Note: This document contains side effect information about anifrolumab. Some dosage forms listed on this page may not apply to the brand name Saphnelo.
Applies to anifrolumab: intravenous solution.
Serious side effects of Saphnelo
Along with its needed effects, anifrolumab (the active ingredient contained in Saphnelo) 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 anifrolumab:
More common
- Back pain
- chest tightness
- chills
- cough or hoarseness
- cough producing mucus
- fever
- flushing
- headache
- lower back or side pain
- nausea and vomiting
- painful blisters on the trunk of the body
- painful or difficult urination
- trouble breathing
- weakness
Less common
- Difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- unusual tiredness or weakness
Other side effects of Saphnelo
Some side effects of anifrolumab 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
- Body aches or pain
- ear congestion
- loss of voice
- muscle aches
- sneezing
- sore throat
- stuffy or runny nose
- tender, swollen glands in the neck
For Healthcare Professionals
Applies to anifrolumab: intravenous solution.
General
The most common adverse drug reactions with an incidence of 5% or greater were nasopharyngitis, upper respiratory tract infections, urinary tract infection, bronchitis, infusion related reactions, herpes zoster, headache, back pain, sinusitis, and cough.[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea, nausea, oral herpes, vomiting
Genitourinary
Very common (10% or more): Urinary tract infection (12%)
Hypersensitivity
Common (1% to 10%): Hypersensitivity
Uncommon (0.1% to 1%): Anaphylactic reaction[Ref]
-Serious hypersensitivity reactions were reported in 0.6% of patients.[Ref]
Immunologic
Common (1% to 10%): Antibody development[Ref]
Local
-The most common infusion-related reaction symptoms were headache, nausea, vomiting, fatigue, and dizziness.[Ref]
Common (1% to 10%): Infusion-related reactions[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, arthralgia
Nervous system
Common (1% to 10%): Headache
Oncologic
-Malignant neoplasms, included non-melanoma skin cancers, were reported in 1.3% of patients.
-Malignancies that were reported in more than one patient included breast cancer and squamous cell carcinoma.[Ref]
Uncommon (0.1% to 1%): Malignancies[Ref]
Other
Very common (10% or more): Infections (69.7%)
Common (1% to 10%): Herpes zoster, serious Infections[Ref]
-The most frequent serious infection was pneumonia.
-Fatal infections occurred in 0.4% of patients.[Ref]
Respiratory
-Upper respiratory tract infections included nasopharyngitis and pharyngitis.
-Bronchitis included viral bronchitis and tracheobronchitis.
-Respiratory tract infection included viral respiratory tract infection and bacterial respiratory tract infection.[Ref]
Very common (10% or more): Bronchitis (11%), upper respiratory tract infection (34%), nasopharyngitis (16.3)
Common (1% to 10%): Cough, respiratory tract infection, sinusitis, cough, pharyngitis, pneumonia[Ref]
