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.

Rx only

17 PATIENT COUNSELING INFORMATION
See FDA-approved Patient Package Insert.

Patients should be instructed to read the Patient Package Insert carefully.

17.1 Need for Folic Acid and Vitamin B12
Patients treated with FOLOTYN must be instructed to take folic acid and vitamin B12 as a prophylactic measure to potentially reduce possible side effects [see Dosage and Administration (2.2)].

17.2 Low Blood Cell Counts
Patients should be informed of the risk of low blood cell counts and instructed to immediately contact their physician should any signs of infection develop, including fever. Patients should also be instructed to contact their physician if bleeding or symptoms of anemia occur.

17.3 Mucositis
Physicians should discuss with patients the signs and symptoms of mucositis. Patients should be instructed on ways to reduce the risk of its development, and/or ways to maintain nutrition and control discomfort from mucositis if it occurs.

17.4 Fatal Dermatologic Reactions
Physicians should discuss with patients the signs and symptoms of dermatologic reactions. Patients should be made aware to immediately notify their physician if any skin reactions occur [see Warnings and Precautions (5.3)].

17.5 Tumor Lysis Syndrome
Physicians should discuss with patients the signs and symptoms of tumor lysis syndrome. Patients should be instructed to notify their physician if they experience these symptoms [see Warnings and Precautions (5.4)].

17.6 Concomitant Medications
Patients should be instructed to inform their physician if they are taking any concomitant medications including prescription drugs (such as trimethoprim/sulfamethoxazole) and nonprescription drugs (such as nonsteroidal anti-inflammatory drugs) [see Drug Interactions (7)].

17.7 Pregnancy/Nursing
Patients should be instructed to tell their physician if they are pregnant or plan to become pregnant due to the risk of fetal harm. Patients should be instructed to tell their physician if they are nursing.

ALLOS® Therapeutics

Manufactured for:
Allos Therapeutics, Inc.
Westminster, CO 80020
1-888-ALLOS88 (1-888-255-6788)

FOLOTYN, ALLOS, and the mobius triangle symbol are all registered trademarks of Allos Therapeutics, Inc.

U.S. Patents: 6,028,071 and 7,622,470

Rev. 4: August 2011
© 2011 Allos Therapeutics, Inc. All rights reserved.

Patient Information

FOLOTYN®(FOH-loh-tin)
(pralatrexate injection)

Read the Patient Information that comes with FOLOTYN before you start treatment and each time you get treated with FOLOTYN. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about FOLOTYN.

What is FOLOTYN?

FOLOTYN is a prescription anti-cancer (chemotherapy) medicine. FOLOTYN is used to treat people with a type of cancer called Peripheral T-cell Lymphoma (PTCL) that does not go away, gets worse, or comes back after use of another cancer treatment.

What should I tell my doctor before recei