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Campath

Last reviewed on RxList: 10/17/2017
Campath Side Effects Center

Last reviewed on RxList 10/17/2017

Campath (alemtuzumab) is an antibody made from animal DNA used to treat chronic lymphocytic leukemia. Campath is usually given after other medications have been tried without successful treatment. Common side effects of Campath include:

  • fever,
  • chills,
  • dizziness,
  • muscle stiffness,
  • joint or muscle pain,
  • nausea,
  • vomiting,
  • loss of appetite,
  • abdominal pain,
  • headache,
  • diarrhea,
  • rash or itching,
  • hives,
  • tiredness,
  • sleep problems (insomnia),
  • anxiety,
  • fatigue,
  • cough,
  • sweating, or
  • trouble breathing during or after the infusion.

These side effects occur more often during the first week of treatment with Campath. Tell your doctor if you have serious side effects of Campath including:

  • shortness of breath,
  • mental/mood changes (such as depression, anxiety),
  • bone or back pain,
  • muscle spasm,
  • unusual weakness,
  • swelling ankles or feet,
  • yellowing skin or eyes,
  • changes in the amount of urine,
  • painful urination,
  • pink or bloody urine,
  • numbness or tingling of arms or legs, or
  • pain/redness/swelling of arms/legs/injection site.

Campath medication is given intravenously under physician supervision, usually over 2 hours. Dosage is based on the patient's response to treatment. Patients are usually started on a low dose of the medication, and the dose may be slowly increased. Other drugs may affect Campath. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. During pregnancy, Campath should be used only when prescribed. It is recommended that men and women receiving this medication use at least 2 forms of birth control (e.g., condoms, birth control pills) during treatment with this medication and for at least 6 months afterwards. It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended during treatment with this medication and for at least 3 months afterwards.

Our Campath (alemtuzumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Campath Consumer Information

Some people receiving an alemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel hot or cold, nauseated, light-headed, sweaty, or have chest tightness or trouble breathing during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, sweating, chills, body aches, flu symptoms, sores in your mouth and throat, weight loss;
  • pale or yellowed skin, dark colored urine, confusion or weakness;
  • easy bruising, unusual bleeding (nosebleed, bleeding gums), purple or red pinpoint spots under your skin;
  • cough with yellow or green mucus, wheezing;
  • tired feeling, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • swelling, warmth, redness, tingling, itching, or oozing of the skin;
  • vision problems, changes in your behavior, seizure (convulsions); or
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Less serious side effects include:

  • nausea, vomiting, diarrhea, loss of appetite;
  • sleep problems (insomnia);
  • headache, anxiety;
  • joint or muscle pain; or
  • mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Campath (Alemtuzumab)

Campath Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

The most common adverse reactions with Campath are: infusion reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), infections (CMV viremia, CMV infection, other infections), gastrointestinal symptoms (nausea, emesis, abdominal pain), and neurological symptoms (insomnia, anxiety). The most common serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data below reflect exposure to Campath in 296 patients with CLL of whom 147 were previously untreated and 149 received at least 2 prior chemotherapy regimens. The median duration of exposure was 11.7 weeks for previously untreated patients and 8 weeks for previously treated patients.

Lymphopenia

Severe lymphopenia and a rapid and sustained decrease in lymphocyte subsets occurred in previously untreated and previously treated patients following administration of Campath. In previously untreated patients, the median CD4+ was 0 cells/µL at one month after treatment and 238 cells/µL [25-75% interquartile range 115 to 418 cells/µL at 6 months post-treatment [see WARNINGS AND PRECAUTIONS].

Neutropenia

In previously untreated patients, the incidence of Grade 3 or 4 neutropenia was 42% with a median time to onset of 31 days and a median duration of 37 days. In previously treated patients, the incidence of Grade 3 or 4 neutropenia was 64% with a median duration of 28 days. Ten percent of previously untreated patients and 17% of previously treated patients received granulocyte colony stimulating factors.

Anemia

In previously untreated patients, the incidence of Grade 3 or 4 anemia was 12% with a median time to onset of 31 days and a median duration of 8 days. In previously treated patients, the incidence of Grade 3 or 4 anemia was 38%. Seventeen percent of previously untreated patients and 66% of previously treated patients received either erythropoiesis stimulating agents, transfusions or both.

Thrombocytopenia

In previously untreated patients, the incidence of Grade 3 or 4 thrombocytopenia was 14% with a median time to onset of 9 days and a median duration of 14 days. In previously treated patients, the incidence of Grade 3 or 4 thrombocytopenia was 52% with a median duration of 21 days. Autoimmune thrombocytopenia was reported in 2% of previously treated patients with one fatality.

Infusion reactions

Infusion reactions, which included pyrexia, chills, hypotension, urticaria, and dyspnea, were common. Grade 3 and 4 pyrexia and/or chills occurred in approximately 10% of previously untreated patients and in approximately 35% of previously treated patients. The occurrence of infusion reactions was greatest during the initial week of treatment and decreased with subsequent doses of Campath. All patients were pretreated with antipyretics and antihistamines; additionally, 43% of previously untreated patients received glucocorticoid pre-treatment.

