PRECAUTIONS
PRECAUTIONS
General
Needles or intravenous administration sets containing aluminum parts that may come in contact with Carboplatin Injection should not be used for the preparation or administration of the drug. Aluminum can react with carboplatin causing precipitate formation and loss of potency.
Drug Interactions
The renal effects of nephrotoxic compounds may be potentiated by carboplatin. A decrease in phenytoin serum levels has been observed with concurrent administration of carboplatin and phenytoin/fosphenytoin. This may lead to exacerbation of seizures.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of carboplatin has not been studied, but compounds with similar mechanisms of action and mutagenicity profiles have been reported to be carcinogenic. Carboplatin has been shown to be mutagenic both in vitro and in vivo. It has also been shown to be embryotoxic and teratogenic in rats receiving the drug during organogenesis. Secondary malignancies have been reported in association with multi-drug therapy. Acute promyelocytic leukemia (APL) and myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) have been reported years after therapy with carboplatin and other antineoplastic treatments.
Nursing Mothers
It is not known whether carboplatin is excreted in human milk. Because there is a possibility of toxicity in nursing infants secondary to carboplatin treatment of the mother, it is recommended that breast-feeding be discontinued if the mother is treated with carboplatin.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established (see WARNINGS; "Audiologic Toxicity").
Geriatric Use
Of the 789 patients in initial treatment combination therapy studies (NCIC and SWOG), 395 patients were treated with carboplatin in combination with cyclophosphamide. Of these, 141 were over 65 years of age and 22 were 75 years or older. In these trials, age was not a prognostic factor for survival. In terms of safety, elderly patients treated with carboplatin were more likely to develop severe thrombocytopenia than younger patients. In a combined database of 1,942 patients (414 were ≥ 65 years of age) that received single agent carboplatin for different tumor types, a similar incidence of adverse events was seen in patients 65 years and older and in patients less than 65. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Because renal function is often decreased in the elderly, renal function should be considered in the selection of carboplatin dosage (see DOSAGE AND ADMINISTRATION).
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:
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- 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;
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- 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:
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- If you are allergic to Carboplatin Injection or other platinum containing products;
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- 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:
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- 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.
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- 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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