Pralatrexate

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Supplement patients with vitamin B 12 mg intramuscularly every 8-10 weeks starting 10 weeks before the first dose and folic acid 1 to 1.25 mg orally once daily starting 10 days before the first dose.
• ( 2.1 ) The recommended dosage of Pralatrexate injection is 30 mg/m 2 intravenously over 3 to 5 minutes once weekly for 6 weeks in 7-week cycles.
• ( 2.1 ) For patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m 2 ), reduce the Pralatrexate injection dose to 15 mg/m 2 ( 2.1 ).
• 2.1 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 Pralatrexate injection.
• Continue folic acid during treatment with Pralatrexate injection and for 30 days after the last dose [see Warnings and Precautions ( 5.1 , 5.2 )].
• Vitamin B 12 Administer vitamin B 12 1 mg intramuscularly within 10 weeks prior to the first dose of Pralatrexate injection and every 8-10 weeks thereafter.
• Subsequent vitamin B 12 injections may be given the same day as treatment with Pralatrexate injection [see Warnings and Precautions ( 5.1 , 5.2 )].
• 2.2 Recommended Dosage The recommended dosage of Pralatrexate injection is 30 mg/m 2 intravenously over 3-5 minutes once weekly for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity.
• 2.3 Dosage Modifications for Renal Impairment and End Stage Renal Disease Severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 by MDRD):
• Reduce the Pralatrexate injection dose to 15 mg/m 2 [see Use in Specific Populations ( 8.6 )] .
• End stage renal disease (ESRD:
• eGFR less than 15 mL/min/1.73 m 2 by MDRD) with or without dialysis:
• Avoid administration.
• If the potential benefit of administration justifies the potential risk, monitor renal function and reduce the Pralatrexate injection dose based on adverse reactions [see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8.6 )] .
• 2.4 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 Pralatrexate injection 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 Pralatrexate Injection Dosage Modifications for Mucositis a Based National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) Mucositis Grade a on Day of Treatment Action Recommended Dose upon Recovery to Grade 0 or 1 Patients Without Severe Renal Impairment Patients with Severe Renal Impairment Grade 2 Omit dose Continue prior dose Continue prior dose Grade 2 recurrence Omit dose 20 mg/m 2 10 mg/m 2 Grade 3 Omit dose 20 mg/m 2 10 mg/m 2 Grade 4 Stop therapy Table 2 Pralatrexate Injection Dosage Modifications for Myelosuppression G-CSF=granulocyte colony-stimulating factor;
• GM-CSF=granulocyte macrophage colony-stimulating factor Blood Count on Day of Treatment Duration of Toxicity Action Recommended Dose Upon Recovery Patients Without Severe Renal Impairment Patients with Severe Renal Impairment Platelet less than 50,000/mcL 1 week Omit dose Continue prior dose Continue prior dose 2 weeks Omit dose 20 mg/m 2 10 mg/m 2 3 weeks Stop therapy ANC 500 to 1,000/mcL and no fever 1 week Omit dose Continue prior dose Continue prior dose ANC 500 to 1,000/mcL with fever or ANC less than 500/mcL 1 week Omit dose, give G-CSF or GM-CSF Continue prior dose with G-CSF or GM-CSF Continue prior dose with G-CSF or GM-CSF 2 weeks or recurrence Omit dose, give G-CSF or GM-CSF 20 mg/m 2 with G-CSF or GM-CSF 10 mg/m 2 with G-CSF or GM-CSF 3 weeks or 2 nd recurrence Stop therapy Table 3 Pralatrexate Injection Dosage Modifications for All Other Adverse Reactions a Based on NCI CTCAE version
• 3.0 Toxicity Grade a on Day of Treatment Action Recommended Dose upon Recovery to Grade 2 or Lower Patients Without Severe Renal Impairment Patients with Severe Renal Impairment Grade 3 Omit dose 20 mg/m 2 10 mg/m 2 Grade 4 Stop therapy
• 2.5 Preparation and Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Do not use any vials exhibiting particulate matter or discoloration.
• Pralatrexate injection is a hazardous drug.
• Follow applicable special handling and disposal procedures. 1 If Pralatrexate injection comes in contact with the skin, immediately and thoroughly wash with soap and water.
• If Pralatrexate injection comes in contact with mucous membranes, flush thoroughly with water.
• Aseptically withdraw the calculated dose from the appropriate number of vial(s) into a syringe for immediate use.
• Do not dilute Pralatrexate injection.
• Administer undiluted Pralatrexate injection intravenously over 3-5 minutes via the side port of a free-flowing 0.9% Sodium Chloride Injection.
• After withdrawal of dose, discard vial(s) including any unused portion.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of Pralatrexate injection in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• In the Study PDX-008, 36% of patients (n = 40) were 65 years of age and over.
• No overall differences in efficacy and safety were observed in patients based on age (< 65 years compared with ≥ 65 years).
• Due to the contribution of renal excretion to overall clearance of pralatrexate (approximately 34%), age-related decline in renal function may lead to a reduction in clearance and a commensurate increase in plasma exposure.
• In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
• Since elderly patients may be at higher risk, monitor more closely.
• Omit dose and subsequently adjust or discontinue therapy for adverse reactions [see Dosage and Administration ( 2.4 )].

