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As a single agent for B-cell chronic lymphocytic leukemia (B-CLL) - Change Your Thinking: Campath First Line(1)
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Side Effects

Does Campath have any serious side effects?

Like many other forms of cancer treatment, Campath has been associated with some serious, sometimes fatal, side effects.

Side effects have included the following:

Although monoclonal antibodies, such as Campath, are targeted to attack cancerous blood cells, they can also affect some noncancerous (healthy) 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, the loss of which can increase the risk of anemia; (b) platelets, the loss of which can increase the risk of bleeding; and (c) germ-fighting white blood cells, the loss of which can increase the risk of bacterial, fungal, and viral infections. Since Campath may reduce the total number of all these blood cells, bone marrow function can be impaired, which can be a serious and even fatal disorder. Your friend's or loved one's treatment team will monitor their blood counts closely during and after Campath therapy to help avoid these complications.

Patient counseling information

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 lessen these effects by giving medications before the treatments. Medicines such as Benadryl® (diphenhydramine) or Tylenol® (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 lessened with premedication, as well as gradual dose escalation.

Symptoms such as bleeding, easy bruising, occurrence of small reddish or purple blood spots on the body ("petechiae" or "purpura"), paleness, weakness, or fatigue, should be reported to the doctor.

Any symptoms of infection should be immediately reported to the doctor.

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

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Indications & Usage

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

Important safety information
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.

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.

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.

In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. The following serious, including fatal, infusion reactions have been identified in post-marketing reports: syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock.

Prolonged myelosuppression have been reported in patients receiving Campath. Campath treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections. Assess CD4+ counts after treatment until recovery to ≥ 200 cells/µL. Obtain complete blood counts (CBC) at weekly intervals during Campath therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs. Withhold Campath for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia).

Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion.

Routinely monitor patients for CMV infection during Campath treatment and for at least 2 months following completion of treatment. Withhold Campath for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia. Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia.

Do not administer live viral vaccines to patients who have recently received Campath.

The most common adverse reactions (≥ 10%) were infusion reactions, cytopenias, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see full Prescribing Information (PDF).