Dosing & Uses
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
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

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
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
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.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
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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Patient Handout
Formulary
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