CARBOplatin 10 mg/mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Platinum-based Drug class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Carboplatin is a chemotherapy drug in the platinum family. It works by binding to the DNA inside cancer cells and blocking them from growing and dividing, which eventually causes t...
- What exactly is carboplatin and why has my doctor prescribed it?
- No, carboplatin is not a pill. It's given as an IV infusion — a drip into your vein — at a cancer center or hospital. Each infusion lasts at least 15 minutes, and you'll receive it...
- How will I actually receive carboplatin — do I take a pill at home?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Carboplatin — tap one for details:
Carboplatin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| CARBOplatin 10 mg/mL 00703-4239-81 | Teva | 1 vial | — | AP | FDA listed | — |
| CARBOplatin 10 mg/mL 00703-4244-81 | Teva | 1 vial | — | AP | FDA listed | — |
| CARBOplatin 10 mg/mL 00703-4246-81 | Teva | 1 vial | — | AP | FDA listed | — |
| CARBOplatin 10 mg/mLthis 00703-4248-91 | Teva | 1 vial | — | AP | Discontinued | — |
| Carboplatin 10 mg/mL 16729-0295-12 | Accord | 1 vial | — | — | FDA listed | — |
| Carboplatin 10 mg/mL 54288-0164-01 | BPI | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 54288-0165-01 | BPI | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 54288-0166-01 | BPI | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 54288-0167-01 | BPI | 1 vial | — | AP | FDA listed | — |
| Carboplatin 50 mg/5mL 55150-0333-01 | Eugia | 1 vial | — | AP | FDA listed | — |
| Carboplatin 150 mg/15mL 55150-0334-01 | Eugia | 1 vial | — | AP | FDA listed | — |
| Carboplatin 450 mg/45mL 55150-0335-01 | Eugia | 1 vial | — | AP | FDA listed | — |
| Carboplatin 600 mg/60mL 55150-0386-01 | Eugia | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 60505-6282-01 | Apotex | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 61703-0150-05 | Hospira, | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 61703-0262-05 | Hospira, | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 61703-0339-18 | Hospira, | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 61703-0360-18 | Hospira, | 1 vial | — | AP | Discontinued | — |
| Carboplatin 10 mg/mL 61703-0600-05 | Hospira, | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 63323-0172-60 | Fresenius | 1 vial | — | — | FDA listed | — |
| Carboplatin 10 mg/mL 68083-0190-01 | Gland | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 68083-0191-01 | Gland | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 68083-0192-01 | Gland | 1 vial | — | AP | FDA listed | — |
| Carboplatin 10 mg/mL 68083-0193-01 | Gland | 1 vial | — | AP | FDA listed | — |
| Carboplatin 50 mg/5mL 82511-0003-05 | Teyro | 1 vial | — | AP | FDA listed | — |
| Carboplatin 150 mg/15mL 82511-0004-15 | Teyro | 1 vial | — | AP | FDA listed | — |
| Carboplatin 450 mg/45mL 82511-0005-45 | Teyro | 1 vial | — | AP | FDA listed | — |
| Carboplatin 600 mg/60mL 82511-0006-60 | Teyro | 1 vial | — | AP | FDA listed | — |
| Kyxata 80 mg/8mL 83831-0141-08 | Avyxa | 1 vial | — | — | FDA listed | — |
| Kyxata 500 mg/50mL 83831-0142-50 | Avyxa | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00703-4248-91 You're viewing this | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-91) / 45 mL in 1 VIAL, MULTI-DOSE | 2015-06-04 | Discontinued by firm |
| 00703-4248-81 | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-81) / 45 mL in 1 VIAL, MULTI-DOSE | 2015-12-09 | Active |
| 00703-4248-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-01) / 45 mL in 1 VIAL, MULTI-DOSE | 2006-02-01 | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 00703-4248-91?
What NDC number is used to bill for this package of CARBOplatin 10 mg/mL Injection, Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING Carboplatin injection 10 mg/mL 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 carboplatin injection administration.
Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.
🎯 Indications and Usage ▾
INDICATIONS Initial Treatment of Advanced Ovarian Carcinoma 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 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 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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. Single Agent Therapy 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 should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000. Combination Therapy with Cyclophosphamide In the chemotherapy of advanced ovarian cancer, an effective combination for previously untreated patients consists of: Carboplatin - 300 mg/m 2 IV on day 1 every 4 weeks for 6 cycles (alternatively see Formula Dosing ). Cyclophosphamide - 600 mg/m 2 IV on day 1 every 4 weeks for 6 cycles.
For directions regarding the use and administration of cyclophosphamide please refer to its package insert (see CLINICAL STUDIES ). Intermittent courses of carboplatin 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. Dose Adjustment Recommendations 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 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 to 100,000 500 to 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 Impaired Kidney Function 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 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 to 59 mL/min 250 mg/m 2 16 to 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.
Formula Dosing 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…
⛔ Contraindications ▾
CONTRAINDICATIONS Carboplatin injection is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum-containing compounds, or mannitol. Carboplatin injection should not be employed in patients with severe bone marrow depression or significant bleeding.
⚠️ Warnings ▾
WARNINGS Bone marrow suppression (leukopenia, neutropenia, and thrombocytopenia) is dose-dependent and is also the dose-limiting toxicity. Peripheral blood counts should be frequently monitored during carboplatin injection treatment and, when appropriate, until recovery is achieved. Median nadir occurs at day 21 in patients receiving single agent carboplatin.
In general, single intermittent courses of carboplatin should not be repeated until leukocyte, neutrophil, and platelet counts have recovered. Since anemia is cumulative, transfusions may be needed during treatment with carboplatin, particularly in patients receiving prolonged therapy. Bone marrow suppression is increased in patients who have received prior therapy, especially regimens including cisplatin.
Marrow suppression is also increased in patients with impaired kidney function. Initial carboplatin injection dosages in these patients should be appropriately reduced (see DOSAGE AND ADMINISTRATION ) and blood counts should be carefully monitored between courses. The use of carboplatin in combination with other bone marrow suppressing therapies must be carefully managed with respect to dosage and timing in order to minimize additive effects.
Carboplatin has limited nephrotoxic potential, but concomitant treatment with aminoglycosides has resulted in increased renal and/or audiologic toxicity, and caution must be exercised when a patient receives both drugs. Clinically significant hearing loss has been reported to occur in pediatric patients when carboplatin was administered at higher than recommended doses in combination with other ototoxic agents. Carboplatin can induce emesis, which can be more severe in patients previously receiving emetogenic therapy.
The incidence and intensity of emesis have been reduced by using premedication with antiemetics. Although no conclusive efficacy data exist with the following schedules of carboplatin, lengthening the duration of single intravenous administration to 24 hours or dividing the total dose over five consecutive daily pulse doses has resulted in reduced emesis. Although peripheral neurotoxicity is infrequent, its incidence is increased in patients older than 65 years and in patients previously treated with cisplatin.
Pre-existing cisplatin-induced neurotoxicity does not worsen in about 70% of the patients receiving carboplatin as secondary treatment. Loss of vision, which can be complete for light and colors, has been reported after the use of carboplatin with doses higher than those recommended in the package insert. Vision appears to recover totally or to a significant extent within weeks of stopping these high doses.
As in the case of other platinum-coordination compounds, allergic reactions to carboplatin have been reported. These may occur within minutes of administration and should be managed with appropriate supportive therapy. There is increased risk of allergic reactions including anaphylaxis in patients previously exposed to platinum therapy (see CONTRAINDICATIONS and ADVERSE REACTIONS, Allergic Reactions ).
High dosages of carboplatin (more than 4 times the recommended dose) have resulted in severe abnormalities of liver function tests. Carboplatin injection may cause fetal harm when administered to a pregnant woman. Carboplatin has been shown to be embryotoxic and teratogenic in rats.
