Cisplatin PhaRes - Injection Cisplatin - 1mg/ml 1 50mg Vial(s) / 50mg Vial ZAS Corporation Introduction: Cisplatin PhaRes is used in the treatment of ovarian, cervical and testicular cancer. It shows its working by stopping or slowing down the growth of cancer cells. Cisplatin PhaRes is given as an injection into veins by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects.... Uses of Cisplatin PhaRes: Ovarian cancerCervical cancerTesticular cancer Side effects of Cisplatin PhaRes: Injection site reactions (pain, swelling, redness)Increased risk of infectionEar disorderVomitingNauseaDecreased blood cells (red cells, white cells, and platelets)Renal impairmentPeripheral neuropathy (tingling and numbness of feet and hand)Kidney damageHearing lossRinging in ear How to use Cisplatin PhaRes: Your doctor or nurse will give you this medicine. Kindly do not self-administer. How Cisplatin PhaRes works: Cisplatin PhaRes is an anti-cancer medication. It works by damaging the genetic material (DNA and RNA) of the cancer cells which stops their growth and multiplication. What if you forget to take Cisplatin PhaRes?: If you miss a dose of Cisplatin PhaRes, please consult your doctor. Indication: Lymphomas, Sarcomas, Carcinomas, Small cell lung cancer, Ovarian cancer, Germ cell tumors, Metastatic Testicular Tumors, Metastatic Ovarian Tumors, Advanced Bladder Cancer Administration: IV Preparation Further dilution stability is dependent on chloride ion concentration & should be mixed in solutions of NS (at least 0.3% NaCl) Further dilution in NS, D5/½NS or D5/NS to a concentration of 0.05-2 mg/mL are stable for 72 hr at 4-25°C in combination with mannitol May administer 12.5-50 g mannitol/L Standard dilution: dose/250-1000 mL NS, D5W/NS or D5/½NS IV Administration Perform pretreatment hydration Do not use aluminum-containing needles or IV administration sets that may come in contact with carboplatin (aluminum can react causing precipitate formation & loss of potency) Administration rate has varied from a 15-120 min infusion,... Adult Dose: Metastatic Testicular Tumors Usual dose in combination with other approved chemotherapeutic agents is 20 mg/m²/day IV for 5 days/cycle Pretreatment hydration: 1-2 L fluid infused for 8-12 hr before dose May use concomitant amifostine to decrease nephrotoxicity Do not repeat course until SCr 4000/mm³ AND platelets >100 k/mm³ Advanced Bladder Cancer 50-70 mg/m² IV cycle q3-4Weeks, depending on prior radiation therapy or chemotherapy; for heavily pretreated patients, give 50 mg/m²/cycle initially; repeat q4Weeks Pretreatment hydration: 1-2 L fluid infused for 8-12 hr before dose May use concomitant amifostine to decrease nephrotoxicity Do not repeat course until SCr 4000/mm³ AND platelets... Renal Dose: Renal Impairment CrCl 10-50 mL/min: Decrease dose 50% CrCl <10 mL/min: Contraindicated Contraindication: Patients with severe renal or auditory disorder, known hypersensitivity, severe bone marrow suppression, peripheral neuropathy, pregnancy, lactation. Mode of Action: Cisplatin modifies cell cycle by interfering with DNA structure and function. Effects are most prominent during the S phase but cells are killed at all stages. Cisplatin synergises with other anticancer drugs e.g. fluorouracil. It has a narrow therapeutic margin and is highly toxic. Precaution: Patients with renal or hepatic disorder, myelosuppression. Monitor renal, neurological and auditory function. Perform blood counts regularly. Maintain adequate hydration before and 24 hr after admin to minimise nephrotoxicity. Lactation: excreted in breast milk; do not nurse Side Effect: >10% Nausea (76-100%),Vomiting (76-100%),Nephrotoxicity (28-36%),Ototoxicity, especially in children (31%),Myelosuppression (25-30%),Anaphylaxis (1-20%),Alopecia Frequency Not Defined Cerebral herniation,Encephalopathy,Leukoencephalopathy and reversible posterior leukoencephalopathy syndrome,Seizure,Peripheral neuropathy (dose and duration dependent),Diarrhea,Electrolyte changes,Hyperuricemia,Hepatotoxicity,Local tissue irritation Potentially Fatal: Rarely, renal damage due to inadequate hydration during therapy. Very rarely life-threatening myelosuppression. Anaphylactoid reactions (rare) and cardiac abnormalities. Pregnancy Category Note: Pregnancy Based on human data from published literature, cisplatin can cause fetal harm when administered to pregnant women; data demonstrates transplacental transfer of cisplatin Exposure associated with oligohydramnios, intrauterine growth restriction, and preterm birth; cases of neonatal acute respiratory distress syndrome, cytopenias, and hearing loss reported Verify the pregnancy status of females of reproductive potential before initiating prior to initiation of cisplatin for injection Contraception Females: Advise females of reproductive potential to use effective contraception during treatment and for 14 months following the last dose Males: Advise male patients with female partners of reproductive potential to use effective contraception during... Interaction: Synergistic with 5-fluorouracil and etoposide. Efficacy increased and toxicity reduced when combined with radioprotecting agent WR 2721. At doses ?100 mg, cisplatin is an ideal drug to combine with other cytotoxic drugs; unlike other antineoplastic drugs, it causes little myelosuppression. Potentially Fatal: Potentiates nephrotoxicity with aminoglycosides. Increased toxicity when combined with other cytotoxic drugs.