Campath Side Effects

Generic name: alemtuzumab

Note: This document contains side effect information about alemtuzumab. Some of the dosage forms listed on this page may not apply to the brand name Campath.

Some side effects of Campath may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to alemtuzumab: intravenous solution

Some people receiving an alemtuzumab (the active ingredient contained in Campath) 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 while taking alemtuzumab: 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.

For Healthcare Professionals

Applies to alemtuzumab: intravenous solution

General

The major adverse effects associated with alemtuzumab (the active ingredient contained in Campath) have included infusion-related reactions, hematologic toxicity, and infections.

Alemtuzumab has been associated with infusion-related events including hypotension, rigors, fever, shortness of breath, bronchospasm, chills, rash, syncope, pulmonary infiltrates, ARDS, respiratory arrest, cardiac arrhythmias, myocardial infarction, and cardiac arrest. Some cases of cardiac adverse events have resulted in death.

Hematologic

Median CD4+ lymphocyte counts were 2/mcL 4 weeks after begin of alemtuzumab (the active ingredient contained in Campath) therapy, 207/mcL two months after discontinuation, and 470/mcL six months after discontinuation. CD8+ cells followed a similar pattern of change. In some patients, CD4+ and CD8+ counts did not return to baseline levels within 1 year after discontinuation.

Hematologic side effects include myelosuppression, which is the major toxicity associated with alemtuzumab and has been fatal in rare cases. The following grade 3 or 4 severity effects have been reported in 93 B-CLL trial patients: anemia (47%), autoimmune hemolytic anemia (1%), neutropenia (70%), thrombocytopenia (52%), autoimmune thrombocytopenia (2%, 1 fatal). Six percent of patients discontinued alemtuzumab permanently due to pancytopenia/marrow hypoplasia, and 2% of these cases were fatal.

The following adverse events were reported in 149 B-CLL trial patients (including the 93 above): neutropenia (85% any grade, 64% grade 3/4), anemia (80% any grade, 38% grade 3/4), pancytopenia (5% any grade, 3% grade 3/4), thrombocytopenia (72% any grade, 50% grade 3/4), purpura (8%), and epistaxis (7% any grade, 1% grade 3/4). Additional serious side effects reported in B-CLL and other trials have included agranulocytosis, aplasia, decreased haptoglobin, lymphadenopathy, marrow depression, coagulation disorder, disseminated intravascular coagulation, hematoma, pulmonary embolism, thrombocythemia, hemolysis, hemolytic anemia, splenic infarction, and splenomegaly.

Immunologic

Immunologic side effects have included infections in 43% of 93 B-CLL patients who had received anti-infective prophylaxis: sepsis (12%), pneumonia (15%), opportunistic infections (17%), neutropenic fever (10%), aplastic anemia, and chronic inflammatory demyelinating polyradiculoneuropathy. Eighteen percent of infections were fatal. Development of antibodies to alemtuzumab (the active ingredient contained in Campath) has occurred in 1.9% (4 of 211) of patients. Postmarketing experiences have included fatal transfusion associated graft versus host disease.

Types of infections reported in the 93 B-CLL patients have included Candida, CMV, Aspergillosis, Mucomycosis, Cryptococcal pneumonia, Listeria monocytogenes meningitis, disseminated Herpes zoster, Herpes simplex, Torulopsis pneumonia, and PCP pneumonia. Infections reported in other trials have included abscess, bacterial infection, Herpes zoster infection, Pneumocystis carinii infection, otitis media, Tuberculosis infection, interstitial pneumonitis, progressive multifocal leukoencephalopathy, and other viral infections.

Postmarketing experiences have included Epstein-Barr virus lymphoproliferative disorder and reactivation of latent viruses.

Respiratory

An initial dose of 80 mg caused acute bronchospasm, cough, shortness of breath, followed by anuria and death in one patient. Tumor lysis syndrome may have been a factor.

Respiratory side effects reported in B-CLL patients have included dyspnea (26% any grade, 9% grade 3/4), cough (25% any grade, 2% grade 3/4), bronchitis/pneumonitis (21% any grade, 13% grade 3/4), pneumonia (16% any grade, 10% grade 3/4), pharyngitis (12%), bronchospasm (9% any grade, 2% grade 3/4), and rhinitis (7%). Serious effects reported in other trials have included asthma, bronchitis, chronic obstructive pulmonary disease, hemoptysis, hypoxia, pleural effusion, pleurisy, pneumothorax, pulmonary edema, pulmonary fibrosis, pulmonary infiltration, respiratory depression, respiratory insufficiency, sinusitis, stridor, and throat tightness. A case of diffuse alveolar hemorrhage has also been reported.

