Paraplatin

Get emergency medical help if you have signs of an allergic reaction: 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. You may report side effects to FDA at 1-800-FDA-1088.

PARAPLATIN® (carboplatin aqueous solution) INJECTION

NDC 0015-3210-30 50 mg/5 mL aqueous solution in multidose vials (with white flip-off seals), individually cartoned.

NDC 0015-3211-30 150 mg/15 mL aqueous solution in multidose vials (with white flip-off seals), individually cartoned.

NDC 0015-3212-30 450 mg/45 mL aqueous solution in multidose vials (with white flip-off seals), individually cartoned.

NDC 0015-3216-30 600 mg/60 mL aqueous solution in multidose vials (with white flip-off seals), individually cartoned.

Storage

Unopened vials of PARAPLATIN (carboplatin aqueous solution) INJECTION are stable to the date indicated on the package when stored at 25°C (77°F); excursions permitted from 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light.

PARAPLATIN (carboplatin aqueous solution) INJECTION multidose vials maintain microbial, chemical, and physical stability for up to 14 days at 25°C following multiple needle entries.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Solutions for infusion should be discarded 8 hours after preparation.

Handling and Disposal

Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing PARAPLATIN (carboplatin aqueous solution) Injection. This includes all handling activities in clinical settings, pharmacies, storerooms, and home healthcare settings, including during unpacking and inspection, transport within a facility, and dose preparation and administration.

REFERENCES

1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.

2. Recommendations for the safe handling of cytotoxic drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services, Public Health Service Publication NIH 92-2621.

3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1592.

4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.

5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. 1983;1:426-428.

6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from The Mount Sinai Medical Center. CA Cancer J Clin. 1983;33:258-263.

7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.

8. Controlling occupational exposure to hazardous drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.

Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA. Rev March 2007

• Bristol-Myers Squibb Company

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Paraplatin , there are no specific foods that you must exclude from your diet.

Paraplatin alone:

• 360 mg/m² IV (into the vein) on day 1 every 4 weeks.

Combination therapy with cyclophosphamide:

• In the chemotherapy of advanced ovarian cancer, an effective combination for previously untreated patients is Paraplatin 300 mg/m² IV on day 1 every four weeks for six cycles.

Another approach for determining the starting dose of Paraplatin is based on your kidney function.

Carboplatin is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Carboplatin is used together with other cancer medications to treat ovarian cancer.

Carboplatin may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Carboplatin can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to be able to see clearly.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

General

• Consult specialized references for procedures for proper handling and disposal of antineoplastics.1

• Carboplatin is considered a moderate antiemetic risk antineoplastic (i.e., 30–90% incidence of emesis without antiemetics).201 Antiemetic therapy (e.g., a 5-HT3 receptor antagonist and dexamethasone) is recommended to prevent nausea and vomiting.201 (See Emetogenic Effects under Cautions.)

• Pretreatment and posttreatment hydration and/or diuresis are not necessary.1 10 11 24 27 37 (See Renal Effects under Cautions.)

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion;1 also has been administered intraperitoneally†.2 3 4 32 43 47

Needles, syringes, catheters, and IV administration sets that contain aluminum parts which may come in contact with carboplatin should not be used for preparation or administration.1

Reconstitute vial containing 50, 150, or 450 mg of carboplatin powder for injection with 5, 15, or 45 mL, respectively, of sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection to provide a solution containing 10 mg/mL.b

Resulting solutions can be further diluted to concentrations as low as 0.5 mg/mL with 5% dextrose injection or 0.9% sodium chloride injection.b

Reconstituted solutions contain no preservatives; solutions preferably should be prepared immediately before use.b

May be diluted with 0.9% sodium chloride injection or 5% dextrose injection to a concentration as low as 0.5 mg/mL.1

Administer by IV infusion over a period of ≥15 minutes;1 2 4 10 13 25 27 42 also has been administered by continuous IV infusion over 24 hours.1 2 3

Dosage

Base dosage on the clinical, renal, and hematologic response and tolerance of the patient in order to obtain optimum therapeutic response with minimum adverse effects.1 10 11

Initial dosage can be based on body surface area, but dosage may be more accurately calculated using formula dosing methods based on the patient’s renal function.1 81 82 83 84 85 93 107 108 137 (See Methods for Individualization of Dosage under Dosage and Administration.)

When used as a component of a multiple-drug regimen, consult published protocols for the dosage of each chemotherapeutic agent and the method and sequence of administration.

