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Generic Name
Gemcitabine
Brand Names
Avgemsi, Inlexzo
FDA approval date: November 15, 2010
Classification: Nucleoside Metabolic Inhibitor
Form: Injection, System
What is Avgemsi (Gemcitabine)?
Gemcitabine for Injection 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.
Approved To Treat
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Brand Information
AVGEMSI (Gemcitabine)
1DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/5.26 mL (38 mg/mL), 1 g/26.3 mL (38 mg/mL), and 2 g/52.6 mL (38 mg/mL) as a clear and colorless to light straw-colored solution in a multiple-dose vial.
2CONTRAINDICATIONS
AVGEMSI is contraindicated in patients with a known hypersensitivity to gemcitabine.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity
- Schedule-Dependent Toxicity [
- Myelosuppression
- Severe Cutaneous Adverse Reactions
- Pulmonary Toxicity and Respiratory Failure
- Hemolytic Uremic Syndrome
- Hepatic Toxicity
- Exacerbation of Radiation Therapy Toxicity
- Capillary Leak Syndrome
- Posterior Reversible Encephalopathy Syndrome
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Single Agent
The data described below reflect exposure to gemcitabine as a single agent administered at doses between 800 mg/m
Tables 5 and 6 present the incidence of selected adverse reactions and laboratory abnormalities reported in patients with various malignancies receiving single agent gemcitabine across 5 clinical trials. Additional clinically significant adverse reactions are provided following Table 6.
Additional adverse reactions include the following:
- Transfusion requirements: Red blood cell transfusions (19%); platelet transfusions (<1%)
- Edema: Edema (13%), peripheral edema (20%), generalized edema (<1%)
- Flu-like symptoms: Fever, asthenia, anorexia, headache, cough, chills, myalgia, insomnia, rhinitis, sweating, and/or malaise (19%)
- Infection: Sepsis (<1%)
- Extravasation: Injection-site reactions (4%)
- Allergic: Bronchospasm (<2%); anaphylactoid reactions
Ovarian Cancer
Tables 7 and 8 present the incidence of selected adverse reactions and laboratory abnormalities, occurring in ≥10% of gemcitabine-treated patients and at a higher incidence in the gemcitabine with carboplatin arm, reported in a randomized trial (Study 1) of gemcitabine with carboplatin (n=175) compared to carboplatin alone (n=174) for the second-line treatment of ovarian cancer in women with disease that had relapsed more than 6 months following first-line platinum-based chemotherapy
The proportion of patients with dose adjustments for carboplatin (1.8% versus 3.8%), doses of carboplatin omitted (0.2% versus 0) and discontinuing treatment for adverse reactions (11% versus 10%), were similar between arms. Dose adjustment for gemcitabine occurred in 10% of patients and gemcitabine dose was omitted in 14% of patients in the gemcitabine /carboplatin arm.
Hematopoietic growth factors were administered more frequently in the gemcitabine-containing arm: leukocyte growth factor (24% and 10%) and erythropoiesis-stimulating agent (7% and 3.9%).
The following clinically relevant, Grade 3 and 4 adverse reactions occurred more frequently in the gemcitabine with carboplatin arm: dyspnea (3.4% versus 2.9%), febrile neutropenia (1.1% versus 0), hemorrhagic event (2.3% versus 1.1%), motor neuropathy (1.1% versus 0.6%), and rash/desquamation (0.6% versus 0).
Breast Cancer
Tables 9 and 10 present the incidence of selected adverse reactions and laboratory abnormalities, occurring in ≥10% of gemcitabine-treated patients and at a higher incidence in the gemcitabine with paclitaxel arm, reported in a randomized trial (Study 2) of gemcitabine with paclitaxel (n=262) compared to paclitaxel alone (n=259) for the first-line treatment of metastatic breast cancer (MBC) in women who received anthracycline-containing chemotherapy in the adjuvant/neo-adjuvant setting or for whom anthracyclines were contraindicated
The requirement for dose reduction of paclitaxel were higher for patients in the gemcitabine /paclitaxel arm (5% versus 2%). The number of paclitaxel doses omitted (<1%), the proportion of patients discontinuing treatment for adverse reactions (7% versus 5%) and the number of treatment-related deaths (1 patient in each arm) were similar between the two arms.
Clinically relevant Grade 3 or 4 dyspnea occurred with a higher incidence in the gemcitabine with paclitaxel arm compared with the paclitaxel arm (1.9% versus 0).
Non-Small Cell Lung Cancer
Tables 11 and 12 present the incidence of selected adverse reactions and laboratory abnormalities, occurring in ≥10% of gemcitabine-treated patients and at a higher incidence in the gemcitabine with cisplatin arm, reported in a randomized trial (Study 3) of gemcitabine with cisplatin (n=260) administered in 28-day cycles as compared to cisplatin alone (n=262) in patients receiving first-line treatment for locally advanced or metastatic NSCLC
Patients randomized to gemcitabine with cisplatin received a median of 4 cycles of treatment and those randomized to cisplatin alone received a median of 2 cycles of treatment. In this trial, the requirement for dose adjustments (>90% versus 16%), discontinuation of treatment for adverse reactions (15% versus 8%), and the proportion of patients hospitalized (36% versus 23%) were all higher for patients receiving gemcitabine with cisplatin compared to those receiving cisplatin alone. The incidence of febrile neutropenia (3% versus <1%), sepsis (4% versus 1%), Grade 3 cardiac dysrhythmias (3% versus <1%) were all higher in the gemcitabine with cisplatin arm compared to the cisplatin alone arm. The two-drug combination was more myelosuppressive with 4 (1.5%) possibly treatment-related deaths, including 3 resulting from myelosuppression with infection and one case of renal failure associated with pancytopenia and infection. No deaths due to treatment were reported on the cisplatin arm.
