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Campath® Alemtuzumab - For Intravenous Use Only
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As a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) - See Things in a Whole New Light: Campath First Line - Campath® Alemtuzumab For Intravenous Use Only
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Campath Patient Kit

 

Side Effects

Does Campath® (alemtuzumab) have any serious side effects?

Although monoclonal antibodies, such as Campath, are targeted to attack cancerous blood cells, they can also affect some noncancerous cells. Because some of these healthy cells are part of the immune system and help the body fight infection, the risk of infection will be increased during and after Campath therapy. Certain infections can be severe and even fatal. The doctor will prescribe medications to help prevent infections, and it is important for the patient to take these medications exactly as prescribed. The doctor will continue to monitor the patient's blood counts after therapy in order to know when these medications can safely be stopped.

How can Campath affect noncancerous cells?

It may temporarily reduce the number of (a) red blood cells, which can increase the risk of anemia; (b) platelets, which can increase the risk of bleeding; and (c) germ-fighting white blood cells, which can increase the risk of bacterial, fungal, and viral infections. And since Campath may reduce the total number of all these blood cells, the bone marrow function can be impaired—which can be a serious and even fatal disorder. The treatment team will monitor the blood counts closely during and after Campath therapy to help avoid these complications.

Men with reproductive potential and women capable of having a baby, should use effective birth control during treatment and for at least 6 months after treatment with Campath. It is not known whether Campath can harm a fetus. Nursing mothers should stop breast-feeding during treatment and for at least 3 months after the last dose of Campath.

What other side effects have been associated with Campath?

Some patients have reactions (such as chills or fever, or more serious reactions, such as heart problems), called "infusion-related" side effects, when they receive their Campath treatments in the doctor's office or clinic. Since the doctor knows this, he or she may help to minimize these effects by giving medications before the treatments. Medicines such as diphenhydramine or acetaminophen may help avoid or reduce allergic reactions and chills/fever. Side effects involving the circulatory system have been fatal in some cases. To help avoid serious reactions, the doctor may prescribe a medication like hydrocortisone. There may be side effects later in the evening after a treatment. The doctor or nurse will provide instructions on what to do if this happens. Some side effects may be severe, so it is important to tell the medical team as soon as your friend or loved one begins to experience them, no matter when they occur.

In clinical studies, most infusion-related side effects were mild to moderate and were more common during the first week of treatment. Chills (rigors), fever, nausea, vomiting, and low blood pressure are common during Campath treatment and may occur while the patient is receiving an infusion. These effects can be minimized with premedication, as well as incremental dose escalation.

Other reported side effects include rash, fatigue, shortness of breath, coughing, diarrhea, hives, headache, loss of appetite, itching, sweating, dizziness, and abdominal pain.

Indication and Important Safety Information

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS

Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see WARNINGS AND PRECAUTIONS (5.1)].

Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see DOSAGE AND ADMINISTRATION (2) and WARNINGS AND PRECAUTIONS (5.2)].

Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections [see DOSAGE AND ADMINISTRATION (2.2) and WARNINGS AND PRECAUTIONS (5.3)].

The most commonly reported adverse reactions are infusion reactions fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings and Precautions," and "Adverse Reactions" sections of full Prescribing Information.

Please see Full Prescribing Information (PDF).