o 10 mg only.
For third occurrence of ANC < 250/mL and/or platelet count £ 25,000/mL Discontinue Campath therapy permanently.
For a decrease of ANC and/or platelet count to £ 50% of the baseline value in patients initiating therapy with a baseline ANC £ 500/mL and/or a baseline platelet count £ 25,000/mL Withhold Campath therapy. When ANC and/or platelet count return to baseline value(s), resume Campath therapy. If the delay between dosing ³ 7 days, initiate therapy at Campath 3 mg and escalate to 10 mg and then to 30 mg as tolerated.
Preparation for Administration:
Parenteral drug products should be inspected for visible particulate matter and discoloration prior to administration. If particulate matter is present or the solution is discolored, the vial should not be used. DO NOT SHAKE AMPOULE PRIOR TO USE. As with all parenteral drug products, aseptic technique should be used during the preparation and administration of Campath. Withdraw the necessary amount of Campath from the ampoule into a syringe. Filter with a sterile, low-protein binding, non-fiber releasing 5 mm filter prior to dilution.
Inject into 100 mL sterile 0.9% Sodium Chloride USP or 5% Dextrose in Water USP. Gently invert the bag to mix the solution. Discard syringe and any unused drug product.
Campath contains no antimicrobial preservative. Campath should be used within 8 hours after dilution. Campath solutions may be stored at room temperature (15-30°C) or refrigerated. Campath solutions should be protected from light.
Incompatibilities:
No incompatibilities between Campath and polyvinylchloride (PVC) bags, PVC or polyethylene-lined PVC administration sets, or low-protein binding filters have been observed. No data are available concerning the incompatibility of Campath with other drug substances. Other drug substances should not be added or simultaneously infused through the same intravenous line.
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HOW SUPPLIED
Campath (Alemtuzumab) is supplied in single-use clear glass ampoules containing 30 mg of Alemtuzumab in 3 mL of solution. Each box contains either three Campath ampoules (NDC 50419-355-10) or 12 Campath ampoules (NDC 50419-355-12).
Campath should be stored at 2-8°C (36-46°F). Do not freeze. DISCARD IF AMPOULE HAS BEEN FROZEN. Protect from direct sunlight.
Rx only.
U.S. Patents: 5,545,403; 5,545,405; 5,654,403; 5,846,534
Other patents pending
Manufactured by: Millennium and ILEX Partners, LP Cambridge, MA 02142
Distributed by: Berlex Laboratories, Richmond, CA 94804
Issued: May 2001
Last Updated: 8/30/2001
Date created: September 26, 2003
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