Home | GEMZAR (gemcitabine HCl for injection) Prescribing Information | Important Safety Information
GEMZAR is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage IIIA or IIIB), or metastatic (stage IV) non-small cell lung cancer.
GEMZAR 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.
GEMZAR is indicated as first-line treatment for patients with locally advanced (nonresectable stage II or stage III) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is indicated for patients previously treated with 5-FU.
Infusions of GEMZAR longer than 60 minutes or dosing more frequently than once weekly have been shown to increase toxicity.
GEMZAR can suppress bone marrow function, as manifested by leukopenia, thrombocytopenia, and anemia. Patients should be monitored for myelosuppression during therapy including a complete blood count with differential prior to each dose.
Pulmonary toxicity has been reported. In cases of severe lung toxicity, GEMZAR therapy should be discontinued immediately and appropriate supportive care measures instituted.
Monitor renal and hepatic function prior to initiation of GEMZAR therapy and periodically thereafter. Use GEMZAR with caution in patients with renal impairment or hepatic impairment. Hemolytic Uremic Syndrome (HUS) and/or renal failure have been reported following one or more doses of GEMZAR. Renal failure leading to death or requiring dialysis, despite discontinuation of therapy, has been reported. The majority of the cases of renal failure leading to death were due to HUS. Serious hepatotoxicity, including liver failure and death, has been reported in patients receiving GEMZAR alone or in combination with other potentially hepatotoxic drugs. Discontinue GEMZAR for HUS, or severe renal or hepatic toxicity.
GEMZAR can cause fetal harm. Advise women of potential risk to the fetus.
GEMZAR has radiosensitizing activity, and radiation recall reactions have been reported. The optimum regimen for safe administration of GEMZAR with therapeutic doses of radiation has not yet been determined in all tumor types.
The most common adverse reactions (all grades, with incidence of 20% or greater) in the same patient population were neutropenia (90 vs 58); anemia (86 vs 75); leukopenia (86 vs 70); thrombocytopenia (78 vs 57); RBC transfusion (38 vs 15); nausea (69 vs 61); alopecia (49 vs 17); vomiting (46 vs 36); constipation (42 vs 37); fatigue (40 vs 32); neuropathy-sensory (29 vs 27); diarrhea (25 vs 14); and stomatitis/pharyngitis (22 vs 13).
The most common adverse reactions (all grades, with incidence of 20% or greater) of the 28-day regimen (GEMZAR plus cisplatin versus cisplatin alone) and the 21-day regimen (GEMZAR plus cisplatin versus etoposide plus cisplatin), respectively, were anemia (89 vs 67, 88 vs 77); neutropenia (79 vs 20, 88 vs 87); leukopenia (82 vs 25, 86 vs 87); thrombocytopenia (85 vs 13, 81 vs 45); lymphocytopenia 28d (75 vs 51); RBC transfusion (39 vs 13, 29 vs 21); platelet transfusions (21 vs 1, 3 vs 8); nausea 28d (93 vs 87); vomiting 28d (78 vs 71); nausea and vomiting 21d (96 vs 86); alopecia (53 vs 33, 77 vs 92); creatinine elevation (38 vs 31, 2 vs 2); paresthesias 21d (38 vs 16); neuromotor 28d (35 vs 15); hyperglycemia 28d (30 vs 23); hypomagnesemia 28d (30 vs 17); infection (18 vs 12, 28 vs 21); neurohearing 28d (25 vs 21); diarrhea (24 vs 13, 14 vs 13); proteinuria (23 vs 18, 12 vs 5); neurosensory 28d (23 vs 18); hematuria (15 vs 13, 22 vs 10); hepatic transaminase 28d (22 vs 10); and stomatitis (14 vs 5, 20 vs 18).
The most common adverse reactions (all grades, with incidence of 20% or greater) in the same patient population were anemia (69 vs 51); neutropenia (69 vs 31); thrombocytopenia (26 vs 7); leukopenia (21 vs 12); alopecia (90 vs 92); neuropathy-sensory (64 vs 58); nausea (50 vs 31); fatigue (40 vs 28); myalgia (33 vs 33); vomiting (29 vs 15); arthralgia (24 vs 22); and diarrhea (20 vs 13).
The most common adverse reactions (all grades, with incidence of 10% or greater) in the same patient population were anemia (73), leukopenia (64), neutropenia (61), thrombocytopenia (36), AST elevation (78), alkaline phosphate (77), ALT elevation (72), nausea/vomiting (71), fever (38), proteinuria (32), diarrhea (30), rash (28), bilirubin elevation (26), hematuria (23), alopecia (16), BUN elevation (15), somnolence (11), dyspnea (10), infection (10), paresthesias (10), and stomatitis (10).
The safety and efficacy of GEMZAR in pediatric patients has not been established.
Use caution in patients with preexisting renal impairment or hepatic insufficiency. Administration of GEMZAR may exacerbate underlying hepatic insufficiency.
GEMZAR clearance is affected by age as well as gender.
Serum creatinine, potassium, calcium, and magnesium should be monitored during combination therapy with cisplatin. See the manufacturers’ prescribing information for more information on any drug indicated in combination with GEMZAR.
Please see the full Prescribing Information for Patient Counseling Information on low blood cell counts and the use of GEMZAR in pregnant and nursing women.
For safety and dosing guidelines, see complete Warnings and Precautions, Adverse Reactions, and Dosage and Administration sections in the full Prescribing Information.
SG25
