Revised: 08/2011
 

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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Peripheral T-cell Lymphoma
2.2 Vitamin Supplementation
2.3 Preparation and Administration Precautions
2.4 Preparation for Intravenous Push Administration
2.5 Monitoring and Dose Modifications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Bone Marrow Suppression
5.2 Mucositis
5.3 Dermatologic Reactions
5.4 Tumor Lysis Syndrome
5.5 Folic Acid and Vitamin B12 Supplementation
5.6 Pregnancy Category D
5.7 Decreased Renal Function
5.8 Elevated Liver Enzymes
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Need for Folic Acid and Vitamin B12
17.2 Low Blood Cell Counts
17.3 Mucositis
17.4 Fatal Dermatologic Reactions
17.5 Tumor Lysis Syndrome
17.6 Concomitant Medications
17.7 Pregnancy/Nursing
 

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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated.

2 DOSAGE AND ADMINISTRATION
FOLOTYN should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

2.1 Peripheral T-cell Lymphoma
The recommended dose of FOLOTYN is 30 mg/m2 administered as an intravenous (IV) push over 3-5 minutes via the side port of a free-flowing 0.9%Sodium Chloride Injection, USP IV line once weekly for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity.

2.2 Vitamin Supplementation
Patients should take low-dose (1.0-1.25 mg) oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of FOLOTYN, and dosing should continue during the full course of therapy and for 30 days after the last dose of FOLOTYN. Patients should also receive a vitamin B12 (1mg) intramuscular injection no more than 10 weeks prior to the first dose of FOLOTYN and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with FOLOTYN [seeWarnings and Precautions (5.5)].

2.3 Preparation and Administration Precau