Drug Detail:Campath (Alemtuzumab [ al-em-tooz-ue-mab ])
Generic Name: ALEMTUZUMAB 30mg in 1mL
Dosage Form: injection
Drug Class: CD52 monoclonal antibodies
Dosing Schedule and Administration
- Administer as an intravenous infusion over 2 hours. Do not administer as intravenous push or bolus.
- Recommended Dosing Regimen
- 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 to 7 days.
- Escalation Strategy:
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- Administer 3 mg daily until infusion-related reactions are ≤ Grade 2 [see Adverse Reactions (6.1)].
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- Then administer 10 mg daily until infusion-related reactions are ≤ Grade 2.
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- 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.
Recommended Concomitant Medications
- Premedicate with diphenhydramine (50 mg) and acetaminophen (500–1000 mg) 30 minutes prior to first infusion and each dose escalation. Institute appropriate medical management (e.g., glucocorticoids, epinephrine, meperidine) for infusion-related reactions as needed [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
- Administer trimethoprim/sulfamethoxazole double strength (DS) twice daily 3 times per week (or equivalent) as Pneumocystis jirovecii pneumonia (PCP) prophylaxis.
- Administer famciclovir 250 mg BID or equivalent as herpetic prophylaxis.
Continue PCP and herpes viral prophylaxis for a minimum of 2 months after completion of CAMPATH or until the CD4+ count is ≥200 cells/µL, whichever occurs later [see Warnings and Precautions (5.3)].
Dosage 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.
| Hematologic Values | Dosage 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. |
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, discard the vial. 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 between 15°C to 30°C (59°F to 86°F) or refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light.
