Applies to spesolimab: intravenous solution.
Serious side effects of Spesolimab
Along with its needed effects, spesolimab 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 spesolimab:
More common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- large, flat, blue, or purplish patches in the skin
- lower back or side pain
Less common
- Blistering, crusting, irritation, itching, or reddening of the skin
- bruising at the injection site
- body aches or pain
- chest pain
- chills
- cough
- coughing or spitting up blood
- ear congestion
- fever
- headache
- itching of the vagina or genitals
- loss of voice
- muscle aches
- night sweats
- sneezing
- sore throat
- stuffy or runny nose
- sudden high fever or low-grade fever for months
- swelling
- thick, white vaginal discharge with mild or no odor
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- Black, tarry stools
- bleeding, blistering, burning, coldness, discoloration of 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
- inability to move the arms and legs
- painful or difficult urination
- sores, ulcers, or white spots on the lips or in the mouth
- sudden numbness and weakness in the arms and legs
- swollen glands
- unusual bleeding or bruising
Other side effects of Spesolimab
Some side effects of spesolimab 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
- Change in hearing
- diarrhea
- earache
- ear drainage
- itching ears
- lack or loss of strength
- nausea
- vomiting
Less common
- Hives, itching, or skin rash
- swelling of the eye
For Healthcare Professionals
Applies to spesolimab: intravenous solution.
Dermatologic
Common (1% to 10%): Cellulitis, furuncle, herpes dermatitis, pruritus and prurigo, subcutaneous abscess, urticaria[Ref]
Two patients experienced drug reaction with eosinophilia and systemic symptoms (DRESS). The validation scoring for reported cases were "no DRESS" and "possible DRESS".[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (11%)
Common (1% to 10%): Gastritis, nausea and vomiting, oral herpes[Ref]
General
The most common adverse effects were infections. Infection occurred in 14% of patients during the first week of treatment as compared to 6% in the placebo group. The majority of infections reported were mild (29%) to moderate (71%).[Ref]
Genitourinary
Common (1% to 10%): Bacteriuria, urinary tract infection, vulvovaginal candidiasis, vulvovaginal mycotic infection[Ref]
Local
Common (1% to 10%): Infusion site hematoma and bruising
Not reported: Injection site reactions[Ref]
During clinical trials, injection site reactions (including injection site erythema, injection site swelling, injection site pain, injection site induration, and injection site warmth) were observed.[Ref]
Nervous system
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Guillain-Barre syndrome[Ref]
Ocular
Common (1% to 10%): Eye edema[Ref]
Other
Common (1% to 10%): Asthenia and fatigue, bacteremia, device-related infection, otitis externa[Ref]
Respiratory
Common (1% to 10%): Dyspnea, influenza, latent tuberculosis, upper respiratory tract infection[Ref]
