Lemtrada 12mg Infusion 1.2ml

Prescription Required Cold Chain i

Salt Composition ALEMTUZUMAB

Marketer SANOFI INDIA LTD

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Introduction to Lemtrada 12mg Infusion 1.2ml

Lemtrada 12mg Infusion 1.2ml is a biologic pharmaceutical preparation containing ALEMTUZUMAB as its active ingredient, classified under the Anti Cancer general category and the Oncology speciality domain. Alemtuzumab is a humanised monoclonal antibody directed against CD52, a protein expressed on the surface of T and B lymphocytes and other immune cells. By depleting these cells, it helps reduce abnormal white blood cell counts in chronic lymphocytic leukaemia (CLL) and helps reset an overactive immune system in relapsing forms of multiple sclerosis (MS). Manufactured by SANOFI INDIA LTD. Because of the risk of serious infusion reactions and secondary autoimmune conditions, treatment is initiated and monitored only by specialists experienced in its use, with pre-medication and an extended monitoring programme.

Uses of Lemtrada 12mg Infusion 1.2ml

Uses of Lemtrada 12mg Infusion 1.2ml
Used in the treatment of B-cell chronic lymphocytic leukaemia (CLL), typically in patients who have not responded adequately to other therapies, and in the treatment of active relapsing forms of multiple sclerosis in patients with an inadequate response to two or more disease-modifying therapies.

Therapeutic Effects of Lemtrada 12mg Infusion 1.2ml

Lemtrada 12mg Infusion 1.2ml containing ALEMTUZUMAB works as described: it binds to CD52 on the surface of T cells, B cells, and other immune cells, causing rapid depletion of these lymphocytes from the circulation through antibody-dependent and complement-mediated mechanisms. Lymphocyte counts fall sharply after each infusion and recover gradually over months, during which the repopulating immune cell profile is altered — an effect thought to underlie its longer-term disease-modifying benefit. Therapeutically, it is classified under the Anti Cancer category and Oncology speciality domain, with use also recognised in relapsing multiple sclerosis. Regular monitoring by the treating specialist is essential to assess treatment response and detect delayed autoimmune adverse effects.

Interaction of Lemtrada 12mg Infusion 1.2ml with other drugs

• Always inform your doctor about every medicine, supplement, or herbal product you are currently taking before starting Lemtrada 12mg Infusion 1.2ml. • Live Vaccines: Avoid live or live-attenuated vaccines shortly before, during, and for a period after treatment, as immune suppression increases infection risk from these vaccines. • Other Immunosuppressants/Antineoplastics: Concomitant use may increase the risk of profound and prolonged immunosuppression and infection. • Prior Alemtuzumab/Campath Use: Inform your doctor if you have previously received alemtuzumab (including under the brand Campath) for any condition, as cumulative immune effects may occur.

More Information about Lemtrada 12mg Infusion 1.2ml

Lemtrada 12mg Infusion 1.2ml is a specialist-administered biologic and must not be purchased or used without a valid prescription and supervision by a licensed specialist in an appropriately equipped centre. Storage: Store refrigerated at 2°C to 8°C. Do not freeze. Protect from light. Disposal: Any unused product must be disposed of by the treating facility as per biomedical/cytotoxic waste guidelines; do not dispose of in household waste. Manufactured by SANOFI INDIA LTD and complies with applicable regulatory standards.

How to consume Lemtrada 12mg Infusion 1.2ml

Administration: Administered only as a slow intravenous infusion by trained healthcare professionals, typically over consecutive days per treatment course, with pre-medication and post-infusion monitoring for reactions. Missed Dose/Cycle: Contact your treatment centre promptly to reschedule; never attempt to self-administer or make up a missed infusion. Overdose: In case of a suspected administration error, the treating team will manage this under close monitoring; contact your doctor or nearest emergency facility immediately if symptoms of a severe reaction occur.

Side Effects of Lemtrada 12mg Infusion 1.2ml

Common: infusion-related reactions (fever, chills, rash, nausea, low blood pressure), headache, and increased risk of infections due to lowered lymphocyte counts.

Serious/rare: severe infusion reactions, secondary autoimmune disorders (thyroid disease, immune thrombocytopenia, autoimmune haemolytic anaemia, nephropathy), serious infections, and, rarely, stroke or arterial dissection around the time of infusion.

Safety Advice for Lemtrada 12mg Infusion 1.2ml

Prescription Compliance: Lemtrada 12mg Infusion 1.2ml must be administered only under direct medical supervision in a facility equipped to manage infusion reactions; it is never self-administered.

Pre-Medication: Corticosteroid, antihistamine, and antipyretic pre-medication is typically given before each infusion to reduce reaction risk.

Medical History: Share your complete medical history, including thyroid disorders, kidney disease, autoimmune conditions, and any prior use of alemtuzumab or Campath, before starting Lemtrada 12mg Infusion 1.2ml.

Pregnancy and Breastfeeding: Use only if specifically advised by your doctor and with effective contraception during and for several months after treatment, as alemtuzumab may cause fetal harm.

Long-Term Monitoring: Regular blood counts, thyroid function tests, and urine/kidney monitoring are required for up to 48 months after the last infusion because autoimmune conditions can develop late.

Safe Storage: Store refrigerated at 2°C to 8°C. Do not freeze. Protect from light. Keep out of reach of children and pets.

Word of Advice for Lemtrada 12mg Infusion 1.2ml

• Adherence to Monitoring: Attend all scheduled infusion visits and the extended follow-up monitoring programme for Lemtrada 12mg Infusion 1.2ml, which continues for up to 48 months after the last dose. • Report Changes: Contact your care team promptly if you notice new symptoms such as unusual bruising or bleeding, persistent fever, breathlessness, swelling, weight change, or signs of thyroid trouble. • Infection Precautions: Take practical steps to reduce infection risk (hand hygiene, avoiding sick contacts) while lymphocyte counts are low. • Do Not Share: Lemtrada 12mg Infusion 1.2ml is prepared and dosed for an individual patient's treatment course and cannot be shared or reused for another patient.

FAQs about Lemtrada 12mg Infusion 1.2ml

Q1. What is Lemtrada 12mg Infusion 1.2ml used for?

Used in the treatment of B-cell chronic lymphocytic leukaemia (CLL) and in active relapsing forms of multiple sclerosis in patients with an inadequate response to other disease-modifying therapies.

Q2. How is it given?

As a slow intravenous infusion administered by healthcare professionals in a monitored clinical setting, with pre-medication to reduce infusion reactions.

Q3. What are the common side effects?

Common: infusion-related reactions such as fever, chills, rash, and headache, along with an increased risk of infections.

Q4. Is long-term monitoring required?

Yes, regular blood counts, thyroid function, and kidney/urine monitoring are recommended for up to 48 months after the last infusion because delayed autoimmune effects can occur.

Q5. Is a prescription required?

Yes, prescription required, and administration only under specialist supervision.

Fact Box of Lemtrada 12mg Infusion 1.2ml

Molecule Name	ALEMTUZUMAB
Marketer	SANOFI INDIA LTD

References for Lemtrada 12mg Infusion 1.2ml

1.DailyMed, LEMTRADA (alemtuzumab) Injection Prescribing Information, U.S. National Library of Medicine, [Accessed 2026]. 2.Cleveland Clinic, Lemtrada (alemtuzumab) Fact Sheet, Mellen Center. 3.Eketorp Sylvan S, et al., Alemtuzumab as single-agent therapy in relapsed/refractory CLL, Exp Hematol Oncol, 2014. 4.Sanofi India Ltd, Product Information, [Accessed 2026].

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