Rystiggo

— THERAPEUTIC CATEGORIES —
  • Myasthenia gravis
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Rystiggo Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Rozanolixizumab-noli 140mg/mL; soln for SC infusion; preservative-free.

    Pharmacological Class

    Neonatal Fc receptor blocker.

    How Supplied

    Single-dose vial (2mL)—1

    Storage

    Store vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the time of use. Do not freeze. Do not shake.
    If needed, vials may be stored at room temperature up to 77°F (25°C) for a single period of up to 30 days in the original carton to protect the vial from light. Once a vial has been stored at room temperature, it should not be returned to the refrigerator. The discard date is 30 days after removal of the vial from the refrigerator. Write the discard date in
    the space provided on the carton. Discard the vial if not used within 30 days or if the expiration date has passed, whichever occurs first. 

    Manufacturer

    UCB Inc.

    Generic Availability

    NO

    Mechanism of Action

    Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.

    Rystiggo Indications

    Indications

    Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

    Rystiggo Dosage and Administration

    Adult

    Give by SC only (with infusion pump) at a rate of up to 20mL/hr once weekly for 6 weeks. <50kg: 420mg; 50–<100kg: 560mg; ≥100kg: 840mg. Administer subsequent cycles based on clinical evaluation. Safety of initiating subsequent cycles sooner than 63 days from the start of the previous treatment cycle: not established. 

    Children

    Not established.

    Rystiggo Contraindications

    Not Applicable

    Rystiggo Boxed Warnings

    Not Applicable

    Rystiggo Warnings/Precautions

    Warnings/Precautions

    Increased risk for infection; monitor. Delay treatment in those with an active infection until resolved. If serious infection occurs, treat appropriately and consider withholding Rystiggo until resolved. Evaluate for age-appropriate vaccinations according to guidelines prior to initiation of a new treatment cycle. Evaluate and treat appropriately if aseptic meningitis develop. Monitor for hypersensitivity reactions during and for 15mins after administration; discontinue if occurs. Pregnancy. Nursing mothers.

    Rystiggo Pharmacokinetics

    Absorption

    Peak plasma levels achieved: after ~2 days.

    Distribution

    Apparent volume of distribution: 6.6 L.

    Metabolism

    Proteolytic enzymes into small peptides and amino acids.

    Elimination

    Apparent clearance: 0.89 L/day.

     

    Rystiggo Interactions

    Interactions

    Concomitant live or live-attenuated vaccines: not recommended. May antagonize immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass; closely monitor for reduced effects; if concomitant long-term use is necessary, consider discontinuing Rystiggo and use alternatives.

    Rystiggo Adverse Reactions

    Adverse Reactions

    Headache, infections, diarrhea, pyrexia, hypersensitivity reactions, nausea; aseptic meningitis.

    Rystiggo Clinical Trials

    Clinical Trials

    The approval was based on data from the phase 3 MycarinG study (ClinicalTrials.gov Identifier: NCT03971422), which included 200 adults with gMG. Patients were randomly assigned 1:1:1 to receive weekly rozanolixizumab 7mg/kg, rozanolixizumab 10mg/kg, or placebo subcutaneously for 6 weeks, followed by an 8-week observation period.

    Results showed that treatment with rozanolixizumab met the primary endpoint demonstrating a significant improvement in the Myasthenia Gravis-Activities of Daily Living total score at day 43, with a least square mean difference vs placebo of -2.6 points at both the 7mg/kg dose and 10mg/kg dose (both doses P <.001).

    Additionally, a statistically significant difference in the Quantitative Myasthenia Gravis total score at day 43 (key secondary endpoint) was observed with rozanolixizumab, with a least square mean difference vs placebo of -3.5 points at the 7mg/kg dose and -4.8 points at the 10mg/kg dose (both doses P <.001).

    Rystiggo Note

    Not Applicable

    Rystiggo Patient Counseling

    See Literature

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