for possible anaphylactic-like reactions and supportive equipment and medication should be available to treat such a complication.
Hepatotoxicity
Transient elevations of liver enzymes, especially SGOT, as well as bilirubin, have been reported to be associated with PLATINOL-AQ administration at the recommended doses.
Other Events
Cardiac abnormalities, hiccups, elevated serum amylase, rash, alopecia, malaise, asthenia, and dehydration have been reported.
Local soft tissue toxicity has been reported following extravasation of PLATINOL-AQ. Severity of the local tissue toxicity appears to be related to the concentration of the PLATINOL-AQ solution. Infusion of solutions with a PLATINOL-AQ concentration greater than 0.5 mg/mL may result in tissue cellulitis, fibrosis, necrosis, pain, edema, and erythema.
OVERDOSAGE
Caution should be exercised to prevent inadvertent overdosage with PLATINOL-AQ. Acute overdosage with this drug may result in kidney failure, liver failure, deafness, ocular toxicity (including detachment of the retina), significant myelosuppression, intractable nausea and vomiting and/or neuritis. In addition, death can occur following overdosage.
No proven antidotes have been established for PLATINOL-AQ overdosage. Hemodialysis, even when initiated four hours after the overdosage, appears to have little effect on removing platinum from the body because of PLATINOL-AQ's rapid and high degree of protein binding. Management of overdosage should include general supportive measures to sustain the patient through any period of toxicity that may occur.
DOSAGE AND ADMINISTRATION
PLATINOL-AQ is administered by slow intravenous infusion. PLATINOL-AQ SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Note: Needles or intravenous sets containing aluminum parts that may come in contact with PLATINOL-AQ should not be used for preparation or administration. Aluminum reacts with PLATINOL-AQ, causing precipitate formation and a loss of potency.
Metastatic Testicular Tumors
The usual PLATINOL-AQ dose for the treatment of testicular cancer in combination with other approved chemotherapeutic agents is 20 mg/m2 IV daily for 5 days per cycle.
Metastatic Ovarian Tumors
The usual PLATINOL-AQ dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2 IV per cycle once every four weeks (DAY 1).
The dose of cyclophosphamide when used in combination with PLATINOL-AQ is 600 mg/m2 IV once every 4 weeks (DAY 1).
For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.
In combination therapy, PLATINOL-AQ and cyclophosphamide are administered sequentially.
As a single agent, PLATINOL-AQ should be administered at a dose of 100 mg/m2 IV per cycle once every four weeks.
Advanced Bladder Cancer
PLATINOL-AQ should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.
All Patients
Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a PLATINOL-AQ dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6- to 8-hour period. If diluted solution is not to be used within 6 hour |
