Alemtuzumab Side Effects
Some side effects of alemtuzumab 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
Along with its needed effects, alemtuzumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking alemtuzumab:More common
- Black, tarry stools
- blood in urine
- faintness, or light-headedness when getting up from a lying or sitting position suddenly
- fast heartbeat
- itching, hives, or rash
- nausea and vomiting
- painful or difficult urination
- pale skin
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- tightness in the chest
- troubled breathing, exertional
- unusual bleeding or bruising
- unusual tiredness or weakness
- Bloating or swelling of the face, hands, lower legs, and/or feet
- chest pain
- lower back or side pain
- muscle weakness
- pounding, or irregular heartbeat or pulse
- rapid weight gain
- red or purple spots on the skin, varying in size and remaining after pushing the skin surface
- Flushing of the face or neck
- swelling of the eyelids, face, or lips
- white patches on the tongue, in the mouth, or in folds of the skin, including the genitals
- Back pain
- blurred vision
- chest discomfort or pain
- decreased urine output
- decreased vision
- dilated neck veins
- extreme fatigue
- eye pain
- feeling of discomfort
- inability to move the arms and legs
- inflammation of the joints
- irregular breathing
- joint pain, stiffness, or swelling
- muscle aches or pain
- numbness, pain, tingling, or weakness
- painful glands
- spitting up blood
- sudden numbness and weakness in the arms and legs
- swelling of the face, fingers, feet, or lower legs
Get emergency help immediately if any of the following symptoms of overdose occur while taking alemtuzumab:
- Inability to urinate
Some side effects of alemtuzumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Fear, nervousness
- trouble sleeping
- unable to sleep
- Acid or sour stomach
- bone pain
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
- lack or loss of strength
- loss of appetite
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- stomach discomfort, upset, or pain
- swelling or inflammation of the mouth
- weight loss
- Bloody nose
- mood or mental changes
- sensation of temperature change
- stuffy nose
- unexplained nosebleeds
For Healthcare Professionals
Applies to alemtuzumab: intravenous solution
The major adverse effects associated with alemtuzumab 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.
Median CD4+ lymphocyte counts were 2/mcL 4 weeks after begin of alemtuzumab 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 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 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.
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 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 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 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 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 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 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 side effects have included serious cases of hyperthyroidism.
Hepatic side effects have included serious cases of hyperbilirubinemia, hepatic failure, hepatocellular damage, hypoalbuminemia, and biliary pain.
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 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 side effects have included cases of cervical dysplasia.
Other side effects have included decreased hearing, taste loss, ascites, influenza-like syndrome, mouth edema, rigors, fever, pain, malaise, and temperature change sensation.
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 side effects have included cases of endophthalmitis.
Hypersensitivity reactions have included allergic and anaphylactoid reactions.
More about alemtuzumab
- Other brands: Campath
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