Gemita RTU Adverse Reactions

Gemcitabine has been used in a wide variety of malignancies, both as a single-agent and in combination with other cytotoxic drugs.
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity; Schedule-Dependent Toxicity; Myelosuppression; Pulmonary Toxicity and Respiratory Failure; Hemolytic Uremic Syndrome; Hepatic Toxicity; Exacerbation of Radiation Therapy Toxicity; Capillary Leak Syndrome; Posterior Reversible Encephalopathy Syndrome.
Single-Agent Use: Gemcitabine as a single agent administered at doses between 800 mg/m² to 1250 mg/m² over 30 minutes intravenously, once weekly, in patients with a variety of malignancies. The most common adverse reactions of single-agent gemcitabine are nausea/vomiting, anemia, increased ALT, increased AST, neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. The most common Grade 3 or 4 adverse reactions were neutropenia, nausea/vomiting; increased ALT, increase alkaline phosphatase, anemia, increased AST, and thrombocytopenia. Adverse reactions resulting in discontinuation of gemcitabine in patients were cardiovascular adverse reactions (myocardial infarction, cerebrovascular accident, arrhythmia, and hypertension), anemia, thrombocytopenia, hepatic dysfunction, renal dysfunction, nausea/vomiting, fever, rash, dyspnea, hemorrhage, infection, stomatitis, somnolence, flu-like syndrome, and edema.
Additional adverse reactions include the following: Transfusion requirements: Red blood cell transfusions; platelet transfusions.
Edema: Edema, peripheral edema, generalized edema.
Flu-like Symptoms: Fever, asthenia, anorexia, headache, cough, chills, myalgia, asthenia, insomnia, rhinitis, sweating, and/or malaise.
Infection: Sepsis.
Extravasation: Injection-site reactions.
Allergic: Bronchospasm; anaphylactoid reactions.
Other Adverse Reactions: These events have occurred after gemcitabine single-agent use and gemcitabine in combination with other cytotoxic agents.
Cardiovascular: Congestive heart failure and myocardial infarction have been observed very rarely with the use of gemcitabine. Arrhythmias, predominantly supraventricular in nature, have been observed very rarely.
Vascular Disorders: Clinical signs of peripheral vasculitis and gangrene have been observed very rarely, capillary leak syndrome has also been observed.
Nervous System Disorders: Posterior reversible encephalopathy syndrome (PRES) has been observed.
Skin: Allergic skin rash frequently associated with pruritus and alopecia are commonly occurred.
Cellulitis and non-serious injection site reactions in the absence of extravasation have been rarely observed. Severe skin reactions, including desquamation and bullous skin eruptions, ulceration, vesicle and sore formation have also been observed rarely. Toxic epidermal necrolysis, Stevens-Johnson Syndrome have been observed very rarely.
Hepatic: Increased liver function tests including elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, and bilirubin levels have been observed rarely. Serious hepatotoxicity including liver failure and death has been observed very rarely in patients receiving gemcitabine alone or in combination with other potentially hepatotoxic drugs.
Pulmonary: Parenchymal toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and adult respiratory distress syndrome (ARDS), has been observed rarely following one or more doses of gemcitabine administered to patients with various malignancies. Some patients experienced the onset of pulmonary symptoms up to 2 weeks after the last gemcitabine dose. Respiratory failure and death occurred very rarely in some patients despite discontinuation of therapy.
Renal: Hemolytic-Uremic Syndrome (HUS) and/or renal failure have been observed following one or more doses of gemcitabine. Renal failure leading to death or requiring dialysis, despite discontinuation of therapy, has been rarely observed. The majority of the cases of renal failure leading to death are due to HUS.
Injury, Poisoning, and Procedural Complications: Radiation recall reactions and radiation toxicity have been observed.
Stomatitis and ulceration of the mouth has also been commonly observed.
The following adverse reactions have been 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 Disorders: Peripheral vasculitis, gangrene, and capillary leak syndrome.
Skin: Cellulitis, pseudocellulitis, severe skin reactions, including desquamation and bullous skin eruptions.
Hepatic: Hepatic failure, hepatic veno-occlusive disease.
Pulmonary: Interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and adult respiratory distress syndrome (ARDS), pulmonary eosinophilia.
Nervous System: Posterior reversible encephalopathy syndrome (PRES).