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cisplatin
Overview
What is Platinol-AQ?
PLATINOL-AQ (cisplatin injection) infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Each 50 mL or 100 mL amber vial of infusion concentrate contains: 1 mg/mL cisplatin, 9 mg/mL sodium chloride, hydrochloric acid and sodium hydroxide to approximate pH of 4.0, and water for injection to a final volume of 50 mL or 100 mL, respectively.
PLATINOL-AQ (cisplatin injection) infusion concentrate must be further diluted prior to administration (see ).
The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtClHN, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207° C.
What does Platinol-AQ look like?
What are the available doses of Platinol-AQ?
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What should I talk to my health care provider before I take Platinol-AQ?
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How should I use Platinol-AQ?
PLATINOL-AQ (cisplatin injection) is indicated as therapy to be employed as follows:
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.
What interacts with Platinol-AQ?
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What are the warnings of Platinol-AQ?
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What are the precautions of Platinol-AQ?
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What are the side effects of Platinol-AQ?
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What should I look out for while using Platinol-AQ?
PLATINOL-AQ is contraindicated in patients with preexisting renal impairment. PLATINOL-AQ should not be employed in myelosuppressed patients, or in patients with hearing impairment.
PLATINOL-AQ is contraindicated in patients with a history of allergic reactions to PLATINOL-AQ or other platinum-containing compounds.
PLATINOL-AQ 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, PLATINOL-AQ should not be given more frequently than once every 3 to 4 weeks (see ). Elderly patients may be more susceptible to nephrotoxicity (see ).
There are reports of severe neuropathies in patients in whom regimens are employed using higher doses of PLATINOL-AQ or greater dose frequencies than those recommended. These neuropathies may be irreversible and are seen as paresthesias in a stocking-glove distribution, areflexia, and loss of proprioception and vibratory sensation. Elderly patients may be more susceptible to peripheral neuropathy (see ).
Loss of motor function has also been reported.
Anaphylactic-like reactions to PLATINOL-AQ have been reported. These reactions have occurred within minutes of administration to patients with prior exposure to PLATINOL-AQ, and have been alleviated by administration of epinephrine, corticosteroids, and antihistamines.
PLATINOL-AQ can commonly cause ototoxicity which is cumulative and may be severe. Audiometric testing should be performed prior to initiating therapy and prior to each subsequent dose of drug (see ).
Certain genetic variants in the thiopurine S-methyltransferase (TPMT) gene are associated with increased risk of ototoxicity in children administered conventional doses of cisplatin (see ). Children who do not have one of these TPMT gene variants remain at risk for ototoxicity. All pediatric patients receiving cisplatin should have audiometric testing at baseline, prior to each subsequent dose, of drug and for several years post therapy.
PLATINOL-AQ can cause fetal harm when administered to a pregnant woman. PLATINOL-AQ is mutagenic in bacteria and produces chromosome aberrations in animal cells in tissue culture. In mice PLATINOL-AQ is teratogenic and embryotoxic. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be advised to avoid becoming pregnant.
The carcinogenic effect of PLATINOL-AQ was studied in BD IX rats. PLATINOL-AQ was administered intraperitoneally (i.p.) to 50 BD IX rats for 3 weeks, 3 X 1 mg/kg body weight per week. Four hundred and fifty-five days after the first application, 33 animals died, 13 of them related to malignancies: 12 leukemias and 1 renal fibrosarcoma.
The development of acute leukemia coincident with the use of PLATINOL-AQ has been reported. In these reports, PLATINOL-AQ was generally given in combination with other leukemogenic agents.
Injection site reactions may occur during the administration of PLATINOL-AQ (see ). Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration. A specific treatment for extravasation reactions is unknown at this time.
What might happen if I take too much Platinol-AQ?
Caution should be exercised to prevent inadvertent overdosage with PLATINOL-AQ.
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.
How should I store and handle Platinol-AQ?
StorageStore at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature].StorageStore at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature].PLATINOL-AQ (cisplatin injection) NDCNDCPLATINOL-AQ (cisplatin injection) NDCNDCPLATINOL-AQ (cisplatin injection) NDCNDC
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Plasma concentrations of the parent compound, cisplatin, decay monoexponentially with a half-life of about 20 to 30 minutes following bolus administrations of 50 or 100 mg/m doses. Monoexponential decay and plasma half-lives of about 0.5 hour are also seen following 2-hour or 7-hour infusions of 100 mg/m. After the latter, the total-body clearances and volumes of distribution at steady-state for cisplatin are about 15 to 16 L/h/m and 11 to 12 L/m.
Due to its unique chemical structure, the chlorine atoms of cisplatin are more subject to chemical displacement reactions by nucleophiles, such as water or sulfhydryl groups, than to enzyme-catalyzed metabolism. At physiological pH in the presence of 0.1M NaCl, the predominant molecular species are cisplatin and monohydroxymonochloro -diammine platinum (II) in nearly equal concentrations. The latter, combined with the possible direct displacement of the chlorine atoms by sulfhydryl groups of amino acids or proteins, accounts for the instability of cisplatin in biological matrices. The ratios of cisplatin to total free (ultrafilterable) platinum in the plasma vary considerably between patients and range from 0.5 to 1.1 after a dose of 100 mg/m.
Cisplatin does not undergo the instantaneous and reversible binding to plasma proteins that is characteristic of normal drug-protein binding. However, the platinum from cisplatin, but not cisplatin itself, becomes bound to several plasma proteins, including albumin, transferrin, and gamma globulin. Three hours after a bolus injection and two hours after the end of a three-hour infusion, 90% of the plasma platinum is protein bound. The complexes between albumin and the platinum from cisplatin do not dissociate to a significant extent and are slowly eliminated with a minimum half-life of five days or more.
