Carboplatin Injection 10 mg/mL, 50 mg Multiple-Dose Amber Vial (RX)

Carboplatin Injection 10 mg Carboplatin is a platinum-based alkylating (chemotherapy) agent (a cisplatin analog) used to treat certain cancers. Each 5 mL vial contains 50 mg carboplatin (10 mg/mL) in sterile, pyrogen-free solution. Mannitol (10 mg/mL) is included as a stabilizer. The solution is clear and colorless to pale yellow. Mechanism of Action: Carboplatin forms reactive platinum complexes that cross-link DNA (interstrand and intrastrand), inhibiting DNA synthesis. It is cell-cycle non-specific, damaging cells during division. Indications: It is FDA-approved (Rx-only) primarily for ovarian carcinoma. Specifically, carboplatin is indicated for first-line treatment of advanced epithelial ovarian cancer (usually given with other chemotherapeutic agents). It’s also indicated for palliative treatment of recurrent ovarian cancer after prior chemotherapy (including cases previously treated with cisplatin). Off-label, carboplatin is frequently used in regimens for other solid tumors (often combined with other drugs) such as lung cancer (especially small-cell lung cancer), cervical cancer, bladder cancer, testicular cancer, head & neck cancers, and various gynecologic tumors. Dosage and Administration Route: Intravenous infusion only. Typical infusions last ≥15 minutes. No special hydration or forced diuresis is required (unlike cisplatin). Typical Dosing: For example, single-agent therapy in recurrent ovarian cancer often uses ~360 mg/m² IV on day 1 every 4 weeks. In combination with cyclophosphamide for first-line ovarian cancer, a regimen might use carboplatin ~300 mg/m² IV on day 1 (with cyclophosphamide 600 mg/m² IV) every 4 weeks. Dosing should be individualized; the Calvert formula is commonly employed to adjust dose by renal function: Dose (mg) = target AUC × (GFR + 25). This accounts for the patient’s creatinine clearance (glomerular filtration rate, GFR). Patients with diminished kidney function (creatinine clearance <60 mL/min) require dose reduction or formula adjustment. As with most cytotoxics, administration should be delayed if the patient’s neutrophils are <2000/mm³ or platelets are <100,000/mm³; repeat dosing is often held until counts recover to at least those levels. Infusion Preparation: Inspect the solution visually before use. Compatible IV fluids include 0.9% NaCl or 5% dextrose (avoid aluminum-containing equipment). Do not use needles or IV sets with aluminum parts (aluminum reacts with carboplatin and causes precipitates/loss of potency). After drawing from the vial, any diluted infusion should be administered promptly (discard prepared infusions after 8 hours). Packaging and Storage Container: Each 50 mg dose is supplied as a 5 mL multiple-dose amber glass vial (NDC 55150-333-01). The amber color and labeling (“Protect from light”) shield the light-sensitive solution. The vial has a gray/flipped cap allowing multiple needle entries. Storage Conditions: Store unopened vials at controlled room temperature (20–25 °C or 68–77 °F) and keep them tightly closed. Do not freeze. Because the solution can degrade with light, keep the vial in its carton or cover it to avoid light exposure. After Opening: Once punctured, the multi-dose vial remains stable for up to 14 days at 20–25 °C (if stored light-protected). After 14 days the vial should be discarded. (This short in-use shelf-life is a consequence of using it without preservative.) Any prepared infusion bag should be used within 8 hours. Warnings and Precautions Administration Supervision: Carboplatin is a potent chemotherapeutic. It should only be administered by a qualified oncologist or healthcare provider experienced in cancer chemotherapy. Appropriate supportive facilities (for transfusions, anti-emetics, emergency care) must be readily available. Hematologic Toxicity: The box warning highlights that bone marrow suppression is dose-related and can be severe. Severe leukopenia/neutropenia, thrombocytopenia, and anemia can occur. Monitor blood counts closely. Reductions in dose or delays in treatment may be needed; as noted, do not give the next cycle until neutrophils ≥2000/mm³ and platelets ≥100,000/mm³. Anemia may be cumulative over multiple cycles and could require blood transfusions. Patients should be observed for signs of infection or bleeding. Hypersensitivity: Anaphylactic-type reactions have been reported, sometimes occurring on first dose. Be prepared to treat severe allergic reactions immediately (e.g. with epinephrine, corticosteroids, antihistamines). If a reaction occurs, discontinue the drug. Nausea/Vomiting: Carboplatin often causes moderate-to-severe nausea and vomiting. Premedication with antiemetics is recommended (e.g. serotonin antagonists, corticosteroids) according to standard chemotherapy practice. Renal Function: Carboplatin is primarily excreted by the kidneys. Unlike cisplatin, it usually does not require aggressive hydration; nevertheless serious renal toxicity, while uncommon, has been reported (e.g. tubular necrosis). Development of significant serum creatinine elevations is uncommon (~6% of cases). Renal function (creatinine clearance) should be assessed before dosing. Reduce the dose if creatinine clearance is <60 mL/min. Carboplatin’s clearance is directly proportional to GFR, so formula dosing is important in renal impairment. Hearing (Ototoxicity): Carboplatin can cause hearing loss (ototoxicity), especially at high doses or with other ototoxic drugs (aminoglycosides, etc.). Audiometric monitoring is advised for patients (particularly children) receiving large doses. Pregnancy and Fertility: Carboplatin can cause fetal harm. In animal studies it was teratogenic and embryotoxic. Pregnant women or women of childbearing potential should be warned of these risks; effective contraception is essential. It is commonly considered Pregnancy Category D. Men and women should avoid conceiving during and for some time after treatment. Other Concerns: Use caution in patients with hepatic impairment (dose adjustments unknown). Carboplatin may exacerbate neurologic or electrolyte abnormalities (e.g. hypomagnesemia or seizures) when used with other ToxicAgents. Concurrent use with phenytoin or warfarin may decrease their levels (monitor accordingly). Adverse Effects Hematologic: As noted, dose-limiting neutropenia, thrombocytopenia and anemia are common. The nadir (lowest point) in blood counts typically occurs ~3–4 weeks after a dose. Monitor CBC regularly. Gastrointestinal: Nausea and vomiting are frequent (often delayed nausea 1–3 days post-dose), so anti-emetic prophylaxis is standard. Mucositis, anorexia, diarrhea or constipation can also occur. Renal/Hepatic: Renal toxicity is uncommon but should be monitored (creatinine and BUN). Mild liver enzyme elevations can occur. Sensory: Ototoxicity (hearing loss, tinnitus) and peripheral neuropathy are possible, especially with high cumulative doses. These are usually less severe than with cisplatin, but baseline and periodic hearing tests are prudent, especially in children. General: Fatigue, headache, fever, rash or itching may occur. Alopecia (hair loss) is common. Injection reactions at the infusion site (pain, phlebitis) can happen. Handling and Disposal Hazardous Drug Precautions: Carboplatin is a hazardous cytotoxic agent. When preparing or administering it, healthcare workers should follow standard chemotherapy handling guidelines. Wear gloves and gowns; if spills occur, clean thoroughly. If the solution contacts skin, wash the area immediately with soap and water; flush eyes or mucous membranes with water if exposed. Disposal: Dispose of unused drug and containers according to institutional policies for antineoplastic waste. Do not reuse syringes or vials.