pralatrexate (Rx)

Brand and Other Names:Folotyn
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 20mg/mL
  • 40mg/2mL

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

Safety and efficacy not established

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Interactions

Interaction Checker

and pralatrexate

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (11)

              • adenovirus types 4 and 7 live, oral

                pralatrexate decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • axicabtagene ciloleucel

                pralatrexate, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • brexucabtagene autoleucel

                pralatrexate, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • ciltacabtagene autoleucel

                pralatrexate, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • idecabtagene vicleucel

                pralatrexate, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • influenza virus vaccine quadrivalent, adjuvanted

                pralatrexate decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                pralatrexate decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • lisocabtagene maraleucel

                pralatrexate, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • palifermin

                palifermin increases toxicity of pralatrexate by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • tisagenlecleucel

                pralatrexate, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tofacitinib

                pralatrexate, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (44)

              • aspirin rectal

                aspirin rectal increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor.

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor.

              • belatacept

                belatacept and pralatrexate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • celecoxib

                celecoxib increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • cholera vaccine

                pralatrexate decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • choline magnesium trisalicylate

                choline magnesium trisalicylate increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor.

              • dengue vaccine

                pralatrexate decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                pralatrexate, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • dichlorphenamide

                dichlorphenamide and pralatrexate both decrease serum potassium. Use Caution/Monitor.

              • diclofenac

                diclofenac increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • diflunisal

                diflunisal increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • etodolac

                etodolac increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • fenoprofen

                fenoprofen increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • fingolimod

                pralatrexate increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • flurbiprofen

                flurbiprofen increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • glucarpidase

                glucarpidase will decrease the level or effect of pralatrexate by increasing metabolism. Modify Therapy/Monitor Closely. Leucorvorin, reduced folates, and folate antimetabolites are substrates for glucarpidase (hydrolyzes glutamate residue from folic acid and antifolates)

              • hydroxyurea

                pralatrexate, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • ibuprofen

                ibuprofen increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • ibuprofen IV

                ibuprofen IV increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • indomethacin

                indomethacin increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • influenza A (H5N1) vaccine

                pralatrexate decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • influenza virus vaccine (H5N1), adjuvanted

                pralatrexate decreases effects of influenza virus vaccine (H5N1), adjuvanted by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • ketoprofen

                ketoprofen increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • ketorolac

                ketorolac increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • ketorolac intranasal

                ketorolac intranasal increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor.

              • meclofenamate

                meclofenamate increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • mefenamic acid

                mefenamic acid increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • meloxicam

                meloxicam increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • meningococcal group B vaccine

                pralatrexate decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • nabumetone

                nabumetone increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • naproxen

                naproxen increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • ofatumumab SC

                ofatumumab SC, pralatrexate. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                pralatrexate and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • oxaprozin

                oxaprozin increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • piroxicam

                piroxicam increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • probenecid

                probenecid increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor.

              • siponimod

                siponimod and pralatrexate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                pralatrexate decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • sulfamethoxazole

                sulfamethoxazole increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor.

              • sulindac

                sulindac increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • tolmetin

                tolmetin increases levels of pralatrexate by decreasing renal clearance. Use Caution/Monitor. NSAIDs may delay pralatrexate clearance, increasing drug exposure. Adjust the pralatrexate dose as needed.

              • trastuzumab

                trastuzumab, pralatrexate. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, pralatrexate. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • ublituximab

                ublituximab and pralatrexate both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered

              Minor (4)

              • maitake

                maitake increases effects of pralatrexate by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).

              • taurine

                pralatrexate decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.

              • vitamin A

                vitamin A, pralatrexate. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

              • vitamin E

                vitamin E, pralatrexate. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

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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

              Treatment can cause mucositis; administer vitamin B12 and instruct patients to take folic acid to reduce risk of mucositis; monitor for mucositis weekly and omit and/or reduce dose for grade 2 or higher 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; reactions may be progressive and increase in severity with further treatment and may involve skin and subcutaneous sites of known lymphoma; monitor closely for dermatologic reactions (withhold or discontinue treatment)

              Treatment can cause tumor lysis syndrome (TLS); monitor patients who are at increased risk of TLS and treat promptly

              Avoid breastfeeding

              Probenecid decreases renal elimination of pralatrexate

              Myelosuppression

              • Therapy can cause myelosuppression, manifested by thrombocytopenia, neutropenia, and/or anemia
              • Administer vitamin B12 and instruct patients to take folic acid to reduce the risk of treatment-related myelosuppression
              • Monitor complete blood counts and omit and/or reduce the dose based on ANC and platelet count prior to each dose

              Hepatotoxicity

              • Can cause hepatic toxicity and liver function test abnormalities; persistent liver function test abnormalities may be indicators of hepatic toxicity and require dose modification or discontinuation.
              • Monitor liver function tests. Omit dose until recovery, adjust or discontinue therapy based on the severity of the hepatic toxicity

              Renal Impairment

              • Patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m2 based on MDRD) may be at greater risk for increased exposure and adverse reactions; reduce dosage in patients with severe renal impairment
              • Serious adverse reactions, including TEN and mucositis, reported in patients receiving therapy with end-stage renal disease (ESRD) undergoing dialysis; avoid therapy in patients with ESRD with or without dialysis; If the potential benefit of administration justifies the potential risk, monitor renal function and reduce dose based on adverse reactions
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              Pregnancy & Lactation

              Pregnancy

              Based on findings from animal studies and mechanism of action therapy can cause fetal harm when administered to a pregnant woman; there are insufficient data on use in pregnant women to evaluate for a drug-associated risk; drug was embryotoxic and fetotoxic in rats and rabbits when administered during organogenesis at doses about 1.2% (0.012 times) of clinical dose on a mg/m2 basis; advise pregnant women of potential risk to a fetus

              Therapy can cause fetal harm when administered to a pregnant woman; verify pregnancy status in females of reproductive potential prior to initiation of therapy

              Contraception

              • Females: Advise females of reproductive potential to use effective contraception during treatment and for 6 months following last dose
              • Males: Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months following last dose

              Lactation

              There is no data on presence in human milk or effects on breastfed child or milk production; because of potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 1 week after last dose

              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 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

              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

              BRAND FORM. UNIT PRICE PILL IMAGE
              Folotyn intravenous
              -
              40 mg/2 mL (20 mg/mL) vial
              Folotyn intravenous
              -
              20 mg/mL (1 mL) vial

              Copyright © 2010 First DataBank, Inc.

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              Formulary

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              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.
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              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.