Following cisplatin doses of 20 to 120 mg/m, the concentrations of platinum are highest in liver, prostate, and kidney; somewhat lower in bladder, muscle, testicle, pancreas, and spleen; and lowest in bowel, adrenal, heart, lung, cerebrum, and cerebellum. Platinum is present in tissues for as long as 180 days after the last administration. With the exception of intracerebral tumors, platinum concentrations in tumors are generally somewhat lower than the concentrations in the organ where the tumor is located. Different metastatic sites in the same patient may have different platinum concentrations. Hepatic metastases have the highest platinum concentrations, but these are similar to the platinum concentrations in normal liver. Maximum red blood cell concentrations of platinum are reached within 90 to 150 minutes after a 100 mg/m dose of cisplatin and decline in a biphasic manner with a terminal half-life of 36 to 47 days.
Over a dose range of 40 to 140 mg cisplatin/m given as a bolus injection or as infusions varying in length from 1 hour to 24 hours, from 10% to about 40% of the administered platinum is excreted in the urine in 24 hours. Over five days following administration of 40 to 100 mg/m doses given as rapid, 2- to 3-hour, or 6- to 8-hour infusions, a mean of 35% to 51% of the dosed platinum is excreted in the urine. Similar mean urinary recoveries of platinum of about 14% to 30% of the dose are found following five daily administrations of 20, 30, or 40 mg/m/day. Only a small percentage of the administered platinum is excreted beyond 24 hours post-infusion and most of the platinum excreted in the urine in 24 hours is excreted within the first few hours. Platinum-containing species excreted in the urine are the same as those found following the incubation of cisplatin with urine from healthy subjects, except that the proportions are different.
The parent compound, cisplatin, is excreted in the urine and accounts for 13% to 17% of the dose excreted within one hour after administration of 50 mg/m. The mean renal clearance of cisplatin exceeds creatinine clearance and is 62 and 50 mL/min/m following administration of 100 mg/m as 2-hour or 6- to 7-hour infusions, respectively.
The renal clearance of free (ultrafilterable) platinum also exceeds the glomerular filtration rate indicating that cisplatin or other platinum-containing molecules are actively secreted by the kidneys. The renal clearance of free platinum is nonlinear and variable and is dependent on dose, urine flow rate, and individual variability in the extent of active secretion and possible tubular reabsorption.
There is a potential for accumulation of ultrafilterable platinum plasma concentrations whenever cisplatin is administered on a daily basis but not when dosed on an intermittent basis.
No significant relationships exist between the renal clearance of either free platinum or cisplatin and creatinine clearance.
Although small amounts of platinum are present in the bile and large intestine after administration of cisplatin, the fecal excretion of platinum appears to be insignificant.
Non-Clinical Toxicology
PLATINOL-AQ is contraindicated in patients with preexisting renal impairment. PLATINOL-AQ should not be employed in myelosuppressed patients, or in patients with hearing impairment.PLATINOL-AQ is contraindicated in patients with a history of allergic reactions to PLATINOL-AQ or other platinum-containing compounds.
PLATINOL-AQ 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, PLATINOL-AQ should not be given more frequently than once every 3 to 4 weeks (see ). Elderly patients may be more susceptible to nephrotoxicity (see ).
There are reports of severe neuropathies in patients in whom regimens are employed using higher doses of PLATINOL-AQ or greater dose frequencies than those recommended. These neuropathies may be irreversible and are seen as paresthesias in a stocking-glove distribution, areflexia, and loss of proprioception and vibratory sensation. Elderly patients may be more susceptible to peripheral neuropathy (see ).
Loss of motor function has also been reported.
Anaphylactic-like reactions to PLATINOL-AQ have been reported. These reactions have occurred within minutes of administration to patients with prior exposure to PLATINOL-AQ, and have been alleviated by administration of epinephrine, corticosteroids, and antihistamines.
PLATINOL-AQ can commonly cause ototoxicity which is cumulative and may be severe. Audiometric testing should be performed prior to initiating therapy and prior to each subsequent dose of drug (see ).
Certain genetic variants in the thiopurine S-methyltransferase (TPMT) gene are associated with increased risk of ototoxicity in children administered conventional doses of cisplatin (see ). Children who do not have one of these TPMT gene variants remain at risk for ototoxicity. All pediatric patients receiving cisplatin should have audiometric testing at baseline, prior to each subsequent dose, of drug and for several years post therapy.
PLATINOL-AQ can cause fetal harm when administered to a pregnant woman. PLATINOL-AQ is mutagenic in bacteria and produces chromosome aberrations in animal cells in tissue culture. In mice PLATINOL-AQ is teratogenic and embryotoxic. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be advised to avoid becoming pregnant.
The carcinogenic effect of PLATINOL-AQ was studied in BD IX rats. PLATINOL-AQ was administered intraperitoneally (i.p.) to 50 BD IX rats for 3 weeks, 3 X 1 mg/kg body weight per week. Four hundred and fifty-five days after the first application, 33 animals died, 13 of them related to malignancies: 12 leukemias and 1 renal fibrosarcoma.
The development of acute leukemia coincident with the use of PLATINOL-AQ has been reported. In these reports, PLATINOL-AQ was generally given in combination with other leukemogenic agents.
Injection site reactions may occur during the administration of PLATINOL-AQ (see ). Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration. A specific treatment for extravasation reactions is unknown at this time.
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 PLATINOL-AQ.
Peripheral blood counts should be monitored weekly. Liver function should be monitored periodically. Neurologic examination should also be performed regularly (see ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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