Infections

In the study of previously untreated patients, patients were tested weekly for CMV using a PCR assay from initiation through completion of therapy, and every 2 weeks for the first 2 months following therapy. CMV infection occurred in 16% (23/147) of previously untreated patients; approximately one-third of these infections were serious or life threatening. In studies of previously treated patients in which routine CMV surveillance was not required, CMV infection was documented in 6% (9/149) of patients; nearly all of these infections were serious or life threatening.

Other infections were reported in approximately 50% of patients across all studies. Grade 3 - 5 sepsis ranged from 3% to 10% across studies and was higher in previously treated patients. Grade 3 - 4 febrile neutropenia ranged from 5 to 10% across studies and was higher in previously treated patients. Infection-related fatalities occurred in 2% of previously untreated patients and 16% of previously treated patients. There were 198 episodes of other infection in 109 previously untreated patients; 16% were bacterial, 7% were fungal, 4% were other viral, and in 73%, the organism was not identified.

Cardiac

Cardiac dysrhythmias occurred in approximately 14% of previously untreated patients. The majority were tachycardias and were temporally associated with infusion; dysrhythmias were Grade 3 or 4 in 1% of patients.

Previously Untreated Patients

Table 1 contains selected adverse reactions observed in 294 patients randomized (1:1) to receive Campath or chlorambucil as first line therapy for B-CLL. Campath was administered at a dose of 30 mg intravenously three times weekly for up to 12 weeks. The median duration of therapy was 11.7 weeks with a median weekly dose of 82 mg (25-75% interquartile range: 69 mg - 90 mg).

Table 1

Per Patient Incidence of Selected1 Adverse Reactions in Treatment Naive B-CLL Patients
    Campath
(n=147)
Chlorambucil
(n=147)
All Grades2 % Grades 3-4 % All Grades % Grades 3-4 %
Blood and Lymphatic System Disorders Lymphopenia 97 97 9 1
Neutropenia 77 42 51 26
Anemia 76 13 54 18
Thrombocytopenia 71 13 70 14
General Disorders and Administration Site Conditions Pyrexia 69 10 11 1
Chills 53 3 1 0
Infections and Infestations CMV viremia3 55 4 8 0
CMV infection 16 5 0 0
Other infections 74 21 65 10
Skin and Subcutaneous Tissue Disorders Urticaria 16 2 1 0
Rash 13 1 4 0
Erythema 4 0 1 0
Vascular Disorders Hypotension 16 1 0 0
Hypertension 14 5 2 1
Nervous System Disorders Headache 14 1 8 0
Tremor 3 0 1 0
Respiratory, Thoracic and Mediastinal Disorders Dyspnea 14 4 7 3
Gastrointestinal Disorders Diarrhea 10 1 4 0
Psychiatric Disorders Insomnia 10 0 3 0
Anxiety 8 0 1 0
Cardiac Disorders Tachycardia 10 0 1 0
1Adverse reactions occurring at a higher relative frequency in the Campath arm
2NCI CTC version 2.0 for adverse reactions; NCI CTCAE version 3.0 for laboratory values
3CMV viremia (without evidence of symptoms) includes both cases of single PCR positive test results and of confirmed CMV viremia ( ≥ 2 occasions in consecutive samples 1 week apart). For the latter, ganciclovir (or equivalent) was initiated per protocol.

Previously Treated Patients

Additional safety information was obtained from 3 single arm studies of 149 previously treated patients with CLL administered 30 mg Campath intravenously three times weekly for 4 to 12 weeks (median cumulative dose 673 mg [range 2 - 1106 mg]; median duration of therapy 8.0 weeks). Adverse reactions in these studies not listed in Table 1 that occurred at an incidence rate of > 5% were fatigue, nausea, emesis, musculoskeletal pain, anorexia, dysesthesia, mucositis, and bronchospasm.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Using an ELISA assay, anti-human antibodies (HAHA) were detected in 11 of 133 (8.3%) previously untreated patients. In addition, two patients were weakly positive for neutralizing activity. Limited data suggest that the anti-Campath antibodies did not adversely affect tumor response. Four of 211 (1.9%) previously-treated patients were found to have antibodies to Campath following treatment.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Campath with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions were identified during post-approval use of Campath. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Campath exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) reported frequency of the reaction, or (3) strength of causal connection to Campath.

Fatal infusion reactions: [see WARNINGS AND PRECAUTIONS].

Cardiovascular: congestive heart failure, cardiomyopathy, decreased ejection fraction (some patients had been previously treated with cardiotoxic agents).

Immune disorders: Goodpasture's syndrome, Graves' disease, aplastic anemia, Guillain Barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, serum sickness, fatal transfusion associated Graft versus Host Disease.

Infections: Epstein-Barr Virus (EBV) including EBV-associated lymphoproliferative disorder, progressive multifocal leukoencephalopathy (PML), re-activation of latent viruses.

Metabolic: tumor lysis syndrome

Neurologic: optic neuropathy

Read the entire FDA prescribing information for Campath (Alemtuzumab)

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© Campath Patient Information is supplied by Cerner Multum, Inc. and Campath Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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