A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Campath Indications, Dosage, Storage, Stability - Alemtuzumab
Campath Indications, Dosage, Storage, Stability - Alemtuzumab
INDICATIONS AND USAGE
Campath is indicated for the treatment of B-cell chronic lymphocytic
leukemia (B-CLL) in patients who have been treated with alkylating agents and
who have failed fludarabine therapy. Determination of the effectiveness of Campath
is based on overall response rates.(See CLINICAL
STUDIES.) Comparative, randomized trials demonstrating increased survival
or clinical benefits such as improvement in disease-related symptoms have not
yet been conducted.
DOSAGE AND ADMINISTRATION
Campath should be administered under the supervision of a physician
experienced in the use of antineoplastic therapy.
Dosing Schedule and Administration
Campath therapy should be initiated at a dose of 3 mg administered
as a 2 hour IV infusion daily.(See ADVERSE EVENTS.)
When the Campath 3 mg daily dose is tolerated (e.g., infusion-related toxicities
are £ Grade 2),the daily dose should be escalated
to 10 mg and continued until tolerated. When the 10 mg dose is tolerated, the
maintenance dose of Campath 30 mg may be initiated. The maintenance dose of
Campath is 30 mg/day administered three times per week on alternate days (i.e.,
Monday, Wednesday, and Friday) for up to 12 weeks. In most patients, escalation
to 30 mg can be accomplished in 3 – 7 days. Dose escalation to the recommended
maintenance dose of 30 mg administered three times per week is required. Single
doses of Campath greater than 30 mg or cumulative weekly doses of greater than
90 mg should not be administered since higher doses are associated with an increased
incidence of pancytopenia. (See BOXED WARNING.)
Campath should be administered intravenously only. The infusion should be administered
over a 2 hour period. DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS.
Recommended Concomitant Medications
Premedication should be given prior to the first dose, at dose
escalations, and as clinically indicated. The premedication used in clinical
studies was diphenhydramine 50 mg and acetaminophen 650 mg administered 30 minutes
prior to Campath infusion. In cases where severe infusion-related events occur,
treatment with hydrocortisone 200 mg was used in decreasing the infusion-related
events.
Patients should receive anti-infective prophylaxis to minimize
the risks of serious opportunistic infections.(See BOXED
WARNING.) The anti-infective regimen used on Study 1 consisted of trimethoprim/sulfamethoxazole
DS twice daily (BID) three times per week and famciclovir or equivalent 250
mg twice a day (BID) upon initiation of Campath therapy. Prophylaxis should
be continued for 2 months after completion of Campath therapy or until the CD4+
count is ≥ 200 cells/µL,
whichever occurs later.
Dose Modification and Reinitiation of Therapy
Campath therapy should be discontinued during serious infection,
serious hematologic toxicity,or other serious toxicity until the event resolves.(See
WARNINGS.) Campath therapy should be permanently
discontinued if evidence of autoimmune anemia or thrombocytopenia appears. Table
3 includes recommendations for dose modification for severe neutropenia or thrombocytopenia.
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Table 3: Dose Modification and Reinitiation of Therapy
for Hematologic Toxicity
|
|
Hematologic Toxicity
|
Dose Modification and Reinitiation of Therapy
|
|
For first occurrence of ANC < 250/µL
and/or platelet count ≤ 25,000/µL
|
Withhold Campath therapy. When ANC ≥ 500/µL
and platelet count ≥ 50,000/µL,resume
Campath therapy at same dose. If delay between dosing is ≥ 7
days, initiate therapy at Campath 3 mg and escalate to 10 mg and then
to 30 mg as tolerated.
|
|
For second occurrence of ANC < 250/µL
and/or platelet count ≤ 25,000/µL
|
Withhold Campath therapy. When ANC ≥ 500/µL
and platelet count ≥ 50,000/µL,resume
Campath therapy at 10 mg. If delay between dosing is ≥ 7
days, initiate therapy at Campath 3 mg and escalate to 10 mg only.
|
|
For third occurrence of ANC < 250/µL
and/or platelet count ≤ 25,000/µL
|
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/µL and/or
a baseline platelet count £ 25,000/µL
|
Withhold Campath therapy. When ANC and/or platelet count
return to baseline value(s),resume Campath therapy. If the delay between
dosing is 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 µm
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.
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
three Campath ampoules (NDC 50419-355-10).
Campath should be stored at 2-8°C
(36-46°F). Do not freeze. DISCARD IF AMPOULE
HAS BEEN FROZEN. Protect from direct sunlight.
U.S. Patents: 5,545,403; 5,545,405; 5,654,403;
5,846,534 Other patents pending, Manufactured by: ILEX Pharmaceuticals, L.P.,
San Antonio, TX 78229 Distributed by: Laboratories, Richmond, CA 94804, Issued:
January 2002
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