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IMDELLTRA is a brand name for Tarlatamab, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
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…
Verbatim from this product's HC label. Tap a section to expand.
and 7 WARNINGS AND PRECAUTIONS, Immune, Cytokine Release Syndrome). • 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. The onset of ICANS may be concurrent with CRS, following the resolution of CRS, or in the absence of CRS. Withhold Imdelltra until the neurologic toxicity resolves or permanently discontinue based on severity (see 4 DOSAGE AND ADMINISTRATION and 7 WARNINGS AND PRECAUTIONS, Neurologic, Immune Effector Cell-Associated Neurotoxicity Syndrome).
2 Recommended Dose and Dosage Adjustment). 4 Administration). 2Recommended Dose and Dosage Adjustment and 7 WARNINGS AND PRECAUTIONS, Immune). 2 Recommended Dose and Dosage Adjustment). • Ensure patients are well hydrated prior to administration of Imdelltra (see 7 WARNINGS AND PRECAUTIONS, Immune).
2 Recommended Dose and Dosage Adjustment for recommended actions based on laboratory results). • Imdelltra should not be administered to patients with active infection. 2 Recommended Dose and Dosage Adjustment Recommended Dose The recommended dosage and schedule of Imdelltra is provided in IMDELLTRA (tarlatamab) Page 6 of 40 Table 1.
Administer following step-up dosing to reduce the incidence and severity of CRS. Treat patients until disease progression or unacceptable toxicity. IMDELLTRA (tarlatamab) Page 7 of 40 Table 1. Recommended Dosage Schedule of Imdelltra Dosing Schedule Day Dose of Imdelltra Recommended Monitoring Step-up Dosing Schedule Cycle 1 Day 1a 1 mga Monitor patients from the start of the Imdelltra infusion for 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the infusion with Imdelltra, accompanied by a caregiver. Day 8a 10 mga Day 15 10 mg Observe patients for 6-8 hours post Imdelltra infusionb.
Cycle 2 Day 1 and 15 10 mg Observe patients for 6-8 hours post Imdelltra infusionb. Cycles 3 and 4 Day 1 and 15 10 mg Observe patients for 3-4 hours post Imdelltra infusion b. Cycle 5 and subsequent infusions Day 1 and 15 10 mg Observe patients for 2 hours post Imdelltra infusion b.
) Grade 3 or 4 Withhold Imdelltra until recovery to ≤ Grade 1 or baseline. Consider permanently discontinuing if adverse reaction does not resolve within 28 days. Consider permanent discontinuation for Grade 4 events. a Refer to Table 2 for dose restarting guidance.
0. 1 Pediatrics). Geriatrics (≥ 65 years of age) No dose adjustment is required for geriatric patients. 3 Pharmacokinetics). Imdelltra has not been studied in patients with moderate or severe hepatic impairment. 3 Pharmacokinetics). Imdelltra has not been studied in patients with severe impairment.
3 Reconstitution Aseptic preparation Strictly observe aseptic technique when preparing the solution for infusion since Imdelltra vials do not contain antimicrobial preservatives. Material Compatibility Information • IV bags composed of ethyl vinyl acetate (EVA), polyolefin, and polyvinyl chloride (PVC) have been shown to be compatible with tarlatamab at the specified administration conditions.
• IV line and catheter materials composed of polyolefin, PVC, and polyurethane have been shown to be compatible with tarlatamab at the specified administration conditions. IMDELLTRA (tarlatamab) Page 14 of 40 • The use of Closed System Transfer Device (CSTD) is not recommended due to potential risk for medication error.
Amgen has not performed compatibility testing of vial adaptor CSTDs with Imdelltra.
Step 1:
Reconstitute Imdelltra with Sterile Water for Injection • Do NOT use IV Solution Stabilizer (IVSS) for reconstitution of Imdelltra. The IV Solution Stabilizer is used to coat the intravenous bag prior to addition of reconstituted Imdelltra to prevent adsorption of Imdelltra to IV bags and IV tubing.
• NOTE: the final concentrations for the different strength vials are NOT the same following reconstitution. Table 6. 4 * Vial contains overfill to ensure delivery at the stated concentration of labeled vial strength. 4 mg/mL (10 mg vial).
