Natalizumab Side Effects

Some side effects of natalizumab 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 natalizumab: intravenous concentrate

Get emergency medical help if you have any of these signs of an allergic reaction while taking natalizumab: skin rash, hives, itching; dizziness, fever; nausea, vomiting; feeling flushed; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat; feeling light-headed or fainting.

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

• change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• pain or burning when you urinate;

• cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

• flu symptoms, sores or white patches in your mouth or on your lips;

• vaginal itching or discharge;

• tooth pain, gum pain or swelling; or

• flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).

Less serious side effects of natalizumab may include:

• headache;

• tired feeling;

• joint or muscle pain;

• stomach pain, diarrhea;

• mild skin rash;

• depression;

• painful menstrual cramps; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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 natalizumab: intravenous concentrate

Nervous system

One patient, a 46-year-old female, developed PML after she received 37 doses of natalizumab over 33 months. The other patient received 28 doses of natalizumab before developing PML and remains severely disabled.

In postmarketing experience, one MS patient who received natalizumab developed herpes encephalitis and died; a second MS patient developed herpes meningitis and recovered with appropriate treatment.

Nervous system side effects have included headache (up to 38%), dizziness (10% or greater), vertigo (6%), tremors (up to 3%), somnolence (2%), and syncope (2%). At least three cases of progressive multifocal leukoencephalopathy (PML) have been reported. Herpes infections of the central nervous system have been reported during postmarketing experience and have included herpes simplex virus (HSV) encephalitis, HSV meningitis, and herpes zoster virus meningitis. PML has also been reported during postmarketing experience.

Respiratory

Respiratory side effects have included opportunistic infections. These have included pneumocystis carinii pneumonia, pulmonary mycobacterium avium intracellulare, bronchopulmonary aspergillosis, and Burkholderia cepacia. Upper respiratory tract infection (22%), lower respiratory tract infection (up to 17%), influenza (12%), influenza-like illness (up to 11%), nasopharyngitis (10% or greater), sinusitis (7%), cough (up to 7%), and pharyngolaryngeal pain (6%) have been reported. At least one patient who had been administered natalizumab (3 mg per kg) experienced bronchospasm that rapidly responded to antihistamines and corticosteroids.

Psychiatric

Psychiatric side effects have included depression (19%), including suicidal ideation or attempt.

Gastrointestinal

Gastrointestinal side effects have included nausea (17%), gastroenteritis (11%), abdominal discomfort (11%), diarrhea (10%), tooth infections (9%), dyspepsia (5%), constipation (4%), toothache (4%), lower abdominal pain (4%), flatulence (3%), aphthous stomatitis (2%), intestinal obstruction or stenosis (2%), cholelithiasis (1%), and abdominal adhesions (0.3%). At least one case of cryptosporidial gastroenteritis has been reported with prolonged use.

Immunologic

Development of antibodies to natalizumab occurred by week 12 in most of the patients (82%) who became persistently antibody-positive. The presence of anti-natalizumab antibodies was correlated with a reduction in serum natalizumab levels. Persistent antibody-positivity to natalizumab was associated with a substantial decrease in the effectiveness of the drug.

Immunologic side effects have included immunosuppression/infections, including pneumonias and urinary tract infections (including serious cases), gastroenteritis, vaginal infections, tooth infections, tonsillitis, and herpes infections. Herpes (8%), tonsillitis (7%), and viral infection (up to 7%) have been reported. Antibodies to natalizumab were detected in approximately 9% of patients at least once during treatment with persistent antibody-positivity in 6% of patients. Immune reconstitution inflammatory syndrome (IRIS) has been reported in the majority of patients who discontinued natalizumab as a result of developing PML, but not in patients who discontinued natalizumab for other reasons; in most cases, IRIS occurred within days to several weeks after plasma exchange was used to remove circulating natalizumab.

Hepatic

Hepatic side effects have included abnormal liver function tests (5%). Clinically significant liver injury (including markedly elevated serum hepatic enzymes and elevated total bilirubin) has been reported during postmarketing experience.

Other

Other side effects have included fatigue (up to 27%), peripheral edema (up to 6%), chest discomfort (up to 5%), rigors (3%), limb injury (3%), skin laceration (2%), and thermal burn (1%). At least one case of shakiness has also been reported.

Local

Local side effects have included infusion related reactions including headache, nausea, dizziness, fatigue, hypersensitivity reactions, urticaria, pruritus, flushing, and rigors in up to 24% of patients. Infusion related anaphylactic reactions have been reported in less than 1% of patients.

Genitourinary

Genitourinary side effects have included urinary tract infection (up to 21%), vaginitis (up to 10%), urinary urgency/frequency (9%), vaginal infections (up to 8%), dysmenorrhea (up to 6%), irregular menstruation (5%), urinary incontinence (4%), amenorrhea (2%), and ovarian cyst (2%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (up to 19%), pain in extremity (16%), back pain (12%), muscle cramp (5%), and joint swelling (2%).

Dermatologic

Dermatologic side effects have included rash (up to 12%), dermatitis (up to 7%), pruritus (4%), perianal abscess (2% or greater), urticaria (1%), dry skin (1%), and night sweats (1%). Serum sickness-like illness and severe cutaneous Candida infection have been reported in at least one patient each.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (7%), acute hypersensitivity (up to 4%), seasonal allergy (3%), and anaphylaxis/anaphylactoid reactions. An infusion-related reaction has been reported to occur within 2 hours of the start of an infusion. At least 2 cases of allergic dermatitis have also been reported.

Patients experiencing hypersensitivity reactions recovered with treatment and/or discontinuation of the infusion. Patients who developed antibodies to natalizumab were more likely to have an infusion-related reaction.

Hematologic

Hematologic side effects have included increases in circulating lymphocytes, monocytes, eosinophils, basophils, and nucleated red blood cells. Hypereosinophilia (greater than 2,000 eosinophils/mm3) and at least one case of immune thrombocytopenic purpura have been reported.

Metabolic

Metabolic side effects have included weight decreased and increased in 2% of patients.

Cardiovascular

Cardiovascular side effects have included pericarditis.

Ocular

Ocular side effects have included at least one case of ocular toxoplasmosis reactivation.

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