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

Applies to alemtuzumab: intravenous solution.

Serious side effects of Lemtrada

Along with its needed effects, alemtuzumab (the active ingredient contained in Lemtrada) 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 or nurse immediately if any of the following side effects occur while taking alemtuzumab:

More common

• Black, tarry stools
• blood in the urine
• chest tightness
• chills
• cough
• diarrhea
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• fever
• headache
• itching, hives, skin rash
• nausea
• painful or difficult urination
• pale skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Bloating or swelling of the face, hands, lower legs, or feet
• chest pain
• hoarseness
• lower back or side pain
• muscle weakness
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• 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
• tremor
• unexplained nosebleeds

Rare

• Bloody nose
• flushing of the face or neck
• swelling of the eyelids, face, or lips
• white patches on the tongue, in the mouth, or in the folds of the skin, including the genitals

Incidence not known

• Anxiety
• back pain
• blindness
• blurred or double vision
• chest pain or discomfort
• confusion
• dark urine
• decreased urine output
• decreased vision
• difficulty in speaking
• dilated neck veins
• discouragement
• double vision
• drowsiness
• extreme tiredness or weakness
• eye pain
• feeling of discomfort
• feeling sad or empty
• general feeling of tiredness and weakness
• inability to move the arms, legs, or facial muscles
• inability to speak
• irregular breathing
• irritability
• joint pain, stiffness, or swelling
• lack of appetite
• light-colored stools
• loss of interest or pleasure
• muscle aches or pain
• nightmares or unusually vivid dreams
• numbness, pain, tingling, or weakness
• pain or discomfort in the arms, jaw, back, or neck
• painful or tender lymph glands in the neck, armpit, or groin
• seizures
• shakiness and unsteady walk
• slow speech
• spitting or coughing up blood
• stiff neck
• sudden numbness and weakness in the arms and legs
• swelling of the face, fingers, feet, or lower legs
• trouble concentrating
• trouble sleeping
• unsteadiness, trembling, or other problems with muscle control or coordination
• upper right abdominal or stomach pain and fullness
• yellow eyes and skin

Other side effects of Lemtrada

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 or nervousness

Less common

• Belching
• bone pain
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• heartburn
• indigestion
• lack or loss of strength
• stomach discomfort, upset, or pain
• swelling or inflammation of the mouth
• weight loss

Rare

• Constipation
• sensation of temperature change
• sleepiness
• stuffy nose

For Healthcare Professionals

Applies to alemtuzumab: intravenous solution.

Hematologic

Very common (10% or more): Lymphopenia (97%), neutropenia (77%), anemia (76%), thrombocytopenia (71%), granulocytopenia

Common (1% to 10%): Decrease in CD4 lymphocytes, decrease in CD8 lymphocytes, decrease in T-lymphocyte count, febrile neutropenia, pancytopenia, leukopenia, lymphopenia, purpura

Uncommon (0.1% to 1%): Aplasia bone marrow, disseminated intravascular coagulation, hemolytic anemia, decreased haptoglobin, bone marrow depression, hematology test abnormal^[Ref]

Immunologic

Very common (10% or more): Immunogenicity (up to 83%), herpes viral infection (16%), fungal infection (13%), sepsis, cytomegalovirus infection, cytomegalovirus

viremia

Common (1% to 10%): Influenza, neutropenic fever

Uncommon (0.1% to 1%): Sepsis, staphylococcal bacteremia, tuberculosis, beta hemolytic streptococcal infections, candidiasis, genital candidiasis, body tinea

Very rare (less than 0.01%): Immune thrombocytopenia

Frequency not reported: Autoimmunity^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (25%), upper respiratory tract infection (16%), sinusitis (11%), pneumonia

Common (1% to 10%): Cough, dyspnea, bronchitis, chest discomfort, epistaxis, hypoxia, hemoptysis, bronchospasm

Uncommon (0.1% to 1%): Stridor, throat tightness, pulmonary infiltration, pleural effusion, breath sounds decreased, respiratory disorder

Frequency not reported: Respiratory alkalosis^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (21%), diarrhea (12%), oropharyngeal pain (11%), abdominal pain (10%), vomiting (10%)