, Immune, Cytokine Release Syndrome). • 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.
The onset of ICANS may be concurrent with CRS, following the resolution of CRS, or in the absence of CRS. Withhold Imdelltra until the neurologic toxicity resolves or permanently discontinue based on severity (see 4 DOSAGE AND ADMINISTRATION and 7 WARNINGS AND PRECAUTIONS, Neurologic, Immune Effector Cell-Associated Neurotoxicity Syndrome).
2 Recommended Dose and Dosage Adjustment). 4 Administration). 2Recommended Dose and Dosage Adjustment and 7 WARNINGS AND PRECAUTIONS, Immune). 2 Recommended Dose and Dosage Adjustment). • Ensure patients are well hydrated prior to administration of Imdelltra (see 7 WARNINGS AND PRECAUTIONS, Immune).
2 Recommended Dose and Dosage Adjustment for recommended actions based on laboratory results). • Imdelltra should not be administered to patients with active infection. 2 Recommended Dose and Dosage Adjustment Recommended Dose The recommended dosage and schedule of Imdelltra is provided in IMDELLTRA (tarlatamab) Page 6 of 40 Table 1.
Administer following step-up dosing to reduce the incidence and severity of CRS. Treat patients until disease progression or unacceptable toxicity. IMDELLTRA (tarlatamab) Page 7 of 40 Table 1. Recommended Dosage Schedule of Imdelltra Dosing Schedule Day Dose of Imdelltra Recommended Monitoring Step-up Dosing Schedule Cycle 1 Day 1a 1 mga Monitor patients from the start of the Imdelltra infusion for 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the infusion with Imdelltra, accompanied by a caregiver. Day 8a 10 mga Day 15 10 mg Observe patients for 6-8 hours post Imdelltra infusionb.
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. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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a Administer recommended concomitant medications before and after Cycle 1 Imdelltra infusions as described in Table 8. b Extended monitoring in a healthcare setting is not required unless the patient experiences Grade ≥ 2 CRS, ICANS or neurological toxicity during prior treatments.
See Table 3 and Table 4 for monitoring recommendations. Note: see Table 2 for recommendation on restarting Imdelltra after dose delays. Restarting Imdelltra After Dosage Delay If a dose of Imdelltra is delayed, restart therapy based on the recommendations as listed in Table 2 and resume the dosing schedule accordingly.
4 Administration). IMDELLTRA (tarlatamab) Page 8 of 40 Table 2. Recommendations for Restarting Therapy with Imdelltra After Dosage Delay Last Dose Administered Time Since the Last Dose Administered Action a, b 1 mg on Cycle 1 Day 1 2 weeks or less (≤ 14 days) Administer Imdelltra 10 mg, then resume with the planned dosage schedule.
Greater than 2 weeks (> 14 days) Administer Imdelltra step-up dose 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosage schedule. 10 mg on Cycle 1 Day 8 3 weeks or less (≤ 21 days) Administer Imdelltra 10 mg, then resume with the planned dosage schedule.
Greater than 3 weeks (> 21 days) Administer Imdelltra step-up dose 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosage schedule. 10 mg on Cycle 1 Day 15 and subsequent Cycles every 2 weeks thereafter 4 weeks or less (≤ 28 days) Administer Imdelltra 10 mg, then resume with the planned dosage schedule.
Greater than 4 weeks (> 28 days) Administer Imdelltra step-up dose 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosage schedule. a Administer recommended concomitant medications as described in Table 8.
b Refer to Table 1 for recommended monitoring. Recommended Dose Modifications No dosage reduction for Imdelltra is recommended. See Table 3 and Error! Reference source not found. for recommended actions for the management of CRS and neurologic toxicity including ICANS, and Table 5 for cytopenias, infections and other adverse reactions.
Management of Cytokine Release Syndrome (CRS) Diagnose CRS based on clinical presentation (see 7 WARNINGS […]
Direct Sterile Water for Injection along the walls of the Imdelltra vial and NOT directly on the lyophilized powder. Do NOT use IV Solution Stabilizer to reconstitute Imdelltra. • Gently swirl contents. Do NOT shake. • Inspect that the solution is clear to slightly opalescent, colourless to slightly yellow.
