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ZEPZELCA is a brand name for Lurbinectedin, supplied as a powder. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ). 4.3 Reconstitution Parenteral Products: • ZEPZELCA is a cytotoxic drug. Follow applicable special handling and disposal procedures. • Prepare the solution for infusion using aseptic technique as follows: • Inject 8 mL of Sterile Water for Injection USP into the vial. Shake the vial until complete dissolution. The…
Verbatim from this product's HC label. Tap a section to expand.
sections below). The following are clinically significant adverse events: • Myelosuppression, including fatal cases (see 7 WARNINGS AND PRECAUTIONS – Hematologic). • Embryofetal toxicity (see 7 WARNINGS AND PRECAUTIONS and Non-clinical toxicology).
• Injection site reactions (see 7 WARNINGS AND PRECAUTIONS - Injection Site Reactions section below). 5 x 109/L). • Platelet count is at least 100,000/mm3 (100 x 109/L). • Hemoglobin count is at least 90 g/L upon initiation of treatment or at least 80 g/L for subsequent treatment cycles.
If clinically indicated, patients may receive red blood cell (RBC) transfusions to increase or maintain adequate hemoglobin levels. • Albumin levels are at least 30 g/L. e. dexamethasone 8 mg intravenously or equivalent). e. ondansetron 8 mg intravenously or equivalent).
2 mg/m2 by intravenous infusion over 1 hour repeated every 21 days until disease progression or unacceptable toxicity. Dose adjustments for adverse reactions The recommended dose reduction schedule for adverse reactions is presented in Table 1, and the recommended dose modifications criteria for adverse reactions are presented in Table 2.
Table 1. ZEPZELCA Dose Reduction Schedule due to adverse reactions Recommended Starting Dose 1st Dose Reduction 2nd Dose Reduction 3rd Dose Reduction A) Recommended dose reduction schedule when no strong or moderate CYP3A inhibitor is coadministered.
0 mg/m2 every 21 days Stop Permanently discontinue ZEPZELCA in patients who are unable to tolerate the 2nd dose reduction or require a dose interruption greater than two weeks, due to an adverse reaction. NOC/c ZEPZELCA (lurbinectedin) Page 7 of 35 Table 2.
5 x 109/L)) or with any value less than the lower limit of normal that is associated with infection/sepsis may receive Granulocyte Colony- Stimulating Factor (G-CSF) rather than undergo a dose reduction. ZEPZELCA (lurbinectedin) Page 8 of 35 Dose adjustments for drug interactions Avoid coadministration of ZEPZELCA with strong or moderate CYP3A inhibitors.
If coadministration of ZEPZELCA with a strong or moderate CYP3A inhibitor cannot be avoided, reduce the dose of ZEPZELCA by 50%. Because the magnitude of the interaction may vary depending on the inhibitor potency and dosing regimen, this reduction may not be sufficient in all cases.
– Special Populations). 2 Contraindications • ZEPZELCA is contraindicated in patients who are hypersensitive to this drug or to any drug 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. 3 Serious Warnings and Precautions Box ZEPZELCA should be administered under the supervision of a physician who is experienced in the use of cancer chemotherapeutics.
Consider use of a central venous catheter to reduce the risk of extravasation with ZEPZELCA (see 7 WARNINGS AND PRECAUTIONS - Injection Site Reactions and 4 DOSAGE AND ADMINISTRATION sections below). The following are clinically significant adverse events: • Myelosuppression, including fatal cases (see 7 WARNINGS AND PRECAUTIONS – Hematologic).
• Embryofetal toxicity (see 7 WARNINGS AND PRECAUTIONS and Non-clinical toxicology). • Injection site reactions (see 7 WARNINGS AND PRECAUTIONS - Injection Site Reactions section below). 5 x 109/L). • Platelet count is at least 100,000/mm3 (100 x 109/L).
• Hemoglobin count is at least 90 g/L upon initiation of treatment or at least 80 g/L for subsequent treatment cycles. If clinically indicated, patients may receive red blood cell (RBC) transfusions to increase or maintain adequate hemoglobin levels.
