Lemtrada Vial

GENERIC NAME(S): Alemtuzumab

OTHER NAME(S): Lemtrada Solution

WARNINGS:

This medication may cause very serious (rarely fatal) blood disorders (low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: signs of infection (such as fever, persistent sore throat, swollen lymph nodes), easy bruising/bleeding, coughing up blood, shortness of breath, unusual tiredness, fast/pounding heartbeat.

This medication may also cause very serious kidney problems. Tell your doctor right away if you notice symptoms such as change in the amount of urine, painful urination, pink/bloody urine, or swelling ankles/feet.

This medication may cause very serious (rarely fatal) infusion-related reactions. (See also Side Effects section.)

This medication may also cause a stroke, or tears in the blood vessels in the head and neck, especially within the first 3 days after receiving treatment. Get medical help right away if you notice symptoms such as weakness on one side of the body, drooping of the face, neck pain, sudden severe headache, trouble speaking, sudden vision changes, or confusion.

This medication may increase your risk of developing certain types of cancer (such as thyroid, skin, blood). Tell your doctor right away if you notice symptoms such as unusual growth or lump in the neck, difficulty swallowing, unusual/lasting hoarseness, unusual skin changes, change in appearance or size of moles.

Your doctor will monitor you closely to decrease the risk of these serious side effects.

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Lemtrada REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Who should not take Lemtrada Vial?

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Uses

Uses

Alemtuzumab is used to treat multiple sclerosis (MS). It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of relapses and may prevent or delay disability.

How to use Lemtrada Vial

Read the Medication Guide, Patient Safety Information Card, and, if available, the Patient Information Leaflet provided by your pharmacist before you start using alemtuzumab and each time you receive treatment with this drug. Carry the Patient Safety Information Card with you at all times. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein over at least 4 hours by a health care professional. It should be given over 2 treatment courses. The first treatment course is usually given daily for 5 days while the second treatment course is usually given daily for 3 days. The treatment courses should be separated by 12 months. Additional treatment courses of 3 days may be given if needed, but should be separated by at least 12 months from the previous treatment.

Before you receive this medication, your doctor will direct you to take other medications (such as acetaminophen, diphenhydramine, corticosteroids) to help prevent side effects. Your doctor should also prescribe other medications (such as antiviral medications) to help prevent infection in your body. Use these additional medications exactly as prescribed by your doctor.

Side Effects

Side Effects

See also Warning section.

Headache, fever, chills, flushing, mild rash/itching, nausea, vomiting, shortness of breath, tiredness, or dizziness may occur during or after the infusion. Tell your doctor or pharmacist right away if any of these effects occur. Your doctor may prescribe additional medications to help control these symptoms. Diarrhea, stomach/abdominal pain, cough, trouble sleeping, or mouth sores may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), muscle/bone/back pain, signs of thyroid disease (such as unusual weight changes, increased sweating, constipation, feeling cold, fast/slow/irregular heartbeat), signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine).

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.

Get medical help right away if you have any very serious side effects, including: fainting, chest/jaw/left arm pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before receiving alemtuzumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV), recent/current infections (such as tuberculosis), bleeding/blood problems, high blood pressure, stroke, cancer, kidney problems, heart problems, blood vessel problems (such as tears in arteries), thyroid problems.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Before receiving a blood transfusion, tell your doctor that you are using this medication.

You should get all necessary immunizations at least 6 weeks before starting treatment with this medication. While on this medication, do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Wash your hands well to prevent the spread of infections.

This medication also increases your risk of getting a very serious infection caused by a bacteria called listeria. During treatment and for some time after treatment with this medication, either avoid food that may contain listeria (such as deli meat, unpasteurized milk and cheese products, soft cheeses, undercooked meat/seafood/poultry), or make sure you heat it well. Ask your doctor for more details.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using alemtuzumab. Alemtuzumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 4 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended during treatment and for at least 4 months after stopping treatment. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as complete blood count, kidney/liver/thyroid function, skin exams, tuberculosis testing, urine tests) should be done before treatment, while you are receiving this medication, and for some time after treatment is completed. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised February 2020. Copyright(c) 2020 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.