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

Applies to satralizumab: subcutaneous solution.

Serious side effects of Enspryng

Along with its needed effects, satralizumab (the active ingredient contained in Enspryng) 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 satralizumab:

More common

• Black, tarry stools
• body aches or pain
• burning feeling in the chest or stomach
• chills
• cough
• dark urine
• depression
• difficulty in moving
• dryness or soreness of the throat
• ear congestion
• falls
• fever
• headache
• hoarseness
• indigestion
• joint pain
• light-colored stools
• loss of voice
• lower back or side pain
• muscle pain or stiffness
• nausea and vomiting
• painful or difficult urination
• pain, redness, swelling, tenderness, or warmth on the skin
• pale skin
• skin rash, hives, itching
• sneezing
• sore throat
• stomach upset
• stuffy or runny nose
• tenderness in the stomach area
• tender, swollen glands in the neck
• trouble breathing or swallowing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right stomach pain
• weight gain
• yellow eyes and skin

Other side effects of Enspryng

Some side effects of satralizumab 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 satralizumab: subcutaneous solution.

Hematologic

Very common (10% or more): Neutropenia (10%), blood creatine phosphokinase^[Ref]

Immunologic

Very common (10% or more): Cellulitis (10%)

Frequency not reported: Potential for immunogenicity^[Ref]

Local

Frequency not reported: Injection site reaction, skin mass^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (17%), pain in extremity (15%)^[Ref]

Metabolic

Very common (10% or more): Weight gain (30%), cholesterol increased (15%)^[Ref]

Psychiatric

Very common (10% or more): Depression (10%)^[Ref]

Hepatic

Very common (10% or more): Fibrinogen levels increased (38%), ALT and AST elevated (43%)^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (31%), upper respiratory tract infection (19%), pharyngitis (12%)^[Ref]

Other

Very common (10% or more): Fatigue (15%), fall (10%)^[Ref]

General

The most common adverse reactions (15% or greater) were nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue, and nausea.^[Ref]

Nervous system

Very common (10% or more): Headache (27%)^[Ref]

Dermatologic

Very common (10% or more): Rash (17%), pruritus (12%)^[Ref]

Gastrointestinal

Very common (10% or more): Gastritis (15%), nausea (15%)^[Ref]