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Alimta

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Overview

What is Alimta?

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 CHNNaO•7HO and a molecular weight of 597.49. The structural formula is as follows:

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 106 mg mannitol. Each 500-mg vial of ALIMTA contains 500 mg pemetrexed (equivalent to 699 mg pemetrexed disodium heptahydrate) and 500 mg mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH.



What does Alimta look like?



What are the available doses of Alimta?

For Injection: 100 mg or 500 mg lyophilized powder in single-dose vial ()

What should I talk to my health care provider before I take Alimta?

Lactation: Advise not to breastfeed. ()

How should I use Alimta?

ALIMTA is indicated for:

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 500 mg/m as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. (, , )

Initiate folic acid 400 mcg to 1000 mcg orally, once daily, beginning 7 days prior to the first dose of ALIMTA and continue until 21 days after the last dose of ALIMTA. ()

Administer vitamin B, 1 mg intramuscularly, 1 week prior to the first dose of ALIMTA and every 3 cycles. ()

Administer dexamethasone 4 mg orally, twice daily the day before, the day of, and the day after ALIMTA administration. ()


What interacts with Alimta?

Sorry No Records found


What are the warnings of Alimta?

Sorry No Records found


What are the precautions of Alimta?

Sorry No Records found


What are the side effects of Alimta?

Sorry No records found


What should I look out for while using Alimta?

ALIMTA is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed


What might happen if I take too much Alimta?

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.


How should I store and handle Alimta?

Storage and HandlingStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. ALIMTA is a cytotoxic drug. Follow applicable special handling and disposal procedures. Storage and HandlingStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. ALIMTA is a cytotoxic drug. Follow applicable special handling and disposal procedures. Storage and HandlingStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. ALIMTA is a cytotoxic drug. Follow applicable special handling and disposal procedures. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet. CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate:CYSTAGON Capsules, 50 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9040-05bottles of 500 capsulesCYSTAGON Capsules, 150 mg are white, opaque capsules printed with on the body and on the cap. They are available as follows:NDC 0378-9045-05bottles of 500 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:The following information is available for patients and/or guardians in the patient leaflet.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

ALIMTA is a folate analog metabolic inhibitor that disrupts folate-dependent metabolic processes essential for cell replication. In vitro studies show that pemetrexed inhibits thymidylate synthase (TS), dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase (GARFT), which are folate-dependent enzymes involved in the de novo biosynthesis of thymidine and purine nucleotides. Pemetrexed is taken into cells by membrane carriers such as the reduced folate carrier and membrane folate binding protein transport systems. Once in the cell, pemetrexed is converted to polyglutamate forms by the enzyme folylpolyglutamate synthetase. The polyglutamate forms are retained in cells and are inhibitors of TS and GARFT.

Non-Clinical Toxicology
ALIMTA is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed

None have been described. CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi Syndrome as well as vitamin D and thyroid hormone.

ALIMTA can cause severe myelosuppression resulting in a requirement for transfusions and which may lead to neutropenic infection. The risk of myelosuppression is increased in patients who do not receive vitamin supplementation. In Study JMCH, incidences of Grade 3-4 neutropenia (38% versus 23%), thrombocytopenia (9% versus 5%), febrile neutropenia (9% versus 0.6%), and neutropenic infection (6% versus 0) were higher in patients who received ALIMTA plus cisplatin without vitamin supplementation as compared to patients who were fully supplemented with folic acid and vitamin B prior to and throughout ALIMTA plus cisplatin treatment.

Initiate supplementation with oral folic acid and intramuscular vitamin B prior to the first dose of ALIMTA; continue vitamin supplementation during treatment and for 21 days after the last dose of ALIMTA to reduce the severity of hematologic and gastrointestinal toxicity of ALIMTA . Obtain a complete blood count at the beginning of each cycle. Do not administer ALIMTA until the ANC is at least 1500 cells/mm and platelet count is at least 100,000 cells/mm. Permanently reduce ALIMTA in patients with an ANC of less than 500 cells/mm or platelet count of less than 50,000 cells/mm in previous cycles .

In Studies JMDB and JMCH, among patients who received vitamin supplementation, incidence of Grade 3-4 neutropenia was 15% and 23%, the incidence of Grade 3-4 anemia was 6% and 4%, and incidence of Grade 3-4 thrombocytopenia was 4% and 5%, respectively. In Study JMCH, 18% of patients in the ALIMTA arm required red blood cell transfusions compared to 7% of patients in the cisplatin arm In Studies JMEN, PARAMOUNT, and JMEI, where all patients received vitamin supplementation, incidence of Grade 3-4 neutropenia ranged from 3% to 5%, and incidence of Grade 3-4 anemia ranged from 3% to 5%.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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