Adults

Initially, 300 mg/m2 given in combination with cyclophosphamide.1 10 11 Adjust subsequent dosage according to the patient’s hematologic tolerance of the previous dose (see Dosage Adjustment in the Treatment of Ovarian Cancer); do not administer doses until hematologic function is within acceptable limits.1

Alternatively, calculate dosage using formula dosing methods (see Methods for Individualization of Dosage).1 81 82 83 84 85 93 107 108 137

A course of carboplatin consists of single doses administered once every 4 weeks (or longer if delayed for hematologic toxicity) for a total of 6 cycles.1 10 11 69 70 71

Initially, 360 mg/m2 as monotherapy.1 Administer drug once every 4 weeks (or longer if delayed for hematologic toxicity).1 Adjust subsequent dosage according to the patient’s hematologic tolerance of the previous dose (see Dosage Adjustment in the Treatment of Ovarian Cancer); do not administer doses until hematologic function is within acceptable limits.1 137

Consult published protocols for dosages and methods and sequences of administration. In general, escalation of dosages above 400 mg/m2 results in substantial hematologic toxicity, but high-dose carboplatin (900–2000 mg/m2) has been used with colony-stimulating factors,40 67 121 autologous bone marrow rescue, and/or peripheral stem cell rescue.28 30 37 40 59 111 137

Alternative methods for calculating initial carboplatin dosage have been suggested based on the patient’s pretreatment renal function or pretreatment renal function and desired platelet nadir.1 38 81 82 83 84 85 93 107 108

Calculation is based on the patient’s GFR (in mL/minute) and the target AUC (in mg/mL per minute).1 81 82 83 93 137 Dosage is calculated in mg, not mg/m2.1

A target AUC of 5 (range: 4–6) mg/mL per minute appears to provide the most appropriate dosage range for use of carboplatin alone in patients previously treated with chemotherapeutic agents.1 82 83 93

For patients who previously did not receive chemotherapy, a target AUC of 7 (range: 6–8) mg/mL per minute has been recommended when carboplatin is used alone.82 83 93 Higher target AUCs (e.g., 7.5 mg/mL) also have been used (e.g., when carboplatin was used as a component of high-intensity dosing with paclitaxel and a hematopoietic agent for non-small cell lung carcinoma).121 Subsequent carboplatin dosage has been adjusted according to hematologic tolerance to the previous dose (e.g., reducing the dose by 25% for moderate to severe hematologic toxicity).121

Formula is not sufficiently accurate to determine dosage for children or for adults with severe renal impairment (i.e., GFR <20 mL/minute); therefore, do not use this formula in such patients.83 Consult specialized references for an alternative pediatric formula.83 93 119 120

Method does not require determination of GFR.84 85 93 Dosage is calculated in mg, not mg/m2.84 93

When carboplatin clearance is calculated as follows:

Do not use this formula for calculating dosage in pediatric patients or those undergoing hemodialysis.84

Special Populations

Renal Impairment

Reduce dosage in patients with Clcr <60 mL/minute.3 5 38

Incidence of severe leukopenia, neutropenia, or thrombocytopenia at these adjusted initial dosages is about 25%.1 Adjust subsequent dosage according to the patient’s hematologic tolerance to the previous dose.1 Experience in patients with Clcr <15 mL/minute is too limited to make dosage recommendations.1

Geriatric Patients

Use of dosing formulas incorporating estimates of GFR to determine dosage recommended in geriatric patients.1

Storage

Parenteral

25°C (may be exposed to 15–30°C).1 Protect from light.1

Discard unused solution 14 days after initial entry into vial.1

Discard diluted solutions 8 hours after preparation.1

20–25°C; protect from light.b

Reconstituted solutions are stable for 8 hours at room temperature (25°C).b Reconstituted solutions contain no preservatives; discard after 8 hours.b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Paraplatin (carboplatin aqueous solution) INJECTION should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available.

Bone marrow suppression is dose related and may be severe, resulting in infection and/or bleeding. Anemia may be cumulative and may require transfusion support. Vomiting is another frequent drug-related side effect.

Anaphylactic-like reactions to carboplatin have been reported and may occur within minutes of Paraplatin administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.

Paraplatin® (carboplatin aqueous solution) INJECTION is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin. Carboplatin is a platinum coordination compound. The chemical name for carboplatin is platinum, diammine[1,1-cyclobutanedicarboxylato(2-)-O,O′]-, (SP-4-2), and carboplatin has the following structural formula:

Carboplatin is a crystalline powder with the molecular formula of C6H12N2O4Pt and a molecular weight of 371.25. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.

Initial Treatment of Advanced Ovarian Carcinoma

Paraplatin (carboplatin aqueous solution) INJECTION is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of Paraplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES).

There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor <2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.

Secondary Treatment of Advanced Ovarian Carcinoma

Paraplatin is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.

Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.

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.

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.

Hematologic Toxicity

Bone marrow suppression is the dose-limiting toxicity of Paraplatin. 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. 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 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, 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%.

Neurologic Toxicity

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.

Nephrotoxicity

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.

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 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, and these electrolyte abnormalities were rarely associated with symptoms.

Allergic Reactions

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.

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.

Applies to carboplatin: intravenous powder for injection, intravenous solution

Hematologic

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).[Ref]

Bone marrow suppression is the dose limiting toxicity of carboplatin. 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.[Ref]

Gastrointestinal

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 (the active ingredient contained in Paraplatin) (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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.