Press Release Prescribing Information
Campath® Alemtuzumab - For Intravenous Use Only - illuminating possibilites
SEARCH
 
I am taking CAMPATH
About Campath
Side Effects
Administering and Dosing
Caring For Yourself During Treatment
What to Expect
Education and Resources
Clinical Trials
Questions For Your Doctor
I Am Considering Campath
I Am a Caregiver
 
Understanding CLL
Resources and Tools
 
   Home  |  Full Prescribing Information (PDF)  |  Contact Us  |  Site Map  
As a single agent for B-cell chronic lymphocytic leukemia (B-CLL) - Change Your Thinking: Campath First Line(1)
Print | Text Size:
 

Side Effects

What should I know before taking Campath?

Like many other forms of cancer treatment, Campath has been associated with 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 your immune system and help your body fight infection, your risk of infection will be increased during and after Campath therapy. Certain infections can be severe and even fatal. Your doctor will prescribe medications to help prevent infections, and it is important for you to take these medications exactly as your doctor prescribes.

Your doctor will continue to monitor your blood counts after therapy in order to know when these medications can safely be stopped. If you develop certain toxic conditions in your bloodstream, your doctor may elect to discontinue Campath. Campath can also be discontinued for serious infections and infusion reactions.

How can Campath affect noncancerous cells?

It may temporarily reduce the number of (a) red blood cells, the loss of which can increase your risk of anemia; (b) platelets, the loss of which can increase your risk of bleeding; and (c) germ-fighting white blood cells, the loss of which can increase your risk of bacterial, fungal, and viral infections. And since Campath may reduce the total number of all these blood cells, your bone marrow function can be impaired, which can be a serious and even fatal disorder. Your treatment team will monitor your 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. Some of these cases have been fatal. Since your doctor knows this, he or she may help to lessen these effects by giving you medications before your treatments. Medicines such as Benadryl® (diphenhydramine) or Tylenol® (acetaminophen) may help avoid or reduce allergic reactions and chills/fever. To help avoid serious reactions, your doctor may prescribe a medication like hydrocortisone. Sometimes you may have side effects later in the evening after a treatment. Your doctor or nurse will tell you what to do if this happens. Some side effects may be severe, so it is important to tell your medical team as soon as you begin 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 you are receiving an infusion. These effects can be lessened with premedication, as well as gradual dose escalation.

You should report to your doctor any symptoms such as bleeding, easy bruising, occurrence of small reddish or purple blood spots on your body ("petechiae" or "purpura"), paleness, weakness, or fatigue.

Be sure to follow your doctor's instructions to take premedications before your treatments to prevent infusion reactions.

You should immediately report any symptoms of infection to your doctor.

You should not be administered any blood products unless they have been irradiated while you wait for your blood cell counts to return to normal following Campath therapy.

You should not receive immunization with any live viral vaccines if you have recently been treated with Campath.

Male and female patients with reproductive potential should use effective contraception during treatment and for at least 6 months after Campath therapy.

If you are pregnant, your doctor will help you decide whether to take Campath. If you are nursing your baby, your doctor will determine whether you should stop Campath or stop nursing.

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

All products mentioned are registered trademarks of there respective companies.
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).