Lemtrada (alemtuzumab)
Sanofi Genzyme · Anti-CD52 Monoclonal Antibody
What is Lemtrada? Lemtrada (alemtuzumab) is an anti-CD52 monoclonal antibody by Sanofi Genzyme. In oncology, alemtuzumab is used for B-cell chronic lymphocytic leukemia (CLL). The Lemtrada brand is approved for relapsing forms of multiple sclerosis (MS). A separate formulation (Campath) was previously marketed for CLL.
About Lemtrada
| Brand Name | Lemtrada |
| Generic / INN | alemtuzumab |
| Drug Class | Anti-CD52 Monoclonal Antibody |
| Manufacturer | Sanofi Genzyme |
| Administration | Intravenous (IV) infusion |
| FDA Approval | 2014 |
FDA-Approved Uses for Lemtrada
Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.
- Relapsing forms of multiple sclerosis (MS) — Lemtrada brand (when other therapies are inadequate)
- B-cell chronic lymphocytic leukemia (CLL) — Campath brand (discontinued but alemtuzumab used under access programs)
How Does Lemtrada Work?
Alemtuzumab targets CD52, a glycoprotein expressed on the surface of mature lymphocytes (B and T cells), monocytes, and NK cells. By binding CD52, alemtuzumab triggers complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC), depleting circulating lymphocytes and resetting the immune system.
Dosage & Administration
MS (Lemtrada): Two treatment courses — Course 1: 12 mg/day IV for 5 consecutive days; Course 2 (12 months later): 12 mg/day IV for 3 consecutive days. CLL (Campath/access programs): weight-based escalating doses per protocol.
Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.
Warnings, Precautions & Side Effects
General Warning
BOXED WARNINGS (Lemtrada): Autoimmune conditions (ITP — potentially fatal, nephropathies, thyroid disorders). Infusion reactions — severe and life-threatening. Malignancies — increased risk including thyroid cancer, melanoma, lymphoproliferative disorders. Lemtrada is only available through a REMS program due to these risks.
- Autoimmune ITP — potentially fatal (boxed)
- Nephropathies (boxed)
- Infusion reactions — life-threatening (boxed)
- Secondary malignancies (boxed)
- Life-threatening infections
Common Side Effects
- Infusion reactions (rash, fever, urticaria)
- Autoimmune thyroid disorders
- Autoimmune ITP
- Infections
- Lymphopenia
- Headache
This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.
Storage & Handling
Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.
Insurance Coverage, Prior Authorization & Patient Assistance
🛡️ Commercial Insurance
Lemtrada is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.
✅ Prior Authorization
Prior authorization is required by virtually all insurance plans for Lemtrada. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.
🏥 Medicare Coverage
Medicare Part B covers this IV medication when administered in a clinical setting. Medicaid coverage varies by state.
🆓 Patient Assistance
Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.
Prior Authorization Patient Assistance Insurance & Savings Medication Costs
Frequently Asked Questions — Lemtrada
Lemtrada (alemtuzumab) is an anti-CD52 antibody approved for relapsing MS when other therapies have been inadequate. It depletes lymphocytes and resets the immune system. An older formulation (Campath) was used for CLL.
Because of serious risks including potentially fatal autoimmune conditions (ITP, nephropathies), severe infusion reactions, and secondary malignancies, Lemtrada is available only through certified healthcare facilities enrolled in the Lemtrada REMS program.
Intensive monitoring is required for at least 48 months after the last infusion — including monthly blood counts, kidney function, and thyroid function tests — to detect autoimmune complications early.
Related Medications & Conditions
Related Medications
Calquence (acalabrutinib) · Imbruvica (ibrutinib) · Ocrevus (ocrelizumab — MS) · Rituxan (rituximab)
Related Conditions
Relapsing multiple sclerosis (MS) · Chronic lymphocytic leukemia (CLL) · B-cell malignancies