What is Folotyn, and how does it work?

Folotyn (pralatrexate injection) is an antineoplastic (anti-cancer) drug used to treat T-cell lymphoma that has spread throughout the body. Folotyn is given for relapsed T-cell lymphoma, or after other medications have been tried without successful treatment.

What are the side effects of Folotyn?

Common side effects of Folotyn include:

Serious skin reactions can occur. Tell your doctor if you develop rash, peeling, sores or blisters on the skin while using Folotyn. Tell your doctor if you have unlikely but serious side effects of Folotyn including:

 

What is the dosage for Folotyn?

Important Dosing Information

Pretreatment Vitamin Supplementation

Folic Acid

Instruct patients to take folic acid 1 to 1.25 mg orally once daily beginning 10 days before the first dose of Folotyn. Continue folic acid during treatment with Folotyn and for 30 days after the last dose.

Vitamin B12

Administer vitamin B12 1 mg intramuscularly within 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.

Recommended Dosage

The recommended dosage of Folotyn is 30 mg/m² intravenously over 3-5 minutes once weekly for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity.

Dosage Modifications For Renal Impairment And End Stage Renal Disease

  • Severe renal impairment (eGFR 15 to 29 mL/min/1.73 m² by MDRD): Reduce the Folotyn dose to 15 mg/m².
  • End stage renal disease (ESRD: eGFR less than 15 mL/min/1.73 m² by MDRD) with or without dialysis: Avoid administration. If the potential benefit of administration justifies the potential risk, monitor renal function and reduce the Folotyn dose based on adverse reactions.

Monitoring And Dosage Modifications For Adverse Reactions

Monitoring

Monitor complete blood cell counts and severity of mucositis at baseline and weekly. Perform serum chemistry tests, including renal and hepatic function, prior to the start of the first and fourth dose of each cycle.

Recommended Dosage Modifications

Do not administer Folotyn until:

  • Mucositis Grade 1 or less.
  • Platelet of 100,000/mcL or greater for first dose and 50,000/mcL or greater for all subsequent doses.
  • Absolute neutrophil count (ANC) of 1,000/mcL or greater. Dosage modifications for adverse reactions are provided in Tables 1, 2, and 3.

Table 1 : Folotyn Dosage Modifications for Mucositis

Mucositis Gradea on Day of TreatmentActionRecommended Dose upon Recovery to Grade 0 or 1
Patients Without Severe Renal ImpairmentPatients with Severe Renal Impairment
Grade 2Omit doseContinue prior doseContinue prior dose
Grade 2 recurrenceOmit dose20 mg/m²10 g/m²
Grade 3Omit dose20 mg/m²10 g/m²
Grade 4Stop therapy
a Based National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0)

Table 2 : Folotyn Dosage Modifications for Myelosuppression

Blood Count on Day of TreatmentDuration of ToxicityActionRecommended Dose Upon Recovery
Patients Without Severe Renal ImpairmentPatients with Severe Renal Impairment
Platelet less than 50,000/mcL1 weekOmit doseContinue prior doseContinue prior dose
2 weeksOmit dose20 mg/m²10 mg/m²
3 weeksStop therapy
ANC 500 to 1,000/mcL and no fever1 weekOmit doseContinue prior doseContinue prior dose
ANC 500 to 1,000/mcL with fever or ANC less than 500/mcL1 weekOmit dose, give G-CSF or GM-CSFContinue prior dose with G-CSF or GM-CSFContinue prior dose with G-CSF or GM-CSF support
2 weeks or recurrenceOmit dose, give G-CSF or GM-CSF20 mg/m² with G-CSF or GM-CSF10 mg/m² with G-CSF or GM-CSF
3 weeks or nd 2 recurrenceStop therapy
G-CSF=granulocyte colony-stimulating factor; GM-CSF=granulocyte macrophage colony-stimulating factor

Table 3 : Folotyn Dosage Modifications for All Other Adverse Reactions

Toxicity Gradea on Day of TreatmentActionRecommended Dose upon Recovery to Grade 2 or Lower
Patients Without Severe Renal ImpairmentPatients with Severe Renal Impairment
Grade 3Omit dose20 mg/m²10 mg/m²
Grade 4Stop therapy
a Based on NCI CTCAE version 3.0

SLIDESHOW

Skin Cancer Symptoms, Types, Images See Slideshow

What drugs interact with Folotyn?

Effects Of Other Drugs On Folotyn

Coadministration of Folotyn with probenecid increased pralatrexate plasma concentrations, which may increase the risk of adverse reactions. Avoid coadministration with probenecid or nonsteroidal anti-inflammatory drugs. If coadministration is unavoidable, monitor for increased risk of adverse reactions.

Is Folotyn safe to use while pregnant or breastfeeding?

  • Based on findings from animal studies and its mechanism of action, Folotyn can cause fetal harm when administered to a pregnant woman.
  • There are insufficient data on Folotyn use in pregnant women to evaluate for a drug-associated risk.
  • Folotyn was embryotoxic and fetotoxic in rats and rabbits when administered during organogenesis at doses about 1.2% (0.012 times) of the clinical dose on a mg/m² basis.
  • Advise pregnant women of the potential risk to a fetus.
  • There is no data on the presence of pralatrexate in human milk or its effects on the breastfed child or milk production.
  • 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.

Summary

Folotyn (pralatrexate injection) is an antineoplastic (anti-cancer) drug used to treat T-cell lymphoma that has spread throughout the body. Folotyn is given for relapsed T-cell lymphoma, or after other medications have been tried without successful treatment.

Treatment & Diagnosis

Medications & Supplements

Health Solutions From Our Sponsors

FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Medically Reviewed on 10/26/2020
References
All sections courtesy of the U.S. Food and Drug Administration