DailyMed Label: Carboplatin

DailyMed Label: Carboplatin

2024

DailyMed Prescription

Carboplatin

Carboplatin

Hospira, Inc.

NDC: 61703-339

NDC: 61703-339

NDC: 61703-339

NDC: 61703-339

NDC: 61703-339

NDC: 61703-339

Carboplatin Injection is supplied as a sterile, pyrogen-free, aqueous solution available in 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL or 600 mg/60 mL multiple-dose vials containing 10 mg/mL of carboplatin for administration by intravenous infusion. Each mL contains 10 mg carboplatin and Water for Injection, USP. Carboplatin is a platinum coordination compound. The chemical name for carboplatin is platinum, diammine [1,1-cyclobutane-dicarboxylato(2-)-0,0']-,(SP-4-2), and carboplatin has the following structural formula: Carboplatin is a crystalline powder with the molecular formula of C 6 H 12 N 2 0 4 Pt 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. Chemical Structure

Carboplatin 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 Carboplatin Injection 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. Carboplatin Injection 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.

NOTE: Aluminum reacts with carboplatin causing precipitate formation and loss of potency, therefore, needles or intravenous sets containing aluminum parts that may come in contact with the drug must not be used for the preparation or administration of 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/m 2 IV on day 1 every 4 weeks (alternatively see Formula Dosing ). In general, however, single intermittent courses of Carboplatin Injection should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000. In the chemotherapy of advanced ovarian cancer, an effective combination for previously untreated patients consists of: Carboplatin Injection - 300 mg/m 2 IV on day 1 every four weeks for six cycles (alternatively see Formula Dosing ). Cyclophosphamide - 600 mg/m 2 IV on day 1 every four weeks for six cycles. For directions regarding the use and administration of cyclophosphamide please refer to its package insert. (see CLINICAL STUDIES . ) Intermittent courses of Carboplatin Injection in combination with cyclophosphamide should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000. Pretreatment platelet count and performance status are important prognostic factors for severity of myelosuppression in previously treated patients. The suggested dose adjustments for single agent or combination therapy shown in the table below are modified from controlled trials in previously treated and untreated patients with ovarian carcinoma. Blood counts were done weekly, and the recommendations are based on the lowest post-treatment platelet or neutrophil value. Platelets Neutrophils Adjusted Dose Percentages apply to Carboplatin Injection as a single agent or to both Carboplatin Injection and cyclophosphamide in combination. In the controlled studies, dosages were also adjusted at a lower level (50% to 60%) for severe myelosuppression. Escalations above 125% were not recommended for these studies. (From Prior Course) >100,000 >2,000 125% 50–100,000 500–2,000 No Adjustment <50,000 <500 75% Carboplatin Injection is usually administered by an infusion lasting 15 minutes or longer. No pre- or post-treatment hydration or forced diuresis is required. Patients with creatinine clearance values below 60 mL/min are at increased risk of severe bone marrow suppression. In renally-impaired patients who received single agent Carboplatin Injection therapy, the incidence of severe leukopenia, neutropenia, or thrombocytopenia has been about 25% when the dosage modifications in the table below have been used. Baseline Creatinine Clearance Recommended Dose on Day 1 41 – 59 mL/min 250 mg/m 2 16 – 40 mL/min 200 mg/m 2 The data available for patients with severely impaired kidney function (creatinine clearance below 15 mL/min) are too limited to permit a recommendation for treatment. These dosing recommendations apply to the initial course of treatment. Subsequent dosages should be adjusted according to the patient's tolerance based on the degree of bone marrow suppression. Another approach for determining the initial dose of Carboplatin Injection is the use of mathematical formulae, which are based on a patient's pre-existing renal function or renal function and desired platelet nadir. Renal excretion is the major route of elimination for carboplatin. (see CLINICAL PHARMACOLOGY . ) The use of dosing formulae, as compared to empirical dose calculation based on body surface area, allows compensation for patient variations in pretreatment renal function that might otherwise result in either underdosing (in patients with above average renal function) or overdosing (in patients with impaired renal function). A simple formula for calculating dosage, based upon a patient's glomerular filtration rate (GFR in mL/min) and Carboplatin Injection target area under the concentration versus time curve (AUC in mg/mL∙min), has been proposed by Calvert. In these studies, GFR was measured by 51 Cr-EDTA clearance. CALVERT FORMULA FOR CARBOPLATIN DOSING Total Dose (mg) = (target AUC) × (GFR + 25) Note: With the Calvert formula, the total dose of Carboplatin Injection is calculated in mg, not mg/m 2 . The target AUC of 4 mg/mL∙min to 6 mg/mL∙min using single agent Carboplatin Injection appears to provide the most appropriate dose range in previously treated patients. This study also showed a trend between the AUC of single agent Carboplatin Injection administered to previously treated patients and the likelihood of developing toxicity. % Actual Toxicity in Previously Treated Patients AUC (mg/mL∙min) Gr 3 or Gr 4 Thrombocytopenia Gr 3 or Gr 4 Leukopenia 4 to 5 16% 13% 6 to 7 33% 34% Because renal function is often decreased in elderly patients, formula dosing of Carboplatin Injection based on estimates of GFR should be used in elderly patients to provide predictable plasma Carboplatin Injection AUCs and thereby minimize the risk of toxicity.

