DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION
NOTE: Aluminum reacts with carboplatin causing precipitate formation and loss of potency, therefore, needles or intravenous sets containing aluminum parts that may come in contact with the drug must not be used for the preparation or administration of Carboplatin Injection.
Single Agent Therapy
Carboplatin Injection, as a single agent, has been shown to be effective in patients with recurrent ovarian carcinoma at a dosage of 360 mg/m2 IV on day 1 every 4 weeks (alternatively see Formula Dosing). In general, however, single intermittent courses of Carboplatin Injection should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000.
Combination Therapy with Cyclophosphamide
In the chemotherapy of advanced ovarian cancer, an effective combination for previously untreated patients consists of:
Carboplatin Injection - 300 mg/m2 IV on day 1 every four weeks for six cycles (alternatively see Formula Dosing).
Cyclophosphamide - 600 mg/m2 IV on day 1 every four weeks for six cycles. For directions regarding the use and administration of cyclophosphamide please refer to its package insert. (see CLINICAL STUDIES.)
Intermittent courses of Carboplatin Injection in combination with cyclophosphamide should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000.
Dose Adjustment Recommendations
Pretreatment platelet count and performance status are important prognostic factors for severity of myelosuppression in previously treated patients.
The suggested dose adjustments for single agent or combination therapy shown in the table below are modified from controlled trials in previously treated and untreated patients with ovarian carcinoma. Blood counts were done weekly, and the recommendations are based on the lowest post-treatment platelet or neutrophil value.
| Platelets | Neutrophils | Adjusted Dose* (From Prior Course) |
|---|---|---|
| ||
>100,000 | >2,000 | 125% |
50–100,000 | 500–2,000 | No Adjustment |
<50,000 | <500 | 75% |
Carboplatin Injection is usually administered by an infusion lasting 15 minutes or longer. No pre- or post-treatment hydration or forced diuresis is required.
Patients with Impaired Kidney Function
Patients with creatinine clearance values below 60 mL/min are at increased risk of severe bone marrow suppression. In renally-impaired patients who received single agent Carboplatin Injection therapy, the incidence of severe leukopenia, neutropenia, or thrombocytopenia has been about 25% when the dosage modifications in the table below have been used.
| Baseline Creatinine Clearance | Recommended Dose on Day 1 |
|---|---|
41 – 59 mL/min | 250 mg/m2 |
16 – 40 mL/min | 200 mg/m2 |
The data available for patients with severely impaired kidney function (creatinine clearance below 15 mL/min) are too limited to permit a recommendation for treatment.
These dosing recommendations apply to the initial course of treatment. Subsequent dosages should be adjusted according to the patient's tolerance based on the degree of bone marrow suppression.
Formula Dosing
Another approach for determining the initial dose of Carboplatin Injection is the use of mathematical formulae, which are based on a patient's pre-existing renal function or renal function and desired platelet nadir. Renal excretion is the major route of elimination for carboplatin. (see CLINICAL PHARMACOLOGY.) The use of dosing formulae, as compared to empirical dose calculation based on body surface area, allows compensation for patient variations in pretreatment renal function that might otherwise result in either underdosing (in patients with above average renal function) or overdosing (in patients with impaired renal function).
A simple formula for calculating dosage, based upon a patient's glomerular filtration rate (GFR in mL/min) and Carboplatin Injection target area under the concentration versus time curve (AUC in mg/mL∙min), has been proposed by Calvert. In these studies, GFR was measured by 51Cr-EDTA clearance.
| CALVERT FORMULA FOR CARBOPLATIN DOSING |
|---|
Total Dose (mg) = (target AUC) × (GFR + 25) |
Note: With the Calvert formula, the total dose of Carboplatin Injection is calculated in mg, not mg/m2. |
The target AUC of 4 mg/mL∙min to 6 mg/mL∙min using single agent Carboplatin Injection appears to provide the most appropriate dose range in previously treated patients. This study also showed a trend between the AUC of single agent Carboplatin Injection administered to previously treated patients and the likelihood of developing toxicity.
| % Actual Toxicity in Previously Treated Patients | ||
|---|---|---|
| AUC (mg/mL∙min) | Gr 3 or Gr 4 Thrombocytopenia | Gr 3 or Gr 4 Leukopenia |
4 to 5 | 16% | 13% |
6 to 7 | 33% | 34% |
PATIENT INFORMATION
PATIENT INFORMATION
Rx only
Read this entire leaflet carefully. Keep it for future reference. |
Carboplatin Injection
This information will help you learn more about Carboplatin Injection. It cannot, however, cover all the possible warnings or side effects relating to Carboplatin Injection, and it does not list all of the benefits and risks of Carboplatin Injection. Your doctor should always be your first choice for detailed information about your medical condition and your treatment. Be sure to ask your doctor about any questions you may have.
What is cancer?
Under normal conditions, the cells in your body divide and grow in an orderly, controlled fashion. Cell division and growth are necessary for the human body to perform its functions and to repair itself. Cancer cells are different from normal cells because they are not able to control their own growth. The reasons for this abnormal growth are not yet fully understood.
