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Alemtuzumab Dosage

Applies to the following strength(s): 10 mg/mL ; 30 mg/mL

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Lymphocytic Leukemia

-Recommended dosing regimen: 3 mg IV daily over 2 hours until infusion reactions are Grade 2 or less; then escalate to 10 mg IV daily over 2 hours until infusion reactions are Grade 2 or less; then escalate to 30 mg IV daily over 2 hours 3 times per week on alternate days (e.g., Monday, Wednesday, Friday).
-Duration of therapy: 12 weeks

Comments:
-Escalation is required at initiation of dosing or if dosing is held for 7 days or longer during treatment.
-Escalation to 30 mg IV daily usually can be accomplished in 3 to 7 days.
-Single doses of greater than 30 mg 3 times per week or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.
-Patients should be premedicated before the infusion is started. Consult manufacturer recommended concomitant medications or local protocol.

Use: As a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL)

Usual Adult Dose for Multiple Sclerosis

Recommended dosing regimen: 12 mg IV daily for 2 treatment courses:
-FIRST TREATMENT COURSE: 12 mg IV daily on 5 consecutive days
-SECOND TREATMENT COURSE: 12 mg IV daily on 3 consecutive days administered 12 months after the first treatment course

Comments:
-Infusions should be administered over 4 hours starting within 8 hours after drug dilution. The duration of the infusion should be extended if clinically indicated.
-Patients should complete any necessary immunizations at least 6 weeks prior to treatment.
-Patients should be premedicated with high dose corticosteroids before the infusion is started. Consult manufacturer recommended concomitant medications or local protocol.
-Missed doses should not be given on the same day as a scheduled dose.
-Anti-viral prophylaxis for herpetic viral infections should be administered starting on the first day of each treatment course and continued for a minimum of 2 months following treatment until the CD4+ lymphocyte count is 200 cells per microliter or greater, whichever occurs later.
-Patients should be observed for infusion reactions during and for at least 2 hours after each infusion. Longer periods of observation should be considered if clinically indicated.
-Patients should be informed to report symptoms that occur during and after each infusion because they may indicate a need for prompt medical intervention

Use: For the treatment of patients with relapsing forms of multiple sclerosis (MS) (use should generally be reserved for MS patients aged 17 years or older who have had an inadequate response to two or more drugs)

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Data not available.

Dose Adjustments

DOSE MODIFICATIONS FOR B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (B-CLL):
-Withhold therapy during serious infection or other serious adverse reactions until resolution.
-Discontinue therapy for autoimmune anemia or autoimmune thrombocytopenia.
-There are no dose modifications recommended for lymphopenia.
-Dose Modification for Neutropenia or Thrombocytopenia:
ANC LESS THAN 250 PER MICROLITER AND/OR PLATELET COUNT LESS THAN OR EQUAL TO 25,000 PER MICROLITER:
-FIRST OCCURRENCE: Withhold therapy. Resume therapy at 30 mg when ANC is greater than or equal to 500 per microliter and platelet count is greater than or equal to 50,000 per microliter.
-SECOND OCCURRENCE: Withhold therapy. Resume therapy at 10 mg when ANC is greater than or equal to 500 per microliter and platelet count is greater than or equal to 50,000 per microliter.
-THIRD OCCURRENCE: Discontinue therapy.
GREATER THAN OR EQUAL TO 50% DECREASE FROM BASELINE IN PATIENTS INITIATING THERAPY WITH A BASELINE ANC LESS THAN OR EQUAL TO 250 PER MICROLITER AND/OR A BASELINE PLATELET COUNT LESS THAN OR EQUAL TO 25,000 PER MICROLITER:
-FIRST OCCURRENCE: Withhold therapy. Resume therapy at 30 mg upon return to baseline value(s).
-SECOND OCCURRENCE: Withhold therapy. Resume therapy at 10 mg upon return to baseline value(s).
-THIRD OCCURRENCE: Discontinue therapy.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for alemtuzumab. It includes a communication plan, elements to assure safe use, and an implementation system. For additional information: www.fda.gov/REMS.

US BOXED WARNINGS:
-Serious, including fatal, pancytopenia/marrow hypoplasia, anti-glomerular basement membrane disease, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving this drug. Complete blood counts should be obtained with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals for 48 months after the last dose. Single doses of greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.
-Administration can result in serious, including fatal, infusion reactions. Patients should be carefully monitored during infusions and therapy should be withheld for Grade 3 or 4 infusion reactions. Gradually escalate to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days. Therapy should be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Patients should be monitored for at least 2 hours after each infusion. Patients should be made aware that serious infusion reactions can also occur after the 2-hour monitoring period.
-Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur. Prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections should be instituted before therapy is begun.
-This drug may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Baseline and yearly skin exams should be performed.
-Because of the risk of autoimmunity, infusion reactions, and malignancies, this drug is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program. Call 1-855-676-6326 to enroll in the LEMTRADA REMS program.

10 mg/mL:
Safety and efficacy have not been established in patients younger than 17 years.

30 mg/mL:
Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

General:
-Different strengths of this drug have different indications. Consult the manufacturer product information before initiating therapy.
-Grade 3 or 4 infusion-related reactions are uncommon after the first week of therapy.
-Patients who have been treated with this drug should receive irradiated blood products.
-If retreatment is considered, it may be prudent to confirm the presence of CD 52 expression.

Administration advice:
-Infusions should be administered over at least 2 hours.
-If infusion reactions persist, the infusion time may be extended to up to 8 hours from the time of preparation of the infusion.
-Patients should be premedicated with steroids, antihistamines, and an analgesic as indicated by the manufacturer or local protocol.
-Recommended anti-infective prophylaxis includes prophylaxis against Pneumocystis jiroveci pneumonia and an anti-herpes agent.
-Doses should be administered using aseptic techniques following protocols for administration of parenteral antineoplastic antibodies.

Storage requirements:
-The manufacturer product information should be consulted.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

Monitoring:
CARDIOVASCULAR:
-Careful monitoring of blood pressure and hypotensive symptoms is recommended especially in patients with ischemic heart disease, angina, and/or in patients receiving antihypertensive medication.
-Assessment and ongoing monitoring of cardiac function is recommended in patients previously treated with potentially cardiotoxic agents.
HEMATOLOGIC:
-Baseline full blood counts and platelet counts, repeated at regular intervals during therapy and more frequently in patients that develop cytopenias.

Patient advice:
-Patients should be given the Package Leaflet, the Patient Alert Card and the Patient Guide.
-Before treatment, patients should be informed about the risks and benefits, and the need to commit to 48-months of follow-up after the last infusion.

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