Rozanolixizumab
Rozanolixizumab is a humanized monoclonal antibody that targets the neonatal Fc receptor (FcRn) to reduce circulating IgG antibody levels. It is used in adults with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific kinase antibody positive. By lowering pathogenic IgG antibodies, it helps improve symptoms of muscle weakness and fatigue.
Rozanolixizumab is an FcRn inhibitor that reduces IgG antibodies to treat generalized myasthenia gravis.
Key facts at a glance
- ATC
- L04AG16
- RxNorm
- 2642274
- Generic
- Rozanolixizumab
- Class
- atc-l04
- Brands
- Rystiggo
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 680mg weekly
- Maximum
- consult physician
- Frequency
- once weekly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- weight-based dosing
- Maximum
- consult physician
- Frequency
- per protocol
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 680mg weekly
- Maximum
- consult physician
- Frequency
- once weekly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus
regular fetal monitoring recommended
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
use only if benefits outweigh potential risks
regular fetal growth and development monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
crosses placenta; consider risks vs benefits
fetal monitoring and assessment at birth
Use with caution and monitor for adverse effects.
lactation
breastfeedingno adjustment
decision to discontinue breastfeeding or therapy should consider infant exposure and maternal benefit
monitor infant for signs of infection or immune effects
Use with caution and monitor for adverse effects.
pediatric_age
children under 18not applicable
not approved for use in pediatric patients
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 years and olderno adjustment
no dose adjustment required; monitor renal function
standard monitoring including renal function
renal_impairment
mild to moderateno adjustment
no dose adjustment needed for mild to moderate impairment
routine monitoring
renal_impairment
severeuse with caution
limited data in severe impairment; use with caution
close monitoring recommended
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateuse with caution
limited data; use with caution
monitor liver function
Use with caution and monitor for adverse effects.
hepatic_impairment
severeuse with caution
not studied in severe hepatic impairment; use only if benefits outweigh risks
close monitoring of liver function
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for generalized myasthenia gravis
Drug class
Drug class information
Primary indication
Therapeutic indication
Mechanism of action
Pharmacological mechanism
Rozanolixizumab is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are seropositive for anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies.
As an FcRn antagonist, rozanolixizumab binds to the neonatal Fc receptor (FcRn), which normally protects IgG antibodies from degradation and recycles them in the bloodstream. By blocking FcRn, the medication accelerates the breakdown of IgG, including pathogenic autoantibodies, thereby reducing overall circulating IgG levels.
Rozanolixizumab is administered via subcutaneous infusion. Common adverse reactions include headache, diarrhea, and infections. Patients should be monitored for signs of infection during treatment. It may lower immunoglobulin levels; consider暂停 in patients with active infections until resolved.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy