Campath (Alemtuzumab)

DNA derived humanized monoclonal antibodyy.
Targeted against CD52.
CD52 is epressed on surface of normal and malignant B and T lymphocytes, NK cells, monocytes, macrophages, tissues of the male reproductive system.
Erythrocytes or hematopoetic stem cells do not have CD52.
Mature sperms have CD52.
Skin and male reproductive tract hace CD52.

Mechanism of action: antibody dependent lysis of leukemic cells following cell surface binding.

Lab monitoring: FBC weekly. CD4 counts.

About 2% risk of antibodies towards Campth (may cross react with other monoclonals)

No long term studies on Carcinogenesis, Mutagenesis, Impairment of fertility

Contraception should be used in childbearing women and men during Campth use and 6 months following Campath therapy

Side Effects:-
Infusion related A/E: 6% discontinue Campath d/t infusion related A/E
Rigors, drug fever, nausea, vomiting, hypotension, rash, fatigue, urticaria,
Dyspnea, pruritus, headache, diarrhoea.

Infection: 43% risk despite PCP/Herpes prophylaxis (1/3 of pt Grade ¾ severity)

Hematological: Pancytopenia, marrow hypoplasia, Anemia, cytopenias, ITP

Dosing:
Campath therapy should be initiated at a dose of 3 mg administered as a 2 hour IV infusion daily.

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 3 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.

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:
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.
trimethoprim/sulfamethoxazole DS twice daily (BID) three times per week and famciclovir or 348 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 ≥ 350

Campath therapy should be discontinued during serious infection, serious hematologic toxicity, or other serious toxicity until the event resolves.
Campath therapy should be permanently discontinued if evidence of autoimmune anemia or thrombocytopenia appears.

Dose is adjusted to Figure above

Preparation:
Aseptic technique should be used.
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.
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.