Cisplatin

Cisplatin is intended for the treatment of: • advanced or metastasised testicular cancer • advanced or metastasised ovarian cancer • advanced or metastasised bladder carcinoma • advanced or metastasised squamous cell carcinoma of the head and neck • advanced or metastasised non-small cell lung carcinoma • advanced or metastasised small cell lung carcinoma.

• Cisplatin is indicated in the treatment of cervical carcinoma in combination with other chemotherapeutics or with radiotherapy. • Cisplatin can be used as monotherapy and in combination therapy

Cisplatin Injection BP is indicated as palliative therapy, to be employed in addition to other modalities, or in established combination therapy with other chemotherapeutic agents in the following: • Metastatic Testicular Tumors: In patients who have already received appropriate surgical and/or radiotherapeutic and/or chemotherapeutic procedures.

• Metastatic Ovarian Tumors: As secondary therapy in patients refractory to standard chemotherapy. • Advanced Bladder Cancer: As a single agent for patients with transitional cell bladder cancer. 3 Special Populations – Pediatrics). 2 Geriatrics Geriatric patients, patients with baseline renal impairment, patients who are taking other nephrotoxic drugs, or patients who are not well hydrated may be more susceptible to nephrotoxicity.

Geriatric patients may be more susceptible to myelosuppression. Geriatric patients may be more susceptible to peripheral neuropathy. 4 Special Populations – Geriatric.

INDICATIONS AND USAGE

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 Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.