Carboplatin Injection is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum-containing compounds. Carboplatin Injection should not be employed in patients with severe bone marrow depression or significant bleeding.

Needles or intravenous administration sets containing aluminum parts that may come in contact with Carboplatin Injection should not be used for the preparation or administration of the drug. Aluminum can react with carboplatin causing precipitate formation and loss of potency. The renal effects of nephrotoxic compounds may be potentiated by carboplatin. A decrease in phenytoin serum levels has been observed with concurrent administration of carboplatin and phenytoin/fosphenytoin. This may lead to exacerbation of seizures. The carcinogenic potential of carboplatin has not been studied, but compounds with similar mechanisms of action and mutagenicity profiles have been reported to be carcinogenic. Carboplatin has been shown to be mutagenic both in vitro and in vivo . It has also been shown to be embryotoxic and teratogenic in rats receiving the drug during organogenesis. Secondary malignancies have been reported in association with multi-drug therapy. Acute promyelocytic leukemia (APL) and myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) have been reported years after therapy with carboplatin and other antineoplastic treatments. (see WARNINGS ). It is not known whether carboplatin is excreted in human milk. Because there is a possibility of toxicity in nursing infants secondary to carboplatin treatment of the mother, it is recommended that breast-feeding be discontinued if the mother is treated with carboplatin. Safety and effectiveness in pediatric patients have not been established (see WARNINGS ; "Audiologic Toxicity" ). Of the 789 patients in initial treatment combination therapy studies (NCIC and SWOG), 395 patients were treated with carboplatin in combination with cyclophosphamide. Of these, 141 were over 65 years of age and 22 were 75 years or older. In these trials, age was not a prognostic factor for survival. In terms of safety, elderly patients treated with carboplatin were more likely to develop severe thrombocytopenia than younger patients. In a combined database of 1,942 patients (414 were ≥ 65 years of age) that received single agent carboplatin for different tumor types, a similar incidence of adverse events was seen in patients 65 years and older and in patients less than 65. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Because renal function is often decreased in the elderly, renal function should be considered in the selection of carboplatin dosage (see DOSAGE AND ADMINISTRATION ).

For a comparison of toxicities when carboplatin or cisplatin was given in combination with cyclophosphamide, see

The renal effects of nephrotoxic compounds may be potentiated by carboplatin. A decrease in phenytoin serum levels has been observed with concurrent administration of carboplatin and phenytoin/fosphenytoin. This may lead to exacerbation of seizures.

Carboplatin Injection 10 mg/mL sterile solution is available in the following presentations: Unit of Sale Concentration NDC 61703-339-18 Carton containing 1 multiple-dose vial (Blue flip-off seals) 50 mg/5 mL (10 mg/mL) NDC 61703-339-22 Carton containing 1 multiple-dose vial (Blue flip-off seals) 150 mg/15 mL (10 mg/mL) NDC 61703-339-50 Carton containing 1 multiple-dose vial (Blue flip-off seals) 450 mg/45 mL (10 mg/mL) NDC 61703-339-56 Carton containing 1 multiple-dose vial (Blue flip-off seals) 600 mg/60 mL (10 mg/mL) Unopened vials of Carboplatin 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. Carboplatin Injection multiple-dose 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.

