Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Existe información en español para pacientes y cuidadores, para acceder, haga clic sobre “Select” al lado de “I am a U.S. Patient / Caregiver”.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

pemetrexed ditromethamine vial Dosage and Administration (pemetrexed for injection)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Non-Squamous NSCLC

  • The recommended dose of Pemetrexed for Injection when administered with cisplatin for initial treatment of locally advanced or metastatic non-squamous NSCLC 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 administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.
  • The recommended dose of Pemetrexed for Injection for maintenance treatment of non-squamous NSCLC 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 after four cycles of platinum-based first-line chemotherapy.
  • The recommended dose of Pemetrexed for Injection for treatment of recurrent non-squamous NSCLC 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.

2.2 Recommended Dosage for Mesothelioma

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.

2.3 Renal Impairment

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)].

2.4 Premedication and Concomitant Medications to Mitigate Toxicity

Vitamin Supplementation

  • Initiate folic acid 400 mcg to 1000 mcg orally once daily, beginning 7 days before the first dose of Pemetrexed for Injection and continuing until 21 days after the last dose of Pemetrexed for Injection [see Warnings and Precautions (5.1)].
  • Administer vitamin B12, 1 mg intramuscularly, 1 week prior to the first dose of Pemetrexed for Injection and every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with Pemetrexed for Injection [see Warnings and Precautions (5.1)]. Do not substitute oral vitamin B12 for intramuscular vitamin B12.

Corticosteroids

  • Administer dexamethasone 4 mg orally twice daily for three consecutive days, beginning the day before each Pemetrexed for Injection administration.

2.5 Dosage Modification of Ibuprofen in Patients with Mild to Moderate Renal Impairment Receiving Pemetrexed for Injection

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)]:

  • Avoid administration of ibuprofen for 2 days before, the day of, and 2 days following administration of Pemetrexed for Injection.
  • Monitor patients more frequently for myelosuppression, renal, and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided.

2.6 Dosage Modifications for Adverse Reactions

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:

  • Recovery of non-hematologic toxicity to Grade 0–2,
  • Absolute neutrophil count (ANC) is 1500 cells/mm3 or higher, and
  • Platelet count is 100,000 cells/mm3 or higher.

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.

Table 1: Recommended Dosage Modifications for Adverse Reactions*
Toxicity in Most Recent Treatment CyclePemetrexed for Injection Dose Modification for Next Cycle
*
National Cancer Institute Common Toxicity Criteria for Adverse Events version 2 (NCI CTCAE v2)
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 bleeding50% of previous dose
Recurrent Grade 3 or 4 myelosuppression after 2 dose reductionsDiscontinue
Non-hematologic toxicity
Any Grade 3 or 4 toxicities EXCEPT mucositis or neurologic toxicity or diarrhea requiring hospitalization75% of previous dose
Grade 3 or 4 mucositis50% 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 toxicityPermanently discontinue
Recurrent Grade 3 or 4 non-hematologic toxicity after 2 dose reductionsPermanently 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

2.7 Preparation for Administration

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.

Table 2: Reconstitution and Further Dilution with 0.9% Sodium Chloride Injection, USP
100 mg vial500 mg vial1 gram vial
*
Do not use calcium containing solutions for reconstitution.
If not used immediately, store reconstituted, preservative-free product under refrigerated conditions [2°C to 8°C (36°F to 46°F)] for no longer than 24 hours from the time of reconstitution. Discard vial after 24 hours.
If not used immediately, store diluted, reconstituted product under refrigerated conditions [2°C to 8°C (36°F to 46°F)] for no more than 24 hours from the time of reconstitution. Discard after 24 hours.
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.
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event