Platinol Side Effects

Generic name: cisplatin

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

Some side effects of Platinol 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 cisplatin: intravenous powder for injection, intravenous solution

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

Call your doctor at once if you have:

• hearing or vision problems, pain behind your eyes;

• trouble with walking or daily activities;

• numbness, tingling, or cold feeling in your hands or feet;

• drowsiness, mood changes, increased thirst, little or no urinating;

• swelling, weight gain, feeling short of breath;

• pale skin, 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;

• chest pain or heavy feeling, pain spreading to the jaw or arm, nausea, sweating, general ill feeling;

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with speech or balance;

• low calcium (numbness or tingly feeling around your mouth, muscle tightness or contraction, overactive reflexes);

• high or low potassium (confusion, tingly feeling, slow or uneven heart rate, weak pulse, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

• low sodium (slurred speech, hallucinations, vomiting, severe weakness, muscle cramps, loss of coordination, feeling unsteady, fainting, seizure, shallow breathing or breathing that stops).

Common side effects may include:

• decreased sense of taste;

• tired feeling;

• temporary hair loss; or

• pain, swelling, burning, or irritation around the IV needle.

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 cisplatin: compounding powder, intravenous powder for injection, intravenous solution

Renal

A study of 12 patients who received recommended doses of cisplatin (the active ingredient contained in Platinol) incurred moderate loss of renal function 12 and 24 months after therapy was discontinued. The renal dysfunction was not progressive. However, glomerular filtration rate (GFR) and effective renal plasma flow (EPRF) were decreased by 23% and 19%, respectively. Other studies have shown moderate and permanent reduction in GFR up to 52 months after cisplatin therapy.

Elderly patients may be more susceptible to nephrotoxicity.

The risk of renal toxicity may be decreased with appropriate monitoring of renal function tests as well as aggressive hydration with chloride-containing fluids and appropriate electrolyte replacement. Amifostine, a thiol chemoprotectant, is approved to reduce cisplatin nephrotoxicity and does not interfere with antitumor activity.

Renal side effects have been reported to present during the second week after a dose of cisplatin and become more prolonged and severe with repeated courses of cisplatin therapy. Nephrotoxicity is the most important dose-limiting side effect of cisplatin, which is dose-related, cumulative, and occurs in 36% of patients after single doses of 50 mg/m2. Renal function should return to baseline before subsequent doses are administered.

Cisplatin-induced renal tubule damage can result in clinically significant hypomagnesemia and hypokalemia as well as hypocalcemia, hyponatremia, hypophosphatemia, and hyperuricemia.

Gastrointestinal

Acute cisplatin-induced emesis occurs one to four hours after cisplatin (the active ingredient contained in Platinol) administration and is primarily serotonin mediated. Appropriate antiemetics are essential. A serotonin-receptor antagonist in combination with a steroid generally controls this emesis effectively.

Delayed emesis occurs two to seven days after cisplatin administration and is more difficult to control. Oral steroid therapy, if tolerated, with or without metoclopramide may be useful in the prevention of delayed emesis. (Serotonin antagonists provide limited benefits for delayed emesis.)

Gastrointestinal side effects have included nausea and vomiting which can be dose-limiting in some patients. Nausea and vomiting usually begin one to four hours after treatment and may last up to five days. Diarrhea, hiccups, and elevated serum amylase have also been reported.

Nervous system

Nervous system side effects can be dose limiting for patients receiving cisplatin (the active ingredient contained in Platinol) The most common form of nerve damage from cisplatin is a sensory polyneuropathy. Other forms of nerve damage from cisplatin include autonomic neuropathies, seizures, encephalopathy, myasthenic syndrome, cortical blindness, Lhermitte's sign, and dorsal column myelopathy. Ototoxicity, headache, loss of taste, strokes, leukoencephalopathy, and reversible posterior leukoencephalopathy syndrome (RPLS) have also been reported.

Symptoms of the sensory polyneuropathy typically begin in toes and feet and, later, affect the fingers and hands in a stocking-and-glove distribution. The neuropathies typically occur after prolonged therapy (4 to 7 months). However, symptoms have been reported after a single dose. Cisplatin neuropathies generally occur with higher dosage regimens and may be irreversible.

