TALVEY SOLUTION FOR INJECTION 3MG/1.5ML [SIN17141P]

Product Info

TALVEY SOLUTION FOR INJECTION 3MG/1.5ML

[SIN17141P]

Indication

Indications

TALVEY®, as monotherapy, is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.

Dosing

Dosage and Administration

TALVEY® is administered via subcutaneous injection.

Administer pretreatment medications prior to each dose of TALVEY® during the step-up phase (see Dosage and Administration – Pretreatment medications).

Dosage – Adults (≥18 years)

Administer TALVEY® subcutaneously on a weekly or biweekly (every 2 weeks) dosing schedule according to Table 1.

Instruct patients to remain within proximity of a healthcare facility and monitor patients for 48 hours after administration of all doses within the TALVEY® step-up phase for signs and symptoms of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Continue treatment until disease progression or unacceptable toxicity.

Pretreatment medications

Administer the following pretreatment medications 1 to 3 hours before each dose of TALVEY® during the step-up phase to reduce the risk of CRS (see Warnings and Precautions – Cytokine release syndrome – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Corticosteroid (oral or intravenous dexamethasone, 16 mg or equivalent)

• Antihistamine (oral or intravenous diphenhydramine, 50 mg or equivalent)

• Antipyretics (oral or intravenous acetaminophen, 650 mg to 1000 mg or equivalent)

Administration of pretreatment medications may be required for subsequent doses of TALVEY® for patients who repeat doses within the TALVEY® step-up phase due to dose delays (Table 2) or for patients who experience CRS (Table 3).

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, restart therapy based on recommendations in Table 2 and resume weekly or biweekly (every 2 weeks) dosing accordingly (see Dosage and Administration – Dosage – Adults (18 years of age and older)). Administer pretreatment medications prior to restarting TALVEY®, and monitor patients following administration of TALVEY® (see Dosage and Administration – Pretreatment medications).

Dose modifications for adverse reactions

Dose delays may be required to manage toxicities related to TALVEY® (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

See Table 3, Table 4 and Table 5 for recommended actions for the management of CRS, ICANS and neurologic toxicities. See Table 6 for recommended dose modifications for other adverse reactions.

Cytokine release syndrome (CRS)

Identify CRS based on clinical presentation (see Warnings and Precautions – Cytokine release syndrome – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Evaluate and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, withhold TALVEY® until CRS resolves, and manage according to the recommendations in Table 3. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS. Consider laboratory testing to monitor for disseminated intravascular coagulation (DIC), hematology parameters, as well as pulmonary, cardiac, renal, and hepatic function.

Neurologic toxicities, including Immune effector cell-associated neurotoxicity syndrome (ICANS)

At the first sign of neurologic toxicity, including ICANS, withhold TALVEY® and consider neurology evaluation. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care, for severe or life-threatening ICANS (see Warnings and Precautions – ICANS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Management recommendations for ICANS and neurologic toxicity are summarized in Table 4 and Table 5.

Other adverse reactions

The recommended dose modifications for other adverse reactions are provided in Table 6.

Special populations

Pediatrics (17 years of age and younger)

The safety and efficacy of TALVEY® have not been established in pediatric patients.

Elderly (65 years of age and older)

Of the 339 patients treated with TALVEY® in MonumenTAL-1, 36% were 65 to less than 75 years of age, and 17% were 75 years of age or older. No clinically important differences in safety or effectiveness were observed in patients 65 to 75 years of age compared to younger patients. There are limited clinical data with talquetamab in patients 75 years of age or over. No dose adjustment is required (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

No formal studies of TALVEY® in patients with renal impairment have been conducted.

Based on population pharmacokinetic analyses, no dose adjustment is recommended for patients with mild or moderate renal impairment (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No formal studies of TALVEY® in patients with hepatic impairment have been conducted.

Based on population pharmacokinetic analyses, no dose adjustment is recommended for patients with mild hepatic impairment (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Limited or no data are available in patients with moderate and severe hepatic impairment.

Administration

Administer TALVEY® via subcutaneous injection.

TALVEY® should be administered by a healthcare professional with adequate medical equipment and personnel to manage severe reactions, including cytokine release syndrome (see Warnings and Precautions - Cytokine release syndrome – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

TALVEY® 2 mg/mL vial and 40 mg/mL vial are supplied as ready-to-use solution for injection that do not need dilution prior to administration.

Do not combine TALVEY® vials of different concentrations to achieve treatment dose.

Use aseptic technique to prepare and administer TALVEY®.

Preparation of TALVEY®

• Refer to the following reference tables for the preparation of TALVEY®.

○ Use Table 7 to determine total dose, injection volume, and number of vials required based on patient’s actual body weight for the 0.01 mg/kg dose using TALVEY® 2 mg/mL vial.

○ Use Table 8 to determine total dose, injection volume, and number of vials required based on patient’s actual body weight for the 0.06 mg/kg dose using TALVEY® 2 mg/mL vial.

○ Use Table 9 to determine total dose, injection volume, and number of vials required based on patient’s actual body weight for the 0.4 mg/kg dose using TALVEY® 40 mg/mL vial.

○ Use Table 10 to determine total dose, injection volume, and number of vials required based on patient’s actual body weight for the 0.8 mg/kg dose using TALVEY® 40 mg/mL vial.

• Check that the TALVEY® solution for injection is colorless to light yellow. Do not use if the solution is discolored, cloudy, or if foreign particles are present.

• Remove the appropriate strength TALVEY® vial(s) from refrigerated storage [2°C to 8°C (36°F to 46°F)] and equilibrate to ambient temperature [15°C to 30°C (59°F to 86°F)] for at least 15 minutes. Do not warm TALVEY® in any other way.

• Once equilibrated, gently swirl the vial for approximately 10 seconds to mix. Do not shake.

• Withdraw the required injection volume of TALVEY® from the vial(s) into an appropriately sized syringe using a transfer needle.

○ Each injection volume should not exceed 2.0 mL. Divide doses requiring greater than 2.0 mL equally into multiple syringes.

• TALVEY® is compatible with stainless steel injection needles and polypropylene or polycarbonate syringe material.

• Replace the transfer needle with an appropriately sized needle for injection.

Administration of TALVEY®

• Inject the required volume of TALVEY® 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.

• Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.

• Any unused medicinal product or waste material should be disposed in accordance with local requirements.

Contraindications

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.