Generic Name
Pemetrexed
Brand Names
Alimta, AXTLE, Pemfexy, Pemrydi Rtu
FDA approval date: February 04, 2004
Classification: Folate Analog Metabolic Inhibitor
Form: Injection, Solution
What is Alimta (Pemetrexed)?
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 non-small cell lung cancer , with no EGFR or ALK genomic tumor aberrations.
Approved To Treat
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Brand Information
Alimta (Pemetrexed disodium)
1DOSAGE FORMS AND STRENGTHS
For injection: 100 mg or 500 mg pemetrexed as a white to light-yellow or green-yellow lyophilized powder in single-dose vials for reconstitution.
2CONTRAINDICATIONS
ALIMTA is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Myelosuppression
- Renal failure
- Bullous and exfoliative skin toxicity
- Interstitial pneumonitis
- Radiation recall
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
In clinical trials, the most common adverse reactions (incidence ≥20%) of ALIMTA, when administered as a single agent, are fatigue, nausea, and anorexia. The most common adverse reactions (incidence ≥20%) of ALIMTA, when administered in combination with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. The most common adverse reactions (incidence ≥20%) 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.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ALIMTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Blood and Lymphatic System — immune-mediated hemolytic anemia
- Gastrointestinal — colitis, pancreatitis
- General Disorders and Administration Site Conditions — edema
- Injury, poisoning, and procedural complications — radiation recall
- Respiratory — interstitial pneumonitis
- Skin — Serious and fatal bullous skin conditions, Stevens-Johnson syndrome, and toxic epidermal necrolysis
4OVERDOSAGE
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.
5DESCRIPTION
ALIMTA (pemetrexed for injection) is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium heptahydrate, has the chemical name L-glutamic acid,
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.
6REFERENCES
- “OSHA Hazardous Drugs.”
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
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 () and Warnings and Precautions (].
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 (.
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 (.
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 (.
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 (.
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 (.
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 (.
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 (. Advise females of reproductive potential to use effective contraception during treatment with ALIMTA and for 6 months after the last 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 last dose [see Warnings and Precautions (.
Lactation: Advise women not to breastfeed during treatment with ALIMTA and for 1 week after the last dose [see Use in Specific Populations (.
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