Carboplatin

Last reviewed on RxList: 11/9/2020
Carboplatin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Carboplatin Injection?

Carboplatin injection solution is an anti-cancer medication indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin injection and cyclophosphamide. Carboplatin injection is also indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. Carboplatin is available in generic form.

What Are Side Effects of Carboplatin Injection?

Common side effects of carboplatin include:

  • nausea,
  • vomiting,
  • numbness and tingling of extremities,
  • ear infection,
  • pain,
  • weakness,
  • allergic reactions, and
  • hair loss.

Tell your doctor if you have serious side effects of carboplatin including:

  • bleeding and reduced blood cells, including reduced red blood cells (anemia) and platelets (needed for proper blood clotting);
  • unusual bruising or bleeding, black tarry stools or blood in the urine;
  • infection;
  • life-threatening allergic reaction;
  • kidney and liver problems; or
  • loss of hearing or ringing in the ears.

Dosage for Carboplatin Injection

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. 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 4 weeks for 6 cycles, or cyclophosphamide 600 mg/m2 IV on day 1 every 4 weeks for 6 cycles.

What Drugs, Substances, or Supplements Interact with Carboplatin Injection?

Carboplatin may interact with nephrotoxic compounds. Tell your doctor all medications and supplements you use.

Carboplatin Injection During Pregnancy and Breastfeeding

Carboplatin is not recommended for use during pregnancy; it may harm a fetus.

Women of childbearing potential are advised to avoid becoming pregnant. Because there is a possibility of toxicity in nursing infants secondary to carboplatin injection treatment of the mother, breastfeeding while receiving carboplatin is not recommended.

Additional Information

Our Carboplatin Injection Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Signs of Cancer in Women: Symptoms You Can't Ignore See Slideshow
Carboplatin Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

You may have a severe allergic reaction within minutes of receiving a carboplatin injection. Your caregivers will quickly treat you if you if this occurs.

Call your doctor at once if you have:

  • severe or ongoing nausea and vomiting;
  • numbness or tingly feeling in your hands or feet;
  • vision problems;
  • hearing problems, ringing in your ears;
  • skin changes where the medicine was injected;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
  • low magnesium--dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling.

Common side effects may include:

  • low blood cell counts;
  • nausea, vomiting;
  • abnormal liver function tests;
  • low magnesium;
  • temporary hair loss; or
  • pain or weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Carboplatin (Carboplatin Injection)

QUESTION

Where does ovarian cancer occur? See Answer
Carboplatin Professional Information

SIDE EFFECTS

For a comparison of toxicities when carboplatin, USP or cisplatin was given in combination with cyclophosphamide, see Clinical Studies, Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer, Comparative Toxicity.

ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER

Bone Marrow   First Line Combination Therapy* Percent Second Line Single Agent Therapy† Percent
Thrombocytopenia < 100,000/mm³ 66 62
< 50,000 /mm³ 33 35
Neutropenia < 2,000 cells/mm³ 96 67
< 1,000 cells/mm³ 82 21
Leukopenia < 4,000 cells/mm³ 97 85
< 2,000 cells/mm³ 71 26
Anemia < 11 g/dL 90 90
< 8 g/dL 14 21
Infections   16 5
Bleeding   8 5
Transfusions   35 44
Gastrointestinal
Nausea and vomiting   93 92
Vomiting   83 81
Other GI side effects   46 21
Neurologic
Peripheral neuropathies   15 6
Ototoxicity   12 1
Other sensory side effects   5 1
Central neurotoxicity   26 5
Renal
Serum creatinine elevations   6 10
Blood urea elevations   17 22
Hepatic
Bilirubin elevations   5 5
SGOT elevations   20 19
Alkaline phosphatase elevations   29 37
Electrolytes loss
Sodium   10 47
Potassium   16 28
Calcium   16 31
Magnesium   61 43
Other side effects
Pain   44 23
Asthenia   41 11
Cardiovascular   19 6
Respiratory   10 6
Allergic   11 2
Genitourinary   10 2
Alopecia +   49 2
Mucositis   8 1
*Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer: Data are based on the experience of 393 patients with ovarian cancer (regardless of baseline status) who received initial combination therapy with carboplatin, USP and cyclophosphamide in two randomized controlled studies conducted by SWOG and NCIC (see Clinical Studies).
† Single Agent Use for the Secondary Treatment of Ovarian Cancer: Data are based on the experience of 553 patients with previously treated ovarian carcinoma (regardless of baseline status) who received single-agent carboplatin, USP.

Hematologic Toxicity

Bone marrow suppression is the dose-limiting toxicity of carboplatin injection. Thrombocytopenia with platelet counts below 50,000/mm³ occurs in 25% of the patients (35% of pretreated ovarian cancer patients); neutropenia with granulocyte counts below 1,000/mm³ occurs in 16% of the patients (21% of pretreated ovarian cancer patients); leukopenia with WBC counts below 2,000/mm occurs in 15% of the patients (26% of pretreated ovarian cancer patients). The nadir usually occurs about day 21 in patients receiving single-agent therapy. By day 28, 90% of patients have platelet counts above 100,000/mm³; 74% have neutrophil counts above 2,000/mm³; 67% have leukocyte counts above 4,000/mm³.

Marrow suppression is usually more severe in patients with impaired kidney function. Patients with poor performance status have also experienced a higher incidence of severe leukopenia and thrombocytopenia.

The hematologic effects, although usually reversible, have resulted in infectious or hemorrhagic complications in 5% of the patients treated with carboplatin, USP, with drug related death occurring in less than 1% of the patients. Fever has also been reported in patients with neutropenia.

