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Molecule

Alemtuzumab

CD52-directed Cytolytic Antibody
Available on requestBiologicOrphanCold chainImmunology and transplantMultiple sclerosisOncology
Presentations
2
Brands
2
Manufacturers
1
Available from stock
0

Alemtuzumab is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). It is available as injection for intravenous use. MedsAcross supplies Alemtuzumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
CD52-directed Cytolytic Antibody, CD52-directed Antibody Interactions
ATC classification
L01XC04 Alemtuzumab · Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XCL04AA34 Alemtuzumab · Immunosuppressive drug, subgroup L04AA
US FDA first approval
7 May 2001
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 3A189DH42VRxCUI 117055CAS 216503-57-0DrugBank DB00087Q420164

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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).

Source: US FDA prescribing information

How it works

CAMPATH binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52. The proposed mechanism of action is antibody-dependent cellular-mediated lysis following cell surface binding of CAMPATH to the leukemic cells.

Source: US FDA prescribing information

Dosing overview

Administer as an intravenous infusion over 2 hours. Escalate to recommended dose of 30 mg/day three times per week for 12 weeks. Premedicate with oral antihistamine and acetaminophen.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (cytopenias, infusion-related reactions, and infections warning: cytopenias, infusion-related reactions, and infections): Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly), higher doses increase risk of pancytopenia. Escalate dose gradually and monitor patients during infusion. Cytopenias: Obtain complete blood counts (CBC) and platelet counts at weekly intervals during therapy and CD4 counts after therapy until recovery to ≥200 cells/µL. Withhold for severe cytopenias. Discontinue for autoimmune or severe hematologic adverse reactions. Immunosuppression/Infections: CAMPATH induces severe and prolonged lymphopenia and increases risk of infection. If a serious infection occurs, withhold treatment until infection resolves.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Cytopenias Infusion-Related Reactions Immunosuppression/Infections Most common adverse reactions (≥10%): cytopenias, infusion-related reactions, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia.

Source: US FDA prescribing information

Storage

Store CAMPATH at 2°C to 8°C (36°F to 46°F). Do not freeze. If accidentally frozen, thaw at 2°C to 8°C before administration. Protect from direct sunlight.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Alemtuzumab, sorted by availability.

MedicineManufacturerRegisterAvailability
Campath 30 mg/1 mL injectionIntravenous Cold chainGenzymeUS FDAAvailable on request
Lemtrada 12 mg/1.2 mL injectionIntravenous Cold chainGenzymeUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 7 May 2001Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Alemtuzumab in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Alemtuzumab available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Alemtuzumab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Alemtuzumab have?

The catalogue lists 2 brand names for Alemtuzumab, including Campath, Lemtrada.

Is Alemtuzumab approved by the US FDA?

Yes. The US FDA first approved Alemtuzumab on 7 May 2001, according to Drugs@FDA.

Is Alemtuzumab authorised in the European Union?

Yes. Alemtuzumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Alemtuzumab need cold chain shipping?

At least one listed presentation of Alemtuzumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Alemtuzumab in?

Alemtuzumab is classified under ATC code L01XC04 (Alemtuzumab).

References

  1. Campath prescribing information (Genzyme). U.S. National Library of Medicine, DailyMed. Retrieved 5 November 2025
  2. Lemtrada: European public assessment report (EPAR). European Medicines Agency. Retrieved 30 October 2026

Request Alemtuzumab for export supply

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