Prescription medicine
Alemtuzumab Brand names: Lemtrada, Campath
Alemtuzumab (Campath) is a prescription medicine with an FDA approval on record since 2001. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the alemtuzumab FDA label on DailyMed (effective November 3, 2025, Genzyme Corporation); the BLA 103948 record on Drugs@FDA; every alemtuzumab label on DailyMed.
Highlights of the record
FDA label of November 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES.
LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last dose of LEMTRADA [see Warnings and Precautions (5.1) ]. LEMTRADA causes serious and life-threatening infusion reactions. LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period [see Warnings and Precautions (5.2) ]. Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur [see Warnings and Precautions (5.3) ]. LEMTRADA may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams [see Warnings and Precautions (5.4) ]. […]
Used for
From the label: indications and usageLEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults.
Forms and strengths
- 12 mg/1.2ml
- 30 mg/ml
Injection (solution) (concentrate); injection.
On the market
- Earliest approval on file
- May 7, 2001 Lemtrada, Genzyme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 19,229 through July 30, 2026
What is alemtuzumab used for?
From the label: indications and usageLEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS [see Warnings and Precautions (5) ]. LEMTRADA is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. […]
Conditions named in the indications of alemtuzumab's FDA labels, with every medicine labeled for each:
From other alemtuzumab labelsLeukemia, lymphoma and myeloma: CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
FDA pharmacologic class: CD52-directed Cytolytic Antibody.
Source: FDA drug label (LEMTRADA), Genzyme Corporation, effective November 3, 2025 (SPL set 6236b0bc-82e9-4447-9a78-f57d94770269), via openFDA; the full label on DailyMed
What does the patient leaflet for alemtuzumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LEMTRADA?LEMTRADA can cause serious side effects, including: 1. Serious autoimmune problems. Some people receiving LEMTRADA develop a condition where the immune cells in your body attack other cells or organs in the body (autoimmunity) which can be serious and may cause death. Serious autoimmune problems may include: immune thrombocytopenic purpura (ITP). LEMTRADA may cause the number of platelets in your blood to be reduced (ITP). ITP can cause severe bleeding that may cause life-threatening problems. Call your healthcare provider right away if you have any of the following symptoms: easy bruising bleeding from a cut that is hard to stop coughing up blood heavier menstrual periods than normal bleeding from your gums or nose that is new or takes longer than usual to stop small, scattered spots on your skin that are red, pink, or purple kidney problems. LEMTRADA may cause a serious kidney problem called anti-glomerular basement membrane disease. […] The blood and urine tests will help your healthcare provider watch for signs and symptoms of serious autoimmune problems. It is important to have your blood and urine tested, even if you are feeling well and do not have any symptoms from LEMTRADA and your multiple sclerosis. This may help your healthcare provider find any problems early. 2. Serious infusion reactions. LEMTRADA can cause serious infusion reactions that may cause death. Serious infusion reactions may happen while you receive, or up to 24 hours or longer after you receive LEMTRADA. You will receive your infusion at a healthcare facility with equipment and staff trained to manage infusion reactions. […]
Source: FDA drug label (LEMTRADA), Genzyme Corporation, effective November 3, 2025 (SPL set 6236b0bc-82e9-4447-9a78-f57d94770269), via openFDA; the full label on DailyMed
Is there a generic for alemtuzumab (Campath)?
No generic alemtuzumab is approved (Drugs@FDA, October 8, 2026).
- 2001 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the alemtuzumab label say about other medicines?
The alemtuzumab label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name alemtuzumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atropine | warnings and precautions | In clinical studies, 0.6% of patients with infusion reactions received epinephrine or atropine. |
| Epinephrine | warnings and precautions | In clinical studies, 0.6% of patients with infusion reactions received epinephrine or atropine. |
| Methylprednisolone | warnings and precautions | In clinical studies, patients received 1,000 mg of methylprednisolone for the first 3 days of each LEMTRADA treatment course. |
Other labels that name alemtuzumab
Source: FDA drug label (LEMTRADA), Genzyme Corporation, effective November 3, 2025 (SPL set 6236b0bc-82e9-4447-9a78-f57d94770269), via openFDA; the full label on DailyMed
What do FAERS reports show for alemtuzumab?
The FDA Adverse Event Reporting System holds 19,229 reports that list alemtuzumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,921 are coded as a death and 6,100 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as alemtuzumab?
2 other medicines are given the same way (intravenous) and in the same FDA class as alemtuzumab or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Natalizumab | Multiple sclerosis | none listed | n/a | No current entry |
| Ublituximab | Multiple sclerosis | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alemtuzumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other