rteen patients went off treatment in cycle 1; 2 patients were uneva luable for response by IWC due to insufficient materials provided to central review.
CR = Complete Response, CRu = Complete Response unconfirmed, PR = Partial Response
CR+CRu+PR 29 (27) 19, 36 287 days
(9.4 months) 1-503 days
CR/CRu 9 (8)
PR 20 (18)
Responses ≥ 14 weeks
CR+CRu+PR 13 (12) 7, 20 Not Reached 98-503 days
CR/CRu 7 (6)
PR 6 (6)
Fourteen patients went off treatment in cycle 1; 2 patients were uneva luable for response by IWC due to insufficient materials provided to central review.
CR = Complete Response, CRu = Complete Response unconfirmed, PR = Partial Response
The initial response assessment was scheduled at the end of cycle 1. Of the responders, 66% responded within cycle 1. The median time to first response was 45 days (range 37-349 days).
REFERENCES
1.Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
2.OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/o tm/otm_vi/otm_vi_2.html
3.American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
4.Polovich, M., White, J. M., & Kelleher, L. O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.
How Supplied/Storage and Handling
Folotyn is available in single-use clear glass vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations:
NDC 48818-001-01: 20 mg of pralatrexate in 1 mL solution in a vial (20 mg / 1 mL)
NDC 48818-001-02: 40 mg of pralatrexate in 2 mL solution in a vial (40 mg / 2 mL)
Vials must be stored refrigerated at 2-8°C (36-46°F) (see USP Controlled Cold Temperature) in original carton to protect from light.
Handle and dispose of Folotyn according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact [see References (15)].
Each vial of Folotyn is intended for single use only. Any unused drug remaining after injection must be discarded.
Patient Counseling Information
See FDA-approved labeling (Patient Information).
Patients should be instructed to read the Patient Information carefully.
Need for Folic Acid and Vitamin B12
Advise patients treated with Folotyn to take folic acid and vitamin B12 as a prophylactic measure to reduce the risk of possible side effects [see Dosage and Administration (2.1)].
Low Blood Cell Counts
Inform patients of the risk of low blood cell counts and to immediately contact their physician should any signs of infection develop, including fever. Inform patients to contact their physician if bleeding or symptoms of anemia occur.
Mucositis
Inform patients of the signs and symptoms of mucositis. Instruct patients on ways to reduce the risk of its development, and on ways to maintain nutrition and control discomfort from mucositis if it occurs.
Fatal Dermatologic Reactions
Advise patients about the risks for and the signs and symptoms of dermatologic reactions. Instruct patients to immediately notify their physician if an |
