WARNING

Alemtuzumab is a medication used for the treatment of multiple sclerosis (MS), particularly in cases where other treatments have not been effective. While it can be effective, it comes with a range of potential risks and side effects. Here are some detailed risks associated with Alemtuzumab:

• Infusion Reactions: Patients may experience reactions during or shortly after the infusion. These can include fever, chills, rash, itching, nausea, and headache. Sometimes, more severe reactions like low blood pressure or breathing difficulties can occur.
• Infections: Alemtuzumab can suppress the immune system, increasing the risk of infections. This can include common infections like colds or more serious infections such as opportunistic infections. Patients need to be monitored closely for signs of infection.
• Autoimmune Disorders: The medication can trigger or worsen autoimmune conditions, such as thyroiditis (inflammation of the thyroid gland), autoimmune hepatitis, or nephropathy (kidney disease). Regular monitoring of thyroid function and other parameters is necessary.
• Blood Disorders: Alemtuzumab may lead to blood-related issues such as low blood cell counts (cytopenias), including anemia (low red blood cells), leukopenia (low white blood cells), or thrombocytopenia (low platelets). Regular blood tests are important to monitor these risks.
• Cancer Risk: There is an increased risk of developing certain types of cancer, including lymphomas and leukemia, with long-term use of Alemtuzumab. Patients should be monitored for any signs of cancer.
• Cardiovascular Issues: The medication may increase the risk of heart-related issues, such as arrhythmias (irregular heartbeats) or hypertension (high blood pressure). Monitoring and managing cardiovascular health are important.
• Neurological Effects: Although Alemtuzumab is used to treat MS, it can sometimes cause or exacerbate neurological symptoms, including neurological deficits or symptoms similar to those of MS.
• Pregnancy and Breastfeeding: Alemtuzumab is generally not recommended during pregnancy or breastfeeding due to potential risks to the fetus or infant. Women of childbearing age should use effective contraception while on the medication.
• Long-Term Effects: Long-term effects of Alemtuzumab are still being studied. Ongoing research is needed to fully understand the long-term safety profile.

Patients receiving Alemtuzumab require close monitoring by healthcare professionals to manage these risks and to ensure any adverse effects are addressed promptly.

Why is this medication prescribed?

Alemtuzumab, marketed under the brand name Lemtrada, is prescribed for multiple sclerosis (MS) because it helps to modify the immune system and reduce the frequency and severity of MS relapses. It works by targeting and depleting specific immune cells that are involved in the autoimmune process that attacks the nervous system in MS. This treatment is generally considered for people with relapsing forms of MS who haven’t responded well to other therapies. It’s usually given in a series of infusions over a period of time.

How should this medicine be used?

Alemtuzumab is administered as an intravenous (IV) infusion. Here’s a general outline of how it’s used:

• Infusion Schedule: The treatment typically starts with an initial course of infusions over 5 consecutive days. A second course is usually given 12 months later over 3 consecutive days.
• Preparation: Infusions are performed in a healthcare setting where the patient can be monitored for potential side effects. The drug is diluted and administered through a vein by a healthcare professional.
• Monitoring: Patients are monitored during and after the infusion for reactions and potential side effects. Regular follow-up appointments are necessary to monitor the patient’s response to the drug and manage any potential complications.
• Pre-medication: Patients may receive pre-medications to minimize the risk of infusion-related reactions.
• Post-Infusion: Patients may need to take other medications to manage symptoms or side effects and to help prevent infections.
• Precautions: Regular blood tests and monitoring are important to check for changes in blood cell counts and to detect any signs of autoimmune conditions or infections early.

It’s crucial to follow your healthcare provider’s instructions and attend all scheduled appointments to ensure the treatment is effective and to manage any potential side effects.

Other uses for this medicine

Alemtuzumab is primarily used for treating multiple sclerosis (MS), but it has other applications as well. For example:

• Chronic Lymphocytic Leukemia (CLL): Alemtuzumab is used in the treatment of CLL, a type of cancer that affects the blood and bone marrow.
• B-Cell Lymphomas: It may also be used for certain types of B-cell lymphomas, a group of cancers that affect lymphoid tissues.

What special precautions should I follow?

