Talvey

Monotherapy for relapsed & refractory multiple myeloma in adults who have received at least 3 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, & an anti-CD38 Ab, & have demonstrated disease progression on the last therapy.

SC Wkly dosing: Step-up phase w/ 0.01 mg/kg on day 1, 0.06 mg/kg on day 3, & 0.4 mg/kg on day 5, followed by treatment phase w/ 0.4 mg/kg once a wk thereafter. Biweekly dosing: Step-up phase w/ 0.01 mg/kg on day 1, 0.06 mg/kg on day 3, 0.4 mg/kg on day 5, & 0.8 mg/kg on day 7, followed by treatment phase w/ 0.8 mg/kg once every 2 wk thereafter.

Hypersensitivity.

Inj should be at least 2 cm apart if multiple inj are required. Must not be injected into tattoos or scars or areas where skin is red, bruised, tender, hard or not intact. Risk of cytokine release syndrome (CRS); neurologic toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS); oral toxicities, including dysgeusia, dry mouth, dysphagia, & stomatitis; serious infections; hypogammaglobulinaemia; treatment-emergent grade 3 or 4 neutropenia, febrile neutropenia & thrombocytopenia; skin reactions including rash, maculo-papular rash, erythema, erythematous rash, as well as nail disorders. Initiate therapy w/ step-up phase dosing & administer pre-treatment medicinal products (corticosteroids, antihistamine, & antipyretics) 1-3 hr prior to each Talvey dose during step-up phase to reduce risk of CRS. Carefully weigh potential benefits of treatment against risk of neurologic events, & exercise heightened caution when administering to patients who experienced grade ≥3 CRS w/ any previous T-cell redirection therapy. Patients who experience grade ≥2 ICANS should remain w/in proximity of a healthcare facility & monitored for signs & symptoms for 48 hr following the next dose. No data in patients w/ CNS involvement of myeloma or other clinically relevant CNS pathologies. Regularly monitor wt change during therapy. Monitor for signs & symptoms of infection prior to & during treatment. Do not administer in patients w/ active serious infection. Monitor Ig levels during treatment. Monitor CBC at baseline & periodically during treatment. Immune response to vaccines may be reduced when taking Talvey. Vaccination w/ live virus vaccines is not recommended for at least 4 wk prior to start of treatment, during treatment, & at least 4 wk after treatment. Major influence on the ability to drive & use machines. Due to the potential for ICANS, patients should avoid driving or operating machines during step-up phase & for 48 hr after completion of step-up phase, & in the event of any new-onset neurological symptoms. Limited or no data available in patients w/ moderate & severe hepatic impairment. Not recommended for pregnant women or for women of childbearing potential not using contraception. Females of reproductive potential should use effective contraception during treatment & for 3 mth after the last dose. Do not breast-feed during treatment & for at least 3 mth after the last dose. No relevant use in the paed population.

CRS, dysgeusia, hypogammaglobulinaemia, nail disorder, musculoskeletal pain, anaemia, skin disorder, fatigue, decreased wt, rash, dry mouth, neutropenia, pyrexia, xerosis, thrombocytopenia, URTI, lymphopenia, dysphagia, diarrhoea, pruritus, cough, pain, decreased appetite, headache.

Potential increase in exposure of CYP substrates.

Cancer Immunotherapy

L01FX29 - talquetamab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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