Do NOT use if solution is cloudy or has particulates. Sterile Water Onc Drug Onc Drug IMDELLTRA (tarlatamab) Page 15 of 40 Preparation of Imdelltra Table 7. 2 a Vial contains overfill to ensure delivery at the stated concentration of labeled vial strength.
NOTE: the final concentrations for the different strength vials are NOT the same following reconstitution. 9% Sodium Chloride bag. Refer to Table 7. Disregard any overfill in the IV bag. 9% Sodium Chloride for Injection. • Gently mix the contents of the bag to avoid foaming.
Do NOT shake. 9% Sodium Chloride for Injection and IVSS. Refer to Table 7. • Gently mix the contents of the bag to avoid foaming. Do NOT shake.
Step 5:
Remove air from the IV bag Remove air from the IV bag using an empty syringe to avoid foaming. 9% Sodium Chloride for Injection OR final prepared product. 4 Administration • Imdelltra should be administered by a healthcare professional with access to appropriate medical support to manage severe reactions, including CRS and neurologic toxicity, including ICANS (see 7 WARNINGS AND PRECAUTIONS).
• Administer recommended concomitant medications for Imdelltra administration during Cycle 1 as presented in Table 8 to reduce the risk of cytokine release syndrome. Table 8. Recommended Concomitant Medications for Imdelltra Administration for Cycle 1 Treatment Day Medication Administration Day 1 and Day 8 Administer 8 mg of dexamethasone intravenously (or equivalent) Within 1-hour prior to Imdelltra administration Day 1, Day 8 and Day 15 Administer 1 liter of normal saline intravenously over 4-5 hours Immediately after completion of Imdelltra infusion • The intravenous (IV) catheter for premedication can […]
Cycle 2 Day 1 and 15 10 mg Observe patients for 6-8 hours post Imdelltra infusionb. Cycles 3 and 4 Day 1 and 15 10 mg Observe patients for 3-4 hours post Imdelltra infusion b. Cycle 5 and subsequent infusions Day 1 and 15 10 mg Observe patients for 2 hours post Imdelltra infusion b.
a Administer recommended concomitant medications before and after Cycle 1 Imdelltra infusions as described in Table 8. b Extended monitoring in a healthcare setting is not required unless the patient experiences Grade ≥ 2 CRS, ICANS or neurological toxicity during prior treatments.
See Table 3 and Table 4 for monitoring recommendations. Note: see Table 2 for recommendation on restarting Imdelltra after dose delays. Restarting Imdelltra After Dosage Delay If a dose of Imdelltra is delayed, restart therapy based on the recommendations as listed in Table 2 and resume the dosing schedule accordingly.
4 Administration). IMDELLTRA (tarlatamab) Page 8 of 40 Table 2. Recommendations for Restarting Therapy with Imdelltra After Dosage Delay Last Dose Administered Time Since the Last Dose Administered Action a, b 1 mg on Cycle 1 Day 1 2 weeks or less (≤ 14 days) Administer Imdelltra 10 mg, then resume with the planned dosage schedule.
Greater than 2 weeks (> 14 days) Administer Imdelltra step-up dose 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosage schedule. 10 mg on Cycle 1 Day 8 3 weeks or less (≤ 21 days) Administer Imdelltra 10 mg, then resume with the planned dosage schedule.
Greater than 3 weeks (> 21 days) Administer Imdelltra step-up dose 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosage schedule. 10 mg on Cycle 1 Day 15 and subsequent Cycles every 2 weeks thereafter 4 weeks or less (≤ 28 days) Administer Imdelltra 10 mg, then resume with the planned dosage schedule.
Greater than 4 weeks (> 28 days) Administer Imdelltra step-up dose 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosage schedule. a Administer recommended concomitant medications as described in Table 8.
b Refer to Table 1 for recommended monitoring. Recommended Dose Modifications No dosage reduction for Imdelltra is recommended. See Table 3 and Error! Reference source not found. for recommended actions for the management of CRS and neurologic toxicity including ICANS, and Table 5 for cytopenias, infections and other adverse reactions.
Management of Cytokine Release Syndrome (CRS) Diagnose CRS based on clinical presentation (see 7 WARNINGS AND PRECAUTIONS, Immune, […]