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions are described elsewhere in the labeling:
• Myelosuppression [see Warnings and Precautions ( 5.1 )] Mucositis [see Warnings and Precautions ( 5.2 )] Dermatologic Reactions [see Warnings and Precautions ( 5.3 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.4 )] Hepatic Toxicity [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (>35%) are mucositis, thrombocytopenia, nausea, and fatigue.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
• Peripheral T-cell Lymphoma The safety of Pralatrexate injection was evaluated in Study PDX-008 [see Clinical Studies ( 14 )].
• Patients received Pralatrexate injection 30 mg/m 2 once weekly for 6 weeks in 7-week cycles.
• The median duration of treatment was 70 days (range: 1 day to 1.5 years).
• The majority of patients (69%, n = 77) remained at the target dose for the duration of treatment.
• Overall, 85% of scheduled doses were administered.
• Forty-four percent of patients (n = 49) experienced a serious adverse event while on study or within 30 days after their last dose of Pralatrexate injection.
• The most common serious adverse events (> 3%), regardless of causality, were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.
• One death from cardiopulmonary arrest in a patient with mucositis and febrile neutropenia was reported in this trial.
• Across clinical trials, deaths from mucositis, febrile neutropenia, sepsis, and pancytopenia occurred in 1.2% of patients who received doses ranging from 30 mg/m 2 to 325 mg/m 2 .
• Twenty-three percent of patients (n = 25) discontinued treatment with Pralatrexate injection due to adverse reactions.
• The most frequent adverse reactions reported as the reason for discontinuation of treatment were mucositis (6%) and thrombocytopenia (5%).
• The most common adverse reactions (> 35%) were mucositis, thrombocytopenia, nausea, and fatigue.
• Table 4 summarizes the adverse reactions in Study PDX-008.
• Table 4 Adverse Reactions in (≥ 10%) in Patients Who Received Pralatrexate Injection in Study PDX-008 a Mucositis includes stomatitis or mucosal inflammation of the gastrointestinal and genitourinary tracts. b Five patients with platelets < 10,000/mcL. c Liver function test abnormal includes increased ALT, increased AST, and increased transaminases Pralatrexate Injection N=111 All Grades (%) Grade 3 (%) Grade 4 (%) Any Adverse Reaction 100 43 31 Mucositis a 70 17 4 Thrombocytopenia b 41 14 19 b Nausea 40 4 0 Fatigue 36 5 2 Anemia 34 15 2 Constipation 33 0 0 Pyrexia 32 1 1 Edema 30 1 0 Cough 28 1 0 Epistaxis 26 0 0 Vomiting 25 2 0 Neutropenia 24 13 7 Diarrhea 21 2 0 Dyspnea 19 7 0 Anorexia 15 3 0 Hypokalemia 15 4 1 Rash 15 0 0 Pruritus 14 2 0 Pharyngolaryngeal pain 14 1 0 Liver function test abnormal c 13 5 0 Abdominal pain 12 4 0 Pain in extremity 12 0 0 Back pain 11 3 0 Leukopenia 11 3 4 Night sweats 11 0 0 Asthenia 10 1 0 Upper respiratory tract infection 10 1 0 Tachycardia 10 0 0
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Pralatrexate injection.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Dermatologic Reactions: Toxic epidermal necrolysis.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Folic Acid and Vitamin B 12 Supplementation Advise patients treated with Pralatrexate injection to take folic acid and vitamin B 12 to reduce the risk of possible side effects [see Dosage and Administration ( 2.1 )].
• Myelosuppression Inform patients of the risk of myelosuppression and to immediately contact their healthcare provider should any signs of infection develop, including fever.
• Inform patients to contact their healthcare provider if bleeding or symptoms of anemia occur [see Warnings and Precautions ( 5.1 )].
• Mucositis Inform patients of the signs and symptoms of mucositis.
• Instruct patients on ways to reduce the risk of its development, and on ways to maintain nutrition and control discomfort from mucositis if it occurs [see Warnings and Precautions ( 5.2 )] .
• Dermatologic Reactions Advise patients about the risks for and the signs and symptoms of dermatologic reactions.
• Instruct patients to immediately notify their healthcare provider if any skin reactions occur [see Warnings and Precautions ( 5.3 )].
• Tumor Lysis Syndrome Inform patients about the risk of and the signs and symptoms of tumor lysis syndrome.
• Patients should be instructed to notify their healthcare provider if they experience these symptoms [see Warnings and Precautions ( 5.4 )].
• Concomitant Medications Patients should be instructed to inform their healthcare provider if they are taking any concomitant medications including prescription drugs (such as trimethoprim/sulfamethoxazole and probenecid) and nonprescription drugs (such as nonsteroidal anti-inflammatory drugs) [see Drug Interactions ( 7.1 )].
• Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
• Advise females or reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 )] .
• Advise females patients of reproductive potential to use effective contraception during treatment with Pralatrexate injection and for 6 months after the final dose [see Use in Specific Populations ( 8.3 )] .
• Advise males with female partners of reproductive potential to use effective contraception during treatment with Pralatrexate injection and for at least 3 months after the final dose [see Use in Specific Populations ( 8.3 )] Lactation Advise females women not to breastfeed during treatment with Pralatrexate injection and for 1 week after the final dose [see Use in Specific Populations ( 8.2 )] .
• Manufactured for:
• Lake Zurich, IL 60047 www.fresenius-kabi.com/us Made in Germany 451756 Fresenius Kabi Logo

