Drugplain

AVGEMSI 38 mg/mL

Gemcitabine · INJECTION, SOLUTION · Avyxa Pharma, LLC

No Recall HistoryCurrently in Shortage
Plain English

AVGEMSI is a injection, solution containing gemcitabine at 38 mg/mL, taken intravenous. Manufactured by Avyxa Pharma, LLC.

Key Facts

Brand Name
AVGEMSI
Generic Name
Gemcitabine
NDC Code (Product)
83831-123
Manufacturer
Avyxa Pharma, LLC
Strength
38 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA219920
Marketing Start
08/03/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

disease progression4,461 reports
thrombocytopenia2,909 reports
off label use2,686 reports
neutropenia2,599 reports
drug ineffective2,573 reports
anaemia2,379 reports
malignant neoplasm progression2,044 reports
nausea1,960 reports
pyrexia1,924 reports
fatigue1,628 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer AVGEMSI in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 1.2 Breast Cancer AVGEMSI in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 1.3 Non-Small Cell Lung Cancer AVGEMSI in combination with cisplatin is indicated for the first-line tre…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION AVGEMSI is for intravenous use only. Ovarian Cancer: 1,000 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.1 ) Breast Cancer: 1,250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.2 ) Non-Small Cell Lung Cancer: 1,000 mg/m 2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1,250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.3 ) Pancreatic Cancer: 1,000 mg/m 2 over 30 minutes once weekly for the first 7 weeks, then one-week rest, then once weekly for 3 weeks of each 28-day cycle. ( 2.4 ) 2.1 Ovarian Cancer Recommended Dose and Schedule The recommended dosage of AVGEMSI is 1,000 mg/m 2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 administered intravenously on Day 1 after AVGEMSI administration. Refer to carboplatin prescribing information for additional information. Dosage Modifications Recommended dosage modifications for AVGEMSI for myelosuppression are described in Tables 1 and 2 [see Warnings and Precautions (5.2) ]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administratio…

Contraindications

4 CONTRAINDICATIONS AVGEMSI is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1) ]. Patients with a known hypersensitivity to gemcitabine. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4) ] Schedule-Dependent Toxicity [ see Warnings and Precautions (5.1) ] Myelosuppression [see Warnings and Precautions (5.2) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions (5.4) ] Hemolytic Uremic Syndrome [see Warnings and Precautions (5.5) ] Hepatic Toxicity [see Warnings and Precautions (5.6) ] Exacerbation of Radiation Therapy Toxicity [see Warnings and Precautions (5.8) ] Capillary Leak Syndrome [see Warnings and Precautions (5.9) ] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.10) ] The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or …

Frequently Asked Questions

What is AVGEMSI used for?

AVGEMSI contains Gemcitabine. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is AVGEMSI a controlled substance?

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

What is the generic name for AVGEMSI?

The generic name for AVGEMSI is Gemcitabine. There are 11 other brand versions of Gemcitabine.

What is the NDC code for AVGEMSI 38 mg/mL?

The NDC (National Drug Code) for AVGEMSI 38 mg/mL is 83831-123, listed by Avyxa Pharma, LLC.

Product NDC

83831-123

Package NDC

83831-123-01

Other AVGEMSI Dosages

Other Gemcitabine Brands

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

Data from openFDA · Public domain (CC0 1.0)