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alemtuzumab

Generic Name: alemtuzumab (AL em TOOZ ue mab)
Brand Name: Campath, Lemtrada

What is alemtuzumab?

Alemtuzumab is an antibody made from animal DNA.

Alemtuzumab is used to treat chronic B-cell lymphocytic leukemia or relapsing forms of multiple sclerosis.

Lemtrada is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks of taking this medicine.

Alemtuzumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about alemtuzumab?

Alemtuzumab can cause your immune system to attack cells and organs in your body. This can lead to life-threatening medical problems such as severe bleeding or kidney damage. Call your doctor right away if you have unusual bruising or bleeding, blood in your urine, swelling in your legs or feet, or if you cough up blood.

Some side effects may occur during the injection or shortly afterward. You will be watched closely for at least 2 hours after receiving alemtuzumab, to make sure you do not have a serious reaction.

Serious and sometimes fatal infections may occur during treatment with alemtuzumab. Call your doctor right away if you have signs of infection such as: fever, chills, cough, mouth sores, or trouble breathing.

Alemtuzumab can have long lasting effects on your body, including an increased risk of developing other types of cancer (such as melanoma, thyroid cancer, or blood cancers). You may need frequent medical tests for as long as 4 years after you stop using this medicine.

What should I discuss with my health care provider before receiving alemtuzumab?

You should not receive alemtuzumab if you are allergic to it. You should not be treated with Lemtrada if you have HIV (human immunodeficiency virus).

To make sure alemtuzumab is safe for you, tell your doctor if you have any of these other conditions:

  • an active or recent infection;

  • kidney disease;

  • a thyroid disorder;

  • a bleeding or blood clotting disorder such as hemophilia; or

  • if you have received a vaccine in the past 6 weeks.

Using alemtuzumab may increase your risk of developing other types of cancer, such as melanoma, thyroid cancer, or blood cancers. Ask your doctor about your specific risk.

It is not known whether alemtuzumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are receiving alemtuzumab, and for at least 4 months after each course of treatment.

It is not known whether alemtuzumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is alemtuzumab given?

Alemtuzumab is injected into a vein through an IV. A healthcare provider will give you this injection, which can take up to 4 hours to complete.

You may be given an antibiotic and other medicines to help prevent certain side effects of alemtuzumab. Take these medicines for the full prescribed length of time.

To treat chronic B-cell lymphocytic leukemia, alemtuzumab is usually given for a total of 12 weeks. You may receive the medicine every day or 3 days per week, depending on any side effects that occur.

For multiple sclerosis, alemtuzumab is given for 5 days followed by 12 months off the medicine. Then alemtuzumab is given for another 3 days. Your doctor will determine how long to treat you with this medicine.

You will be watched closely for at least 2 hours after receiving alemtuzumab, to make sure you do not have a serious reaction.

Serious and sometimes fatal infections may occur during treatment with alemtuzumab. Call your doctor right away if you have signs of infection such as: fever, chills, cough, mouth sores, or trouble breathing.

Your blood and urine will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Alemtuzumab can have long lasting effects on your body. You may need frequent medical tests for as long as 4 years after you stop using this medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your alemtuzumab injection.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving alemtuzumab?

Do not receive a "live" vaccine while using alemtuzumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Alemtuzumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or shortly afterward. Tell your caregiver right away if you feel weak, dizzy, itchy, nauseated, chilled or feverish, or if you have chest tightness or trouble breathing.

Alemtuzumab can cause your immune system to attack cells and organs in your body. This can lead to life-threatening medical problems such as severe bleeding or kidney damage. Call your doctor right away if you have:

  • unusual bruising or bleeding;

  • blood in your urine;

  • swelling in your legs or feet; or

  • if you cough up blood.

Also call your doctor at once if you have:

  • pain or swelling in your neck or throat, hoarse voice, trouble swallowing;

  • a mole that has changed in size or color;

  • lung problems--cough, wheezing, chest pain, feeling short of breath;

  • signs of infection--fever, swollen glands, weakness, pale or yellowed skin, dark colored urine, pain or burning when you urinate;

  • symptoms of herpes virus--cold sores around your mouth, skin sores or blisters, itching, tingling, burning pain in your thigh or lower back; or

  • thyroid problems--extreme tired feeling, nervousness, fast heartbeats, heavy sweating, weight gain or loss, swelling of your eyes, feeling more sensitive to cold temperatures, constipation.

Common side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;

  • infections;

  • headache, joint pain, back pain;

  • itching, rash, tingling;

  • dizziness, tiredness, sleep problems (insomnia);

  • vaginal itching or discharge;

  • stuffy nose, throat pain or itching, white patches in your mouth or throat; or

  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Alemtuzumab dosing information

Usual Adult Dose for Chronic Lymphocytic Leukemia:

-Recommended dosing regimen: 3 mg IV daily over 2 hours until infusion reactions are Grade 2 or less; then escalate to 10 mg IV daily over 2 hours until infusion reactions are Grade 2 or less; then escalate to 30 mg IV daily over 2 hours 3 times per week on alternate days (e.g., Monday, Wednesday, Friday).
-Duration of therapy: 12 weeks

Comments:
-Escalation is required at initiation of dosing or if dosing is held for 7 days or longer during treatment.
-Escalation to 30 mg IV daily usually can be accomplished in 3 to 7 days.
-Single doses of greater than 30 mg 3 times per week or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.
-Patients should be premedicated before the infusion is started. Consult manufacturer recommended concomitant medications or local protocol.

Use: As a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL)

Usual Adult Dose for Multiple Sclerosis:

Recommended dosing regimen: 12 mg IV daily for 2 treatment courses:
-FIRST TREATMENT COURSE: 12 mg IV daily on 5 consecutive days
-SECOND TREATMENT COURSE: 12 mg IV daily on 3 consecutive days administered 12 months after the first treatment course

Comments:
-Infusions should be administered over 4 hours starting within 8 hours after drug dilution. The duration of the infusion should be extended if clinically indicated.
-Patients should complete any necessary immunizations at least 6 weeks prior to treatment.
-Patients should be premedicated with high dose corticosteroids before the infusion is started. Consult manufacturer recommended concomitant medications or local protocol.
-Missed doses should not be given on the same day as a scheduled dose.
-Anti-viral prophylaxis for herpetic viral infections should be administered starting on the first day of each treatment course and continued for a minimum of 2 months following treatment until the CD4+ lymphocyte count is 200 cells per microliter or greater, whichever occurs later.
-Patients should be observed for infusion reactions during and for at least 2 hours after each infusion. Longer periods of observation should be considered if clinically indicated.
-Patients should be informed to report symptoms that occur during and after each infusion because they may indicate a need for prompt medical intervention

Use: For the treatment of patients with relapsing forms of multiple sclerosis (MS) (use should generally be reserved for MS patients aged 17 years or older who have had an inadequate response to two or more drugs)

What other drugs will affect alemtuzumab?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with alemtuzumab, especially:

  • drugs that weaken the immune system such as cancer medicine, or medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with alemtuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about alemtuzumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01. Revision Date: 2014-12-30, 4:56:11 PM.

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