Sanbeplatin

Sanbeplatin

carboplatin

Manufacturer:

Sanbe
Full Prescribing Info
Contents
Carboplatin.
Description
Each mL contains: Carboplatin 10 mg.
Action
Pharmacology: Carboplatin an analogue of Cisplatin, interferes with DNA intrastrand and interstrand cross links in cells exposed to the drug. DNA reactivity has been correlated with cytotoxicity.
Indications/Uses
Advanced ovarian carcinoma; Small cell and non-small cell lung cancer; Squamous cell carcinoma of the head and neck; Advanced transitional cell carcinoma of the bladder; Significant responses have been observed when administration of SANBEPLATIN employed in the treatment of carcinoma of the cervix. SANBEPLATIN is frequently used in combination with other chemotherapeutic agent in various indications, such as with Paclitaxel in first line therapy of ovarian carcinoma and non small cell lung cancer.
Dosage/Direction for Use
Dosage: The recommended dose of SANBEPLATIN in previously untreated adult patients with normal kidney is 400 mg/m2, as a single short term intravenous infusion over 15-60 minutes. Therapy should not be repeated until four weeks after the previous SANBEPLATIN course and/or the neutrophil count is at least 2,000 cells/mm3 and the platelet count is at least 100,000 cells/mm3. It is recommended that according to clinical circumstances the initial dosage may require reduction by 20-25% in patients with risk factors such as previous myelosuppressive therapy and poor performance status.
Determination of haematologic nadir by weekly blood counts during initial course is recommended for future dosage adjustment and scheduling SANBEPLATIN.
Combination Therapy: The optimal use of SANBEPLATIN in combination with other myelosuppressive agents requires dosage adjustments according to the regimen and schedule to be adopted.
Formula dosing: Because the pharmacokinetics and, ultimately, the pharmacodynamics of SANBEPLATIN are highly dependent on the status of renal function, fixed dosing based on body surface area has led to Carboplatin over-dosing or, especially, underdosing. Another approach for determining the initial dose of SANBEPLATIN using Calvert formula, a simple formula for calculating dosage based upon a patients glomerular filtration rate (GFR in mL/min) and SANBEPLATIN target area under the concentration versus time curve SANBEPLATIN (AUC in mg/mL.min). SANBEPLATIN dose could then be measured in milligrams. (See Equation 1 and Table 1.)


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Click on icon to see table/diagram/image


An approach in heavily pre-treated patients** receiving single-agent SANBEPLATIN, when there is the desire to target a particular platelet nadir, is the use of the Ergorin formula: See Equation 2.


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** Patients are considered heavily pre-treated if they have received any of the following: Mitomycin-C; a Nitrosurea; combination chemotherapy with Doxorubicin, Cyclophosphamide and Cisplatin; chemotherapy with ≥ 5 different agents; or radiotherapy ≥ 4500 rads to single port 20 x 20 cm or 1 field of therapy.
Impaired renal function: In patients with initial impaired renal function reduction of dosage of SANBEPLATIN may be required. Haematological nadirs and renal function should be monitored in these circumstances. The risk of bone marrow suppression may be increased in patients with creatinine clearance < 60 mL/min.
A suggested dosage schedule in patients with impaired renal function based in creatinine clearane is a follows: See Table 2.


