Cistor IV Injection
Cisplatin
50mg
Eskayef Pharmaceuticals Ltd.
| Pack size | 1's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 950.00 AED |
Available as:
Indications
Cistor IV Injection is used for:
Metastatic Testicular Tumors, Metastatic Ovarian Tumors, Advanced Bladder Cancer, Small cell lung cancer, Cervical cancer, Head and neck cancer
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 <1.5 mg/dL [<133 micromoles/L] or BUN <25 mg/dL [<8.93 mmol/L] or WBC >4000/mm³ AND platelets >100 k/mm³
Advanced Bladder Cancer
50-70 mg/m² IV cycle once every 3 to 4 weeks, depending on prior radiation therapy or chemotherapy; for heavily pretreated patients, give 50 mg/m²/cycle initially; repeat once every 4 weeks
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 <1.5 mg/dL [<133 micromoles/L] or BUN <25 mg/dL [<8.93 mmol/L] or WBC >4000/mm³ AND platelets >100 k/mm³
Metastatic Ovarian Carcinoma
75-100 mg/m² IV per cycle once every 3 to 4 weeks with cyclophosphamide (600 mg/m² IV once every 4 weeks); administer sequentially
Off-label: 90-270 mg/m² intraperitoneal; retain for 4 hr before draining; repeat once every 3 weeks (may coadminister systemic Na thiosulfate)
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 <1.5 mg/dL [<133 micromoles/L] or BUN <25 mg/dL [<8.93 mmol/L] or WBC >4000/mm³ AND platelets >100 k/mm³
Child Dose
Renal Dose
Renal Impairment
CrCl 10-50 mL/min: Decrease dose by 25%
CrCl <10 mL/min: Administer 50% of dose
Hemodialysis
Partially cleared by hemodialysis
Posthemodialysis: Administer 50% of dose
Continuous ambulatory peritoneal dialysis: Administer 50% of dose
Continuous renal replacement therapy (CRRT): Administer 75% of dose
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, 1 mg/min infusion, 6-8 hr infusion, 24 hr infusion, or per protocol
Maximum rate of infusion: 1 mg/min in patients with CHF
When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before platinum derivatives to limit myelosuppression & to enhance efficacy
Contra Indications
Patients with severe renal or auditory disorder, known hypersensitivity, severe bone marrow suppression, peripheral neuropathy, pregnancy, lactation.
Precautions
Nephrotoxicity: cisplatin for injection can cause severe renal toxicity, including acute renal failure. Ensure adequate hydration.
Consider dose reductions or alternative treatments in patients with renal impairment.
Peripheral Neuropathy: cisplatin for injection can cause doserelated peripheral neuropathy.
Nausea and Vomiting: cisplatin for injection can cause severe nausea and vomiting. Premedicate with antiemetics.
Myelosuppression: cisplatin for injection can cause severe myelosuppression with fatalities due to infections. Monitor blood counts and interrupt therapy accordingly.
Hypersensitivity reactions: Anaphylaxis and death may occur; monitor for and treat accordingly
Ototoxicity: Cumulative toxicity may be severe particularly in pediatric patients; consider audiometric and vestibular function monitoring
Ocular toxicity: Optic neuritis, papilledema, and cortical blindness may occur
Secondary leukemia: Secondary acute leukemia may occur
Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.
MONITORING PARAMETERS
Monitor renal, neurological and auditory function.
Monitor full blood count.
Monitor audiology.
Monitor plasma electrolytes.
Monitoring of renal function is essential.
Pregnancy-Lactation
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 treatment and for 11 months after the last dose
Infertility
Females: Use associated with cumulative dose-dependent ovarian failure, premature menopause, and reduced fertility
Males: Use associated with a cumulative dose-dependent impairment of spermatogenesis (oligospermia, azoospermia; possibly irreversible) and reduced fertility
Lactation
Limited data from published literature report the presence of drug in human milk; because of potential for serious adverse reactions in a breastfed child and because of potential for tumorigenicity, advise lactating women not to breastfeed during treatment
Animal data
Cisplatin for injection administration to animals during and after organogenesis resulted in teratogenicity; a published study in mice showed placental transfer of cisplatin increased with placenta maturation
Interactions
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.
Adverse Effects
Side effects of Cisplatin :
>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.
Mechanism 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.
Note
Cistor 50mg IV Injection manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Cisplatin. Cistor is availble in Bangladesh.
Farmaco BD drug index information on Cistor IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.