There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 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. Percent Second Line Single Agent Therapy 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. Percent Bone Marrow Thrombocytopenia < 100,000/mm 3 66 62 < 50,000/mm 3 33 35 Neutropenia < 2,000 cells/mm 3 96 67 < 1,000 cells/mm 3 82 21 Leukopenia < 4,000 cells/mm 3 97 85 < 2,000 cells/mm 3 71 26 Anemia < 11 g/dL 90 90 < 8g/dL 14 21 Infections 16 5 Bleeding 8 5 Transfusions 35 44 Gastrointestinal Nausea and vomiting 93 92 Vomiting 83 81 Other GI side effects 46 21 Neurologic Peripheral neuropathies 15 6 Ototoxicity 12 1 Other sensory side effects 5 1 Central neurotoxicity 26 5 Renal Serum creatinine elevations 6 10 Blood urea elevations 17 22 Hepatic Bilirubin elevations 5 5 SGOT elevations 20 19 Alkaline phosphatase elevations 29 37 Electrolytes loss Sodium 10 47 Potassium 16 28 Calcium 16 31 Magnesium 61 43 Other side effects Pain 44 23 Asthenia 41 11 Cardiovascular 19 6 Respiratory 10 6 Allergic 11 2 Genitourinary 10 2 Alopecia 49 2 Mucositis 8 1 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 carboplatin. Thrombocytopenia with platelet counts below 50,000/mm 3 occurs in 25% of the patients (35% of pretreated ovarian cancer patients); neutropenia with granulocyte counts below 1,000/mm 3 occurs in 16% of the patients (21% of pretreated ovarian cancer patients); leukopenia with WBC counts below 2,000/mm 3 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/mm 3 ; 74% have neutrophil counts above 2,000/mm 3 ; 67% have leukocyte counts above 4,000/mm 3 . 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 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 carboplatin 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. Carbo…
🔄 Drug Interactions ▾
Drug Interactions The renal effects of nephrotoxic compounds may be potentiated by carboplatin.
🤰 Pregnancy ▾
Pregnancy Pregnancy Category D See WARNINGS .
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established (see WARNINGS, "audiologic toxicity" ).
🧓 Geriatric Use ▾
Geriatric Use 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 injection dosage (see DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE There is no known antidote for carboplatin injection overdosage. The anticipated complications of overdosage would be secondary to bone marrow suppression and/or hepatic toxicity.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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
4.4L/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 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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Carboplatin injection, 10 mg/mL is available in multi-dose vials (with brown flip-off seals), individually cartoned: NDC 0703-4244-01 10 mg/mL, 5 mL Vial NDC 0703-4246-01 10 mg/mL, 15 mL Vial NDC 0703-4248-01 10 mg/mL, 45 mL Vial NDC 0703-4239-01 10 mg/mL, 60 mL Vial STORAGE Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Carboplatin 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 Caution should be exercised in handling and preparing carboplatin injection.
Several guidelines on this subject have been published. 1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing carboplatin injection. If carboplatin injection contacts the skin, immediately wash the skin thoroughly with soap and water.
If carboplatin injection contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.
📦 Storage and Handling ▾
STORAGE Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Carboplatin 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 Caution should be exercised in handling and preparing carboplatin injection. Several guidelines on this subject have been published. 1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing carboplatin injection.
If carboplatin injection contacts the skin, immediately wash the skin thoroughly with soap and water. If carboplatin injection contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.
📋 Description ▾
DESCRIPTION Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP. Carboplatin, USP is a platinum coordination compound.
The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0']-, (SP-4-2), and carboplatin, USP has the following structural formula: C 6 H 12 N 2 O 4 Pt M.W. 371.25 Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5.0 to 7.0.
It is virtually insoluble in ethanol, acetone, and dimethylacetamide. Structural Formula