alemtuzumab 30 mg/mL intravenous solution

Generic name:
Alemtuzumab (anti-cancer) - injection

Pronunciation
(AL-em-TOOZ-ue-mab)

Brand name(s)
Campath

This medication may cause very serious (rarely fatal) blood disorders (decreased bone marrow function leading to 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 sore throat that doesn't go away, fever, swollen lymph nodes), easy bruising/bleeding, coughing up blood, shortness of breath, unusual tiredness, fast/pounding heartbeat.

Serious (rarely fatal) infusion reactions may happen during the infusion of this drug and for a short time afterward. These reactions occur more often during the first week of treatment. Your doctor will prescribe other medications (such as acetaminophen, diphenhydramine, corticosteroids) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as fever, chills, flushing, dizziness, shortness of breath, nausea, vomiting, or mild rash/itching. Your doctor may give you other medications to help with these side effects.

Alemtuzumab is used to treat a certain type of leukemia (B-cell chronic lymphocytic leukemia, also known as B-CLL). This medication works by slowing or stopping the growth of cancer cells.

This medication is given by injection into a vein over 2 hours by a health care professional. The dosage is based on your medical condition and response to treatment. Your doctor will increase your dose slowly to decrease the risk of side effects.

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

See also Warning section.

Diarrhea, stomach/abdominal pain, tiredness, headache, shaking (tremor), trouble sleeping, or mouth sores may 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, you have been prescribed this drug because your doctor 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 pain
• numbness/tingling of arms/legs
• fast/slow/irregular heartbeat
• unusual weight changes
• signs of kidney problems (such as change in the amount of urine, painful urination, pink/bloody urine, swelling ankles/feet)
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin)

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
• neck pain
• weakness on one side of the body
• sudden severe headache

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.

Before receiving this 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
• other cancers
• 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.

Tell your health care professional that you are using alemtuzumab before having any immunizations/vaccinations. 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 at least 3 months after the last dose. 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, breastfeeding is not recommended while using this drug and for at least 3 months after the last dose. Consult your doctor before breastfeeding.

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)

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: trouble breathing.

Lab and/or medical tests (such as complete blood count, kidney/liver/thyroid function, blood pressure) 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.

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.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.