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection:
• 40 mg/2 mL (20 mg/mL) and 20 mg/mL clear yellow sterile solution in single-dose vial Injection:
• 20 mg/1 mL or 40 mg/2 mL in a single-dose vial ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Pralatrexate Injection is available in single-dose clear glass vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations:
• Product Code Unit of Sale Strength 550101 NDC 65219-550-01 20 mg/1 mL 552102 NDC 65219-552-02 40 mg/2 mL Store refrigerated at 2-8°C (36-46°F) [ see USP Controlled Cold Temperature] in original carton to protect from light.
• Pralatrexate Injection is a hazardous drug.
• Follow applicable special handling and disposal procedures. 1

Quoted from the official label, section “How Supplied”.

What is in it

• Pralatrexate is a dihydrofolate reductase inhibitor.
• Pralatrexate has the chemical name (2 S )-2[[4-[(1 RS )-1-[(2, 4-diaminopteridin-6-yl)methyl]but-3- ynyl]benzoyl]amino]pentanedioic acid.
• The molecular formula is C 23 H 23 N 7 O 5 and the molecular weight is 477.48 g/mol.
• Pralatrexate is a 1:1 racemic mixture of S- and R- diastereomers at the C10 position (indicated with *).
• The structural formula is as follows: Pralatrexate is an off-white to yellow solid.
• It is soluble in aqueous solutions at pH 6.5 or higher.
• Pralatrexate is practically insoluble in chloroform and ethanol.
• The pKa values are 3.25, 4.76, and 6.17.
• Pralatrexate Injection is supplied as a preservative-free, sterile, isotonic, non-pyrogenic clear yellow aqueous solution contained in a clear glass single-dose vial (Type I) for intravenous use.
• Each 1 mL of solution contains 20 mg of pralatrexate, sufficient sodium chloride to achieve an isotonic (280-300 mOsm) solution, and sufficient sodium hydroxide, and hydrochloric acid if needed, to adjust and maintain the pH at 7.5-8.5.
• Pralatrexate Injection is supplied as either 20 mg (1 mL) or 40 mg (2 mL) single-dose vials at a concentration of 20 mg/mL.
• Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

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