Pralatrexate
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From MedlinePlus, U.S. National Library of Medicine
Folate Analog Metabolic Inhibitor
Dosing in kidney impairment
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] . 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, Use in Specific Populations] .
| a Based National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) | |||
| Mucositis Gradea 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/m2 | 10 mg/m2 |
| Grade 3 | Omit dose | 20 mg/m2 | 10 mg/m2 |
| Grade 4 | Stop therapy | ||
| 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/m2 | 10 mg/m2 | |
| 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/m2 with G-CSF or GM-CSF | 10 mg/m2 with G-CSF or GM-CSF | |
| 3 weeks or 2nd recurrence | Stop therapy | |||
| a Based on NCI CTCAE version 3.0 | |||
| Toxicity Gradea 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/m2 | 10 mg/m2 |
| Grade 4 | Stop therapy | ||
Preparation and administration
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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.
Drug interactions
Check pralatrexate against a medication listLabel text (2 paragraphs)
Avoid coadministration with probenecid or nonsteroidal anti-inflammatory drugs. If coadministration is unavoidable, monitor for increased risk of adverse reactions. ( 7.1 )
7.1 Effects of Other Drugs on Pralatrexate Injection Coadministration of Pralatrexate injection with probenecid increased pralatrexate plasma concentrations [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of adverse reactions. Avoid coadministration with probenecid or nonsteroidal anti-inflammatory drugs. If coadministration is unavoidable, monitor for increased risk of adverse reactions.
Contraindications
None None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )], Pralatrexate injection can cause fetal harm when administered to a pregnant woman. There are insufficient data on Pralatrexate injection use in pregnant women to evaluate for a drug- associated risk. Pralatrexate injection was embryotoxic and fetotoxic in rats and rabbits when administered during organogenesis at doses about 1.2% (0.012 times) of the clinical dose on a mg/m 2 basis. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Pralatrexate was embryotoxic and fetotoxic in rats at intravenous doses of 0.06 mg/kg/day (0.36 mg/m 2 /day or about 1.2% of the clinical dose on a mg/m 2 basis) given on gestation days 7 through 20. Treatment with pralatrexate caused a dose-dependent decrease in fetal viability manifested as an increase in late, early, and total resorptions. There was also a dosedependent increase in post-implantation loss.
In rabbits, intravenous doses of 0.03 mg/kg/day (0.36 mg/m 2 /day) or greater given on gestation days 8 through 21 also caused abortion and fetal lethality. This toxicity manifested as early and total resorptions, post-implantation loss, and a decrease in the total number of live fetuses.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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