Registered South Africa · SAHPRA

LEMTRADA

Alemtuzumab

48/30.1/0263 antineoplastic and immunomodulating agents INN generic

What it does

Alemtuzumab is a medication that helps treat certain autoimmune conditions by targeting specific immune cells.

Commonly used for: multiple sclerosis, autoimmune diseases

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
48/30.1/0263
Registration date
2020/02/25
Expiry date
-
Status
Registered
Active ingredient
Alemtuzumab
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
L04AG - Monoclonal antibodies
RxNorm RxCUI
117055
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:24:36 · updated 2026-10-25 04:01:38

Drug Interactions

4
Check interactions

Pharmacodynamic Warnings

Alemtuzumab appears in TABLE 15: Drugs that cause myelosuppression

Severe (3)

Fingolimod - increases risk of generalised infection (possibly life-threatening)

Alemtuzumab is predicted to increase the risk of generalised infection (possibly life-threatening) when given with fingolimod. Avoid.

Severe Theoretical

Ozanimod - increases risk of generalised infection (possibly life-threatening)

Alemtuzumab is predicted to increase the risk of generalised infection (possibly life-threatening) when given with ozanimod.

Severe Theoretical

Siponimod - increases risk of generalised infection (possibly life-threatening)

Alemtuzumab is predicted to increase the risk of generalised infection (possibly life-threatening) when given with siponimod. Avoid.

Severe Theoretical

Unknown (1)

Ponesimod - increases risk of generalised infection (possibly life-threatening)

Alemtuzumab is predicted to increase the risk of generalised infection (possibly life-threatening) when given with ponesimod.

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Alemtuzumab is a medication that helps treat certain autoimmune conditions by targeting specific immune cells.

What it treats

  • multiple sclerosis
  • autoimmune diseases

How it works

It works by reducing the number of certain immune cells that mistakenly attack the body.

Who it's for

This medicine is for adults with specific autoimmune conditions like multiple sclerosis.

Cautions

  • • Be careful if you are taking other medications that affect blood cell production.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Alemtuzumab

BNF-referenced

Alemtuzumab is a monoclonal antibody used primarily in the treatment of relapsing-remitting multiple sclerosis (RRMS). It works by targeting CD52, a protein found on the surface of certain immune cells, leading to their depletion. This action helps to reduce the autoimmune response that characterizes multiple sclerosis, thereby alleviating symptoms and reducing relapse rates.

Indications

  • Relapsing-remitting multiple sclerosis with active disease
  • Patients with a high tumour burden
  • Autoimmune mediated conditions

Dosage

Children: The safety and efficacy of alemtuzumab in the paediatric population have not been established, thus specific dosing information is not available. Refer to the BNF for Children for guidance.

Adults: Refer to the BNF for specific dosing regimens as they may vary based on clinical context and patient response. Premedication prior to infusion is recommended to manage infusion-related reactions.

Mechanism of action

Alemtuzumab binds to the CD52 antigen on the surface of T and B lymphocytes, leading to their antibody-dependent cellular cytotoxicity and subsequent apoptosis. This results in a significant reduction in peripheral lymphocyte levels, which modulates the immune system and decreases autoimmune activity.

Pharmacodynamics

The drug exhibits immunosuppressive effects by selectively depleting certain immune cells. This targeted approach reduces inflammation and demyelination in the central nervous system associated with multiple sclerosis. The onset of action is seen within weeks, but full effects may take several months as the immune system reconstitutes.

Pharmacokinetics

Alemtuzumab has a half-life of approximately 19 to 25 days, allowing for infrequent dosing schedules. It is administered via intravenous infusion, and its pharmacokinetics can be influenced by individual patient factors, including prior treatment history and immune status. The drug is largely eliminated by the immune-mediated clearance of antibody-coated cells.

Contra-indications

  • Active infection
  • History of hypersensitivity to alemtuzumab or any of its components
  • Severe autoimmune conditions
  • Severe hepatic impairment
  • Pregnancy and women of childbearing potential not using effective contraception

Adverse effects

  • Cytokine release syndrome
  • Autoimmune mediated conditions (e.g., immune thrombocytopenic purpura, thyroid disorders)
  • Acquired hemophilia A
  • Hepatitis B reactivation
  • Myocardial ischemia
  • Thyroid disorders
  • Influenza-like illness
  • Leukocytosis
  • Hyperhidrosis
  • Lymphadenopathy
  • Hiccups

Interactions

  • Fingolimod: Increases risk of generalized infection (possibly life-threatening)
  • Ozanimod: Increases risk of generalized infection (possibly life-threatening)
  • Siponimod: Increases risk of generalized infection (possibly life-threatening)
  • Ponesimod: Unknown risk of generalized infection (possibly life-threatening)

Precautions

  • Screen for hepatitis B before treatment
  • Monitor for autoimmune mediated conditions during treatment
  • Premedication recommended to reduce infusion-related reactions
  • Use caution in patients with high tumor burden or pulmonary disorders
  • Monitor for signs of cardiovascular or immune-mediated reactions

Pregnancy

Alemtuzumab is contraindicated during pregnancy. Women of childbearing potential should use effective contraception during treatment and for 4 months after the last dose.

Breast-feeding

It is unknown whether alemtuzumab is excreted in human milk. Caution is advised when administering to breastfeeding women.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.

Formulations

  • Injection, solution for infusion: 12 mg/1.2 mL
BNF 85 (British National Formulary) p.960 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.