Carboplatin, like cisplatin, produces predominantly interstrand DNA cross-links rather than DNA-protein cross-links. This effect is apparently cell-cycle nonspecific. The aquation of carboplatin, which is thought to produce the active species, occurs at a slower rate than in the case of cisplatin. Despite this difference, it appears that both carboplatin and cisplatin induce equal numbers of drug-DNA cross-links, causing equivalent lesions and biological effects. The differences in potencies for carboplatin and cisplatin appear to be directly related to the difference in aquation rates. In patients with creatinine clearances of about 60 mL/min or greater, plasma levels of intact carboplatin decay in a biphasic manner after a 30-minute intravenous infusion of 300 mg/m 2 to 500 mg/m 2 of carboplatin. The initial plasma half-life (alpha) was found to be 1.1 to 2 hours (n=6), and the postdistribution plasma half-life (beta) was found to be 2.6 to 5.9 hours (n=6). The total body clearance, apparent volume of distribution and mean residence time for carboplatin are 4.4 L/hour, 16 L and 3.5 hours, respectively. The C max values and areas under the plasma concentration versus time curves from 0 to infinity (AUC inf) increase linearly with dose, although the increase was slightly more than dose proportional. Carboplatin, therefore, exhibits linear pharmacokinetics over the dosing range studied (300 mg/m 2 to 500 mg/m 2 ). Carboplatin is not bound to plasma proteins. No significant quantities of protein-free, ultrafilterable platinum-containing species other than carboplatin are present in plasma. However, platinum from carboplatin becomes irreversibly bound to plasma proteins and is slowly eliminated with a minimum half-life of 5 days. The major route of elimination of carboplatin is renal excretion. Patients with creatinine clearances of approximately 60 mL/min or greater excrete 65% of the dose in the urine within 12 hours and 71% of the dose within 24 hours. All of the platinum in the 24-hour urine is present as carboplatin. Only 3% to 5% of the administered platinum is excreted in the urine between 24 and 96 hours. There are insufficient data to determine whether biliary excretion occurs. In patients with creatinine clearances below 60 mL/min, the total body and renal clearances of carboplatin decrease as the creatinine clearance decreases. Carboplatin Injection dosages should therefore be reduced in these patients (see DOSAGE AND ADMINISTRATION ). The primary determinant of Carboplatin Injection clearance is glomerular filtration rate (GFR) and this parameter of renal function is often decreased in elderly patients. Dosing formulas incorporating estimates of GFR (see DOSAGE AND ADMINISTRATION ) to provide predictable Carboplatin Injection plasma AUCs should be used in elderly patients to minimize the risk of toxicity.

