Lyophilized Carboplatin Injection 150mg & 450 mg

Reconstituted solution of Lyophilized Carboplatin injection is stable for 8 h at controlled room temperature (77°F). Reconstituted solution does not contain a preservative and any unused solution must be discarded 8 h after reconstitution. Do not save any unused solution for future use. Carboplatin aqueous solution multidose vials are stable at room temperature (77°F) for up to 14 days following initial needle entry.

Cardiovascular

CV events (11%); fatal CV events including cardiac failure, embolism, cerebrovascular accidents (less than 1%); hypertension .

CNS

Asthenia (23%); peripheral neuropathies including mild paresthesias (6%); central neurotoxicity (5%); ototoxicity (1%); malaise .

Dermatologic

Alopecia (3%).

EENT

Reversible vision loss.

Electrolytes

Sodium loss (47%); magnesium loss (43%); calcium loss (31%); potassium loss (28%).

GI

Nausea and vomiting (92%); vomiting (81%); other GI side effects (21%); anorexia.

Genitourinary

Elevated BUN (22%); elevated serum creatinine (10%).

Hepatic

Elevated alkaline phosphatase (37%); elevated AST (19%); elevated bilirubin (5%).

Hematologic-Lymphatic

Anemia (90%); leukopenia (85%); neutropenia (67%); thrombocytopenia (62%); infections, bleeding (5%).

Hypersensitivity

Allergic reaction (2%).

Local

Pain, redness, swelling.

Respiratory

Respiratory (6%).

Miscellaneous

Pain (23%); mucositis (1%).