Pemetrexed
Dosing in kidney impairment
Renal Impairment PEMFEXY dosing recommendations are provided for patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater [see Dosage and Administration ( 2.1 , 2.2 )] . There is no recommended dose for patients whose creatinine clearance is less than 45 mL/min [see Use in Specific Populations] .
Dosage Modification of Ibuprofen in Patients with Mild to Moderate Renal Impairment Receiving PEMFEXY In patients with creatinine clearances between 45 mL/min and 79 mL/min, modify administration of ibuprofen as follows [see Warnings and Precautions, Drug Interactions and Clinical Pharmacology] . Avoid administration of ibuprofen for 2 days before, the day of, and 2 days following administration of PEMFEXY.
Monitor patients more frequently for myelosuppression, renal, and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided.
| Table 1: Recommended Dosage Modifications for Adverse Reactionsa | |
| a National Cancer Institute Common Toxicity Criteria for Adverse Events version 2 (NCI CTCAE v2) | |
| Toxicity in Most Recent Treatment Cycle | PEMFEXY Dosage Modifications for Next Cycle |
| Myelosuppressive toxicity [see Warnings and Precautions (5.1)] | |
| ANC less than 500/mm3 and platelets greater than or equal to 50,000/mm3 OR Platelet count less than 50,000/mm3 without bleeding. | 75% of previous dose |
| Platelet count less than 50,000/mm3 with bleeding | 50% of previous dose |
| Recurrent Grade 3 or 4 myelosuppression after 2 dose reductions | Permanently discontinue. |
| Non-hematologic toxicity | |
| Any Grade 3 or 4 toxicities EXCEPT mucositis or neurologic toxicity OR Diarrhea requiring hospitalization | 75% of previous dose |
| Grade 3 or 4 mucositis | 50% of previous dose |
| Renal toxicity [see Warnings and Precautions (5.2)] | Withhold until creatinine clearance is 45 mL/min or greater. |
| Grade 3 or 4 neurologic toxicity | Permanently discontinue. |
| Recurrent Grade 3 or 4 non-hematologic toxicity after 2 dose reductions | Permanently discontinue. |
| Severe and life-threatening skin toxicity [see Warnings and Precautions (5.3)] | Permanently discontinue. |
| Interstitial pneumonitis [see Warnings and Precautions (5.4)] | Permanently discontinue. |
Preparation and administration
Preparation and Administration PEMFEXY is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Calculate the dose of PEMFEXY and determine the number of vials needed. Withdraw the calculated dose of PEMFEXY from the vial(s). Store unused portion in vial refrigerated at 2°C to 8°C (36°F to 46°F) for up to 28 days.
Each vial contains 500 mg pemetrexed per 20 mL (25 mg/mL). The vial contains an excess of pemetrexed to facilitate delivery of labeled amount. Dilute PEMFEXY with 5% Dextrose in Water, USP or Normal Saline to achieve a total volume of 100 mL for intravenous infusion. Do not use other diluents, such as Lactated Ringer’s Injection, USP or Ringer’s Injection, USP.
Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if particulate matter or discoloration is observed. Administer PEMFEXY as an intravenous infusion over 10 minutes. Store diluted PEMFEXY refrigerated at 2°C to 8°C (36 °F to 46°F) for no more than 48 hours.
PEMFEXY diluted with 5% Dextrose in Water, USP can also be stored at ambient room temperature and room light for no more than 48 hours. When prepared as directed, infusion solutions of PEMFEXY contain no antimicrobial preservatives. Discard after 48 hours. PEMFEXY is compatible with polyolefin infusion bags with polyvinyl chloride (PVC) ports.