IMDELLTRA 1 MG

What is IMDELLTRA?

IMDELLTRA 1 MG contains TARLATAMAB 1 MG. It is listed in the Health Canada Drug Product Database under DIN 02551551, held by AMGEN CANADA INC, supplied as Powder For Solution for Intravenous administration. Health Canada currently lists it as marketed, status dated 28-Nov-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is IMDELLTRA used for?

IMDELLTRA™ (tarlatamab for injection) is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy including platinum-based chemotherapy. This indication is issued market authorization with conditions based on objective response rate (ORR) and duration of response (DOR). An improvement in survival has not yet been established.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Administer Imdelltra according to the step-up dosing schedule to reduce the incidence and severity of cytokine release syndrome (CRS). Administer concomitant medication as recommended to reduce the risk of CRS reactions. Imdelltra should only be administered by a healthcare professional with appropriate medical support to manage CRS and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS). Monitor patients for 24 hours from the start of Imdelltra infusion on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting. Recommend patients to remain within 1 hour of an appropriate healthcare setting for 48 hours from the start of the Imdelltra infusion following Cycle 1 Day 1 and Cycle 1 Day 8 doses accompanied by a caregiver. Ensure patients are well hydrated prior to administration of Imdelltra. Prior to administration of Imdelltra evaluate complete blood count, liver enzymes and bilirubin before each dose, and as clinically indicated. Imdelltra should not be administered to patients with active infection. The recommended dosage and schedule of Imdelltra is: Day 1: 1 mg, Day 8: 10 mg, Day 15: 10 mg, and then 10 mg every 2 weeks thereafter. Treat patients until disease progression or unacceptable toxicity. If a dose is delayed, restart therapy based on recommendations for dosage delay. No dosage reduction for Imdelltra is recommended.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store Imdelltra and IV Solution Stabilizer vials in the original package refrigerated at 2°C to 8°C and protect from light until time of use. Do NOT freeze. Store lyophilized Imdelltra and IV Solution Stabilizer (IVSS) vials for a maximum of 24 hours at room temperature in the original carton to protect from light. Prepared Imdelltra solution in the IV bag can be stored refrigerated (2°C to 8°C) for up to 7 days, or at room temperature (20°C to 25°C) for up to 8 hours. Keep out of reach and sight of children.

How is it supplied?

1 mg package includes 1 vial of 1 mg Imdelltra and 2 vials of 7 mL IV Solution Stabilizer. 10 mg package contains 1 vial of 10 mg Imdelltra and 2 vials of 7 mL IV Solution Stabilizer.

Contraindications

Imdelltra is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Warnings and precautions

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, can occur in patients receiving Imdelltra. Initiate treatment with Imdelltra using the step-up dosing schedule to reduce the incidence and severity of CRS. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be serious or life-threatening, can occur in patients receiving Imdelltra. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold Imdelltra until CRS or neurologic toxicity resolves or permanently discontinue based on severity. Imdelltra may have an influence on the ability to drive or operate machinery. Patients experiencing symptoms that might affect their ability to drive or use machines (e.g., symptoms of ICANS, such as seizures, depressed level of consciousness) should be advised not to drive or use machines in the event of any symptoms until resolved. Tumour Lysis Syndrome (TLS) has been reported. Monitoring for signs or symptoms of TLS is particularly important for patients with a high tumor burden, rapidly proliferating tumors, or reduced renal function. Patients at increased risk for TLS are advised to receive adequate hydration and prophylactic treatment with a uric acid-lowering agent. Regular monitoring of blood chemistries is recommended. Imdelltra can cause cytopenias including neutropenia, thrombocytopenia, and anemia. Patients should be closely monitored for signs and symptoms of cytopenias. Imdelltra can cause hepatotoxicity. Monitor liver enzymes and bilirubin prior to treatment with Imdelltra, before each dose, and as clinically indicated. Imdelltra can cause serious infections including life-threatening and fatal infections. Monitor patients for signs and symptoms of infection prior to and during treatment with Imdelltra and treat as clinically indicated. Hypersensitivity reactions, including severe reactions, have been reported. Monitor patients for signs and symptoms of hypersensitivity during treatment with Imdelltra and manage as clinically indicated.

What can be used instead?

Other Canadian products sharing ATC code L01FX33 TARLATAMAB. 2 of 2 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.