In two prospectively randomized, controlled studies conducted by the National Cancer Institute of Canada, Clinical Trials Group (NCIC), and the Southwest Oncology Group (SWOG), 789 chemotherapy naive patients with advanced ovarian cancer were treated with carboplatin or cisplatin, both in combination with cyclophosphamide every 28 days for six courses before surgical reevaluation. The following results were obtained from both studies: Overview of Pivotal Trials NCIC SWOG Number of patients randomized 447 342 Median age (years) 60 62 Dose of cisplatin 75 mg/m 2 100 mg/m 2 Dose of carboplatin 300 mg/m 2 300 mg/m 2 Dose of cyclophosphamide 600 mg/m 2 600 mg/m 2 Residual tumor <2 cm (number of patients) 39% (174/447) 14% (49/342) Clinical Response in Measurable Disease Patients NCIC SWOG Carboplatin (number of patients) 60% (48/80) 58% (48/83) Cisplatin (number of patients) 58% (49/85) 43% (33/76) 95% C.I. of difference (Carboplatin - Cisplatin) (-13.9%, 18.6%) (-2.3%, 31.1%) Pathologic Complete Response 114 Carboplatin and 109 Cisplatin patients did not undergo second look surgery in NCIC study. 90 Carboplatin and 106 Cisplatin patients did not undergo second look surgery in SWOG study. NCIC SWOG Carboplatin (number of patients) 11% (24/224) 10% (17/171) Cisplatin (number of patients) 15% (33/223) 10% (17/171) 95% C.I. of difference (Carboplatin - Cisplatin) (-10.7%, 2.5%) (-6.9%, 6.9%) Progression-Free Survival (PFS) NCIC SWOG Median Carboplatin 59 weeks 49 weeks Cisplatin 61 weeks 47 weeks 2-year PFS Kaplan-Meier Estimates Unrelated deaths occurring in the absence of progression were counted as events (progression) in this analysis. Carboplatin 31% 21% Cisplatin 31% 21% 95% C.I. of difference (Carboplatin - Cisplatin) (-9.3, 8.7) (-9.0, 9.4) 3-year PFS Carboplatin 19% 8% Cisplatin 23% 14% 95% C.I. of difference (Carboplatin - Cisplatin) (-11.5, 4.5) (-14.1, 0.3) Hazard Ratio Analysis adjusted for factors found to be of prognostic significance were consistent with unadjusted analysis. 1.10 1.02 95% C.I. (Carboplatin - Cisplatin) (0.89, 1.35) (0.81, 1.29) Survival NCIC SWOG Median Carboplatin 110 weeks 86 weeks Cisplatin 99 weeks 79 weeks 2-year Survival Kaplan-Meier Estimates Carboplatin 51.9% 40.2% Cisplatin 48.4% 39.0% 95% C.I. of difference (Carboplatin - Cisplatin) (-6.2, 13.2) (-9.8, 12.2) 3-year Survival Carboplatin 34.6% 18.3% Cisplatin 33.1% 24.9% 95% C.I. of difference (Carboplatin - Cisplatin) (-7.7, 10.7) (-15.9, 2.7) Hazard Ratio Analysis adjusted for factors found to be of prognostic significance were consistent with unadjusted analysis. 0.98 1.01 95% C.I. (Carboplatin - Cisplatin) (0.78, 1.23) (0.78, 1.30) The pattern of toxicity exerted by the carboplatin containing regimen was significantly different from that of the cisplatin-containing combinations. Differences between the two studies may be explained by different cisplatin dosages and by different supportive care. The carboplatin-containing regimen induced significantly more thrombocytopenia and, in one study, significantly more leukopenia and more need for transfusional support. The cisplatin-containing regimen produced significantly more anemia in one study. However, no significant differences occurred in incidences of infections and hemorrhagic episodes. Non-hematologic toxicities (emesis, neurotoxicity, ototoxicity, renal toxicity, hypomagnesemia, and alopecia) were significantly more frequent in the cisplatin-containing arms. ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER NCIC STUDY Carboplatin Arm Percent Values are in percent of evaluable patients Cisplatin Arm Percent P-Values ns = not significant, p>0.05 Bone Marrow   Thrombocytopenia <100,000/mm 3 70 29 <0.001 <50,000/mm 3 41 6 <0.001   Neutropenia <2,000 cells/mm 3 97 96 ns <1,000 cells/mm 3 81 79 ns   Leukopenia <4,000 cells/mm 3 98 97 ns <2,000 cells/mm 3 68 52 0.001   Anemia <11 g/dL 91 91 ns <8 g/dL 18 12 ns   Infections 14 12 ns   Bleeding 10 4 ns   Transfusions 42 31 0.018 Gastrointestinal   Nausea and vomiting 93 98 0.010   Vomiting 84 97 <0.001   Other GI side effects 50 62 0.013 Neurologic   Peripheral neuropathies 16 42 <0.001   Ototoxicity 13 33 <0.001   Other sensory side effects 6 10 ns   Central neurotoxicity 28 40 0.009 Renal   Serum creatinine elevations 5 13 0.006   Blood urea elevations 17 31 <0.001 Hepatic   Bilirubin elevations 5 3 ns   SGOT elevations 17 13 ns   Alkaline phosphatase elevations - - - Electrolytes loss   Sodium 10 20 0.005   Potassium 16 22 ns   Calcium 16 19 ns   Magnesium 63 88 <0.001 Other side effects   Pain 36 37 ns   Asthenia 40 33 ns   Cardiovascular 15 19 ns   Respiratory 8 9 ns   Allergic 12 9 ns   Genitourinary 10 10 ns   Alopecia May have been affected by cyclophosphamide dosage delivered 50 62 0.017   Mucositis 10 9 ns ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER SWOG STUDY Carboplatin Arm Percent Values are in percent of evaluable patients Cisplatin Arm Percent P-Values ns = not significant, p>0.05 Bone Marrow   Thrombocytopenia <100,000/mm 3 59 35 <0.001 <50,000/mm 3 22 11 0.006   Neutropenia <2,000 cells/mm 3 95 97 ns <1,000 cells/mm 3 84 78 ns   Leukopenia <4,000 cells/mm 3 97 97 ns <2,000 cells/mm 3 76 67 ns   Anemia <11 g/dL 88 87 ns <8 g/dL 8 24 <0.001   Infections 18 21 ns   Bleeding 6 4 ns   Transfusions 25 33 ns Gastrointestinal   Nausea and vomiting 94 96 ns   Vomiting 82 91 0.007   Other GI side effects 40 48 ns Neurologic   Peripheral neuropathies 13 28 0.001   Ototoxicity 12 30 <0.001   Other sensory side effects 4 6 ns   Central neurotoxicity 23 29 ns Renal   Serum creatinine elevations 7 38 <0.001   Blood urea elevations - - - Hepatic   Bilirubin elevations 5 3 ns   SGOT elevations 23 16 ns   Alkaline phosphatase elevations 29 20 ns Electrolytes loss   Sodium - - -   Potassium - - -   Calcium - - -   Magnesium 58 77 <0.001 Other side effects   Pain 54 52 ns   Asthenia 43 46 ns   Cardiovascular 23 30 ns   Respiratory 12 11 ns   Allergic 10 11 ns   Genitourinary 11 13 ns   Alopecia May have been affected by cyclophosphamide dosage delivered 43 57 0.009   Mucositis 6 11 ns In two prospective, randomized controlled studies in patients with advanced ovarian cancer previously treated with chemotherapy, carboplatin achieved six clinical complete responses in 47 patients. The duration of these responses ranged from 45 to 71 + weeks.

