How is FOLOTYN administered?

FOLOTYN is given once a week over a period of 6 weeks, with no treatment during the 7th week. These 7-week treatment cycles with FOLOTYN can be continued for as long as you and your healthcare team agree that the treatment is working for you and is being tolerated.

FOLOTYN is an “outpatient” treatment so you do not need to be hospitalized. It is administered as an intravenous (IV) infusion that can last up to 5 minutes. That means that a healthcare professional will insert a needle and FOLOTYN will be delivered into your vein through a small tube.

While you are taking FOLOTYN, you should also take vitamin B₁₂ and folic acid, two important nutrients that may help to reduce your chances of mucositis and low blood counts.

Your healthcare team will instruct you to take folic acid by mouth every day starting 10 days before your first dose of FOLOTYN. Your doctor will tell you when it is okay to stop taking folic acid.

You will also receive a vitamin B₁₂ injection (into a muscle) prior to your first dose of FOLOTYN, as well as every 8-10 weeks while you are getting treatment with FOLOTYN. Subsequent vitamin B₁₂ injections may be given the same day as treatment with FOLOTYN. You will also have weekly blood tests, so that your healthcare team can monitor your health.

Cycle 1: Outpatient Dosing Schedule

It is important to take vitamin B12 and folic acid, as directed by your doctor.

FOLOTYN Important Safety Information

Indication

FOLOTYN^® (pralatrexate injection) is a dihydrofolate reductase inhibitor 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

FOLOTYN Important Safety Information

Warnings and Precautions

Myelosuppression: FOLOTYN can cause myelosuppression, manifested by thrombocytopenia, neutropenia, and/or anemia. Monitor complete blood counts and omit and/or reduce the dose based on ANC and platelet count.
Mucositis: FOLOTYN can cause mucositis. Monitor for mucositis weekly and omit and/or reduce the dose for ≥ grade 2 mucositis.
Dermatologic Reactions: Dermatologic reactions, including fatal reactions, occurred and may be progressive and increase in severity with further treatment. Monitor closely and withhold or discontinue FOLOTYN based on severity.
Tumor Lysis Syndrome: FOLOTYN can cause tumor lysis syndrome. Monitor patients who are at increased risk of TLS and treat promptly.
Hepatic Toxicity: FOLOTYN can cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests. Omit dose until recovery, adjust or discontinue therapy based on the severity.
Risk of Increased Toxicity with Renal Impairment: Patients with severe renal function impairment may be at greater risk for increased exposure and adverse reactions. Reduce FOLOTYN dosage in patients with severe renal impairment. Avoid FOLOTYN use in patients with end stage renal disease with or without dialysis. If the potential benefit of administration justifies the potential risk, monitor renal function and reduce the dose based on adverse reactions.
Embryo-Fetal Toxicity: FOLOTYN can cause fetal harm. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with FOLOTYN and for 6 months after last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with FOLOTN and for three months after last dose.

Adverse Reactions

The most common adverse reactions occurring in greater than 35% of patients were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse reactions occurring in more than 3% of patients were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.

Drug Interactions

Avoid coadministration with probenecid or nonsteroidal anti-inflammatory drugs (NSAIDs). If coadministration is unavoidable, monitor for increased risk of adverse reactions.

Use in Specific Populations

Lactation: Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with FOLOTYN and for 1 week after the last dose.
Pregnancy Testing: Verify pregnancy status in females of reproductive potential prior to initiation of FOLOTYN
Pediatric Use: The Safety and effectiveness of FOLOTYN in pediatric patients have not been established.
Renal Impairment: Reduce the dose of FOLOTYN for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m²). No dosage modification is recommended for patients with mild or moderate renal impairment.

Please click here to see full Prescribing Information for FOLOTYN.

ISI-FOL-0180