A tumor is a mass of unhealthy cells that are dividing and growing fast and in an uncontrolled way. When a tumor invades surrounding healthy body tissue it is known as a malignant tumor. A malignant tumor can spread (metastasize) from its original location to other parts of the body.
What is Carboplatin Injection?
Carboplatin Injection is a medicine that is used to treat cancer of the ovaries. It acts by interfering with the division of rapidly multiplying cells, particularly cancer cells.
Who should not take Carboplatin Injection?
Treatment with Carboplatin Injection is not recommended if you:
- •
- are allergic to Carboplatin Injection or other platinum-containing products;
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- have a weakened blood-forming system (bone marrow depression) or significant bleeding;
- •
- are pregnant, intend to become pregnant, or are breast-feeding a baby.
How is Carboplatin Injection used?
Only a professional experienced in the use of cancer drugs should give you this medication. Carboplatin Injection is given by dripping the medicine slowly and directly into a vein (intravenous infusion) for 15 minutes or longer. Your doctor will determine the dose of Carboplatin Injection for you based on your weight, height, and kidney function. Carboplatin Injection may be given alone or with other drugs. Treatment is usually repeated every four weeks for a number of cycles.
Before and after Carboplatin Injection treatment, your doctor may give you medication to lessen the nausea and vomiting associated with this cancer treatment.
What should you tell your doctor before starting treatment with Carboplatin Injection?
Discuss the benefits and risks of Carboplatin Injection with your doctor before beginning treatment.
Be sure to inform your doctor:
- •
- If you are allergic to Carboplatin Injection or other platinum containing products;
- •
- If you are or intend to become pregnant, since Carboplatin Injection may harm the developing fetus. It is important to use effective birth control while you are being treated with Carboplatin Injection;
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- If you are breast-feeding, since nursing infants may be exposed to Carboplatin Injection in this way;
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- If you are taking other medicines, including all prescription and non prescription (over-the-counter) drugs, since Carboplatin Injection may affect the action of other medicines;
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- If you have any other medical problems, especially chicken pox (including recent exposure to adults or children with chicken pox), shingles, hearing problems, infection, or kidney disease, since treatment with Carboplatin Injection increases the risk and severity of these conditions.
What should I avoid while taking Carboplatin Injection?
If you are pregnant or think you might be pregnant, or if you are breast feeding, let your doctor know right away. Carboplatin Injection may harm your developing fetus or breast-feeding baby. If you are a woman of childbearing age, you should use birth control to avoid getting pregnant while you are taking Carboplatin Injection.
You should avoid contact with adults and children who have infections, and tell your doctor right away if you show signs of infection such as cough, fever, and/or chills.
Also, while you are being treated with Carboplatin Injection or after you stop treatment, first check with your doctor before getting any immunizations (vaccinations). Avoid contact with adults or children who have received oral polio vaccine since they can pass the polio virus to you.
What are the possible side effects of Carboplatin Injection?
Carboplatin Injection may cause unwanted effects, particularly because Carboplatin Injection interferes with the growth of normal cells as well as cancer cells. For example, the occurrence of another cancer (secondary malignancy) has been reported in patients receiving cancer chemotherapy with multiple drugs. It is not always possible to tell whether such effects are caused by Carboplatin Injection, another drug you may be taking, or your illness. Because some of these effects may be serious, you will need close medical supervision during treatment with Carboplatin Injection.
The most serious side effects of Carboplatin Injection are:
- •
- bleeding and reduced blood cells, including reduced red blood cells (anemia) and platelets (needed for proper blood clotting), which may be severe enough to require blood transfusion. You should tell your doctor right away if you notice any unusual bruising or bleeding, including black tarry stools or blood in the urine.
- •
- infection – Carboplatin Injection can temporarily lower the number of white blood cells in your blood, increasing the risk of infection;
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- life-threatening allergic reaction – during and after treatment the doctor or nurse will observe you carefully for signs of allergic reaction;
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- kidney and liver problems;
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- loss of hearing or ringing in the ears;
Contact your doctor right away if you experience any of these effects, or notice effects that worry you or are troublesome.
Of the less serious side effects associated with Carboplatin Injection treatment, the most common are nausea, vomiting, diarrhea, loss of appetite, hair loss and numbness, tingling, burning, or pain in the hands or feet.
This medicine was prescribed for your particular condition. It must be given under close medical supervision by a doctor trained in the use of drugs for the treatment of cancer. This summary does not include everything there is to know about Carboplatin Injection. Medicines are sometimes prescribed for purposes other than those listed in patient leaflets. If you have questions or concerns, or want more information about Carboplatin Injection, your physician and pharmacist have the complete prescribing information upon which this information is based. You may want to read it and discuss it with your doctor. Remember, no written summary can replace careful discussion with your doctor.
Distributed by Hospira, Inc. Lake Forest, IL 60045
LAB-1016-2.0
Revised: 4/2018
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