The recommended dose of Pemetrexed for Injection when administered with cisplatin in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Pemetrexed for Injection 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 (8.6)].
Vitamin Supplementation
In patients with creatinine clearances between 45 mL/min and 79 mL/min, modify administration of ibuprofen as follows [see Warnings and Precautions (5.6), Drug Interactions (7) and Clinical Pharmacology (12.3)]:
Obtain complete blood count on Days 1, 8, and 15 of each cycle. Assess creatinine clearance prior to each cycle. Do not administer Pemetrexed for Injection if the creatinine clearance is less than 45 mL/min.
Delay initiation of the next cycle of Pemetrexed for Injection until:
Upon recovery, modify the dosage of Pemetrexed for Injection in the next cycle as specified in Table 1.
For dosing modifications for cisplatin, refer to the prescribing information for cisplatin.
| Toxicity in Most Recent Treatment Cycle | Pemetrexed for Injection 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 |
Pemetrexed for Injection is a hazardous drug. Follow applicable special handling and disposal procedures.1
Determine the number of vials needed, then reconstitute and further dilute Pemetrexed for Injection as follows:
Reconstitute each vial with 0.9% Sodium Chloride Injection, USP (preservative-free) AND further dilute prior to intravenous administration with 0.9% Sodium Chloride Injection, USP (preservative-free) as shown in Table 2.
| 100 mg vial | 500 mg vial | 1 gram vial | |
|---|---|---|---|
| |||
| Step 1 Reconstitute to achieve a 25 mg/mL concentration* | 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). | Reconstitute each 1-gram vial with 40 mL of 0.9% Sodium Chloride Injection, USP (preservative-free). |
| Step 2 Swirl and Inspect† | 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. Inspect reconstituted product visually for particulate matter and discoloration prior to further dilution. If particulate matter is observed, discard vial. | ||
| Step 3 Withdraw Calculated Dose | Withdraw the calculated dose of Pemetrexed for Injection from the vial(s) and discard vial with any unused portion. | ||
| Step 4 Further Dilute‡ | Further dilute Pemetrexed for Injection with 0.9% Sodium Chloride Injection, USP (preservative-free) to achieve a total volume of 100 mL for intravenous infusion. | ||
The recommended dose of Pemetrexed for Injection when administered with cisplatin in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Pemetrexed for Injection 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 (8.6)].
Vitamin Supplementation
In patients with creatinine clearances between 45 mL/min and 79 mL/min, modify administration of ibuprofen as follows [see Warnings and Precautions (5.6), Drug Interactions (7) and Clinical Pharmacology (12.3)]:
Obtain complete blood count on Days 1, 8, and 15 of each cycle. Assess creatinine clearance prior to each cycle. Do not administer Pemetrexed for Injection if the creatinine clearance is less than 45 mL/min.
Delay initiation of the next cycle of Pemetrexed for Injection until:
Upon recovery, modify the dosage of Pemetrexed for Injection in the next cycle as specified in Table 1.
For dosing modifications for cisplatin, refer to the prescribing information for cisplatin.
| Toxicity in Most Recent Treatment Cycle | Pemetrexed for Injection 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 |
Pemetrexed for Injection is a hazardous drug. Follow applicable special handling and disposal procedures.1
Determine the number of vials needed, then reconstitute and further dilute Pemetrexed for Injection as follows:
Reconstitute each vial with 0.9% Sodium Chloride Injection, USP (preservative-free) AND further dilute prior to intravenous administration with 0.9% Sodium Chloride Injection, USP (preservative-free) as shown in Table 2.
| 100 mg vial | 500 mg vial | 1 gram vial | |
|---|---|---|---|
| |||
| Step 1 Reconstitute to achieve a 25 mg/mL concentration* | 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). | Reconstitute each 1-gram vial with 40 mL of 0.9% Sodium Chloride Injection, USP (preservative-free). |
| Step 2 Swirl and Inspect† | 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. Inspect reconstituted product visually for particulate matter and discoloration prior to further dilution. If particulate matter is observed, discard vial. | ||
| Step 3 Withdraw Calculated Dose | Withdraw the calculated dose of Pemetrexed for Injection from the vial(s) and discard vial with any unused portion. | ||
| Step 4 Further Dilute‡ | Further dilute Pemetrexed for Injection with 0.9% Sodium Chloride Injection, USP (preservative-free) to achieve a total volume of 100 mL for intravenous infusion. | ||
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