Pemetrexed Disodium (Alimta)

Trade Name : Alimta

Eli Lilly and Company

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 500 mg/20mL

PEMETREXED DISODIUM HEPTAHYDRATE Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pemetrexed Disodium (Alimta) which is also known as Alimta and Manufactured by Eli Lilly and Company. It is available in strength of 500 mg/20mL per ml. Read more

Pemetrexed Disodium (Alimta) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • ALIMTA is a folate analog metabolic inhibitor indicated:n
  • 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. ()n
  • in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). ()n
  • 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. ()n
  • as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ()n ALIMTA is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. ()n
  • 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. ()n
  • No data
  • The recommended dose of ALIMTA administered with pembrolizumab and platinum chemotherapy in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45u00a0mL/min or greater is 500u00a0mg/m as an intravenous infusion over 10u00a0minutes, administered after pembrolizumab and prior to platinum chemotherapy, on Day 1 of each 21-day cycle. ()n
  • The recommended dose of ALIMTA, administered as a single agent or with cisplatin, in patients with creatinine clearance of 45 mL/minute or greater is 500u00a0mg/m as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. (, )n
  • Initiate folic acid 400u00a0mcg to 1000u00a0mcg orally, once daily, beginning 7 days prior to the first dose of ALIMTA and continue until 21 days after the last dose of ALIMTA. ()n
  • Administer vitamin B, 1u00a0mg intramuscularly, 1 week prior to the first dose of ALIMTA and every 3 cycles. ()n
  • Administer dexamethasone 4u00a0mg orally, twice daily the day before, the day of, and the day after ALIMTA administration. ()n
  • For injection: 100u00a0mg or 500u00a0mg pemetrexed as a white to light-yellow or green-yellow lyophilized powder in single-dose vials for reconstitution.n
  • For Injection: 100u00a0mg or 500u00a0mg lyophilized powder in single-dose vial ()n
  • ALIMTA is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed n
  • History of severe hypersensitivity reaction to pemetrexed. ()n
  • No data
  • Myelosuppression: Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer ALIMTA when the absolute neutrophil count is less than 1500u00a0cells/mm and platelets are less than 100,000u00a0cells/mm. Initiate supplementation with oral folic acid and intramuscular vitamin B to reduce the severity of hematologic and gastrointestinal toxicity of ALIMTA. (, )n
  • Renal Failure: Can cause severe, and sometimes fatal, renal failure. Do not administer when creatinine clearance is less than 45u00a0mL/min. (, )n
  • Bullous and Exfoliative Skin Toxicity: Permanently discontinue for severe and life-threatening bullous, blistering or exfoliating skin toxicity. ()n
  • Interstitial Pneumonitis: Withhold for acute onset of new or progressive unexplained pulmonary symptoms. Permanently discontinue if pneumonitis is confirmed. ()n
  • Radiation Recall: Can occur in patients who received radiation weeks to years previously; permanently discontinue for signs of radiation recall. ()n
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (, , )n
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:n
  • To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The most common adverse reactions (incidence u226520%) of ALIMTA, when administered as a single agent are fatigue, nausea, and anorexia. ()n
  • The most common adverse reactions (incidence u226520%) of ALIMTA when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. ()n
  • The most common adverse reactions (incidence u226520%) of ALIMTA when administered in combination with pembrolizumab and platinum chemotherapy are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia. ()n
  • Effects of Ibuprofen on Pemetrexed
  • Ibuprofen increases exposure (AUC) of pemetrexed . In patients with creatinine clearance between 45u00a0mL/min and 79u00a0mL/min:n
  • 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 45u00a0mL/min and 79u00a0mL/min. (, , )n
  • Lactation: Advise not to breastfeed. ()n
  • No drugs are approved for the treatment of ALIMTA overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of ALIMTA overdosage. It is not known whether pemetrexed is dialyzable.n
  • ALIMTA (pemetrexed for injection) is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium heptahydrate, has the chemical name L-glutamic acid, -[4-[2-(2-amino-4,7-dihydro-4-oxo-1-pyrrolo[2,3-]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate with a molecular formula of CHNNaOu20227HO and a molecular weight of 597.49. The structural formula is as follows:n
  • ALIMTA is a sterile white-to-light yellow or green-yellow lyophilized powder in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of ALIMTA contains 100 mg pemetrexed (equivalent to 139.8 mg pemetrexed disodium heptahydrate) and 106u00a0mg mannitol. Each 500-mg vial of ALIMTA contains 500 mg pemetrexed (equivalent to 699 mg pemetrexed disodium heptahydrate) and 500u00a0mg mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH.n
  • No data
  • No carcinogenicity studies have been conducted with pemetrexed. Pemetrexed was clastogenic in an in vivo micronucleus assay in mouse bone marrow but was not mutagenic in multiple in vitro tests (Ames assay, Chinese Hamster Ovary cell assay).n
  • Pemetrexed administered intraperitoneally at doses of u22650.1u00a0mg/kg/day to male mice (approximately 0.006 times the recommended human dose based on BSA) resulted in reduced fertility, hypospermia, and testicular atrophy.n
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling ().n
  • No data
  • PACKAGE CARTON u2013 ALIMTA 100 mg single-dose vial
  • NDC 0002-7640-01n
  • Single-Dose Vialn
  • VL7640n
  • ALIMTAn
  • pemetrexed for injectionn
  • 100 mgn
  • For intravenous use only.n
  • Rx onlyn
  • www.ALIMTA.comn
  • Lillyn
  • PACKAGE CARTON u2013 ALIMTA 500 mg single-dose vial
  • Single-Dose Vialn
  • NDC 0002-7623-01n
  • VL7623n
  • ALIMTAn
  • pemetrexed for injectionn
  • 500 mgn
  • For intravenous use only.n
  • Rx onlyn
  • www.ALIMTA.comn
  • Lillyn

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