Pemetrexed disodium heptahydrate
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment ALIMTA 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 ALIMTA 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 ALIMTA.
Monitor patients more frequently for myelosuppression, renal, and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided.
| a National Cancer Institute Common Toxicity Criteria for Adverse Events version 2 (NCI CTCAE v2). | |
| Toxicity in Most Recent Treatment Cycle | ALIMTA Dose Modification 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 | 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
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Preparation for Administration ALIMTA is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Calculate the dose of ALIMTA and determine the number of vials needed. Reconstitute ALIMTA to achieve a concentration of 25 mg/mL as follows: Reconstitute each 100-mg vial with 4.2 mL of 0.9% Sodium Chloride Injection, USP (preservative-free) Reconstitute each 500-mg vial with 20 mL of 0.9% Sodium Chloride Injection, USP (preservative-free) Do not use calcium-containing solutions for reconstitution.
Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in color from colorless to yellow or green-yellow. FURTHER DILUTION IS REQUIRED prior to administration. Store reconstituted, preservative-free product under refrigerated conditions [2-8°C (36-46°F)] for no longer than 24 hours from the time of reconstitution.
Discard vial after 24 hours. Inspect reconstituted product visually for particulate matter and discoloration prior to further dilution. If particulate matter is observed, discard vial. Withdraw the calculated dose of ALIMTA from the vial(s) and discard vial with any unused portion. Further dilute ALIMTA with 0.9% Sodium Chloride Injection (preservative-free) to achieve a total volume of 100 mL for intravenous infusion.
Store diluted, reconstituted product under refrigerated conditions [2-8°C (36-46°F)] for no more than 24 hours from the time of reconstitution. Discard after 24 hours.
Drug interactions
Check pemetrexed disodium heptahydrate against a medication listLabel text (2 paragraphs)
Ibuprofen increased risk of ALIMTA toxicity in patients with mild to moderate renal impairment. Modify the ibuprofen dosage as recommended for patients with a creatinine clearance between 45 mL/min and 79 mL/min. ( 2.5 , 5.6 , 7 ) Effects of Ibuprofen on Pemetrexed Ibuprofen increases exposure (AUC) of pemetrexed [see Clinical Pharmacology ( 12.3 )] . In patients with creatinine clearance between 45 mL/min and 79 mL/min: Avoid administration of ibuprofen for 2 days before, the day of, and 2 days following administration of ALIMTA [see Dosage and Administration ( 2.5 )] .
Monitor patients more frequently for myelosuppression, renal, and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided.
Contraindications
4 CONTRAINDICATIONS ALIMTA is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see Adverse Reactions ( 6.1 )]. History of severe hypersensitivity reaction to pemetrexed. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, ALIMTA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on ALIMTA use in pregnant women. In animal reproduction studies, intravenous administration of pemetrexed to pregnant mice during the period of organogenesis was teratogenic, resulting in developmental delays and malformations at doses lower than the recommended human dose of 500 mg/m 2 [see Data ] . Advise pregnant women of the potential risk to a fetus [see Use in Special Populations ( 8.3 )] . In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Pemetrexed was teratogenic in mice. Daily dosing of pemetrexed by intravenous injection to pregnant mice during the period of organogenesis increased the incidence of fetal malformations (cleft palate; protruding tongue; enlarged or misshaped kidney; and fused lumbar vertebra) at doses (based on BSA) 0.03 times the human dose of 500 mg/m 2 .
At doses, based on BSA, greater than or equal to 0.0012 times the 500 mg/m 2 human dose, pemetrexed administration resulted in dose-dependent increases in developmental delays (incomplete ossification of talus and skull bone; and decreased fetal weight).
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)
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