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Imdelltra

Imdelltra

Manufacturer:

Amgen

Distributor:

Zuellig
Concise Prescribing Info
Contents
Tarlatamab
Indications/Uses
Extensive-stage small cell lung cancer in adults w/ disease progression on or after at least 2 prior lines of therapy including platinum-based chemotherapy.
Dosage/Direction for Use
Administer as IV infusion over 1 hr at a constant flow rate using an infusion pump. Step-up dosing w/ 1 mg on day 1 of cycle 1 & 10 mg on day 8 of cycle 1, followed by 10 mg on day 15 of cycle 1 & on days 1 & 15 of subsequent cycles.
Contraindications
Hypersensitivity.
Special Precautions
Risk of tumour lysis syndrome (TLS). Monitor for signs or symptoms of TLS, particularly in patients w/ high tumour burden, rapidly proliferating tumors, or reduced renal function. Risk of cytopenias including neutropenia, thrombocytopenia, & anemia. Perform CBCs prior to treatment, before each dose, & as clinically indicated. Closely monitor for signs & symptoms of cytopenias, & temporarily w/hold or permanently discontinue treatment based on severity. Risk of hepatotoxicity. Monitor liver enzymes & bilirubin prior to treatment, before each dose, & as clinically indicated. W/hold or permanently discontinue treatment based on severity of hepatotoxicity. Risk of cytokine release syndrome (CRS). Administer Imdelltra following the recommended step-up dosing & administer pre-treatment medications before & after cycle 1 Imdelltra infusions to reduce risk of CRS. Ensure patients are well hydrated prior to initiating Imdelltra. Closely monitor for signs & symptoms of CRS during treatment, & w/hold or permanently discontinue treatment based on severity. Risk of hypersensitivity reactions. Monitor for signs & symptoms of hypersensitivity during treatment, & w/hold or consider permanent discontinuation of treatment based on severity. Risk of serious infections. Monitor for signs & symptoms of infection prior to & during treatment, & w/hold or permanently discontinue treatment based on severity. Do not administer to patients w/ active infection. Risk of neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Closely monitor for signs & symptoms of neurologic toxicity & ICANS during treatment, & w/hold or permanently discontinue treatment based on severity. Vaccination w/ live & live-attenuated vaccines is not recommended w/in 4 wk of the 1st Imdelltra dose & 42 days following Imdelltra treatment. May have influence on ability to drive or operate machinery. Has not been studied in patients w/ moderate or severe hepatic impairment; severe renal impairment. May cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment & for 2 mth after the last dose. Breastfeeding is not recommended during treatment & for 2 mth after the last dose. Safety & effectiveness in ped patients have not been established.
Adverse Reactions
CRS, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia, nausea.
Drug Interactions
Monitor for known adverse events in patients who are receiving concomitant CYP450 substrates, particularly those w/ narrow therapeutic index.
MIMS Class
Cancer Immunotherapy
ATC Classification
L01FX33 - tarlatamab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
Presentation/Packing
Form
Imdelltra powd for soln for infusion 1 mg
Packing/Price
1's
Form
Imdelltra powd for soln for infusion 10 mg
Packing/Price
1's
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