Clinical Information
Gen. Code and Des.
53600 pemetrexed disodium INTRAVEN VIAL 500 MG
GCN and Des.
21179 pemetrexed disodium INTRAVEN VIAL 500 MG
Strength
500MG
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
8495 pemetrexed disodium 150399238
Inactive Ingredients
2272 mannitol 69658
These highlights do not include all the information needed to use ALIMTA safely and effectively. See full prescribing information for ALIMTA.
ALIMTA (pemetrexed for injection), for Intravenous Use
Initial U.S. Approval: 2004
RECENT MAJOR CHANGES
Indications and Usage (1.1) 06/2018
Dosage and Administration (2.1) 06/2018
INDICATIONS AND USAGE
ALIMTA� is a folate analog metabolic inhibitor indicated:
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)
in combination with carboplatin and pembrolizumab for the initial treatment of patients with metastatic, non-squamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. (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)
DOSAGE AND ADMINISTRATION
The recommended dose of ALIMTA, administered as a single agent or with cisplatin or with carboplatin and pembrolizumab, in patients with creatinine clearance of 45 mL/minute or greater, is 500 mg/m2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. (2.1, 2.2)
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. (2.4)
Administer vitamin B12, 1 mg intramuscularly, 1 week prior to the first dose of ALIMTA and every 3 cycles. (2.4)
Administer dexamethasone 4 mg orally, twice daily the day before, the day of, and the day after ALIMTA administration. (2.4)
DOSAGE FORMS AND STRENGTHS
For Injection: 100 mg or 500 mg lyophilized powder in single-dose vial. (3)
CONTRAINDICATIONS
History of severe hypersensitivity reaction to pemetrexed. (4)
WARNINGS AND PRECAUTIONS
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 1500 cells/mm3 and platelets are less than 100,000 cells/mm3. Initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of ALIMTA. (2.6, 5.1)
Renal Failure: Can cause severe, and sometimes fatal, renal failure. Do not administer when creatinine clearance is less than 45 mL/min. (2.3, 5.2)
Bullous and Exfoliative Skin Toxicity: Permanently discontinue for severe and life-threatening bullous, blistering or exfoliating skin toxicity. (5.3)
Interstitial Pneumonitis: Withhold for acute onset of new or progressive unexplained pulmonary symptoms. Permanently discontinue if pneumonitis is confirmed. (5.4)
Radiation Recall: Can occur in patients who received radiation weeks to years previously; permanently discontinue for signs of radiation recall. (5.5)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (5.7, 8.1, 8.3)
ADVERSE REACTIONS
The most common adverse reactions (incidence ?20%) of ALIMTA, when administered as a single agent are fatigue, nausea, and anorexia. (6.1)
The most common adverse reactions (incidence ?20%) of ALIMTA when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. (6.1)
The most common adverse reactions (incidence ?30%) of ALIMTA when administered in combination with carboplatin and pembrolizumab are fatigue, nausea, constipation, rash, vomiting, dyspnea, diarrhea, headache, and decreased appetite.
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.
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)
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 6/2018