In the U.S.—

• Antineoplastic
• Monoclonal antibody

Alemtuzumab ( uh-lem-TOOZ-uh-mab) is a monoclonal antibody. It is used to treat a certain type of leukemia in patients whose disease has progressed, despite treatment with other chemotherapeutic agents.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parenteral
• Injection (U.S.)

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 alemtuzumab, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to alemtuzumab or other monoclonal antibodies. Also tell your health care provider if you are allergic to any other substances, such as preservatives.

Pregnancy—Alemtuzumab may cause harm to the fetus when administered during pregnancy. There are no adequate, well-controlled studies in pregnant women. You should avoid becoming pregnant while receiving alemtuzumab. Contraception should be used in men and women, during treatment and for at least 6 months after treatment is over. However, this medicine may be needed in serious diseases or other situations that threaten the mother's life. Be sure you have discussed this with your doctor.

Breast-feeding—It is not known if alemtuzumab passes into the breast milk. However, due to potential serious side effects in nursing babies from alemtuzumab, breast feeding should be discontinued during treatment and for at least 3 months following the last dose of alemtuzumab.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of alemtuzumab in children with use in other age groups. Safety and efficacy have not been established in children.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of alemtuzumab in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 taking alemtuzumab, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Acyclovir (e.g., Zovirax) or
• Anticonvulsants (seizure medicine) or
• Antidiabetics, oral (diabetes medicine taken by mouth) or
• Anti-infectives by mouth or by injection (medicine for infection) or
• Antipsychotics (medicine for mental illness) or
• Captopril (e.g., Capoten) or
• Enalapril (e.g., Vasotec) or
• Flecainide (e.g., Tambocor) or
• Gold salts (medicine for arthritis) or
• Imipenem or
• Inflammation or pain medicine, except narcotics or
• Lisinopril (e.g., Prinivil, Zestril) or
• Maprotiline (e.g., Ludiomil) or
• Penicillamine (e.g., Cuprimine) or
• Pimozide (e.g., Orap) or
• Procainamide (e.g., Pronestyl) or
• Promethazine (e.g., Phenergan) or
• Ramipril (e.g., Altace) or
• Sulfasalazine (e.g., Azulfidine) or
• Tiopronin (e.g., Thiola) or
• Tocainide (e.g., Tonocard) or
• Tricyclic antidepressants (medicine for depression) or
• Trimeprazine (e.g., Temaril)—Concurrent use of these agents with alemtuzumab may cause blood disorders

• Alpha interferons (e.g., Intron A, Roferon-A) or
• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics, other (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g. Cytoxan) or
• Flucytosine (e.g. Ancoban) or
• Ganciclovir (e.g., Cytovene) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Rheumatrex) or
• Plicamycin (e.g., Mithracin)
• Zidovudine (e.g., AZT, Retrovir)—Concurrent use of these agents with alemtuzumab increases the risk of infection

• If you have ever been treated with radiation or cancer medicines—Alemtuzumab may increase the effects of these medicines or radiation therapy on the blood

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

• Heart disease—Increased risk of low blood pressure, monitor blood pressure during therapy

• Bone marrow depression or
• Infection—Risk increased or worsening of infection by alemtuzumab

• Immune deficiency condition—HIV infection may increase the risk of side effects of alemtuzumab

Dosing—

The dose of alemtuzumab will be different for different patients. The dose that is used may depend on a number of things, including how many doses you have already received and how well you tolerate the dose given. Alemtuzumab is usually given by a doctor or nurse in the hospital or outpatient clinic. If you have any questions about the proper dose of alemtuzumab, ask your doctor.

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

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, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain 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.

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 as soon as possible if any of the following side effects occur:

• More common (>50%)
  • Black, tarry stools;  blood in urine ;  chills;  cough;  diarrhea;  dizziness;  faintness, or light-headedness when getting up from a lying or sitting position ;  fever;  headache;  itching, hives, or rash;  nausea and vomiting;  pale skin;  painful or difficult urination;  shortness of breath;  sore throat;  sores, ulcers or white spots on lips or in mouth;  sudden sweating;  swollen glands;  tightness in chest;  troubled breathing, exertional;  unusual bleeding or bruising;  unusual tiredness or weakness ;  wheezing 
  
  

• Less common (10–50%)
  • 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 (<10%)
  • Flushing of the face or neck;  swelling of the eyelids, face, or lips;  white patches on the tongue, in the mouth, of in folds of skin, including the genitals 
  
  

• Symptoms of Overdose
  • Chest tightness;  cough;  inability to urinate;  shortness of breath ;  troubled breathing 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• Less common (10–50%)
  • Acid or sour stomach;  back pain;  belching;  bone pain;  burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings;  heartburn;  indigestion;  lack or loss of strength;  loss of appetite;  muscle aches;  painful cold sores or blisters on lips, nose, eyes, or genitals ;  sleeplessness;  stomach discomfort, upset or pain;  swelling or inflammation of the mouth;  weight loss 
  
  

• Rare (<10%)
  • Bloody nose;  constipation;  general feeling of discomfort of illness;  mood or mental changes;  sleepiness or unusual drowsiness ;  stuffy nose;  sensation of temperature change;  tremor;  unexplained nosebleeds 
  
  

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