ZEPZELCA- lurbinectedin injection, powder, lyophilized, for solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

LURBINECTEDIN (UNII: 2CN60TN6ZS) (LURBINECTEDIN - UNII:2CN60TN6ZS)

MAH:

Jazz Pharmaceuticals, Inc.

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

ZEPZELCA is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). None. Risk Summary Based on animal data and its mechanism of action [see Clinical Pharmacology (12.1)] , ZEPZELCA can cause fetal harm when administered to a pregnant woman. There are no available data to inform the risk of ZEPZELCA use in pregnant women. Intravenous administration of a single lurbinectedin dose (approximately 0.2 times the 3.2 mg/m2 clinical dose) to pregnant rats during the period of organogenesis caused embryolethality (see Data) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and mi

leaflet_short:

How Supplied ZEPZELCA (lurbinectedin) for injection is supplied as a sterile, preservative-free, white to off‑white lyophilized powder in a single-dose clear glass vial. Each carton (NDC 68727‑712-01) contains 4 mg in one single-dose vial. Storage and Handling Store refrigerated at 2° to 8°C (36° to 46°F). ZEPZELCA is a hazardous drug. Follow applicable special handling and disposal procedures1 .

authorization_status:

New Drug Application

PIL

Jazz Pharmaceuticals, Inc.
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Patient Information
PATIENT INFORMATION
ZEPZELCA® [zep zel' kah]
(lurbinectedin)
for injection
What is ZEPZELCA?
ZEPZELCA is used to treat adults with a kind of lung cancer called
small cell lung cancer (SCLC).
ZEPZELCA may be used when your lung cancer:
o
has spread to other parts of the body (metastatic), and
o
you have received treatment with chemotherapy that contains platinum,
and it did not work or is
no longer working.
It is not known if ZEPZELCA is safe and effective in children.
Before receiving ZEPZELCA, tell your healthcare provider about all of
your medical conditions, including if
you:
•
have liver or kidney problems.
•
are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn
baby.
Females who are able to become pregnant:
o
Your healthcare provider should do a pregnancy test before you start
treatment with
ZEPZELCA.
o
You should use effective birth control (contraception) during
treatment with and for 6 months
after your final dose of ZEPZELCA.
o
Tell your healthcare provider right away if you become pregnant or
think that you are pregnant
during treatment with ZEPZELCA.
Males with female partners who are able to become pregnant should use
effective birth control during
treatment with and for 4 months after your final dose of ZEPZELCA.
•
are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA
passes into your breastmilk. Do
not breastfeed during treatment with ZEPZELCA and for 2 weeks after
your final dose of
ZEPZELCA. Talk to your healthcare provider about the best way to feed
your baby during treatment
with ZEPZELCA.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Certain other medicines
may affect how ZEPZELCA works.
Know the medicines you take. Keep a list of them to show your
healthcare provider and pharmacist when
you get a new medicine.
How will I receive ZEPZELCA?
•
ZEPZELCA is given by an intravenous (IV) infusion i

SPC

ZEPZELCA- LURBINECTEDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
JAZZ PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZEPZELCA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZEPZELCA.
ZEPZELCA (LURBINECTEDIN) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020
RECENT MAJOR CHANGES
Dosage and Administration (2.3) 07/2023
INDICATIONS AND USAGE
ZEPZELCA is an alkylating drug indicated for the treatment of adult
patients with metastatic small cell lung
cancer (SCLC) with disease progression on or after platinum-based
chemotherapy. (1)
This indication is approved under accelerated approval based on
overall response rate and duration of
response. Continued approval for this indication may be contingent
upon verification and description of
clinical benefit in a confirmatory trial(s). (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
For injection: 4 mg lyophilized powder in a single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions, including laboratory abnormalities,
(≥20%) are leukopenia,
lymphopenia, fatigue, anemia, neutropenia, increased creatinine,
increased alanine aminotransferase,
increased glucose, thrombocytopenia, nausea, decreased appetite,
musculoskeletal pain, decreased
albumin, constipation, dyspnea, decreased sodium, increased aspartate
aminotransferase, vomiting,
cough, decreased magnesium and diarrhea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JAZZ PHARMACEUTICALS,
INC. AT 1-800-
520-5568 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
USE IN SPECIFIC POPULATIONS
®
Recommended dosage: 3.2 mg/m every 21 days. (2.1)
2
Administer ZEPZELCA as an intravenous infusion over 60 minutes. (2.1)
Consider premedication with corticosteroids and serotonin antagonists.
(2.3)
Myelosuppression: Monitor blood counts prior to each administration.
Initiate trea