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pralatrexate (Rx)Brand and Other Names:Folotyn

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 20mg/mL
  • 40mg/2mL
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Peripheral T-Cell Lymphoma

Indicated for relapsed or refractory PTCL

30 mg/m² IV qweek for 6 week in 7 week cycles

Dosage modifications

  • Before administering any pralatrexate dose, mucositis should be ≤Grade 1, platelet count should be ≥100,000/mcL (first dose) and ≥50,000/mcL (subsequent doses), and absolute neutrophil count (ANC) should be ≥1,000/mcL
  • See Prescribing Information for omitting or reducing dose based on patient tolerance
  • Omitted doses will not be made up at the end of the cycle
  • Once dose reduction occurs for toxicity, do not re-escalate

Renal Impairment

eGFR ≥ 30 mL/min/1.73 m²: Dose adjustment not necessary

Estimated GFR (eGFR) 15 to <30 mL/min/1.73 m²: Reduce initial dose to 15 mg/m²; if dose reduction necessary because of toxicity, reduce each dose to 10 mg/m²

End-stage renal disease (ESRD): Avoid use unless potential benefits outweigh risks

Hepatic Impairment

Grade 3 (AST or ALT >5 to 20 times ULN or bilirubin >3 to 10 times ULN): Omit dose; decrease to 20 mg/m m² when recovers to grade 2

Grade 4 (AST or ALT >20 times ULN or bilirubin >10 times ULN): Discontinue treatment

Orphan Indications

Diffuse large B-cell lymphoma

Advanced or metastatic transitional cell urinary bladder carcinoma

Follicular lymphoma

Orphan indications sponsor

  • Allos Therapeutics, Inc; 11080 CirclePoint Road; Westminster, CO

Administration

Infuse IV over 3-5 minute via side port of free flowing 0.9% NaCl IV line

Dose omissions and/or dose reductions may be needed to manage adverse drug reactions

Pretreatment vitamin supplementation

  • Folic acid: Initiate 1-1.25 mg PO qDay 10 days before first pralatrexate dose; continue daily folic acid during entire treatment course and for 30 days after last pralatrexate dose
  • Vitamin B12: 1 mg IM within 10 weeks before first pralatrexate dose and q8-10 wk thereafter

Safety and efficacy not established

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Interactions

Interaction Checker

pralatrexate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Inflammatory disease of mucous membrane, Any grade (70% )

            Thrombocytopenia, Any grade (41% )

            Nausea (40% )

            Fatigue (36% )

            Anemia, Any grade (34% )

            Constipation (33% )

            Pancytopenia, Thrombocytopenia, Grade 3/4 (33% )

            Edema (30% )

            Cough (28% )

            Neutropenia, Any grade (24% )

            Inflammatory disease of mucous membrane, Grade 3/4 (21% )

            Neutropenia, Grade 3/4 (20% )

            Dyspnea (19% )

            Anemia (17% )

            1-10%

            Febrile neutropenia (>3% )

            Sepsis (>3% )

            Postmarketing Reports

            Skin exfoliation, ulceration, and toxic epidermal necrolysis

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Supplement with vitamin B12 and folic acid to decrease mucositis

            Treatment interruption or dose reduction to 20 mg/sq.meter may be required with severe mucositis, thrombocytopenia, or elevated liver function tests

            Caution with moderate-to-severe renal impairment (higher risk for toxicity); monitor for systemic toxicity and adjust dose accordingly

            Reports of severe dermatologic reactions including skin exfoliation, ulceration, and toxic epidermal necrolysis (withhold or discontinue treatment)

            Avoid breast feeding

            Probenecid decreases renal elimination of pralatrexate

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Unknown if excreted in breast milk; do not breast feed

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Folate inhibitor

            Pharmacokinetics

            Clearance: 417 mL/min (S-diastereomer); 191 mL/min (R-diastereomer)

            Half-life: 12-18 hr

            Vd: 105 L (S-diastereomer); 37 L (R-diastereomer)

            Protein Bound: 67%

            Metabolism: Not significantly metabolized by CYP450 or hepatic glucuronidases

            Excretion: (urine) 34% unchanged

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            Administration

            IV Preparation

            Do not dilute

            Contains no preservatives

            Clear, yellow solution; inspect for discoloration/particulate matter

            IV Administration

            Infuse IV over 3-5 min via side port of free flowing 0.9% NaCl IV line

            Extravasation Management

            Terminate injection or infusion immediately & aspirate back as much as possible

            Apply warm pack for 15-20 min QID & elevate

            Storage

            Store intact vials under refrigeration at 2-8°C

            Store in original carton to protect from light

            Intact, unopened vials stable at room temperature for 72 hr if protected from light (discard after 72 hr)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
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            OR Other Restrictions
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