Gastrointestinal

Gastrointestinal side effects reported in B-CLL patients have included nausea (54%), vomiting (41%), diarrhea (22%), stomatitis/ulcerative stomatitis/mucositis (14%), abdominal pain (11%), dyspepsia (10%), and constipation (9%). Serious gastrointestinal effects which have been reported in other trials include: duodenal ulcer, esophagitis, gingivitis, gastroenteritis, GI hemorrhage, hematemesis, hemorrhoids, intestinal obstruction, intestinal perforation, melena, paralytic ileus, peptic ulcer, pseudomembranous colitis, colitis, pancreatitis, and peritonitis.

Nervous system

Nervous system side effects reported in B-CLL patients have included headache (24%), dysthesias (15%), dizziness (12%), and tremor (7%). Serious nervous system effects which have been reported in other trials include: abnormal gait, aphasia, coma, grand mal convulsions, paralysis, meningitis, and syncope.

Cardiovascular

Cardiovascular side effects reported in B-CLL patients have included hypotension (32% any grade, 5% grade 3/4), hypertension (11% any grade, 2% grade 3/4), and tachycardia/SVT (11% any grade, 3% grade 3/4). Serious effects which have been reported in other trials include: cardiac failure, cyanosis, atrial fibrillation, cardiac arrest, ventricular arrhythmia, ventricular tachycardia, angina pectoris, coronary artery disorder, myocardial infarction, pericarditis, cerebral hemorrhage, cerebrovascular disorder, deep vein thrombosis, increased capillary fragility, intracranial hemorrhage, phlebitis, subarachnoid hemorrhage, cardiomyopathy and thrombophlebitis. Decreased ejection fraction has been reported in patients previously treated with cardiotoxic agents. Postmarketing experiences have included reports of congestive heart failure.

Musculoskeletal

Musculoskeletal side effects reported in B-CLL patients have included myalgias (11%). Serious side effects reported in other trials have included arthritis or worsening arthritis, arthropathy, bone fracture, myositis, muscle atrophy, muscle weakness, osteomyelitis, polymyositis, asthenia, skeletal pain, back pain, and chest pain.

Psychiatric

Psychiatric side effects reported in B-CLL patients have included insomnia (10%), depression (7%), and somnolence (5%). Serious effects reported in other trials have included confusion, hallucinations, nervousness, abnormal thinking and apathy.

Dermatologic

Dermatologic side effects reported in B-CLL patients have included rashes (40% any grade, 3% grade 3/4), urticaria (30% any grade, 5% grade 3/4), pruritus (24% any grade), and increased sweating (19%). Serious effects reported in other trials include angioedema, bullous eruption, cellulitis, and purpuric rash.

Endocrine

Endocrine side effects have included serious cases of hyperthyroidism.

Hepatic

Hepatic side effects have included serious cases of hyperbilirubinemia, hepatic failure, hepatocellular damage, hypoalbuminemia, and biliary pain.

Metabolic

Metabolic side effects have included serious cases of acidosis, aggravated diabetes mellitus, dehydration, fluid overload, hyperglycemia, hyperkalemia, hypoglycemia, hyponatremia, increased alkaline phosphatase, and respiratory alkalosis, edema, peripheral edema, and hypovolemia.

Oncologic

Oncologic side effects have included cases of malignant lymphoma, malignant testicular neoplasm, prostatic cancer, plasma cell dyscrasia, secondary leukemia, squamous cell carcinoma, transformation to aggressive lymphoma, transformation or prolymphocytic leukemia. A case of Epstein-Barr virus positive lymphoproliferative disorder has also been reported.

Genitourinary

Genitourinary side effects have included cases of cervical dysplasia.

Other

Other side effects have included decreased hearing, taste loss, ascites, influenza-like syndrome, mouth edema, rigors, fever, pain, malaise, and temperature change sensation.

Renal

Renal side effects have included serious cases of abnormal renal function, acute renal failure, facial edema, hematuria, toxic nephropathy, ureteric obstruction, urinary retention, and urinary tract infection.

Ocular

Ocular side effects have included cases of endophthalmitis.

Hypersensitivity

Hypersensitivity reactions have included allergic and anaphylactoid reactions.

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