Loading…
Rystiggo is a brand name for Rozanolixizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's EMA label. Tap a section to expand.
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.
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
4. 4. 1. 3. 6. Rystiggo has an osmolality of 309-371 mOsmol/kg. 4. 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.
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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
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. 1. 4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Myasthenic crisis Treatment with rozanolixizumab in patients with impending or manifest myasthenic crisis has not been studied. 5). Aseptic meningitis Aseptic meningitis (drug induced aseptic meningitis) has been reported following rozanolixizumab treatment.
If symptoms consistent with aseptic meningitis (headache, pyrexia, neck stiffness, nausea, vomiting) occur, diagnostic workup and treatment should be initiated as per standard of care. Infections As rozanolixizumab causes transient reduction in IgG levels the risk of […]