• Albumin levels are at least 30 g/L. e. dexamethasone 8 mg intravenously or equivalent). e. ondansetron 8 mg intravenously or equivalent). 2 mg/m2 by intravenous infusion over 1 hour repeated every 21 days until disease progression or unacceptable toxicity.
Dose adjustments for adverse reactions The recommended dose reduction schedule for adverse reactions is presented in Table 1, and the recommended dose modifications criteria for adverse reactions are presented in Table 2. Table 1. ZEPZELCA Dose Reduction Schedule due to adverse reactions Recommended Starting Dose 1st Dose Reduction 2nd Dose Reduction 3rd Dose Reduction A) Recommended dose reduction schedule when no strong or moderate CYP3A inhibitor is coadministered.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Therefore, monitor patients closely for toxicity and adjust the dose further as needed based on tolerability (see Table 1 (row B), Table 2, and Table 7, 9 DRUG INTERACTIONS). After the moderate or strong CYP3A inhibitor has been discontinued for at least 5 half-lives, resume ZEPZELCA at the dose used prior to initiating the inhibitor.
No clinical data are available in patients who require concomitant treatment with moderate or strong CYP3A inhibitors and who also have moderate hepatic impairment. Special Populations Renal insufficiency No dose adjustment is required in patients with mild (CrCl 60-89 mL/min) or moderate (CrCl of 30-59 mL/min) renal impairment (see 10 CLINICAL PHARMACOLOGY).
Lurbinectedin has not been evaluated in a sufficient number of patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease to estimate the risk, however it should only be used with caution and careful monitoring.
5 x ULN and any AST) (see 10 CLINICAL PHARMACOLOGY). 6 mg/m2(see 10 CLINICAL PHARMACOLOGY). 6 mg/m2 due to adverse reactions, treatment with ZEPZELCA should be discontinued. Avoid administration of ZEPZELCA to patients with severe hepatic impairment (total bilirubin> 3 x ULN and/or AST or ALT 3 x ULN) (see 10 CLINICAL PHARMACOLOGY).
No clinical data are available in patients with moderate hepatic impairment who require concomitant treatment with moderate or strong CYP3A inhibitors. […]
0 mg/m2 every 21 days Stop Permanently discontinue ZEPZELCA in patients who are unable to tolerate the 2nd dose reduction or require a dose interruption greater than two weeks, due to an adverse reaction. NOC/c ZEPZELCA (lurbinectedin) Page 7 of 35 Table 2.
5 x 109/L)) or with any value less than the lower limit of normal that is associated with infection/sepsis may receive Granulocyte Colony- Stimulating Factor (G-CSF) rather than undergo a dose reduction. ZEPZELCA (lurbinectedin) Page 8 of 35 Dose adjustments for drug interactions Avoid coadministration of ZEPZELCA with strong or moderate CYP3A inhibitors.
If coadministration of ZEPZELCA with a strong or moderate CYP3A inhibitor cannot be avoided, reduce the dose of ZEPZELCA by 50%. Because the magnitude of the interaction may vary depending on the inhibitor potency and dosing regimen, this reduction may not be sufficient in all cases.
Therefore, monitor patients closely for toxicity and adjust the dose further as needed based on tolerability (see Table 1 (row B), Table 2, and Table 7, 9 DRUG INTERACTIONS). After the moderate or strong CYP3A inhibitor has been discontinued for at least 5 half-lives, resume ZEPZELCA at the dose used prior to initiating the inhibitor.
No clinical data are available in patients who require concomitant treatment with moderate or strong CYP3A inhibitors and who also have moderate hepatic impairment. Special Populations Renal insufficiency No dose adjustment is required in patients with mild (CrCl 60-89 mL/min) or moderate (CrCl of 30-59 mL/min) renal impairment (see 10 CLINICAL PHARMACOLOGY).
Lurbinectedin has not been evaluated in a sufficient number of patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease to estimate the risk, however it should only be used with caution and careful monitoring.
5 x ULN […]