What to Expect
How will your doctor and you know that Campath is working?
You may see a response to Campath in as few as 4 to 6 weeks, but the proper duration
is 12 weeks. Your doctor will perform lab work and a clinical evaluation to measure
your body's response against established criteria to determine if therapy is working.
You will know Campath is working if blood tests during treatment show the following:
- Fewer B and T cells (lymphocytes)
- Temporarily lower counts for the following blood cells:
- Red blood cells (which carry oxygen)
- Cells that control bleeding (platelets)
- White blood cells that kill bacteria (neutrophils)
Please use the Campath Treatment Diary to record your blood counts given to you
by your doctor over the course of your treatments. Be sure to discuss these and
all laboratory results with your doctor.
In addition to frequent blood tests, you may have your bone marrow tested from time
to time. The type and number of cells in bone marrow can also confirm if Campath
is working.
What results can you expect from Campath?
As you probably know, although a lot of progress has been made, B-CLL is a chronic
disease that has no cure.
- In a study of 297 patients who had never before been treated for B-CLL, Campath,
as a single medicine, was found to be superior to another widely used therapy (chlorambucil)
in the following ways:
- The 149 patients treated with Campath had a 42% reduction in the chance of their
disease getting worse or of dying, compared with the 148 patients receiving chorambucil
- The 149 patients treated with Campath were able to get along without needing another
medication for a 60% longer period of time than the 148 patients receiving chorambucil1
- More patients treated with Campath had a
complete response than those receiving chlorambucil (24% [36 patients] versus
2% [3 patients]).1
"Complete response" means the disappearance of all signs of cancer in
response to treatment through a clinical evaluation by a physician. This does not
always mean the cancer has been cured
- More patients treated with Campath also had an
overall response versus those receiving chlorambucil (83% [124 patients] versus
55% [81 patients]).1
"Overall response" is the number of patients who had either a
complete response or a partial
response. "Partial response" means a decrease in the extent
of cancer in the body in response to treatment
Each patient is different. Not every patient will respond to Campath in the same
way, if at all.
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).
