Drug SummaryTeva Parenteral Medicines, Inc.
Carboplatin
(carboplatin)
BOXED WARNING
Administer 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 may also occur frequently. Anaphylactic-like reactions reported and may occur within minutes of administration; epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.
THERAPEUTIC CLASS
Platinum analogue
DEA CLASS
RX
ADULT DOSAGE & INDICATIONS
Ovarian Carcinoma
Do not repeat intermittent courses until neutrophil count is ≥2000 and platelet count is ≥100,000
Single Agent:
360mg/m2 every 4 weeks
Combination with Cyclophosphamide:
Carboplatin: 300mg/m2 every 4 weeks for 6 cycles
Cyclophosphamide: 600mg/m2 every 4 weeks for 6 cycles
Alternative Formula Dosing:
Total Dose (mg) = (target AUC) x (GFR + 25)
DOSING CONSIDERATIONS
Renal Impairment
CrCl 41-59mL/min: Administer 250mg/m2 on Day 1
CrCl 16-40mL/min: Administer 200mg/m2 on Day 1
Adverse Reactions
Platelets >100,000 and Neutrophils >2000: Administer 125% of dose
Platelets <50,000 and Neutrophils <500: Administer 75% of dose
Refer to PI for formula dosing
Elderly
Use formula dosing
ADMINISTRATION
IV route
Administer by an infusion lasting ≥15 min
Avoid preparing or administering inj with needles or IV sets containing aluminum parts
Preparation of IV Sol
1. Sol may be further diluted to concentrations as low as 0.5mg/mL with 5% Dextrose in Water or 0.9% Sodium Chloride Injection, USP
2. When prepared as directed, sol is stable for 8 hrs at room temperature (25°C)
HOW SUPPLIED
Inj: 10mg/mL [5mL, 15mL, 45mL, 60mL]
CONTRAINDICATIONS
History of severe allergic reactions to cisplatin or other platinum-containing compounds, or mannitol; severe bone marrow depression; significant bleeding.
WARNINGS/PRECAUTIONS
Frequently monitor peripheral blood counts during treatment and, when appropriate, until recovery is achieved. Increased bone marrow suppression in patients who have received prior therapy, especially regimens with cisplatin, and with renal impairment. May induce emesis; may be more severe in patients previously receiving emetogenic therapy. Increased incidence of peripheral neurotoxicity in patients >65 yrs of age and in patients previously treated with cisplatin. Loss of vision, which can be complete for light and colors, reported with higher than recommended doses. High doses (>4X the recommended dose) resulted in severe LFT abnormalities. May cause fetal harm. Aluminum may react with drug, causing precipitate formation and loss of potency.
ADVERSE REACTIONS
N/V, thrombocytopenia, neutropenia, leukopenia, anemia, pain, asthenia, central neurotoxicity, electrolyte loss, SrCr/BUN/Bilirubin/AST/alkaline phosphatase elevations.
DRUG INTERACTIONS
Bone marrow depression may be more severe with other bone marrow suppressing drugs or with radiotherapy; use with other bone marrow suppressing drugs must be carefully managed with respect to dosage and timing to minimize additive effects. Increased renal and/or audiologic toxicity with aminoglycosides; use with caution. May potentiate renal effects of nephrotoxic compounds.
PREGNANCY AND LACTATION
Category D, not for use in nursing.
MECHANISM OF ACTION
Platinum coordination compound; produces predominantly interstrand DNA cross-links.
PHARMACOKINETICS
Distribution: Vd=16L. Elimination: Urine (65% unchanged within 12 hrs; 71% unchanged within 24 hrs); T1/2=5 days (platinum).
ASSESSMENT
Assess for severe bone marrow depression, significant bleeding, history of severe allergic reactions to drug, other platinum-containing compounds, or mannitol, renal impairment, pregnancy/nursing status, and possible drug interactions.
MONITORING
Monitor for bone marrow suppression, anemia, anaphylactic-like reactions, and other adverse reactions. Monitor peripheral blood counts.
PATIENT COUNSELING
Instruct to inform physician if pregnant/breastfeeding or intending to become pregnant; advise women of childbearing potential to avoid becoming pregnant. Inform of the possible side effects and instruct to contact physician should any occur.
STORAGE
Unopened Vials: 20-25°C (68-77°F). Protect from light. Opened Vials: 25°C (77°F) for up to 14 days following multiple needle entries. Further Diluted Sol: 25°C (77°F) for 8 hrs. Refer to PI for handling and disposal instructions. |
