Campath®

Class: Biologic therapy

Generic Name: Alemtuzumab (al-em-TOO-zoo-mab)

Trade Name: Campath®

For which conditions is this drug approved?

Alemtuzumab is FDA approved for the treatment of B-cell chronic lymphocytic leukemia (CLL) that has stopped responding to prior treatment with chemotherapy agents referred to as alkylating agents and has stopped responding to the chemotherapy agent Fludara® (fludarabine).

It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action?

Alemtuzumab belongs to a group of agents called monoclonal antibodies. Alemtuzumab is an agent that is made through laboratory processes and binds to a specific region that is present on B cells, a type of immune cell that is cancerous in B-cell CLL, as well as other healthy immune cells. The binding action stimulates the immune system to attack the cell to which the monoclonal antibody is bound.

How is alemtuzumab typically given (administered)?

Alemtuzumab is given intravenously (into a vein) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient. Alemtuzumab has also been administered subcutaneously (as an injection under the skin). Patients typically receive an antihistamine and acetaminophen prior to the administration of alemtuzumab to reduce or prevent reactions that may occur during infusion. A low dose of alemtuzumab is given initially and then the dose is gradually escalated if the patient is able to tolerate treatment. During administration, patients will have their pulse, blood pressure and temperature monitored. Side effects that may occur during administration of alemtuzumab (usually within the first 30-60 minutes after the start of the infusion) include fever, chills, shaking, nausea and vomiting, skin rash, itching, shortness of breath, diarrhea, headache, and/or low blood pressure. Patients should tell their healthcare provider immediately if they are experiencing any of these side effects. Patients should be started on anti-infective preventive therapy to reduce the risk of serious infections.

How are patients typically monitored?

Patients will usually have scheduled meetings with their healthcare provider while they are being treated with alemtuzumab. Typically, blood will be drawn to check levels of blood cells, particularly white blood cells, and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the common (occur in 30% or more of patients) side effects of treatment with alemtuzumab?

• Low white blood cell levels – increases risk for infection

• Low red blood cell levels – increases risk of anemia

• Low platelet levels – increases risk of bleeding

• Infection, including sepsis, pneumonia or opportunistic infection

• Nausea and vomiting

• Fever

• Fatigue

• Shivering

• Low blood pressure

• Rash

What are the less common (occur in 10% to 29% of patients) side effects of treatment with alemtuzumab?

• Cough and bronchitis

• Loss of appetite

• Muscle pain

• Sweating

• Headache

• Mouth sores or ulcers

• Weakness

• Dizziness

• Numbness and/or swelling of the hands and feet

• Pain in the abdomen

• Back pain

• Chest pain

• Sore throat

• High blood pressure

• Heartburn

• Changes in heart rate

• Difficulty breathing

• Insomnia

• Diarrhea

• Hives, itchiness

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.

• Wear sunscreen and protective clothing and try to minimize sun exposure.

• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)

• Maintain adequate rest and nutrition.

• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.

• Wash hands often to reduce the risk of infection.

• Avoid activities that may cause injury or bruising.

• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.

• Eat small meals frequently to help alleviate nausea.

• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should tell their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.

• It is important that patients inform their physician of any pre-existing conditions (chicken pox, infection, heart disease, kidney disease, liver disease, lung disease, thyroid disease, etc.) as they may worsen with this drug.

• Patients should inform their physician if they have ever had convulsions or seizures.

• Patients should inform their physician about any other medication they are taking (whether prescription or over the counter, including vitamins, herbs, etc.) as they may interfere with treatment.

• Patients should check with their physician before starting any new drug or nutritional supplement.

• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

• Patients should inform their physician of any reaction to another monoclonal antibody.

When should patients notify their physician?

• Fever

• Chills

• Sore throat

• Cough

• Unusual bleeding or bruising

• Extreme fatigue

• Any signs of infection

• Prolonged and/or severe nausea or vomiting

• Prolonged and/or severe diarrhea

• Blood in the urine, burning on urination

• Black, tarry stools

• Mouth sores

• White plaques in mouth or perianal area

• Difficulty breathing

• Chest pain or palpitations

• Rash

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

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