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Paraplatin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Paraplatin (carboplatin aqueous solution) Injection is a cancer medication used to treat ovarian cancer. It is available in generic form. Common side effects of Paraplatin include nausea, vomiting, loss of appetite, feeling tired, hair loss, pain, swelling and redness where the medicine was injected.
The usual dosage of Paraplatin is 300mg/m2 on day 1 every 4 weeks for 6 cycles. Medication used to treat bowel disorder or prevent organ transplant rejection, antiviral medicine, pain or arthritis medicine, and injected antibiotics can interact with Paraplatin. Tell your doctor all medications you take. Do not take Paraplatin if you have severe bleeding or bone marrow suppression. Paraplatin can lower your blood cells that help your body's ability to fight infections. Do not take Paraplatin if you are pregnant or breastfeeding.
Our Paraplatin (carboplatin aqueous solution) Injection 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Paraplatin in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- severe or ongoing vomiting;
- stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- numbness or tingly feeling in your hands or feet;
- hearing or vision problems;
- skin changes where the medicine was injected; or
- low magnesium (confusion, uneven heart rate, jerking muscle movements, muscle weakness or limp feeling).
Less serious side effects may include:
- nausea, vomiting, loss of appetite;
- tired feeling;
- temporary hair loss; or
- pain, swelling or redness where the medicine was injected.
Read the entire detailed patient monograph for Paraplatin (Carboplatin) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Paraplatin Overview - Patient Information: Side Effects
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: numbness or tingling in the hands/feet, mouth sores, yellowing eyes/skin, dark urine, unusual tiredness, change in the amount of urine, pain/swelling/redness at the injection site, hearing problems (e.g., ringing in the ears, hearing loss), easy bruising/bleeding, blood in the urine, black/bloody stools, fast/irregular heartbeat.
Rarely, temporary vision loss may occur with high doses of carboplatin. Normal vision usually returns within several weeks after the end of treatment. Consult your doctor or pharmacist for more details and report this side effect immediately if it occurs.
This medication can lower your body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.
A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Paraplatin (Carboplatin)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Paraplatin FDA Prescribing Information: Side Effects
For a comparison of toxicities when carboplatin 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
|First Line Combination Therapy* Percent||Second Line Single-Agent Therapy** Percent|
|Neutropenia||< 2000 cells/mm3||96||67|
|< 1000 cells/mm3||82||21|
|Leukopenia||< 4000 cells/mm3||97||85|
|< 2000 cells/mm3||71||26|
|Anemia||< 11 g/dL||90||90|
|< 8 g/dL||14||21|
|Nausea and vomiting||93||92|
|Other GI side effects||46||21|
|Other sensory side effects||5||1|
|Serum creatinine elevations||6||10|
|Blood urea elevations||17||22|
|Alkaline phosphatase elevations||29||37|
|Other side effects|
|* 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 and cyclophosphamide in two randomized controlled
studies conducted by SWOG and NCIC (see Clinical Studies).
Combination with cyclophosphamide as well as duration of treatment may be responsible for the differences that can be noted in the adverse experience table.
** 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.
In the narrative section that follows, the incidences of adverse events are based on data from 1,893 patients with various types of tumors who received carboplatin as single-agent therapy.
Bone marrow suppression is the dose-limiting toxicity of PARAPLATIN (carboplatin) . 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/mm3 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, 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 PARAPLATIN (carboplatin) . Transfusions have been administered to 26% of the patients treated with carboplatin (44% of previously treated ovarian cancer patients).
Bone marrow depression may be more severe when PARAPLATIN (carboplatin) is combined with other bone marrow suppressing drugs or with radiotherapy.
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, 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, 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 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%.
Peripheral neuropathies have been observed in 4% of the patients receiving carboplatin (6% of pretreated ovarian cancer patients) with mild paresthesias occurring most frequently. Carboplatin 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 cisplatin-induced peripheral neurotoxicity, there was no worsening of symptoms during therapy with carboplatin. 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 is low, prolonged treatment, particularly in cisplatin pretreated patients, may result in cumulative neurotoxicity.
Development of abnormal renal function test results is uncommon, despite the fact that carboplatin, 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, 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 therapy.
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 and autologous bone marrow transplantation, severe abnormalities of liver function tests were reported.
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, and these electrolyte abnormalities were rarely associated with symptoms.
Hypersensitivity to carboplatin 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, ie, 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.
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.
Read the entire FDA prescribing information for Paraplatin (Carboplatin) »
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