Rozanolixizumab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026🚩 Report this page

Rozanolixizumab

Active ingredient · 2 therapeutic classes

Sold as Rystiggo

GB MHRAEU EMACA Health Canada

Drug class: Monoclonal Antibodies
Availability: See label
Routes: Subcutaneous
Markets covered: 3
Products on record: 6

L04AGMonoclonal Antibodies L04ALNeonatal Fragment Crystallizable Receptor (Fcrn) Inhibitors

Overview

Rozanolixizumab is an active pharmaceutical ingredient in the Monoclonal Antibodies group (L04AG). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	May 22, 2026
EU European Union	EMA	1	January 16, 2026
CA Canada	Health Canada	4	May 7, 2026

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised May 22, 2026[1]

Rystiggo is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 16, 2026[2]

Rystiggo is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

How to take

CACanada· Health Canada

4 products

4 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

RYSTIGGOUCB CANADA INC

Sources & citations

[1]MHRA (UK) · PLGB000390808 · revised May 22, 2026
[2]European Medicines Agency · EMEA/H/C/005824 · revised January 16, 2026
[3]Health Canada (DPD) · 02556081 · revised May 7, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment should be initiated and supervised by specialist healthcare professionals experienced in the management of patients with neuromuscular or neuro- inflammatory disorders. Posology A treatment cycle consists of 1 dose per week for 6 weeks.
The following table indicates the recommended total weekly dose of rozanolixizumab according to the patient’s body weight. One or more vials might be needed to meet the appropriate volume to be administered, depending on vial size availability.
Body weight ≥ 35 to < 50 kg ≥ 50 to < 70 kg ≥ 70 to < 100 kg ≥ 100 kg Weekly dose (mg) 280 mg 420 mg 560 mg 840 mg Weekly dose (ml) 2 ml* 3 ml* 4 ml* 6 ml* * One ml of solution for injection contains 140 mg of rozanolixizumab. Each vial contains excess volume for priming of the infusion line, see “Instructions For Use in the Package leaflet ”.
Subsequent treatment cycles should be administered according to clinical evaluation. The frequency of treatment cycles may vary by patient. In the clinical development program, most patients had treatment-free intervals of 4-13 weeks between cycles.
From cycle to cycle approximately 10 % of patients had a treatment-free interval of less than 4 weeks. If a scheduled infusion is missed, rozanolixizumab may be administered up to 4 days after the scheduled time point. Thereafter, the original dosing schedule should be resumed until the treatment cycle is completed.
2). 73 m2). No data is available in patients with severe renal impairment. 2). Hepatic impairment No data is available in patients with hepatic impairment. 2). Paediatric population The safety and efficacy of rozanolixizumab in children and adolescents below the age of 18 years have not been established.
No data are available. Method of administration For subcutaneous use. It is recommended that rozanolixizumab is administered subcutaneously preferably into the lower right or lower left part of the abdomen, below the belly button. Infusions should not be given into areas where the skin is tender, erythematous, or indurated.
4). 6. 6. Rystiggo can be administered using: • An infusion pump (also known as syringe pump), or • By manual push with a syringe Rystiggo can be self-administered or administered by a caregiver, following the Instructions for Use after proper training by a healthcare professional on how to administer subcutaneous infusions.
6). If not using a programmable pump, the volume in the syringe should be adjusted to the prescribed dose prior to administration. Rozanolixizumab administration using an infusion pump should be performed at a constant flow rate up to 20ml/hr.
Infusion by manual push with a syringe Syringes and infusion sets appropriate for subcutaneous administration of medicinal products should be used. The volume in the syringe should be adjusted to the prescribed dose prior to administration.
Rozanolixizumab administration using a syringe should be performed at a flow rate that is comfortable for the patient. In clinical trials, infusion times by manual push ranged from 1 to 30 minutes with a median infusion time of 5 minutes per patient.
This range of infusion times may serve as a guide when training the patient or caregiver.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]

5 %). Tabulated list of adverse reactions Adverse reactions from clinical studies and post-marketing experience in gMG are listed in Table 1 below, classified by MedDRA System Organ Class (SOC). Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Frequency categories are defined as follows:
Very common ( ≥ 1/10); Common (1/100 to < 1/10); Uncommon ( ≥ 1/1 000 to < 1/100); Rare ( ≥ 1/10 000 to < 1/1 000); Very rare (< 1/10 000), not known (cannot be estimated from the available data). 4 %) of the patients treated with rozanolixizumab and placebo, respectively.
Headache occurred most frequently after the first infusion of rozanolixizumab and within 1 to 4 days after infusion. 8 % [n=12]) and there was no increase in incidences of headache with repeated cyclic treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]

