Soliris Side Effects

Generic name: eculizumab

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

Some side effects of Soliris 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 eculizumab: intravenous solution

Seek emergency medical attention or call your doctor right away if you notice any of these symptoms of meningitis:

• headache and fever with nausea or vomiting;

• high fever (103 degrees or higher), body aches, flu symptoms;

• confusion, increased sensitivity to light; or

• stiffness in your neck or back.

With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times.

Get emergency medical help if you have any of these signs of an allergic reaction while taking eculizumab (the active ingredient contained in Soliris) hives; chest pain, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these side effects during or after your treatment with eculizumab:

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• pain or burning when you urinate;

• swelling, rapid weight gain, urinating less or not at all;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, problems with vision, speech, or balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs; or

• increased blood pressure (severe headache, blurred vision, buzzing in your ears, shortness of breath).

Common side effects may include:

• mild headache;

• nausea, vomiting, diarrhea;

• back pain; 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 eculizumab: intravenous solution

Immunologic

Immunologic side effects have included herpes simplex infections (up to 7%), influenza-like illness (up to 5%), and immunogenicity (antibodies to eculizumab (the active ingredient contained in Soliris) detected in up to 3% of patients). Postmarketing cases of serious or fatal meningococcal infections have also been reported.

Respiratory

Respiratory side effects have included upper respiratory tract infection (up to 35%), nasopharyngitis (up to 23%), cough ( up to 14%), pharyngolaryngeal pain (up to 14%), sinusitis (up to 7%), and low titers of antibodies to eculizumab (the active ingredient contained in Soliris) (up to 3%).

Musculoskeletal

Musculoskeletal side effects have included back pain (up to 19%), pain in extremity (up to 11%), arthralgia (up to 7%), and myalgia (up to 7%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 32%), vomiting (up to 22%), nausea (up to 19%), abdominal pain (up to 11%), and constipation (up to 7%).

Hematologic

Hematologic side effects have included anemia (up to 24%), and leukopenia (up to 16%).

Cardiovascular

Cardiovascular side effects have included hypertension (up to 35%).

Nervous system

Nervous system side effects have included headache (up to 44%), vertigo (up to 11%), and dizziness (up to 5%).

General

General side effects have included fatigue (up to 12%), peripheral edema (up to 11%), and pyrexia (up to 11%).

Psychiatric

Psychiatric side effects have included insomnia (up to 14%).

Genitourinary

Genitourinary side effects have included urinary tract infection (up to 16%).

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