Note: This document contains side effect information about rozanolixizumab. Some dosage forms listed on this page may not apply to the brand name Rystiggo.
Applies to rozanolixizumab: subcutaneous solution.
Serious side effects of Rystiggo
Along with its needed effects, rozanolixizumab (the active ingredient contained in Rystiggo) 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 rozanolixizumab:
More common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- burning or stinging of the skin
- chills
- cough
- difficult, burning, or painful urination
- ear congestion
- fast heartbeat
- fever
- frequent urge to urinate
- headache
- lower back or side pain
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- skin itching, rash, or redness
- sneezing
- sore throat
- stuffy or runny nose
- swelling of the face, throat, or tongue
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- Nausea
- stiff neck or back
- vomiting
Other side effects of Rystiggo
Some side effects of rozanolixizumab 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 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
- diarrhea
- difficulty in moving
- joint pain
- muscle pain or stiffness
- stomach pain
For Healthcare Professionals
Applies to rozanolixizumab: subcutaneous solution.
General
Headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea were the prevailing adverse reactions observed in a minimum of 10% of patients who received treatment with this drug.[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (20%), nausea (10%)
Common (1% to 10%): Abdominal pain[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infections[Ref]
Hypersensitivity
-During clinical trials, hypersensitivity reactions were observed within a range of 1 day to 2 weeks following administration of this drug.
-One patient discontinued treatment with this drug due to a hypersensitivity reaction.
-Furthermore, local reactions at the site of administration were reported within 1 to 3 days after the most recent infusion of this drug.[Ref]
Very common (10% or more): Hypersensitivity reactions (11%)[Ref]
Local
Common (1% to 10%): Administration site reactions[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia[Ref]
Nervous system
-Cases of severe headache were reported in 5.3% of patients.
-A patient required hospitalization due to a severe headache, while another patient discontinued treatment as a result of a severe headache accompanied by fever, photophobia, phonophobia, nausea, and vertigo.[Ref]
Very common (10% or more): Headache (44%)[Ref]
Other
Very common (10% or more): Any infection (23%), pyrexia (17%)
Common (1% to 10%): Herpes simplex[Ref]
Respiratory
Very common (10% or more): COVID-19 infection (14%)
Common (1% to 10%): Upper respiratory tract infection[Ref]
Three fatal cases of pneumonia were identified, with two cases attributed to COVID-19 infection and one case caused by an unknown pathogen.[Ref]