4. 4. 1. 6. Rystiggo has an osmolality of 309-371 mOsmol/kg. 1 Therapeutic indications Rystiggo is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
2 Posology and method of administration Treatment should be initiated and supervised by specialist healthcare professionals experienced in the management of patients with neuromuscular or neuro- inflammatory disorders. Posology A treatment cycle consists of 1 dose per week for 6 weeks.
The following table indicates the recommended total weekly dose of rozanolixizumab according to the patient’s body weight. One or more vials might be needed to meet the appropriate volume to be administered, depending on vial size availability.
Body weight ≥ 35 to < 50 kg ≥ 50 to < 70 kg ≥ 70 to < 100 kg ≥ 100 kg Weekly dose (mg) 280 mg 420 mg 560 mg 840 mg Weekly dose (ml) 2 ml* 3 ml* 4 ml* 6 ml* * One ml of solution for injection contains 140 mg of rozanolixizumab. Each vial contains excess volume for priming of the infusion line, see “Instructions For Use in the Package leaflet ”.
Subsequent treatment cycles should be administered according to clinical evaluation. The frequency of treatment cycles may vary by patient. In the clinical development program, most patients had treatment-free intervals of 4-13 weeks between cycles.
From cycle to cycle approximately 10 % of patients had a treatment-free interval of less than 4 weeks. If a scheduled infusion is missed, rozanolixizumab may be administered up to 4 days after the scheduled time point. Thereafter, the original dosing schedule should be resumed until the treatment cycle is completed.
2). 73 m2). No data is available in patients with severe renal impairment. 2). Hepatic impairment No data is available in patients with hepatic impairment. 2). Paediatric population The safety and efficacy of rozanolixizumab in children and adolescents below the age of 18 years have not been established.
No data are available. Method of administration For subcutaneous use. It is recommended that rozanolixizumab is administered subcutaneously preferably into the lower right or lower left part of the abdomen, below the belly button. Infusions should not be given into areas where the skin is tender, erythematous, or indurated.
4). 6. 6. Rystiggo can be administered using: • An infusion pump (also known as syringe pump), or • By manual push with a syringe Rystiggo can be self-administered or administered by a caregiver, following the Instructions for Use after proper training by a healthcare professional on how to administer subcutaneous infusions.
6). If not using a programmable pump, the volume in the syringe should be adjusted to the prescribed dose prior to administration. Rozanolixizumab administration using an infusion pump should be performed at a constant flow rate up to 20ml/hr.

This is not medical advice. Consult a qualified healthcare professional.

Treatment should be initiated and supervised by specialist healthcare professionals experienced in the management of patients with neuromuscular or neuro-inflammatory disorders. Posology A treatment cycle consists of 1 dose per week for 6 weeks.
3 The following table indicates the recommended total weekly dose of rozanolixizumab according to the patient’s body weight. One or more vials might be needed to meet the appropriate volume to be administered, depending on vial size availability.
Body weight ≥ 35 to <50 kg ≥ 50 to < 70 kg ≥ 70 to < 100 kg ≥ 100 kg Weekly dose (mg) 280 mg 420 mg 560 mg 840 mg Weekly dose (ml) 2 ml* 3 ml* 4 ml* 6 ml* * One ml of solution for injection contains 140 mg of rozanolixizumab. Each vial contains excess volume for priming of the infusion line, see “Instructions For Use” in the Package leaflet.
Subsequent treatment cycles should be administered according to clinical evaluation. The frequency of treatment cycles may vary by patient. In the clinical development program, most patients had treatment-free intervals of 4-13 weeks between cycles.
From cycle to cycle approximately 10 % of patients had a treatment-free interval of less than 4 weeks. If a scheduled infusion is missed, rozanolixizumab may be administered up to 4 days after the scheduled time point. Thereafter, the original dosing schedule should be resumed until the treatment cycle is completed.
2). 73 m2). No data is available in patients with severe renal impairment. 2). Hepatic impairment No data is available in patients with hepatic impairment. 2). Paediatric population The safety and efficacy of rozanolixizumab in children and adolescents below the age of 18 years have not been established.
No data are available. Method of administration For subcutaneous use. It is recommended that rozanolixizumab is administered subcutaneously preferably into the lower right or lower left part of the abdomen, below the belly button. Infusions should not be given into areas where the skin is tender, erythematous, or indurated.
4). 6. 6. Rystiggo can be administered using: 4 • An infusion pump (also known as syringe pump), or • By manual push with a syringe Rystiggo can be self-administered or administered by a caregiver, following the Instructions for Use after proper training by a healthcare professional on how to administer subcutaneous infusions.
6). If not using a programmable pump, the volume in the syringe should be adjusted to the prescribed dose prior to administration. Rozanolixizumab administration using an infusion pump should be performed at a constant flow rate up to 20 ml/hr.
Infusion by manual push with a syringe Syringes and infusion sets appropriate for subcutaneous administration of medicinal products should be used. The volume in the syringe should be adjusted to the prescribed dose prior to administration.
Rozanolixizumab administration using a syringe should be performed at a flow rate that is comfortable for the patient. In clinical trials, infusion times by manual push ranged from 1 to 30 minutes with a median infusion time of 5 minutes per patient.
This range of infusion times may serve as a guide when training the patient or caregiver.