Pronunciation:

al-em-TOOZ-oo-mab

Brand Names:

• Campath

Dosage Forms:

• Solution

Warnings:

Serious, including fatal, cytopenias, infusion reactions, and infections can occur in patients receiving alemtuzumab. Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion reactions. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections .

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Alemtuzumab is a monoclonal antibody. It is used to treat a certain type of leukemia called B-cell chronic lymphocytic leukemia (B-CLL). It is given to recently diagnosed patients and to patients whose disease has progressed despite treatment with other cancer medicines. Alemtuzumab interferes with the growth of leukemic cells, which are then destroyed by the body.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of alemtuzumab in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of alemtuzumab have not been performed in the geriatric population. However, geriatric-specific problems that would limit the usefulness of this medication in the elderly are not expected.

Pregnancy—

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Varicella Virus Vaccine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow depression (e.g., anemia, neutropenia, thrombocytopenia) or
• Heart disease or
• Infection, severe (e.g., cytomegalovirus, pneumocystis)—May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.

You will receive a medicine to prevent allergic reactions (such as diphenhydramine, Benadryl®) before you receive this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits to make sure this medication is working properly. Blood tests may be needed to check for any unwanted effects.

This medicine may cause birth defects if it is used by the mother while she is pregnant or by the father when his sexual partner becomes pregnant. Use an effective form of birth control to avoid pregnancy while you are using this medicine and for at least 6 months after your treatment ends. This is very important whether you are a man or a woman. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

Alemtuzumab may cause a serious allergic reaction which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection.

While you are being treated with alemtuzumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Alemtuzumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Alemtuzumab can temporarily lower the number of white blood cells in your blood, which will increase the risk of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, these are precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

blood in urine

chills

cough

diarrhea

dizziness

faintness, or light-headedness when getting up from a lying or sitting position suddenly

fast heartbeat

fever

headache

itching, hives, or rash

nausea and vomiting

painful or difficult urination

pale skin

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sweating

swollen glands

tightness in the chest

troubled breathing, exertional

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

Less common

Bloating or swelling of the face, hands, lower legs, and/or feet

chest pain

hoarseness

lower back or side pain

muscle weakness

palpitations

pounding, or irregular heartbeat or pulse

rapid weight gain

rash

red or purple spots on the skin, varying in size and remaining after pushing the skin surface

Rare

Flushing of the face or neck

swelling of the eyelids, face, or lips

white patches on the tongue, in the mouth, or in folds of the skin, including the genitals

Incidence not determined

Back pain

blindness

blurred vision

chest discomfort or pain

confusion

convulsions

decreased urine output

decreased vision

dilated neck veins

drowsiness

extreme fatigue

eye pain

feeling of discomfort

inability to move the arms and legs

inflammation of the joints

irregular breathing

joint pain, stiffness, or swelling

muscle aches or pain

numbness, pain, tingling, or weakness

painful glands

spitting up blood

sudden numbness and weakness in the arms and legs

swelling of the face, fingers, feet, or lower legs

Get emergency help immediately if any of the following symptoms of overdose occur:

Inability to urinate

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Fear, nervousness

sleeplessness

trouble sleeping

unable to sleep

Less common

Acid or sour stomach

belching

bone pain

burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings

heartburn

indigestion

lack or loss of strength

loss of appetite

painful cold sores or blisters on the lips, nose, eyes, or genitals

stomach discomfort, upset, or pain

swelling or inflammation of the mouth

weight loss

Rare

Bloody nose

constipation

mood or mental changes

sensation of temperature change

sleepiness

stuffy nose

tremor

unexplained nosebleeds

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.