ZEPZELCA Powder for solution for injection (2022)
Βιβλιογραφική αναφορά
Συγγραφείς
Jazz Pharmaceuticals, Inc.
Λέξεις κλειδιά
68727-712
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1. Indications and Usage
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 ...
2. Dosage and Administration
2.1 Recommended Dosage The recommended dosage of ZEPZELCA is 3.2 mg/m² by intravenous infusion over 60 minutes every 21 days until disease progression or unacceptable toxicity. Initiate treatment with ...
3. Dosage Forms and Strengths
<u>For injection:</u> 4 mg of lurbinectedin as a sterile, preservative-free, white to off-white lyophilized powder in a single-dose vial for reconstitution prior to intravenous infusion.
4. Contraindications
None.
5. Warnings and Precautions
5.1 Myelosuppression ZEPZELCA can cause myelosuppression. In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA <em>[see Adverse Reactions (6.1)]</em>, Grade 3 or 4 neutropenia ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression <em>[see Warnings and Precautions (5.1)]</em> Hepatotoxicity <em>[see Warnings and Precautions ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ZEPZELCA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Effect of Other Drugs on ZEPZELCA Strong and Moderate CYP3A Inhibitors Coadministration with a strong or a moderate CYP3A inhibitor increases lurbinectedin systemic exposure <em>[see Clinical Pharmacology ...
8.1. Pregnancy
Risk Summary Based on animal data and its mechanism of action <em>[see Clinical Pharmacology (12.1)]</em>, ZEPZELCA can cause fetal harm when administered to a pregnant woman. There are no available data ...
8.2. Lactation
Risk Summary There are no data on the presence of lurbinectedin in human milk or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions from ZEPZELCA ...
8.3. Females and Males of Reproductive Potential
ZEPZELCA can cause embryolethality at doses lower than the human dose of 3.2 mg/m² <em>[see Use in Specific Populations (8.1)]</em>. Pregnancy Testing Verify the pregnancy status of females of reproductive ...
8.4. Pediatric Use
The safety and effectiveness of ZEPZELCA in pediatric patients have not been established.
8.5. Geriatric Use
Of the 105 patients with SCLC administered ZEPZELCA in clinical studies, 37 (35%) patients were 65 years of age and older, while 9 (9%) patients were 75 years of age and older. No overall difference in ...
8.6. Hepatic Impairment
The effect of moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST) on the pharmacokinetics of lurbinectedin has not been studied. No dose adjustment of ZEPZELCA is recommended ...
11. Description
ZEPZELCA is an alkylating drug. The chemical name of ZEPZELCA (lurbinectedin) is (1R,6R,6aR,7R,13S,14S,16R)-8,14-dihydroxy-6',9-dimethoxy-4,10,23-trimethyl-19-oxo-2',3',4',6,7,9',12,13,14,16-decahydro-6aH-spiro[7,13-azano-6,16-(epithiopropanooxymethano) ...
12.1. Mechanism of Action
Lurbinectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers ...
12.2. Pharmacodynamics
Lurbinectedin exposure-response relationships and the pharmacodynamic time-course for efficacy have not been fully characterized. Increased incidence of Grade 4 neutropenia and Grade ≥ 3 thrombocytopenia ...
12.3. Pharmacokinetics
Following the approved recommended dosage, geometric means (CV) of plasma C<sub>max</sub> and AUC<sub>0-inf</sub>, were 107 µg/L (79) and 551 µg•h/L (94%), respectively. No accumulation of lurbinectedin ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity testing of lurbinectedin has not been performed. Lurbinectedin is genotoxic to mammalian cells in the presence and absence of metabolic activation. Lurbinectedin was not mutagenic in vitro ...
14. Clinical Studies
PM1183-B-005-14 (Study B-005; NCT02454972) is a multicenter, open-label, multi-cohort trial evaluating ZEPZELCA as a single agent in patients with advanced or metastatic solid tumors. A cohort of patients ...
15. References
1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
16.1. 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 ...
16.2. 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 procedures<sup>1</sup>.
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Myelosuppression Advise patients to immediately contact their healthcare provider for fever, other signs of infection, ...