Alimta Pemetrexed disodium

Get an overview of ALIMTA (pemetrexed disodium injection, powder, lyophilized, for solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Alimta can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Alimta.

Drug Basics

Brand Name: Alimta

Generic Name: PEMETREXED DISODIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Data Current As Of: 2020-04-27

Indications and Usage (1.1) 01/2019
Dosage and Administration (2.1) 01/2019

indications & usage

ALIMTA® is a folate analog metabolic inhibitor indicated:

  • in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. (1.1)
  • 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: ALIMTA 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)

non-squamous non-small cell lung cancer (nsclc)

ALIMTA® is indicated:

  • in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
  • in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
  • 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.
  • as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.

Limitations of Use: ALIMTA is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies (14.1)].

mesothelioma

ALIMTA is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

drug interactions

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.

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Premedication and Concomitant Medication: Instruct patients to take folic acid as directed and to keep appointments for vitamin B12 injections to reduce the risk of treatment-related toxicity. Instruct patients of the requirement to take corticosteroids to reduce the risks of treatment-related toxicity [see Dosage and Administration (2.4 ) and Warnings and Precautions (5.1)].

Myelosuppression: Inform patients of the risk of low blood cell counts and instruct them to immediately contact their physician for signs of infection, fever, bleeding, or symptoms of anemia [see Warnings and Precautions (5.1)].

Renal Failure: Inform patients of the risks of renal failure, which may be exacerbated in patients with dehydration arising from severe vomiting or diarrhea. Instruct patients to immediately contact their healthcare provider for a decrease in urine output [see Warnings and Precautions (5.2)].

Bullous and Exfoliative Skin Disorders: Inform patients of the risks of severe and exfoliative skin disorders. Instruct patients to immediately contact their healthcare provider for development of bullous lesions or exfoliation in the skin or mucous membranes [see Warnings and Precautions (5.3)].

Interstitial Pneumonitis: Inform patients of the risks of pneumonitis. Instruct patients to immediately contact their healthcare provider for development of dyspnea or persistent cough [see Warnings and Precautions (5.4)].

Radiation Recall: Inform patients who have received prior radiation of the risks of radiation recall. Instruct patients to immediately contact their healthcare provider for development of inflammation or blisters in an area that was previously irradiated [see Warnings and Precautions (5.5)].

Increased Risk of Toxicity with Ibuprofen in Patients with Renal Impairment: Advise patients with mild to moderate renal impairment of the risks associated with concomitant ibuprofen use and instruct them to avoid use of all ibuprofen containing products for 2 days before, the day of, and 2 days following administration of ALIMTA [see Dosage and Administration (2.5), Warnings and Precautions (5.6), and Drug Interactions (7)].

Embryo-Fetal Toxicity: Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with ALIMTA and for 6 months after the final dose. Advise females to inform their prescriber of a known or suspected pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALIMTA and for 3 months after the final dose [see Warnings and Precautions (5.7) and Use in Specific Populations (8.3)].

Lactation: Advise women not to breastfeed during treatment with ALIMTA and for 1 week after the final dose [see Use in Specific Populations (8.2)].

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
Copyright © 2004, 2019, Eli Lilly and Company. All rights reserved.

ALM-0004-USPI-20190130

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: January 2019

PATIENT INFORMATION
ALIMTA ® (uh-LIM-tuh)
(pemetrexed for injection)
What is ALIMTA?
ALIMTA is a prescription medicine used to treat:
  • a kind of lung cancer called non-squamous non-small cell lung cancer (NSCLC). ALIMTA is used:
    • as the first treatment in combination with pembrolizumab and platinum chemotherapy when your lung cancer with no abnormal EGFR or ALK gene has spread (advanced NSCLC).
    • 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.
  • a kind of cancer called malignant pleural mesothelioma. This cancer affects the lining of the lungs and chest wall. ALIMTA 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.
It is not known if ALIMTA is safe and effective in children.
Do not take ALIMTA: if you have had a severe allergic reaction to any medicine that contains pemetrexed.
Before taking ALIMTA, 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. ALIMTA can harm your unborn baby.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with ALIMTA and for 6 months after the final dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ALIMTA.
    • Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ALIMTA and for 3 months after the final dose.
  • are breastfeeding or plan to breastfeed. It is not known if ALIMTA passes into breast milk. Do not breastfeed during treatment with ALIMTA and for 1 week after the final 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 ALIMTA.
How is ALIMTA given?
  • It is very important to take folic acid and vitamin B 12 during your treatment with ALIMTA 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 ALIMTA and continue taking folic acid until 21 days (3 weeks) after your last dose of ALIMTA.
    • Your healthcare provider will give you vitamin B12 injections during treatment with ALIMTA. You will get your first vitamin B12 injection 7 days (1 week) before your first dose of ALIMTA, 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 ALIMTA.
  • ALIMTA is given to you by intravenous (IV) infusion into your vein. The infusion is given over 10 minutes.
  • ALIMTA is usually given once every 21 days (3 weeks).
What are the possible side effects of ALIMTA?
ALIMTA 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 a blood test to check your blood cell counts regularly during your treatment with ALIMTA. Tell your healthcare provider right away if you have any signs of infection, fever, bleeding, or severe tiredness during your treatment with ALIMTA.
  • Kidney problems, including kidney failure. ALIMTA 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 ALIMTA. 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). ALIMTA 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 ALIMTA. 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 ALIMTA when given alone are:
  • tiredness
  • loss of appetite
The most common side effects of ALIMTA 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)
The most common side effects of ALIMTA when given with pembrolizumab and platinum chemotherapy are:
  • nausea
  • diarrhea
  • rash
  • cough
  • fever
ALIMTA 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 test to check for side effects during treatment with ALIMTA. Your healthcare provider may change your dose of ALIMTA, 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 ALIMTA. 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 ALIMTA.
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 ALIMTA that is written for health professionals.
What are the ingredients in ALIMTA?
Active ingredient: pemetrexed
Inactive ingredients: mannitol, hydrochloric acid and/or sodium hydroxide may have been added to adjust pH.
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 2004, 2019, Eli Lilly and Company. All rights reserved.
ALM-0004-PPI-20190130
For more information, go to www. ALIMTA.com or call 1-800-LILLY-RX (1-800-545-5979).

PACKAGE CARTON – ALIMTA 100 mg single-dose vial

NDC 0002-7640-01

Single-Dose Vial

VL7640

ALIMTA®

pemetrexed for injection

100 mg

For intravenous use only.

Rx only

www.ALIMTA.com

Lilly

alimta 100mg 011 02.jpg

PACKAGE CARTON – ALIMTA 500 mg single-dose vial

Single-Dose Vial

NDC 0002-7623-01

VL7623

ALIMTA®

pemetrexed for injection

500 mg

For intravenous use only.

Rx only

www.ALIMTA.com

Lilly

alimta 500mg 010 02.jpg

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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