Anemia with hemoglobin less than 11 g/dL has been observed in 71% of the patients who started therapy with a baseline above that value. The incidence of anemia increases with increasing exposure to carboplatin injection. Transfusions have been administered to 26% of the patients treated with carboplatin, USP (44% of previously treated ovarian cancer patients).

Bone marrow depression may be more severe when carboplatin injection is combined with other bone marrow suppressing drugs or with radiotherapy.

Gastrointestinal Toxicity

Vomiting occurs in 65% of the patients (81% of previously treated ovarian cancer patients) and in about one-third of these patients it is severe. Carboplatin, USP, as a single agent or in combination, is significantly less emetogenic than cisplatin; however, patients previously treated with emetogenic agents, especially cisplatin, appear to be more prone to vomiting. Nausea alone occurs in an additional 10% to 15% of patients. Both nausea and vomiting usually cease within 24 hours of treatment and are often responsive to antiemetic measures. Although no conclusive efficacy data exist with the following schedules, prolonged administration of carboplatin, USP, either by continuous 24-hour infusion or by daily pulse doses given for 5 consecutive days, was associated with less severe vomiting than the single-dose intermittent schedule. Emesis was increased when carboplatin, USP was used in combination with other emetogenic compounds. Other gastrointestinal effects observed frequently were pain, in 17% of the patients; diarrhea, in 6%; and constipation, also in 6%.

Neurologic Toxicity

Peripheral neuropathies have been observed in 4% of the patients receiving carboplatin, USP (6% of pretreated ovarian cancer patients) with mild paresthesias occurring most frequently. Carboplatin, USP therapy produces significantly fewer and less severe neurologic side effects than does therapy with cisplatin. However, patients older than 65 years and/or previously treated with cisplatin appear to have an increased risk (10%) for peripheral neuropathies. In 70% of the patients with pre-existing cisplatininduced peripheral neurotoxicity, there was no worsening of symptoms during therapy with carboplatin, USP. Clinical ototoxicity and other sensory abnormalities such as visual disturbances and change in taste have been reported in only 1% of the patients. Central nervous system symptoms have been reported in 5% of the patients and appear to be most often related to the use of antiemetics.

Although the overall incidence of peripheral neurologic side effects induced by carboplatin, USP is low, prolonged treatment, particularly in cisplatin-pretreated patients, may result in cumulative neurotoxicity.

Nephrotoxicity

Development of abnormal renal function test results is uncommon, despite the fact that carboplatin, USP, unlike cisplatin, has usually been administered without high-volume fluid hydration and/or forced diuresis. The incidences of abnormal renal function tests reported are 6% for serum creatinine and 14% for blood urea nitrogen (10% and 22%, respectively, in pretreated ovarian cancer patients). Most of these reported abnormalities have been mild and about one-half of them were reversible.

Creatinine clearance has proven to be the most sensitive measure of kidney function in patients receiving carboplatin, USP, and it appears to be the most useful test for correlating drug clearance and bone marrow suppression. Twenty-seven percent of the patients who had a baseline value of 60 mL/min or more demonstrated a reduction below this value during carboplatin, USP therapy.

Hepatic Toxicity

The incidences of abnormal liver function tests in patients with normal baseline values were reported as follows: total bilirubin, 5%; SGOT, 15%; and alkaline phosphatase, 24%; (5%, 19%, and 37%, respectively, in pretreated ovarian cancer patients). These abnormalities have generally been mild and reversible in about one-half of the cases, although the role of metastatic tumor in the liver may complicate the assessment in many patients. In a limited series of patients receiving very high dosages of carboplatin, USP and autologous bone marrow transplantation, severe abnormalities of liver function tests were reported.

Electrolyte Changes

The incidences of abnormally decreased serum electrolyte values reported were as follows: sodium, 29%; potassium, 20%; calcium, 22%; and magnesium, 29%; (47%, 28%, 31%, and 43%, respectively, in pretreated ovarian cancer patients). Electrolyte supplementation was not routinely administered concomitantly with carboplatin, USP, and these electrolyte abnormalities were rarely associated with symptoms.

Allergic Reactions

Hypersensitivity to carboplatin, USP has been reported in 2% of the patients. These allergic reactions have been similar in nature and severity to those reported with other platinum-containing compounds, i.e., rash, urticaria, erythema, pruritus, and rarely bronchospasm and hypotension. Anaphylactic reactions have been reported as part of postmarketing surveillance (see WARNINGS). These reactions have been successfully managed with standard epinephrine, corticosteroid, and antihistamine therapy.

Injection Site Reactions

Injection site reactions, including redness, swelling, and pain, have been reported during postmarketing surveillance. Necrosis associated with extravasation has also been reported.

Other Events

Pain and asthenia were the most frequently reported miscellaneous adverse effects; their relationship to the tumor and to anemia was likely. Alopecia was reported (3%). Cardiovascular, respiratory, genitourinary, and mucosal side effects have occurred in 6% or less of the patients. Cardiovascular events (cardiac failure, embolism, cerebrovascular accidents) were fatal in less than 1% of the patients and did not appear to be related to chemotherapy. Cancer-associated hemolytic uremic syndrome has been reported rarely.

Malaise, anorexia, hypertension, dehydration, and stomatitis have been reported as part of postmarketing surveillance.

Read the entire FDA prescribing information for Carboplatin (Carboplatin Injection)

© Carboplatin Patient Information is supplied by Cerner Multum, Inc. and Carboplatin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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