Common (1% to 10%): Dyspepsia, gastrointestinal hemorrhage, ulcerative stomatitis, stomatitis, gastroenteritis, tongue ulceration, gingivitis, hiccup, eructation, dyspepsia, constipation, flatulence, oral candidiasis

Uncommon (0.1% to 1%): Gingival bleeding, dry mouth, paralytic ileus, oral discomfort

Frequency not reported: Duodenal ulcer, intestinal perforation, melena, peptic ulcer, pseudomembranous colitis, colitis, pancreatitis, peritonitis^[Ref]

Nervous system

Very common (10% or more): Headache (52%), insomnia (16%), paresthesia (10%), dizziness (10%)

Common (1% to 10%): Dysgeusia, vertigo, tremor, paresthesia, hypoesthesia, hyperkinesia, taste loss

Uncommon (0.1% to 1%): Syncope, abnormal gait, dystonia, hyperesthesia, neuropathy, taste perversion^[Ref]

Cardiovascular

Very common (10% or more): Hypotension, hypertension

Common (1% to 10%): Tachycardia, peripheral edema, vasospasm

Uncommon (0.1% to 1%): Cardiac arrest, myocardial infarction, atrial fibrillation, supraventricular tachycardia, arrhythmia, bradycardia, abnormal ECG, peripheral ischemia, cyanosis, orthostatic hypotension, hot flush

Frequency not reported: Congestive heart failure, cardiomyopathy, decreased ejection fraction in non-MS patients previously treated with potentially cardiotoxic agents^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (12%), pain in extremity (12%), back pain (12%)

Common (1% to 10%): Chills, muscular weakness, muscle spasms, myalgia, neck pain, arthralgia, skeletal pain, back pain

Uncommon (0.1% to 1%): Leg pain, hypertonia, muscle spasms

Frequency not reported: Arthritis or worsening arthritis, bone fracture, myositis, muscle atrophy, osteomyelitis, polymyositis, skeletal pain^[Ref]

Dermatologic

Very common (10% or more): Rash (53%), urticaria (16%), pruritus (14%)

Common (1% to 10%): Dermatitis, erythema, hyperhidrosis, bullous eruption, erythematous rash

Uncommon (0.1% to 1%): Maculopapular rash, skin disorder^[Ref]

Endocrine

Very common (10% or more): Thyroid gland disorders (13%)^[Ref]

Hepatic

Frequency not reported: Hyperbilirubinemia, hepatic failure, hepatocellular damage, hypoalbuminemia, biliary pain^[Ref]

Metabolic

Very common (10% or more): Anorexia

Common (1% to 10%): hyponatremia, hypocalcemia, weight decrease, dehydration, thirst

Uncommon (0.1% to 1%): Hypokalemia, diabetes mellitus aggravated

Frequency not reported: Thyroid disorder, fluid overload^[Ref]

Oncologic

Frequency not reported: Malignancies (e.g., malignant lymphoma, malignant testicular neoplasm, prostatic cancer, plasma cell dyscrasias, secondary leukemia, squamous cell carcinoma)^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (19%)

Common (1% to 10%): Blood in urine, abnormal uterine bleeding

Uncommon (0.1% to 1%): Impotence, urinary incontinence, urine flow decreased, polyuria, cystitis

Frequency not reported: Cervical dysplasia^[Ref]

Other

Very common (10% or more): Pyrexia (29%), fatigue (18%), flushing (10%)

Common (1% to 10%): Asthenia^[Ref]

Renal

Uncommon (0.1% to 1%): Renal function abnormal

Frequency not reported: Acute renal failure^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis

Uncommon (0.1% to 1%): Endophthalmitis^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction

Frequency not reported: Anaphylactoid reaction^[Ref]

Local

Uncommon (0.1% to 1%): Infusion site bruising, infusion site dermatitis, infusion site pain

Frequency not reported: Infusion reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, chest pain, bradycardia, tachycardia (including atrial fibrillation), hypoxia, syncope, acute respiratory distress syndrome, respiratory arrest, myocardial infarction, acute cardiac insufficiency, cardiac arrest, transient neurologic symptoms, hypertension, headache, pyrexia, rash, nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnea, pulmonary infiltrates, dysgeusia, dyspepsia, dizziness, pain)^[Ref]