Special Precautions for Alemtuzumab:

• Infection Risk: Alemtuzumab can increase the risk of infections due to its effect on the immune system. It’s crucial to monitor for signs of infection and report them to your healthcare provider.
• Autoimmune Conditions: It can trigger autoimmune conditions, such as thyroiditis or nephropathy. Regular monitoring of thyroid function and kidney function is important.
• Pre-medications: Your healthcare provider may prescribe medications to manage side effects and pre-medications to reduce infusion reactions.
• Infusion Reactions: Be aware of potential infusion-related reactions, such as fever, chills, rash, or hypotension. Report any severe reactions to your healthcare team immediately.
• Blood Monitoring: Regular blood tests are necessary to monitor blood cell counts and detect any abnormalities or potential side effects.
• Vaccinations: Live vaccines should be avoided while on alemtuzumab, and it’s important to discuss vaccination schedules with your healthcare provider.
• Pregnancy and Breastfeeding: Alemtuzumab is not recommended during pregnancy or breastfeeding due to potential risks to the baby. Discuss contraceptive options with your healthcare provider if you are of childbearing age.
• Long-Term Monitoring: Long-term monitoring is essential for managing potential late-onset side effects and ensuring continued effectiveness of the treatment.

Always follow your healthcare provider’s instructions and attend all scheduled appointments for monitoring and managing your treatment.

What special dietary instructions should I follow?

• General Diet: There are no specific dietary restrictions associated with alemtuzumab. However, maintaining a balanced diet is important for overall health and immune system support.
• Hydration: Ensure adequate hydration, especially if you experience side effects like fever or gastrointestinal issues.
• Consult Your Provider: If you have any dietary concerns or underlying health conditions, discuss them with your healthcare provider to tailor dietary recommendations to your needs.

What should I do if I forget a dose?

• Infusion Schedule: If you miss a scheduled infusion, contact your healthcare provider immediately. They will guide you on rescheduling the missed dose.
• Do Not Self-Medicate: Do not attempt to make up for missed infusions on your own or adjust the dose without professional guidance.
• Follow Instructions: Always adhere to the prescribed infusion schedule and follow your healthcare provider’s instructions for managing missed doses.

What side effects can this medication cause?

Alemtuzumab (brand name Lemtrada) is used to treat multiple sclerosis and can have a range of side effects. Common ones include:

• Infusion Reactions: Fever, chills, rash, itching, and headache during or after the infusion.
• Infections: Increased risk of infections such as upper respiratory infections, urinary tract infections, and herpes simplex.
• Thyroid Disorders: Both hyperthyroidism and hypothyroidism can occur.
• Autoimmune Disorders: Conditions such as autoimmune thrombocytopenia (low platelet count) and autoimmune nephropathy (kidney issues).
• Skin Reactions: Rash, pruritus (itching), or eczema.
• Gastrointestinal Issues: Nausea, vomiting, or diarrhea.
• Neurological Issues: Headache or dizziness.

Serious side effects, though less common, can include severe infections, kidney problems, and severe allergic reactions. Regular monitoring and blood tests are typically recommended to manage these risks. Always consult with your healthcare provider for a full understanding of potential side effects and to address any concerns specific to your situation.

What should I know about storage and disposal of this medication?

Storage and Disposal of Alemtuzumab:

Storage:

• Alemtuzumab should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Avoid freezing the medication.
• Store the medication away from light to preserve its efficacy.
• Always check the expiration date before use. Do not use the medication if it has expired.

Disposal:

• Take unused or expired alemtuzumab to a pharmacy or a local take-back program for safe disposal.
• Dispose of the medication according to local regulations or guidelines for handling hazardous waste.

In case of emergency/overdose

• Contact Healthcare Provider: If you experience severe symptoms or side effects, contact your healthcare provider immediately.
• Seek Emergency Care: For serious reactions such as difficulty breathing, chest pain, or severe allergic reactions, seek emergency medical care.
• Immediate Action: If an overdose is suspected or if you have missed an infusion, contact your healthcare provider right away.
• Follow Professional Guidance: Do not attempt to self-treat or adjust the dose without professional advice.

What other information should I know?

• Medical History: Inform your healthcare provider about any pre-existing medical conditions or medications you are taking to avoid interactions or complications.
• Allergic Reactions: Inform your healthcare provider if you have a history of allergies or adverse reactions to medications, especially other monoclonal antibodies.
• Vaccinations and Other Medications: Discuss any vaccinations or other medications you are considering to avoid potential interactions with alemtuzumab.
• Pregnancy and Breastfeeding: Alemtuzumab is not recommended during pregnancy or breastfeeding. Discuss family planning and contraceptive methods with your healthcare provider.
• Lifestyle and Health Monitoring: Maintain regular health check-ups and follow a healthy lifestyle to support overall well-being and manage potential side effects.

Always follow your healthcare provider’s instructions and consult them for any questions or concerns regarding your treatment with alemtuzumab.