Celplat-50 Injection

Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radio therapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of cisplatin and cyclophosphamide. …

• Cisplatin is administered by slow intravenous infusion
• CISPLATIN SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION
• Note: Needles or intravenous sets containing aluminum parts that may come in contact with cisplatin should not be used for preparation or administration
• Aluminum reacts with cisplatin, causing precipitate formation and a loss of potency
• Metastatic Testicular Tumors The usual cisplatin dose
• For the treatment of testicular cancer in combination with other approved chemotherapeutic agents is 20 mg/m 2 IV daily for 5 days per cycle
• Metastatic Ovarian Tumors The usual cisplatin dose
• For the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m 2 IV per cycle once every 4 weeks (DAY 1)
• The dose of cyclophosphamide when used in combination with cisplatin is 600 mg/m 2 IV once every 4 weeks (DAY 1)
• For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert
• In combination therapy, cisplatin and cyclophosphamide are administered sequentially
• As a single agent, cisplatin should be administered at a dose of 100 mg/m 2 IV per cycle once every 4 weeks
• Advanced Bladder Cancer Cisplatin should be administered as a single agent at a dose of 50 to 70 mg/m 2 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/m 2 per cycle repeated every 4 weeks is recommended. …

• Safety and effectiveness
• Pediatric patients have not been established
• All children should have audiometric monitoring performed prior to initiation of therapy, prior to each subsequent dose, and for several years post therapy
• Advanced testing methods may allow for earlier detection of hearing loss in an attempt to facilitate the rapid initiation of interventions that can limit the potential adverse impact of hearing impairment on a child's cognitive and social development

Insufficient data are available from clinical trials of cisplatin in the treatment of metastatic testicular tumors or advanced bladder cancer to determine whether elderly patients respond differently than younger patients. In four clinical trials of combination chemotherapy for advanced ovarian carcinoma, 1,484 patients received cisplatin either in combination with cyclophosphamide or paclitaxel. Of these, 426 (29%) were older than 65 years. …

• Cisplatin is contraindicated in patients with pre-existing renal impairment
• Cisplatin should not be employed in myelosuppressed patients, or in patients with hearing impairment
• Cisplatin is contraindicated in patients with a history of allergic reactions to cisplatin or other platinum containing compounds

Plasma levels of anticonvulsant agents may become subtherapeutic during cisplatin therapy. In a randomized trial in advanced ovarian cancer, response duration was adversely affected when pyridoxine was used in combination with altretamine (hexamethylmelamine) and cisplatin.

Cisplatin produces cumulative nephrotoxicity which is potentiated by aminoglycoside antibiotics. The serum creatinine, blood urea nitrogen (BUN), creatinine clearance, and magnesium, sodium, potassium, and calcium levels should be measured prior to initiating therapy, and prior to each subsequent course. At the recommended dosage, cisplatin should not be given more frequently than once every 3 to 4 weeks (see ADVERSE REACTIONS ). Elderly patients may be more susceptible to nephrotoxicity (see PRECAUTIONS, Geriatric Use ). There are reports of severe neuropathies in patients in whom regimens are employed using higher doses of cisplatin or greater dose frequencies than those recommended. …

Nephrotoxicity Dose-related and cumulative renal insufficiency, including acute renal failure, is the major dose-limiting toxicity of cisplatin. Renal toxicity has been noted in 28% to 36% of patients treated with a single dose of 50 mg/m 2 . It is first noted during the second week after a dose and is manifested by elevations in BUN and creatinine, serum uric acid and/or a decrease in creatinine clearance. Renal toxicity becomes more prolonged and severe with repeated courses of the drug. Renal function must return to normal before another dose of cisplatin can be given. Elderly patients may be more susceptible to nephrotoxicity (see PRECAUTIONS, Geriatric Use ). …

Pregnancy Pregnancy Category D (See WARNINGS ).

Caution should be exercised to prevent inadvertent overdosage with cisplatin. 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 cisplatin overdosage. …

Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Protect from light. Sterile, Nonpyrogenic, Preservative-free. This container closure is not made with natural rubber latex.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.