Label Changes for:
Folotyn (pralatrexate) injection
Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNING AND PRECAUTIONS
- Treatment with FOLOTYN may cause mucositis. If ≥ Grade 2 mucositis is observed, omit dose and follow guidelines in Section 2.5, Table 1[see Dosage and Administration (2.5)].
5.3 Dermatologic Reactions
- FOLOTYN has been associated with severe dermatologic reactions, which may result in death. These dermatologic reactions have been reported in clinical studies (14/663 patients [2.1%]) and post marketing experience, and have included skin exfoliation, ulceration, and toxic epidermal necrolysis (TEN). These reactions may be progressive and increase in severity with further treatment, and may involve skin and subcutaneous sites of known lymphoma. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued.
PATIENT PACKAGE INSERT
- Re: ... dermatological reactions ...
- Newly approved Patient Package Insert