Paraplatin Side Effects

Generic name: carboplatin

Note: This document contains side effect information about carboplatin. Some of the dosage forms listed on this page may not apply to the brand name Paraplatin.

Some side effects of Paraplatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to carboplatin: intravenous powder for injection, intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking carboplatin (the active ingredient contained in Paraplatin) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• 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).

Common side effects may include:

• nausea, vomiting, loss of appetite;

• tired feeling;

• temporary hair loss; or

• pain, swelling or redness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to carboplatin: intravenous powder for injection, intravenous solution

Hematologic

Bone marrow suppression is the dose limiting toxicity of carboplatin (the active ingredient contained in Paraplatin) Marrow suppression is usually more severe in patients with impaired kidney function. Anemia with a hemoglobin count less than 11 g/dL has been observed in 71% of patients who started therapy with a baseline above that value. The incidence of anemia increases with increasing exposure. Bone marrow depression may be more severe when carboplatin is combined with other bone marrow suppressing drugs or with radiotherapy. One study has suggested that myelotoxicity could be minimized by the use of regimes based on the circadian rhythm of the bone marrow.

Hematologic side effects have been reported to include thrombocytopenia with platelet counts below 50,000/mm3 in 25% of patients and in 35% of previously treated ovarian cancer patients (PTOCP), neutropenia with granulocyte counts below 1,000/mm3 in 16% of patients (21% of PTOCP), and leukopenia with WBC counts below 2,000/mm3 in 15% of patients (26% of PTOCP).

Gastrointestinal

Gastrointestinal side effects have included vomiting which occurred in 65% of patients and in 81% of PTOCP. In approximately one third of these patients, the vomiting was reported as severe. Other gastrointestinal side effects have included pain (17%), diarrhea (6%), constipation (6%), and stomatitis.

Patients previously treated with emetogenic agents (especially cisplatin) have been more prone to vomiting. Nausea alone occurs in an additional 10% to 15% of patients. Prolonged administration of carboplatin (either by continuous 24 hour infusion or daily pulse doses given for 5 consecutive days) was associated with less severe vomiting than the single dose intermittent schedule.

Nervous system

Nervous system side effects have included peripheral neuropathies which have been reported in 4% of patients and 6% of PTOCP, with mild paresthesias occurring most frequently. Patients older than 65 years of age or previously treated with cisplatin have a been reported to have a 10% risk for peripheral neuropathies. Prolonged treatment, particularly in cisplatin-pretreated patients, may result in cumulative neurotoxicity.

Hepatic

Hepatic side effects have included abnormal liver function tests reported in patients with normal baseline values receiving standard dosages including total bilirubin (5%), SGOT (15%), and alkaline phosphatase (24%), and 5%, 19%, and 37% respectively in PTOCP. These abnormalities were mild and reversible in about one-half of the cases.

In patients receiving very high dosages of carboplatin (the active ingredient contained in Paraplatin) and autologous bone marrow transplantation, severe abnormalities of liver function tests have been reported.

Renal

Renal side effects have included abnormalities in 6% of serum creatinine test results (10% for PTOCP) and 14% of blood urea nitrogen test results (22% for PTOCP). Most of these reported abnormalities have been mild and about one-half of them were reversible. There have been at least two case reports in the literature of patients with preexisting renal dysfunction deteriorating into renal failure due to intravenous carboplatin (the active ingredient contained in Paraplatin) therapy. In one of the cases, renal failure followed high-dose therapy. In the other patient, acute renal failure was reversible. There have also been at least two reports in the literature of acute renal failure associated with the use of intraperitoneal carboplatin. Neither patient had a full return of renal function to baseline.

Creatinine clearance is the most sensitive measure of renal function in patients receiving carboplatin. Creatinine clearance also appears to be the most useful test for correlating drug clearance and bone marrow suppression.

Other

Other side effects have included abnormally decreased serum electrolyte values such as sodium (29%), magnesium (29%), calcium (22%), and potassium (20%), 47%, 43%, 31%, and 28% respectively in PTOCP. Electrolyte abnormalities were rarely associated with symptoms.

Ototoxicity has been reported with the use of high-dose carboplatin (the active ingredient contained in Paraplatin)

The most frequently reported miscellaneous side effects were pain and asthenia.

Hypersensitivity

One study has noted that approximately 40 instances of hypersensitivity have been reported. The study further notes that there is generally a slow development of hypersensitivity, with reactions evolving only after several cycles of therapy.

Allergic reactions have generally been manageable with standard epinephrine, corticosteroid, and antihistamine therapy.

Hypersensitivity side effects have been reported to include rash, urticaria, erythema, pruritus, and rarely bronchospasm and hypotension. Hypersensitivity reactions may be common in patients with gynecological malignancies.

Metabolic

Metabolic side effects have included dehydration.

Ocular

Ocular side effects including a case of blindness associated with the use of high dose carboplatin (the active ingredient contained in Paraplatin) have been reported.

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