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ALIMTA- pemetrexed disodium injection, powder, lyophilized, for solution


  1. Patient Information
  2. Before Taking Alimta, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  3. How Is Alimta Given?
  4. Alimta Can Cause Serious Side Effects, Including:
  5. The Most Common Side Effects Of Alimta When Given Alone Are:
  6. The Most Common Side Effects Of Alimta When Given With Cisplatin Are:
  7. The Most Common Side Effects Of Alimta When Given With Pembrolizumab And Platinum Chemotherapy Are:
  8. Active Ingredient:
  9. Inactive Ingredients:
  10. Revised: 8/2019document Id:

Patient 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 B12injections to reduce the risk of treatment-related toxicity. Instruct patients of the requirement to take corticosteroids to reduce the risks of treatment-related toxicity[
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.
    • Femaleswho 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.
    • Maleswith 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 B12during 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 B12injections during treatment with ALIMTA. You will get your first vitamin B12injection 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).

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
  • nausea
  • 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: 

  • tiredness/weakness
  • constipation
  • loss of appetite
  • vomiting
  • shortness of breath
  • 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.

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

PACKAGE CARTON     ALIMTA 100 mg single-dose vial

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

PACKAGE CARTON     ALIMTA 500 mg single-dose vial
ALIMTA
pemetrexed disodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0002-7640
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pemetrexed disodium heptahydrate(UNII: 9T47E4OM16) (Pemetrexed - UNII:04Q9AIZ7NO)Pemetrexed100 mg in 4 mL
Inactive Ingredients
Ingredient NameStrength
Mannitol(UNII: 3OWL53L36A)106 mg in 4 mL
Hydrochloric acid(UNII: QTT17582CB)
Sodium hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0002-7640-011 in 1 CARTON01/15/2008
14 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02146209/07/2007
ALIMTA
pemetrexed disodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0002-7623
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pemetrexed disodium heptahydrate(UNII: 9T47E4OM16) (Pemetrexed - UNII:04Q9AIZ7NO)Pemetrexed500 mg in 20 mL
Inactive Ingredients
Ingredient NameStrength
Mannitol(UNII: 3OWL53L36A)500 mg in 20 mL
Hydrochloric acid(UNII: QTT17582CB)
Sodium hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0002-7623-011 in 1 CARTON02/13/2004
120 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02146202/04/2004
Labeler -Eli Lilly and Company (006421325)

Revised: 8/2019document Id: 

d30721e5-0a06-400e-aee3-bb3fa0a444ecSet id: f5a860f3-37ec-429c-ae04-9c88d7c55c08Version: 54Effective Time: 20190809Eli Lilly and Company



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