FOLOTYN Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Acrotech Biopharma LLC
Λέξεις κλειδιά
72893-003 72893-005
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1. Indications and Usage
FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate ...
2. Dosage and Administration
2.1 Important Dosing Information Pretreatment Vitamin Supplementation <u>Folic Acid:</u> Instruct patients to take folic acid 1 to 1.25 mg orally once daily beginning 10 days before the first dose of FOLOTYN. ...
3. Dosage Forms and Strengths
Injection: 40 mg/2 mL (20 mg/mL) and 20 mg/mL clear yellow sterile solution in single-dose vial
4. Contraindications
None.
5. Warnings and Precautions
5.1 Myelosuppression FOLOTYN can cause myelosuppression, manifested by thrombocytopenia, neutropenia, and/or anemia. Administer vitamin B<sub>12</sub> and instruct patients to take folic acid to reduce ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression <em>[see Warnings and Precautions (5.1)]</em> Mucositis <em>[see Warnings and Precautions ...
6.1. Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during postapproval use of FOLOTYN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Effects of Other Drugs on FOLOTYN Coadministration of FOLOTYN with probenecid increased pralatrexate plasma concentrations <em>[see Clinical Pharmacology (12.3)]</em>, which may increase the risk of ...
8.1. Pregnancy
Risk Summary Based on findings from animal studies and its mechanism of action <em>[see Clinical Pharmacology (12.1)]</em>, FOLOTYN can cause fetal harm when administered to a pregnant woman. There are ...
8.2. Lactation
Risk Summary There is no data on the presence of pralatrexate in human milk or its effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed ...
8.3. Females and Males of Reproductive Potential
FOLOTYN can cause fetal harm when administered to a pregnant woman <em>[see Use in Specific Populations (8.1)]</em>. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior ...
8.4. Pediatric Use
The safety and effectiveness of FOLOTYN in pediatric patients have not been established.
8.5. Geriatric Use
In the Study PDX-008, 36% of patients (n=40) were 65 years of age and over. No overall differences in efficacy and safety were observed in patients based on age (<65 years compared with ≥65 years). Due ...
8.6. Renal Impairment
No dosage modification is recommended for patients with mild or moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m² based on MDRD). For patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 ...
10. Overdosage
No specific information is available on the treatment of overdosage of FOLOTYN. If an overdose occurs, general supportive measures should be instituted as deemed necessary by the treating healthcare provider. ...
11. Description
Pralatrexate is a dihydrofolate reductase inhibitor. Pralatrexate has the chemical name (2S)2[[4-[(1RS)1[(2,4-diaminopteridin-6-yl)methyl]but-3-ynyl]benzoyl]amino]pentanedioic acid. The molecular formula ...
12.1. Mechanism of Action
Pralatrexate is a folate analog metabolic inhibitor that competitively inhibits dihydrofolate reductase. It is also a competitive inhibitor for polyglutamylation by the enzyme folylpolyglutamyl synthetase. ...
12.2. Pharmacodynamics
Pralatrexate exposure-response relationship and the time course of pharmacodynamics responses are unknown.
12.3. Pharmacokinetics
Pralatrexate is a racemic mixture of S- and R-diastereomers. The pharmacokinetics of pralatrexate at the recommended dosage of 30 mg/m² once weekly have been evaluated in 10 patients with PTCL. Pralatrexate ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Carcinogenicity studies have not been performed with pralatrexate. Mutagenesis Pralatrexate did not cause mutations in the Ames test or the Chinese hamster ovary cell chromosome aberration ...
14. Clinical Studies
The efficacy of FOLOTYN was evaluated in Study PDX-008, an open-label, single-arm, multi-center, international trial that enrolled patients with relapsed or refractory PTCL. One hundred and eleven patients ...
15. References
1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
16.1. How Supplied
FOLOTYN is available in clear glass single-dose vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous ...
16.2. Storage and Handling
Store refrigerated at 2-8°C (36-46°F) [see USP Controlled Cold Temperature] in original carton to protect from light. FOLOTYN is a hazardous drug. Follow applicable special handling and disposal procedures. ...
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Folic Acid and Vitamin B<sub>12</sub> Supplementation Advise patients treated with FOLOTYN to take folic acid and vitamin ...