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Folotyn Generic Name & Formulations
Legal Class
Rx
General Description
Pralatrexate 20mg/mL; soln for IV inj; preservative-free.
Pharmacological Class
Folate analogue inhibitor.
How Supplied
Single-use vials (1mL, 2mL)—1
Manufacturer
Folotyn Indications
Indications
Relapsed or refractory peripheral T-cell lymphoma.
Folotyn Dosage and Administration
Adult
Prior to administration: mucositis should be ≤Grade 1, platelets should be ≥100,000/μL for first dose and ≥50,000/μL for subsequent doses, absolute neutrophil count should be ≥1,000/μL. Give by IV push over 3–5mins. 30mg/m2 once weekly for 6 weeks in 7-week cycles. Continue until disease progression or unacceptable toxicity develops. Supplement with vitamin B12 (1mg IM every 8–10 weeks, starting within 10 weeks before first Folotyn dose) and folic acid (1–1.25mg orally daily, beginning 10 days before starting Folotyn and for 30 days after stopping). Severe renal impairment (CrCL 15–<30mL/min): 15mg/m2. Dose modifications: see full labeling.
Children
Not established.
Folotyn Contraindications
Not Applicable
Folotyn Boxed Warnings
Not Applicable
Folotyn Warnings/Precautions
Warnings/Precautions
Myelosuppression. Monitor CBCs and for mucositis at baseline and weekly. Omit and/or reduce dose to manage toxicities (eg, hematological, mucositis, hepatic impairment); see full labeling. End stage renal disease (including dialysis): avoid, unless benefit justifies potential risk for toxicity. Monitor serum chemistry, renal and hepatic function before the 1st and 4th dose per cycle. Monitor for dermatological reactions; withhold dose or discontinue if severe. Monitor patients at increased risk of tumor lysis syndrome. Renal or hepatic impairment. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Folotyn Pharmacokinetics
See Literature
Folotyn Interactions
Interactions
May be potentiated by probenecid, NSAIDs, trimethoprim/sulfamethoxazole.
Folotyn Adverse Reactions
Adverse Reactions
Mucositis, thrombocytopenia, neutropenia, anemia, abnormal liver function tests, nausea, fatigue, pyrexia, dehydration, sepsis, dyspnea; dermatological reactions (eg, skin exfoliation, ulceration, toxic epidermal necrolysis), tumor lysis syndrome.
Folotyn Clinical Trials
See Literature
Folotyn Note
Not Applicable
Folotyn Patient Counseling
See Literature
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