(pemetrexed for injection)

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION.

PEMETREXED FOR INJECTION, for intravenous use
Initial U.S. Approval: 2004

INDICATIONS AND USAGE

Pemetrexed for Injection is a folate analog metabolic inhibitor indicated:

  • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1)
  • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1)
  • As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1)
  • Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1)
  • Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2)

DOSAGE AND ADMINISTRATION

  • The recommended dose of Pemetrexed for Injection, administered as a single agent or with cisplatin, in patients with creatinine clearance of 45 mL/minute or greater is 500 mg/m2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. (2.1, 2.2)
  • Initiate folic acid 400 mcg to 1000 mcg orally, once daily, beginning 7 days prior to the first dose of Pemetrexed for Injection and continue until 21 days after the last dose of Pemetrexed for Injection. (2.4)
  • Administer vitamin B12, 1 mg intramuscularly, 1 week prior to the first dose of Pemetrexed for Injection and every 3 cycles. (2.4)
  • Administer dexamethasone 4 mg orally, twice daily the day before, the day of, and the day after Pemetrexed for Injection administration. (2.4)

DOSAGE FORMS AND STRENGTHS

For Injection: 100 mg, 500 mg or 1 gram lyophilized powder in a single-dose vial. (3)

CONTRAINDICATIONS

History of severe hypersensitivity reaction to pemetrexed. (4)

WARNINGS AND PRECAUTIONS

  • Myelosuppression: Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer Pemetrexed for Injection when the absolute neutrophil count is less than 1500 cells/mm3 and platelets are less than 100,000 cells/mm3. Initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of Pemetrexed for Injection. (2.4, 5.1)
  • Renal Failure: Can cause severe, and sometimes fatal, renal failure. Do not administer when creatinine clearance is less than 45 mL/min. (2.3, 5.2)
  • Bullous and Exfoliative Skin Toxicity: Permanently discontinue for severe and life-threatening bullous, blistering or exfoliating skin toxicity. (5.3)
  • Interstitial Pneumonitis: Withhold for acute onset of new or progressive unexplained pulmonary symptoms. Permanently discontinue if pneumonitis is confirmed. (5.4)
  • Radiation Recall: Can occur in patients who received radiation weeks to years previously; permanently discontinue for signs of radiation recall. (5.5)
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (5.7, 8.1, 8.3)

ADVERSE REACTIONS

  • The most common adverse reactions (incidence ≥20%) of pemetrexed, when administered as a single agent, are fatigue, nausea, and anorexia. (6.1)
  • The most common adverse reactions (incidence ≥20%) of pemetrexed when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Ibuprofen increased risk of Pemetrexed for Injection 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)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2022

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
For more information, go to www.pfizer.com or call 1-800-438-1985.

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