Talvey Dosage/Direction for Use

Treatment with TALVEY should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.
TALVEY 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) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).
Posology: Pre-treatment medicinal products should be administered prior to each dose of TALVEY during the step-up phase (see as follows).
TALVEY should be administered subcutaneously on a weekly or biweekly (every 2 weeks) dosing schedule according to Table 6. Patients who receive talquetamab according to the 0.4 mg/kg body weight weekly dosing schedule and have attained an adequate clinical response that is confirmed in at least two consecutive disease assessments can be considered for switch to the 0.8 mg/kg body weight biweekly dosing schedule. (See Table 6.)

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Patients should be instructed to remain within proximity of a healthcare facility and monitored for 48 hours after administration of all doses within the TALVEY step-up phase for signs and symptoms of CRS and ICANS (see Precautions).
Duration of treatment: Patients should be treated with TALVEY until disease progression or unacceptable toxicity.
Pre-treatment: The following pre-treatment medicinal products must be administered 1 to 3 hours before each dose of TALVEY during the step-up phase to reduce the risk of CRS (see Precautions): Corticosteroid (oral or intravenous dexamethasone 16 mg or equivalent); Antihistamine (oral or intravenous diphenhydramine 50 mg or equivalent); Antipyretics (oral or intravenous paracetamol 650 mg to 1 000 mg or equivalent).
Pre-treatment medicinal products should be administered prior to subsequent doses for patients who repeat doses within the TALVEY step-up phase due to dose delays (see Table 7) or for patients who experienced CRS (see Table 8).
Prevention of infection: Prior to starting treatment with TALVEY, prophylaxis should be considered for the prevention of infections, per local institutional guidelines.
Dose delays: If a dose of TALVEY is delayed, therapy should be restarted based on recommendations in Table 7, and weekly or biweekly dosing should be resumed accordingly (see Posology as previously mentioned). Pre-treatment medicinal products should be administered prior to restarting TALVEY, and patients should be monitored accordingly. (See Table 7.)

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Dose modifications for adverse reactions: Dose delays may be required to manage toxicities related to TALVEY (see Precautions). See Table 7 for recommendations on restarting TALVEY after a dose delay.
See Tables 8 and 9 for recommended actions for the management of CRS and ICANS. See Table 11 for recommended dose modifications for other adverse reactions.
Cytokine release syndrome (CRS): CRS should be identified based on clinical presentation (see Precautions). Other causes of fever, hypoxia, and hypotension should be evaluated and treated If CRS is suspected, TALVEY should be withheld until CRS resolves and should be managed according to the recommendations in Table 8. Supportive therapy for CRS should be administered, which may include intensive care for severe or life-threatening CRS. Laboratory testing should be considered to monitor for disseminated intravascular coagulation (DIC), haematology parameters, as well as pulmonary, cardiac, renal, and hepatic function. (See Table 8.)

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Neurologic toxicity, including ICANS: At the first sign of neurologic toxicity, including ICANS, TALVEY should be withheld and neurology evaluation should be considered. Other causes of neurologic symptoms should be ruled out.
Supportive therapy should be provided, which may include intensive care, for severe or life-threatening ICANS (see Precautions). Management recommendations for ICANS are summarised in Table 9. (See Tables 9 and 10.)

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Other adverse reactions: The recommended dose modifications for other adverse reactions are provided in Table 11. (See Table 11.)

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Special populations: Paediatric population: There is no relevant use of TALVEY in the paediatric population in the treatment of multiple myeloma.
Elderly: No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is recommended for patients with mild hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). Limited or no data are available in patients with moderate and severe hepatic impairment.
Method of administration: TALVEY is for subcutaneous use.
The required volume of TALVEY should be injected into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, TALVEY may be injected into the subcutaneous tissue at other sites (e.g., thigh). If multiple injections are required, TALVEY injections should be at least 2 cm apart.
TALVEY must not be injected into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.
For instructions on handling of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.