Applies to crizanlizumab: intravenous solution.

Serious side effects of Crizanlizumab

Along with its needed effects, crizanlizumab 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 crizanlizumab:

More common

• Back, joint, or body pain
• chest pain or discomfort
• diarrhea
• difficulty with moving
• fever
• muscle pain or stiffness
• nausea and vomiting
• sore throat
• stomach pain

Less common

• Chest tightness
• chills
• dizziness
• flushing
• headache
• itching skin or rash
• sweating
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Confusion
• cough
• numbness or tingling in the face, arms, or legs
• trouble walking or speaking

Other side effects of Crizanlizumab

Some side effects of crizanlizumab 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

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to crizanlizumab: intravenous solution.

General

The most commonly reported adverse reactions have included nausea, arthralgia, back pain, and pyrexia.^[Ref]

Other

Very common (10% or more): Pyrexia (11%)

Gastrointestinal

Very common (10% or more): Nausea (18%)

Frequency not reported: Oropharyngeal pain, abdominal pain, diarrhea, vomiting

Musculoskeletal

Very common (10% or more): Arthralgia (18%), Back pain (15%)

Frequency not reported: Musculoskeletal chest pain, myalgia

Dermatologic

Frequency not reported: Pruritus

Genitourinary

Frequency not reported: Vulvovaginal pruritus

Immunologic

Common (1% to 10%): Anti-drug antibodies

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and therefore, comparison of the incidence of antibodies with the incidence of antibodies in other studies may be misleading. In a study in patients with sickle cell disease, 0 of 45 patients tested positive for anti-drug antibodies. In a study in healthy subjects 1 of 61 patients tested positive for antidrug antibodies.

Local

There have been postmarketing reports of infusion-related pain occurring in various locations during/within 24 hours of the infusion. Some cases have required hospitalization.

Frequency not reported: Infusion-site extravasation, infusion-site pain, infusion-site swelling

Postmarketing reports: Infusion-related pain occurring in various locations