Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
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.
Treatment should be initiated and supervised by specialist healthcare professionals experienced in the management of patients with neuromuscular or neuro-inflammatory disorders.
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:
| 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 |
| Number of vials to be used* | 1 | 2 | 2 | 3 |
* each vial contains excess volume for priming of the infusion line, see “Method of administration”.
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.
No dose adjustment is required (see section 5.2).
Limited safety and efficacy data is available in patients with mild to moderate renal impairment (eGFR >45 ml/min/1.73 m²). No data is available in patients with severe renal impairment. No dose adjustment is considered necessary as the pharmacokinetics of rozanolixizumab are unlikely to be affected by renal impairment (see section 5.2).
No data is available in patients with hepatic impairment. No dose adjustment is considered necessary as the pharmacokinetics of rozanolixizumab are unlikely to be affected by hepatic impairment (see section 5.2).
The safety and efficacy of rozanolixizumab in children and adolescents below the age of 18 years have not been established. No data are available.
For subcutaneous use.
For subcutaneous infusion using a pump.
Infusion pumps, syringes and infusion sets appropriate for subcutaneous administration of medicinal products should be used (see section 6.6). It is recommended to use pumps where administered volume can be pre-set as each vial contains excess volume for priming of the infusion line.
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.
During administration of the first treatment cycle and administration of the first dose of the second treatment cycle of rozanolixizumab, appropriate treatment for injection and hypersensitivity-related reactions should be readily available (see section 4.4).
Rozanolixizumab is administered using an infusion pump at a constant flow rate up to 20 ml/hr.
For further instructions on material specificities for administration, see section 6.6.
Before administering rozanolixizumab, the instructions for use must be read carefully, see section 6.6.
There are no data on symptoms associated with an overdose. Single subcutaneous dose of up to 20 mg/kg (2 162 mg) and weekly subcutaneous doses of ≈10 mg/kg (1 120 mg) for up to 52 weeks have been administered per protocol in clinical studies without dose limiting toxicity.
In case of overdose, it is recommended that patients are monitored closely for any adverse reactions, and appropriate supportive measures should be instituted immediately.
2 years.
The chemical and physical in-use stability has been demonstrated for 19 hours at 25°C. From a microbiological point of view, unless the method of preparation precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
2 ml solution in a vial (Type I glass) with a stopper (rubber) sealed with a crimp seal and flip off cap.
Pack size of 1 vial.
The rozanolixizumab solution for injection can be administered using polypropylene syringes as well as infusion sets containing polyethylene (PE), low density polyethylene (LDPE), polyester, polyvinyl chloride (PVC without DEHP), polycarbonate (PC), fluorinated ethylene polypropylene (FEP), urethane/acrylate, polyurethane, meta-acrylonitrile butadiene styrene (MABS), silicone or cyclohexanone. Do not use administration devices labelled as containing di(2-ethylhexyl)phthalate (DEHP).
In order to avoid potential interruptions in delivery of Rystiggo, the following criteria should be respected:
Each vial is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Before administering Rystiggo, the instructions for use must be read carefully (for further details please refer to the instructions for use included in the patient information leaflet):
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