Campath is indicated as a single agent for the treatment of B-cell Chronic Lymphocytic Leukemia (B-CLL).

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

License:

FDA

Class:

CD52 MAb

Newly Diagnosed

PIhttp://www.campath.com/pdfs/2014-09-Campath_US_PI.pdf 

1. Approved Labelling 

Campath is indicated as a single agent for the treatment of B-cell Chronic Lymphocytic Leukemia (B-CLL). 

2. Treatment Regimen 

Administer as an IV infusion over 2 hours. Do not administer as intravenous push or bolus.

Recommended Dosing Regime:

Gradually escalate to the maximum recommended single dose of 30 mg. Escalation is required at initiation of dosing or if dosing is held ≥ 7 days during treatment. Escalation to 30 mg ordinarily can be accomplished in 3 - 7 days.

Escalation Strategy:

Administer 3 mg daily until infusion reactions are ≤ grade 2.

Then administer 10 mg daily until infusion reactions are ≤ grade 2.

Then administer 30 mg/day three times per week on alternate days (e.g.,Mon-Wed-Fri). The total duration of therapy, including dose escalation, is 12 weeks.

Single doses of greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.

 

3. AE/Warnings

Please see section 5 of the PI.

 

 

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