Quick answers
- What is Alemtuzumab used for?
- The FDA-approved label (Campath, Genzyme Corporation, November 5, 2025) says: “CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alemtuzumab have a boxed warning?
- Yes. The FDA label for Campath has a boxed warning (“WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Alemtuzumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alemtuzumab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Alemtuzumab?
- 1 company lists prescription products of Alemtuzumab in the FDA NDC Directory, including Genzyme Corporation.
What Alemtuzumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
— FDA label: Campath, Genzyme Corporation, effective November 5, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Genzyme Corporation2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103948 CAMPATH, LEMTRADA | Genzyme | May 7, 2001 | 35, latest May 20, 2024 2024: Labeling · 2024: REMS · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 828265, 828267, 1594658, 1594663 |
|---|---|
| SPL set ID of the quoted label | 4f5f7255-7abc-4328-bd1a-ceaf139ef3e0 |
| FDA labels (SPL) | 2 |
| FDA applications | BLA103948 |
| Active ingredients (FDA) | ALEMTUZUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Campath, Genzyme Corporation, effective November 5, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →