Indication

What are the possible side effects of Folotyn?

FOLOTYN may cause serious side effects, including:

Low Blood Cell Counts: FOLOTYN can affect your bone marrow and cause you to have low blood cell counts. Your doctor will do blood tests as needed to check your blood cell counts.

Low Platelet Count (thrombocytopenia): Tell your doctor right away if you have any unusual bleeding, such as nosebleeds, or bruising under your skin.

Low White Blood Cell Count (neutropenia): A low white blood cell count can cause you to get infections, which may be serious. Serious illness or death can happen if an infection is not treated right away when white blood cell counts are very low.

Tell your doctor right away if you have any of the following signs or symptoms of an infection:

Low Red Blood Cell Count (anemia): Tell your doctor if you have any of these symptoms of anemia during treatment with FOLOTYN:

  • feeling weak, tired, or you get tired easily
  • you look pale
  • you feel short of breath

Redness and sores of the mucous membrane lining of the mouth, lips, throat, digestive tract, and genitals (mucositis). Discomfort or pain due to mucositis may happen as early as a few days after treatment with FOLOTYN. Your doctor should tell you about ways to reduce your risk of getting mucositis, and how to maintain nutrition and control the discomfort from mucositis.

Severe Skin Reactions. Severe skin reactions may happen after treatment with FOLOTYN, especially if you have lymphoma in or under your skin. If your skin reactions are severe, they may lead to serious illness or death.

Tell your doctor right away if you have any of the following skin reactions:

Tumor Lysis Syndrome (TLS).  FOLOTYN can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.

Harm to an unborn baby. Females should avoid becoming pregnant while being treated with FOLOTYN. Talk to your doctor about how to avoid pregnancy while taking FOLOTYN.

Fever. Fever is often one of the most common and earliest signs of infection. Follow your doctor’s instructions about how often to take your temperature, especially during the days after treatment with FOLOTYN. If you have a fever, tell your doctor or nurse right away.

Loss of too much fluid from the body (dehydration). If you feel tired and weak this could be a sign of dehydration. Follow your doctor’s instructions for what to do to help prevent or treat dehydration.

Shortness of breath. Tell your doctor if this is a problem for you.

Common side effects of FOLOTYN include:

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of FOLOTYN. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

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

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