Elderly patients may be more susceptible to peripheral neuropathy.

Tinnitus and/or high-frequency (4000 to 8000 Hz) hearing loss occurs first, is unilateral or bilateral and may appear 3 to 4 days after initial treatment; however, deafness after the initial dose of cisplatin is rare. Cisplatin-induced ototoxicity is related to the loss of outer hair cells in the cochlea. Ototoxicity is associated with both high cisplatin doses and high cumulative doses. Hearing impairment is generally irreversible; however, hearing aids may help.

Hematologic

Hematologic side effects including myelosuppression have been reported. Cisplatin (the active ingredient contained in Platinol) causes moderate and transient myelosuppression in 25% to 30% of patients. Coombs' positive hemolytic anemia has also been reported.

Myelosuppression is a dose-related effect and usually occurs with doses greater than 50 mg/m2. Cisplatin-based therapy may result in a cumulative, clinically significant anemia which is disproportionate to the drugs effects on other blood cells.

Elderly patients may be more susceptible to myelosuppression.

Frequent anemia was reported in one study with 28 patients receiving six cycles of cisplatin in combination with 3 other chemotherapeutic agents. Thirteen patients became severely anemic, 12 became moderately anemic, and three became mildly anemic. The anemia was progressive and 66.7% of the patients became severely anemic during the third and fourth months of therapy.

Treatment of anemia with recombinant erythropoietin is generally helpful. Epoetin alfa has been approved for use in the treatment of anemia in patients with nonmyeloid malignancies where anemia is the result of concomitantly administered chemotherapy.

The nadirs in circulating erythrocytes, platelets, and leukocytes occur between days 18 to 23 (range 7.5 to 45), with most patients recovering by day 39 (range 13 to 62). Leukocytes usually recover after 14 to 21 days. Most patients are able to be retreated at 21 day intervals.

Ocular

Ocular side effects including optic neuritis, papilledema, cortical blindness, focal deficits, and cerebral blindness have been infrequently reported in patients receiving standard doses of cisplatin (the active ingredient contained in Platinol) Improvement and/or total recovery usually occurs after discontinuation of cisplatin. Blurred vision and altered color perception have been reported after the use of regimens with higher doses or greater dose frequencies than those recommended by the manufacturer.

Hypersensitivity

Hypersensitivity side effects including anaphylactic-like reactions have been occasionally reported in patients previously exposed to cisplatin (the active ingredient contained in Platinol) The reactions consist of facial edema, wheezing, tachycardia, and hypotension within a few minutes of drug administration.

Reactions may be treated with intravenous epinephrine, corticosteroids and/or antihistamines. Supportive equipment and medications should be available for possible anaphylactic-like reactions.

Hepatic

Hepatic side effects including transient elevations of liver enzymes, especially SGOT, as well as bilirubin, have been reported. However, the incidence and clinical importance is relatively low.

Local

Severity of the local tissue toxicity appears to be related to the concentration of the cisplatin (the active ingredient contained in Platinol) solution. Infusions of solutions with a cisplatin concentration greater than 0.5 mg/mL may rarely result in tissue inflammation and fibrosis.

Local side effects including soft tissue toxicity have rarely been reported following extravasation of cisplatin.

Cardiovascular

Cardiovascular side effects including myocardial infarction, cerebrovascular accident, deep vein thrombosis, pulmonary embolism, transient ischemic attack, thrombotic microangiopathy (hemolytic uremic syndrome), cerebral arteritis, and blood pressure abnormalities have been reported. Raynaud's phenomenon has been reported in patients receiving bleomycin and vinblastine, with or without cisplatin (the active ingredient contained in Platinol) Distal ischemic changes have been reported in patients receiving combination chemotherapy with cisplatin and gemcitabine. Possible cardiotoxicity (ST-T wave abnormalities and bundle branch block) have rarely been reported. Atrial fibrillation, supraventricular tachycardia, and bradycardia have also been reported.

Endocrine

Endocrine side effects including the syndrome of inappropriate antidiuretic hormone have been reported.

Dermatologic

Dermatologic side effects including rash and alopecia have been reported. A case of digital necrosis has also been reported.

Metabolic

Metabolic side effects have included chronic lipid abnormalities.

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