AVGEMSI (gemcitabine hcl)

There are 4 contraindications. Absolute contraindication.

Contraindication List
Acute respiratory distress syndrome
Hemolytic uremic syndrome
Interstitial pneumonitis
Lactation

There are 9 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Anemia
Bone marrow depression
Capillary leak syndrome
Drug-induced hepatitis
Kidney disease with reduction in glomerular filtration rate (GFr)
Neutropenic disorder
Posterior reversible encephalopathy syndrome
Pregnancy
Thrombocytopenic disorder

There are 5 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Alcoholic liver damage
Hepatic cirrhosis
Hepatic metastases
Hepatitis
Infection

There are 48 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Anemia Dyspnea Hypomagnesemia Increased alanine transaminase Increased aspartate transaminase Leukopenia Neutropenic disorder Thrombocytopenic disorder	Bronchospastic pulmonary disease Hemorrhage Hyperbilirubinemia Hypocalcemia Peripheral motor neuropathy Systemic infection

Rare/Very Rare

Abnormal desquamation Acute generalized exanthematous pustulosis Acute myocardial infarction Acute respiratory distress syndrome Anaphylaxis Bacterial sepsis Bullous dermatitis Capillary leak syndrome Cardiac arrhythmia Cellulitis Cerebrovascular accident DRESS syndrome Eosinophilic pneumonia Gangrene Heart failure Hemolytic uremic syndrome Hepatic failure Hepatic veno-occlusive disease Hepatitis Hypersensitivity drug reaction Hypertension Interstitial pneumonitis Kidney disease with reduction in glomerular filtration rate (GFr) Posterior reversible encephalopathy syndrome Pulmonary edema Pulmonary fibrosis Radiation recall syndrome Renal failure Stevens-johnson syndrome Supraventricular arrhythmias Thrombotic thrombocytopenic purpura Toxic epidermal necrolysis Vasculitis

There are 27 less severe adverse reactions.

More Frequent	Less Frequent
Alopecia Constipation Diarrhea Edema Fatigue Fever Flu-like symptoms Hematuria Hyperglycemia Nausea Peripheral edema Peripheral sensory neuropathy Proteinuria Skin rash Vomiting	Anorexia Arthralgia Drowsy General weakness Hyperhidrosis Injection site sequelae Insomnia Malaise Paresthesia Rhinitis Stomatitis

Rare/Very Rare
Pseudocellulitis

Category D. (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.) (See Users Guide.)

It is not known whether gemcitabine is distributed into milk. The manufacturer states that a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman and the potential risk to nursing infants..

Because gemcitabine clearance is reduced and half-life is increased in geriatric patients, dosage reductions, including withholding of doses in some cases, may be more likely in this population; however, there currently is no evidence that unusual dosage adjustments (i.e., other than those recommended in general for hematologic and nonhematologic toxicity) would be required. Information derived from the safety database for gemcitabine monotherapy indicates that the frequency of adverse effects in patients older than 65 years of age is similar to that in younger adults; however, severe (grade 3/4) thrombocytopenia has occurred more frequently in geriatric patients. In the clinical study of gemcitabine given in combination with carboplatin for recurrent ovarian cancer, no overall differences in efficacy or safety were observed between geriatric and younger patients; however, grade 3/4 neutropenia occurred more frequently in geriatric patients 65 years of age or older.