AXTLE 100 mg/4mL

pemetrexed · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Avyxa Pharma, LLC

No Recall HistoryCurrently in Shortage

Plain English

AXTLE is a injection, powder, lyophilized, for solution containing pemetrexed at 100 mg/4mL, taken intravenous. Manufactured by Avyxa Pharma, LLC.

Key Facts

Brand Name: AXTLE
Generic Name: pemetrexed
NDC Code (Product): 83831-131
Manufacturer: Avyxa Pharma, LLC
Strength: 100 mg/4mL
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA210661
Drug Class: Folate Analog Metabolic Inhibitor [EPC]
Marketing Start: 01/01/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

malignant neoplasm progression1,641 reports

anaemia1,221 reports

disease progression1,090 reports

off label use1,048 reports

nausea993 reports

neutropenia981 reports

diarrhoea957 reports

drug ineffective927 reports

thrombocytopenia919 reports

pancytopenia907 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE AXTLE 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 (NSCLC), with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 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: AXTLE 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 ) 1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC) AXTLE is indicated: in combination with pembro…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dose of AXTLE administered with pembrolizumab and platinum chemotherapy in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m 2 as an intravenous infusion over 10 minutes, administered after pembrolizumab and prior to platinum chemotherapy, on Day 1 of each 21-day cycle. ( 2.1 ) The recommended dose of AXTLE, administered as a single agent or with cisplatin, in patients with creatinine clearance of 45 mL/minute or greater is 500 mg/m 2 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 AXTLE and continue until 21 days after the last dose of AXTLE. ( 2.4 ) Administer vitamin B 12 , 1 mg intramuscularly, 1 week prior to the first dose of AXTLE and every 3 cycles. ( 2.4 ) Administer dexamethasone 4 mg orally, twice daily the day before, the day of, and the day after AXTLE administration. ( 2.4 ) 2.1 Recommended Dosage for Non-Squamous NSCLC The recommended dose of AXTLE when administered with pembrolizumab and platinum chemotherapy for the i…

Contraindications

4 CONTRAINDICATIONS AXTLE is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see Adverse Reactions (6.1) ] . History of severe hypersensitivity reaction to pemetrexed. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Effects of Ibuprofen on Pemetrexed Ibuprofen increases exposure (AUC) of pemetrexed [see Clinical Pharmacology (12.3) ] . In patients with creatinine clearance between 45 mL/min and 79 mL/min: Avoid administration of ibuprofen for 2 days before, the day of, and 2 days following administration of AXTLE [see Dosage and Administration (2.5) ] . Monitor patients more frequently for myelosuppression, renal, and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided. Ibuprofen increased risk of pemetrexed 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 )

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Renal failure [see Warnings and Precautions (5.2) ] Bullous and exfoliative skin toxicity [see Warnings and Precautions (5.3) ] Interstitial pneumonitis [see Warnings and Precautions (5.4) ] Radiation recall [see Warnings and Precautions (5.5) ] The most common adverse reactions (incidence ≥20%) of pemetrexed, when administered as a single agent are fatigue, nausea, and anorexia. ( 6.1 ) The most common adverse reactions (incidence ≥20%) of pemetrexed when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. ( 6.1 ) The most common adverse reactions (incidence ≥20%) of pemetrexed when administered in combination with pembrolizumab and platinum chemotherapy are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience …

Frequently Asked Questions

What is AXTLE used for?

AXTLE contains pemetrexed. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.

Is AXTLE a controlled substance?

AXTLE is not classified as a controlled substance by the DEA.

What is the generic name for AXTLE?

The generic name for AXTLE is pemetrexed. There are 12 other brand versions of pemetrexed.

What is the NDC code for AXTLE 100 mg/4mL?

The NDC (National Drug Code) for AXTLE 100 mg/4mL is 83831-131, listed by Avyxa Pharma, LLC.

Product NDC

83831-131

Package NDC

83831-131-01

Other Pemetrexed Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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