(pemetrexed for injection)

Prescribing Information
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2 DOSAGE AND ADMINISTRATION

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.
Medication Guide

MEDICATION GUIDE

PATIENT INFORMATION
PEMETREXED (peh-meh-TREX-ed) FOR INJECTION
for intravenous use
This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: June 2022            
What is Pemetrexed for Injection?
Pemetrexed for Injection is a prescription medicine used to treat:
  • a kind of lung cancer called non-squamous non-small cell lung cancer (NSCLC). Pemetrexed for Injection is used:
    • as the first treatment in combination with cisplatin when your lung cancer has spread (advanced NSCLC).
    • alone as maintenance treatment after you have received 4 cycles of chemotherapy that contains platinum for first treatment of your advanced NSCLC and your cancer has not progressed.
    • alone when your lung cancer has returned or spread after prior chemotherapy.
    Pemtrexed for Injection is not for use for the treatment of people with squamous cell, non-small cell lung cancer.
  • a kind of cancer called malignant pleural mesothelioma. This cancer affects the lining of the lungs and chest wall. Pemetrexed for Injection is used in combination with cisplatin as the first treatment for malignant pleural mesothelioma that cannot be removed by surgery or you are not able to have surgery.
Pemetrexed for Injection has not been shown to be safe and effective in children.
Do not take Pemetrexed for Injection if you have had a severe allergic reaction to any medicine that contains pemetrexed.
Before taking Pemetrexed for Injection, tell your healthcare provider about all of your medical conditions, including if you:
  • have kidney problems.
  • have had radiation therapy.
  • are pregnant or plan to become pregnant. Pemetrexed for Injection can harm your unborn baby.
    Females who are able to become pregnant:
    Your healthcare provider will check to see if you are pregnant before you start treatment with Pemetrexed for Injection.
    You should use effective birth control (contraception) during treatment with Pemetrexed for Injection and for 6 months after the last dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Pemetrexed for Injection.
    Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with Pemetrexed for Injection and for 3 months after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if Pemetrexed for Injection passes into breast milk. Do not breastfeed during treatment with Pemetrexed for Injection and for 1 week after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Tell your healthcare provider if you have kidney problems and take a medicine that contains ibuprofen. You should avoid taking ibuprofen for 2 days before, the day of, and 2 days after receiving treatment with Pemetrexed for Injection.
How is Pemetrexed for Injection given?
  • It is very important to take folic acid and vitamin B12 during your treatment with Pemetrexed for Injection to lower your risk of harmful side effects.
    • Take folic acid exactly as prescribed by your healthcare provider 1 time a day, beginning 7 days (1 week) before your first dose of Pemetrexed for Injection and continue taking folic acid until 21 days (3 weeks) after your last dose of Pemetrexed for Injection.
    • Your healthcare provider will give you vitamin B12 injections during treatment with Pemetrexed for Injection. You will get your first vitamin B12 injection 7 days (1 week) before your first dose of Pemetrexed for Injection, and then every 3 cycles.
  • Your healthcare provider will prescribe a medicine called corticosteroid for you to take 2 times a day for 3 days, beginning the day before each treatment with Pemetrexed for Injection.
  • Pemetrexed for Injection is given to you by intravenous (IV) infusion into your vein. The infusion is given over 10 minutes.
  • Pemetrexed for Injection is usually given once every 21 days (3 weeks).
What are the possible side effects of Pemetrexed for Injection?
Pemetrexed for Injection can cause serious side effects, including:
  • Low blood cell counts. Low blood cell counts can be severe, including low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), and low red blood cell counts (anemia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with Pemetrexed for Injection. Tell your healthcare provider right away if you have any signs of infection, fever, bleeding, or severe tiredness during your treatment with Pemetrexed for Injection.
  • Kidney problems, including kidney failure. Pemetrexed for Injection can cause severe kidney problems that can lead to death. Severe vomiting or diarrhea can lead to loss of fluids (dehydration) which may cause kidney problems to become worse. Tell your healthcare provider right away if you have a decrease in amount of urine.
  • Severe skin reactions. Severe skin reactions that may lead to death can happen with Pemetrexed for Injection. Tell your healthcare provider right away if you develop blisters, skin sores, skin peeling, or painful sores, or ulcers in your mouth, nose, throat or genital area.
  • Lung problems (pneumonitis). Pemetrexed for Injection can cause serious lung problems that can lead to death. Tell your healthcare provider right away if you get any new or worsening symptoms of shortness of breath, cough, or fever.
  • Radiation recall. Radiation recall is a skin reaction that can happen in people who have received radiation treatment in the past and are treated with Pemetrexed for Injection. Tell your healthcare provider if you get swelling, blistering, or a rash that looks like a sunburn in an area that was previously treated with radiation.
The most common side effects of Pemetrexed for Injection when given alone are:
  • tiredness
  • nausea
  • loss of appetite
The most common side effects of Pemetrexed for Injection when given with cisplatin are:
  • vomiting
  • swelling or sores in your mouth or sore throat
  • constipation
  • low white blood cell counts (neutropenia)
  • low platelet counts (thrombocytopenia)
  • low red blood cell counts (anemia)
Pemetrexed for Injection may cause fertility problems in males. This may affect your ability to father a child. It is not known if these effects are reversible. Talk to your healthcare provider if this is a concern for you.
Your healthcare provider will do blood tests to check for side effects during treatment with Pemetrexed for Injection. Your healthcare provider may change your dose of Pemetrexed for Injection, delay treatment, or stop treatment if you have certain side effects.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the side effects of Pemetrexed for Injection. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.
General information about the safe and effective use of Pemetrexed for Injection.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
You can ask your pharmacist or healthcare provider for information about Pemetrexed for Injection that is written for health professionals.
What are the ingredients in Pemetrexed for Injection?
Active ingredient: pemetrexed
Inactive ingredient: mannitol

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Manufactured by: Zydus Hospira Oncology Private Ltd.
Ahmedabad 382-213, Gujarat, India

Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA
LAB-1264-1.0
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