Click on icon to see table/diagram/image


The dose should be adjusted according to patient condition. There are limited data in patients with creatinine clearance < 15 mL/min.
Use in children: Specific dosage recommendations cannot be made due to insufficient use in paediatrics at this time.
Administration: Preparation of SANBEPLATIN solution: Equipment containing aluminium components should be avoided. (See PRECAUTIONS)
SANBEPLATIN Injection: Is a ready to use solution containing 10 mg/mL SANBEPLATIN in water for injection. The solution maybe further diluted in glucose intravenous infusion 5% or Sodium Chloride Intravenous Infusion 0.9%.
Handling guidelines: Carboplatin should be prepared for administered only by professionals who have been trained in the safe use of the preparation.
The personnel carrying out these procedures should be adequately protected with clothing, gloves and eye shield.
Pregnant personnel are advised not to handle chemotherapeutic agents.
Contaminations: In the event of contact of with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat transient stinging of skin. Medical advice should be sought if the eyes are affected.
In the event of a spillage, operators should use gloves and mop up the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with water. Put all solutions and sponges into a plastic bag and then seal it. The bag should be prominently labelled with the words: "Cytotoxic Waste" or similar.
Disposal: Syringes, containers absorbent materials, solutions and any other material which has come into contact with Carboplatin should be placed in a thick plastic bag or other impervious container and incinerated at 1000°C or more.
Stability: The product and admixture contain no antimicrobial agent. In order to reduce microbiological contamination hazard, infusion should be commenced as soon as practicable after preparation.
The solution of Carboplatin should be kept at room temperature (25°C) and used within 8 hours.
Overdosage
If it happens, the patient should receive supportive theraphy for complications related to myelosuppression, kidney disease and liver. From reports which is doses up to 600 mg/m2 were used, the patient said he felt very bad, diarrhea and apecia occurred.
Contraindications
Carboplatin is contraindicated in patients with the following conditions: Severe myelosuppression; Pre-existing severe renal impairment; dose adjustment may allow use in the presence of mild renal impairment (see DOSAGE & ADMINISTRATION); History of severe allergic reactions to Carboplatin, other platinum-containing compounds or mannitol; Bleeding tumors.
Use in pregnancy: Safe use of Carboplatin in pregnancy has not been established and its use in pregnancy is not recommended. Women of child bearing potential should use adequate contraception.
Use in lactation: It is not known whether Carboplatin is excreted in breastmilk. To avoid possible harmful effects in the infant, breast feeding is not advised during Carboplatin therapy.
Warnings
Myelosuppression as a result of Carboplatin treatment is closely related to the renal clearance of the drug. Therefore in patients who have abnormal renal function or who are receive concomitant therapy with nephrotoxic drugs, myelosuppression, especially thrombocytopenia, may be more severe and prolonged.
The occurrence, severity and protraction of toxicity is likely to be greater in patients who have received extensive prior treatment for their disease, have poor performance status and are more advance in age.
Renal function parameters should be assessed prior to, during and after therapy.
Peripheral blood counts (including platelets, white blood cells and haemoglobin) should be followed during and after therapy. Combination therapy with other myelosuppressive drugs may require modification of dosage and/or timing of schedules in order to minimize additive effects. Carboplatin courses should not, in general, be repeated more frequently than every four weeks in order to ensure that the nadir in blood counts has occurred and there has been recovery to a satisfactory level.
Mutagenicity: Carboplatin has been shown to be mutagenic in mammalian cells. Patients should be advised of its mutagenic potential and should use effective contraception for an adequate duration of time after ceasing therapy.
Special Precautions
Carboplatin should only be administered to patients under the supervision of qualified physician who is experienced in the use of chemotherapeutic agents. Diagnostic and treatment facilities should be readily available for appropriate management of therapy and possible complications.
Peripheral blood counts and renal function should be monitored closely. Blood counts should be performed prior to commencement of Carboplatin therapy and weekly thereafter. Aside from monitoring toxicity, this practice will help determine the nadir and recovery of the generally seen between days 14 and 28, and days 14 and 21 respectively after initial therapy. A greater reduction in platelets is seen in patients who previously received extensive myelosuppressive chemotherapy than non-treated patients. Blood cell counts less than 2,000 cells/mm3 or platelets less than 50,000 cells/mm3 should cause consideration of postponement of Carboplatin therapy until bone marrow recovery is evident, which is usually 5 to 6 weeks. Transfusion may be required.
Renal toxicity is not usually dose-limiting. Pre-treatment and post-treatment hydration is not necessary. However, about 25% of patients show decreases in creatinine clearance and, less frequently, rises in serum creatinine and blood urea nitrogen may be seen. Impairment of renal function is more likely to be seen in patients who have previously experienced nephrotoxicity as a result of Cisplatin therapy.
Neurotoxicity such as paraesthesias and decrease deep tendon reflexes, and ototoxicity are more likely to be seen in patients who have received Cisplatin previously. Neurological evaluations and an assessment of hearing should be performed on a regular basis. Vomiting that may increase in patient getting other emetogenic treatment Aluminium-containing equipment should not be used (see INTERACTIONS).
Use In Pregnancy & Lactation
Use in pregnancy: Safe use of Carboplatin in pregnancy has not been established and its use in pregnancy is not recommended. Women of child bearing potential should use adequate contraception.
Use in lactation: It is not known whether Carboplatin is excreted in breast milk. To avoid possible harmful effects in the infant, breast feeding is not advised during Carboplatin therapy.
Adverse Reactions
Myelosuppression is the dose-limiting toxicity of Carboplatin. It is generally reversible and is not cumulative when Carboplatin is used as single agent and at the recommended frequencies of administration. Adverse reactions which have been observed in studies to date can be grouped under the following organ systems: Haematopoietic system: Leucopenia, thrombocytopenia, anaemia. Transfusional support has been required in about one-fifth of patients.
Gastrointestinal system: Nausea and vomiting, nausea only, diarrhea, constipation. Nausea and vomiting are generally delay 6-12 hours after administration of Carboplatin and disappear within 24 hours. It is readily controlled (or may be prevented) with antiemetic medication.
Renal system: Decrease in creatinine clearance: increase in uric acid, blood urea nitrogen and serum creatinine.
Biochemistry: Decreases in serum magnesium, potassium and rarely, calcium. These changes have not been severe enough to cause clinical symptoms.
Neurotoxicity: Peripheral neuropathy which was mild and dysgeusia. Paraesthesias present prior to treatment, especially if caused by Cisplatin, may persist or worsen during Carboplatin therapy (see Precautions).
Ototoxicity: Subclinical decrease in hearing acuity as determined by audiogram, in the high frequency (4,000-8,000 Hz) range; clinical ototoxicity, usually manifested as tinnitus. In patients who developed hearing loss as a result of Cisplatin therapy, the impairment may persist or worsen.
Hepatic System: Increases in liver enzymes have been transient in the majority of cases. Alkaline phosphatase (ALP), aspartate, aminotransferase (AST), bilirubin.
Allergic reactions: In less than 2 % of patients similar to those seen after Cisplatin have been observed i.e. erythematous rash, fever and pruritus. In a few cases no cross-reactivity was present.
Others: Alopecia, flu-like syndrome, reaction at injection site (<1%).
Drug Interactions
Carboplatin may interact with aluminium to form block precipitate. Needles, syringes, catheters or i.v. administration sets that contains aluminium parts which may come in contract with Carboplatin should not be used for preparation or administration of the drug. Concurrent therapy with nephrotoxic drugs may increase or exacerbate toxicity due to Carboplatin included changes in renal clearance. Combination therapy with other myelosuppressive drugs may cause consideration to altering the dose or timing of Carboplatin therapy in order to minimize additive myelosuppressive effects.
Storage
Store below 30°C, away from light.
Do not freeze.
ATC Classification
L01XA02 - carboplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Inj (vial) 10 mg/mL x 45 mL x 1's.
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