BOXED WARNING and WARNINGS AND PRECAUTIONS (5.3)].
2.3 Dose Modification
Withhold Campath during serious infection or other serious adverse reactions until resolution.
Discontinue Campath for autoimmune anemia or autoimmune thrombocytopenia.
There are no dose modifications recommended for lymphopenia.
Dose Modification for Neutropenia or Thrombocytopenia [see WARNINGS AND PRECAUTIONS (5.1)] *
If the delay between dosing is ≥ 7 days, initiate therapy at Campath 3 mg and escalate to 10 mg and then to 30 mg as tolerated [see DOSAGE AND ADMINISTRATION (2.1)].
Hematologic Values
Dose Modification*
ANC < 250/μL and/or platelet count ≤25,000/μL
For first occurrence:
Withhold Campath therapy. Resume Campath
at 30 mg when ANC ≥ 500/μL and platelet count ≥ 50,000/μL.
For second occurrence:
Withhold Campath therapy. Resume Campath
at 10 mg when ANC ≥ 500/μL and platelet count ≥ 50,000/μL.
For third occurrence:
Discontinue Campath therapy.
≥ 50% decrease from baseline in patients initiating therapy with a baseline ANC ≤ 250/μL and/or a baseline platelet count ≤ 25,000/μL
For first occurrence:
Withhold Campath therapy. Resume Campath
at 30 mg upon return to baseline value(s).
For second occurrence:
Withhold Campath therapy. Resume Campath
at 10 mg upon return to baseline value(s).
For third occurrence:
Discontinue Campath therapy.
2.4 Preparation and Administration
Parenteral drug products should be inspected visually for 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 VIAL.
Use aseptic technique during the preparation and administration of Campath. Withdraw the necessary amount of Campath from the vial into a syringe.
To prepare the 3 mg dose, withdraw 0.1 mL into a 1 mL syringe calibrated in increments of 0.01 mL.
To prepare the 10 mg dose, withdraw 0.33 mL into a 1 mL syringe calibrated in increments of 0.01 mL.
To prepare the 30 mg dose, withdraw 1 mL in either a 1 mL or 3 mL syringe calibrated in 0.1 mL increments.
Inject syringe contents 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.
The vial contains no preservatives and is intended for single use only. DISCARD VIAL including any unused portion after withdrawal of dose.
Use within 8 hours after dilution. Store diluted Campath at room temperature (15-30°C) or refrigerated (2-8°C). Protect from light.
2.5 Incompatibilities
Campath is compatible with polyvinylchloride (PVC) bags and PVC or polyethylene-lined PVC administration sets. Do not add or simultaneously infuse other drug substances through the same intravenous line.
3 DOSAGE FORMS AND STRENGTHS
30 mg/1 mL single use vial
4 CONTRAINDICATIONS
None
5 WARNINGS AND PRECAUTIONS
5.1 Cytopenias
Severe, including fatal, autoimmune anemia and thrombocytopenia, and prolonged myelosuppression have been reported in patients receiving Campath.
In addition, hemolytic anemia, pure red cell aplasia, bone marrow aplasia, and hypoplasia have been reported after treatment with Campath at the recommended dose. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the inc |