Tables 13 and 14 present the incidence of selected adverse reactions and laboratory abnormalities occurring in ≥10% of gemcitabine-treated patients and at a higher incidence in the gemcitabine with cisplatin arm, reported in a randomized trial (Study 4) of gemcitabine with cisplatin (n=69) administered in 21-day cycles as compared to etoposide with cisplatin (n=66) in patients receiving first-line treatment for locally advanced or metastatic NSCLC
Patients in the gemcitabine/cisplatin (GC) arm received a median of 5 cycles and those in the etoposide/cisplatin (EC) arm received a median of 4 cycles. The majority of patients receiving more than one cycle of treatment required dose adjustments; 81% in the GC arm and 68% in the EC arm. The incidence of hospitalizations for adverse reactions was 22% in the GC arm and 27% in the EC arm. The proportion of patients who discontinued treatment for adverse reactions was higher in the GC arm (14% versus 8%). The proportion of patients who were hospitalized for febrile neutropenia was lower in the GC arm (7% versus 12%). There was one death attributed to treatment, a patient with febrile neutropenia and renal failure, which occurred in the GC arm.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of gemcitabine. 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: Thrombotic microangiopathy (TMA)
- Cardiovascular: Congestive heart failure, myocardial infarction, arrhythmias, supraventricular arrhythmias
- Vascular: Peripheral vasculitis, gangrene, capillary leak syndrome
- Skin: Cellulitis; pseudocellulitis; severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP); desquamation and bullous skin eruptions
- Hepatic: Hepatic failure, hepatic veno-occlusive disease
- Pulmonary: Interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, adult respiratory distress syndrome (ARDS), pulmonary eosinophilia
- Nervous System: Posterior reversible encephalopathy syndrome (PRES)
4OVERDOSAGE
There is no known antidote for overdoses of gemcitabine. Myelosuppression, paresthesias, and severe rash were the principal toxicities seen when a single dose as high as 5700 mg/m
5DESCRIPTION
Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine hydrochloride, is 2'-deoxy-2',2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows:
Gemcitabine hydrochloride, USP is a white to off-white solid with a molecular formula of C
AVGEMSI is a sterile solution in multiple-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine hydrochloride, USP. Each mL contains 38 mg of gemcitabine-free base in water for injection equivalent to 43.26 mg of gemcitabine hydrochloride, USP. Sodium hydroxide is used for pH adjustment.
6REFERENCES
1. "OSHA Hazardous Drugs." OSHA.
7HOW SUPPLIED/STORAGE AND HANDLING
AVGEMSI
- 200 mg/5.26 mL (38 mg/mL), NDC 83831-122-01
- 1 g/26.3 mL (38 mg/mL), NDC 83831-123-01
- 2 g/52.6 mL (38 mg/mL), NDC 83831-124-01
Store unopened multiple-dose vials at 2° to 8°C (36° to 46°F). Do not freeze.
AVGEMSI is a hazardous drug. Follow applicable special handling and disposal procedures
8PATIENT COUNSELING INFORMATION
Myelosuppression
Advise patients of the risks of myelosuppression. Instruct patients to immediately contact their healthcare provider should any signs or symptoms of infection, including fever, or if bleeding, or signs of anemia, occur
Severe Cutaneous Adverse Reactions (SCARs)
Advise patients of the risks of SCARs, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Instruct patients to immediately contact their healthcare provider should any signs or symptoms of severe skin rash or skin peeling, blistering and/or mouth sores occur
Pulmonary Toxicity
Advise patients of the risks of pulmonary toxicity, including respiratory failure and death. Instruct patients to immediately contact their healthcare provider for development of shortness of breath, wheezing, or cough
Hemolytic Uremic Syndrome and Renal Failure
Advise patients of the risks of hemolytic uremic syndrome and associated renal failure. Instruct patients to immediately contact their healthcare provider for changes in the color or volume of urine output or for increased bruising or bleeding
Hepatic Toxicity
Advise patients of the risks of hepatic toxicity including liver failure and death. Instruct patients to immediately contact their healthcare provider for signs of jaundice or for pain/tenderness in the right upper abdominal quadrant
Embryo-Fetal Toxicity
Advise females and males of reproductive potential that AVGEMSI can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment with AVGEMSI and for 6 months after the final dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with AVGEMSI and for 3 months after the final dose
Lactation
Advise women not to breastfeed during treatment with AVGEMSI and for at least one week after the last dose
Infertility
Advise males of reproductive potential of the potential for reduced fertility with AVGEMSI
Rx Only
Manufactured for:
Avyxa Pharma, LLC
New Jersey 07054, USA
Made in Switzerland
1204-0001
Revised: 07/2025
9PRINCIPAL DISPLAY PANEL
NDC 83831-123-01
AVGEMSI
(gemcitabine) Injection
(gemcitabine) Injection
1 g/26.3 mL
(38 mg/mL)
For Intravenous Infusion After Dilution
WARNING: Hazardous Drug
One Multiple-Dose Vial
Rx Only
Label
Carton
NDC 83831-124-01
AVGEMSI
(gemcitabine) Injection
(gemcitabine) Injection
2 g/52.6 mL
(38 mg/mL)
For Intravenous Infusion After Dilution
WARNING: Hazardous Drug
One Multiple-Dose Vial
Rx Only
Label
Carton
