 3). Pre-treatment medicinal products should be administered as indicated in Table 4. Patients should be monitored accordingly (see as previously mentioned). (See Table 4.)

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Dose modifications: Treatment with TECVAYLI should be initiated according to the step-up dosing schedule in Table 3.
Dose reductions of TECVAYLI are not recommended.
Dose delays may be required to manage toxicities related to TECVAYLI (see Precautions). Recommendations on restarting TECVAYLI after a dose delay are provided in Table 4.
Recommended actions after adverse reactions following administration of TECVAYLI are listed in Table 5. (See Table 5.)

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Special populations: Paediatric population: There is no relevant use of TECVAYLI in the paediatric population for the treatment of multiple myeloma.
Elderly (65 years of age and older): No dosage adjustment is necessary (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dosage adjustment is recommended for patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dosage adjustment is recommended for patients with mild hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: TECVAYLI is for subcutaneous injection only.
For instructions on handling of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.