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ZEPZELCA^® (lurbinectedin) for injection is indicated for the treatment of adult patients with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy.

ZEPZELCA has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for ZEPZELCA please refer to Health Canada’s Notice of Compliance with conditions – drug products web site.

Please consult the Product Monograph for complete information about ZEPZELCA, including patient selection, adverse event management, and dosing details.

Download the Product Monograph

ZEPZELCA was studied in a Phase 2, open-label, multi centre, multi-cohort, single-arm study that enrolled 105 patients with SCLC whose disease progressed on or after platinum-based therapy.

Patients were treated with 3.2 mg/m² ZEPZELCA, administered as a 60-minute intravenous infusion repeated every 21 days (1 cycle).
Patients received a median of 4 cycles of ZEPZELCA (range 1 to 24 cycles).
The primary efficacy endpoint was overall response rate (ORR), as assessed by the investigator.

Efficacy across the relapsed SCLC spectrum

Encouraging results shown:^1,2

35.2%

of patients had an overall response.

65.3%

of patients saw a shrinkage in the size of their tumour.

5.3 months

was the median duration of response (DOR).

Durable
response

seen in patients with platinum-resistant* and patients with platinum-sensitive^† disease.

dosing schedule

One 60-minute infusion every 21 days.¹

1 Treatment

per 21-day cycle.

Safety Profile

Generally well-tolerated safety profile.¹

patients discontinued the study due to adverse events. One patient experienced peripheral neuropathy, and one patient experienced myelosuppression.

27%

of patients had dose reductions due to adverse reactions, which included neutropenia, febrile neutropenia, fatigue, thrombocytopenia, and pneumonia.

The most common (≥ 20%) adverse events (all grades) were fatigue (77%), nausea (37%), neutropenia (33%), decreased appetite (33%), musculoskeletal pain (31%), dyspnea (31%), constipation (31%), respiratory tract infection (26%), vomiting (22%), diarrhea (20%), and cough (20%).

Download the Product Monograph
The ZEPZELCA press release announcing approval and commercial availability can be found here

Available in Canada!

DIN: 02520834 | 4 mg/vial UPC: 368727004870

The ZEPZELCA Patient Access Program helps patients access therapy

ZEPZELCA is available through a patient access program.
Contact ZepzelcaAccess@jazzpharma.com for details.

Download the enrolment form

The ZEPZELCA patient booklet contains helpful information on small cell lung cancer and ZEPZELCA

It also has lifestyle tips for patients and information for caregivers.

Download the patient booklet

Have questions?
Contact Jazz Pharmaceuticals directly

This site will be updated periodically. Check back for the latest updates!
A site for patients will be developed in the near future.

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Jazz Pharmaceuticals

Visit our global site

Important safety information

Indications and clinical use:

^PrZEPZELCA^® (lurbinectedin) is indicated for the treatment of adult patients with Stage III or metastatic SCLC (small cell lung cancer) who have progressed on or after platinum-containing therapy.

The marketing authorization with conditions was based on overall response rate and duration of response; no overall survival benefit has been demonstrated.

Pediatrics: Not indicated for pediatric use.

Geriatrics: In the clinical trial, there was a higher incidence of serious adverse reactions in patients ≥ 65 years of age than in patients < 65 years of age.

Most serious warnings and precautions:

Experience: ZEPZELCA should be administered under the supervision of a physician who is experienced in the use of cancer chemotherapeutics.

Risk of extravasation: Consider use of a central venous catheter to reduce risk of extravasation with ZEPZELCA.

Myelosuppression: Fatal cases observed. Administer ZEPZELCA only to patients with baseline neutrophil count of
≥ 1,500 cells/mm³ (1.5 x 10⁹/L) and platelet count ≥ 100,000/mm³ (100 x 10⁹/L). In case of neutrophil counts < 500 cells/mm³ (0.5 x 10⁹/L) or less than the lower limit of normal, the use of G-CSF (granulocyte colony-stimulating factor) is recommended.

Embryofetal toxicity: ZEPZELCA can cause fetal harm when administered to a pregnant woman. Animal studies in pregnant rats during the period of organogenesis reported embryofetal lethality and maternal toxicity following administration of a single intravenous dose.

Injection site reactions: Extravasation of ZEPZELCA resulting in skin and soft tissue injury, including necrosis requiring debridement, can occur.

Other relevant warnings and precautions:

Genotoxicity.
Driving and operating machinery.
Liver function monitoring.
Complete blood count monitoring.
Peripheral neuropathy monitoring.
Use in patients of reproductive potential or with partners of reproductive potential.
Consider more frequent laboratory monitoring in patients who are > 75 years of age, have poor performance status, have low blood albumin levels, or are of low weight or have low body surface area.

For more information:

Please consult the Product Monograph at
https://pp.jazzpharma.com/pi/zepzelca.ca.PM-en.pdf for important information relating to adverse reactions, drug interactions, and dosing that has not been discussed in this piece.

The Product Monograph is also available by calling us at 1-800-520-5568.

Find out more about ZEPZELCA in your practice and for your patients.

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