R x only Read this entire leaflet carefully. Keep it for future reference. Carboplatin Injection This information will help you learn more about Carboplatin Injection. It cannot, however, cover all the possible warnings or side effects relating to Carboplatin Injection, and it does not list all of the benefits and risks of Carboplatin Injection. Your doctor should always be your first choice for detailed information about your medical condition and your treatment. Be sure to ask your doctor about any questions you may have. What is cancer? Under normal conditions, the cells in your body divide and grow in an orderly, controlled fashion. Cell division and growth are necessary for the human body to perform its functions and to repair itself. Cancer cells are different from normal cells because they are not able to control their own growth. The reasons for this abnormal growth are not yet fully understood. A tumor is a mass of unhealthy cells that are dividing and growing fast and in an uncontrolled way. When a tumor invades surrounding healthy body tissue it is known as a malignant tumor. A malignant tumor can spread (metastasize) from its original location to other parts of the body. What is Carboplatin Injection? Carboplatin Injection is a medicine that is used to treat cancer of the ovaries. It acts by interfering with the division of rapidly multiplying cells, particularly cancer cells. Who should not take Carboplatin Injection? Treatment with Carboplatin Injection is not recommended if you: • are allergic to Carboplatin Injection or other platinum-containing products; • have a weakened blood-forming system (bone marrow depression) or significant bleeding; • are pregnant, intend to become pregnant, or are breast-feeding a baby. How is Carboplatin Injection used? Only a professional experienced in the use of cancer drugs should give you this medication. Carboplatin Injection is given by dripping the medicine slowly and directly into a vein (intravenous infusion) for 15 minutes or longer. Your doctor will determine the dose of Carboplatin Injection for you based on your weight, height, and kidney function. Carboplatin Injection may be given alone or with other drugs. Treatment is usually repeated every four weeks for a number of cycles. Before and after Carboplatin Injection treatment, your doctor may give you medication to lessen the nausea and vomiting associated with this cancer treatment. What should you tell your doctor before starting treatment with Carboplatin Injection? Discuss the benefits and risks of Carboplatin Injection with your doctor before beginning treatment. Be sure to inform your doctor: • If you are allergic to Carboplatin Injection or other platinum containing products; • If you are or intend to become pregnant, since Carboplatin Injection may harm the developing fetus. It is important to use effective birth control while you are being treated with Carboplatin Injection; • If you are breast-feeding, since nursing infants may be exposed to Carboplatin Injection in this way; • If you are taking other medicines, including all prescription and non prescription (over-the-counter) drugs, since Carboplatin Injection may affect the action of other medicines; • If you have any other medical problems, especially chicken pox (including recent exposure to adults or children with chicken pox), shingles, hearing problems, infection, or kidney disease, since treatment with Carboplatin Injection increases the risk and severity of these conditions. What should I avoid while taking Carboplatin Injection? If you are pregnant or think you might be pregnant, or if you are breast feeding, let your doctor know right away. Carboplatin Injection may harm your developing fetus or breast-feeding baby. If you are a woman of childbearing age, you should use birth control to avoid getting pregnant while you are taking Carboplatin Injection. You should avoid contact with adults and children who have infections, and tell your doctor right away if you show signs of infection such as cough, fever, and/or chills. Also, while you are being treated with Carboplatin Injection or after you stop treatment, first check with your doctor before getting any immunizations (vaccinations). Avoid contact with adults or children who have received oral polio vaccine since they can pass the polio virus to you. What are the possible side effects of Carboplatin Injection? Carboplatin Injection may cause unwanted effects, particularly because Carboplatin Injection interferes with the growth of normal cells as well as cancer cells. For example, the occurrence of another cancer (secondary malignancy) has been reported in patients receiving cancer chemotherapy with multiple drugs. It is not always possible to tell whether such effects are caused by Carboplatin Injection, another drug you may be taking, or your illness. Because some of these effects may be serious, you will need close medical supervision during treatment with Carboplatin Injection. The most serious side effects of Carboplatin Injection are: • bleeding and reduced blood cells, including reduced red blood cells (anemia) and platelets (needed for proper blood clotting) , which may be severe enough to require blood transfusion. You should tell your doctor right away if you notice any unusual bruising or bleeding, including black tarry stools or blood in the urine. • infection – Carboplatin Injection can temporarily lower the number of white blood cells in your blood, increasing the risk of infection; • life-threatening allergic reaction – during and after treatment the doctor or nurse will observe you carefully for signs of allergic reaction; • kidney and liver problems; • loss of hearing or ringing in the ears; Contact your doctor right away if you experience any of these effects, or notice effects that worry you or are troublesome. Of the less serious side effects associated with Carboplatin Injection treatment, the most common are nausea, vomiting, diarrhea, loss of appetite, hair loss and numbness, tingling, burning, or pain in the hands or feet. This medicine was prescribed for your particular condition. It must be given under close medical supervision by a doctor trained in the use of drugs for the treatment of cancer. This summary does not include everything there is to know about Carboplatin Injection. Medicines are sometimes prescribed for purposes other than those listed in patient leaflets. If you have questions or concerns, or want more information about Carboplatin Injection, your physician and pharmacist have the complete prescribing information upon which this information is based. You may want to read it and discuss it with your doctor. Remember, no written summary can replace careful discussion with your doctor. Distributed by Hospira, Inc. Lake Forest, IL 60045 LAB-1016-2.0 Revised: 4/2018 Logo

5 mL Multiple-dose Vial NDC 61703-339-18 Sterile Rx only CARBOplatin Injection 50 mg/ 5 mL (10 mg/mL) For Intravenous Use Cytotoxic Agent PRINCIPAL DISPLAY PANEL - 5 mL Vial Label