Rystiggo

Rystiggo

Rystiggo

What is Rystiggo?

Generalized myasthenia gravis is a rare disease characterized by severe, life-threatening muscle weakness and can cause symptoms such as difficulty breathing, double vision, drooping eyelids, and difficulty swallowing, chewing, and speaking. The global prevalence is 100-350 cases per 1 million people and can occur in any race, gender and age.

Rystiggo (rozanolixizumab-noli) binds to and blocks a protein called neonatal Fc receptor (FcRn), which is involved in regulating autoantibody levels. The immune system of people with generalized myasthenia gravis produces autoantibodies that damage the acetylcholine receptors, preventing acetylcholine from activating them. In order for a muscle to contract, acetylcholine released from the end of a nerve must be able to bind to acetylcholine receptors. When autoantibodies damage these receptors, muscles cannot contract as well as normal, leading to muscle weakness and difficulty moving. Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody.

Rystiggo was approved by the FDA on June 27, 2023. It is the first treatment approved for the two most common subtypes of gMG in adults, anti-AChR and anti-MuSK antibody-positive gMG.

Warnings

Rystiggo may increase your risk of infection and should not be given if you currently have an infection. Call your doctor immediately if you experience fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising, or bleeding.

Serious cases of aseptic meningitis have been reported. Your doctor will monitor you for symptoms and initiate treatment if necessary.

Hypersensitivity reactions including angioedema and rash have occurred in some patients treated with Rystiggo. Your doctor will monitor you for hypersensitivity reactions during the infusion. Seek medical attention if allergic reactions occur after the infusion.

Before you take this medicine

To make sure Rystiggo is safe for you, tell your doctor if you:

• Sie haben derzeit eine Infektion oder hatten in letzter Zeit Infektionen
• Sie haben einen Impfstoff (Impfung) erhalten oder sollen diesen erhalten. Alle altersgerechten Impfungen sollten vor Beginn der Behandlung mit Rystiggo abgeschlossen sein. Die Verabreichung von Lebendimpfstoffen oder abgeschwächten Lebendimpfstoffen wird während der Behandlung nicht empfohlen
• Sie sind schwanger oder planen schwanger zu werden
• Sie stillen oder planen zu stillen.

Based on animal studies, Rystiggo can harm the fetus. It is not known whether Rystiggo passes into breast milk.

How is Rystiggo administered?

Rystiggo will be given by your doctor in his clinic. It is given subcutaneously (that is, under the skin) using an infusion pump into the lower right or lower left part of your abdominal area, but not near your navel.

The duration of the infusion depends on your drug dose, but the infusion rate is 20 ml/hour, meaning most infusions last 1 to 2 minutes. You will be monitored for hypersensitivity reactions during the infusion and for at least 15 minutes afterwards.

Rystiggo is usually given as a course of treatment given once a week for 6 weeks. The usual dosage depends on body weight:

• Weniger als 50 kg: 420 mg (3 ml zur Infusion). [1 minute])
• 50 kg bis weniger als 100 kg: 560 mg (4 ml zur Infusion). [1.3 minutes])
• 100 kg oder mehr: 840 mg (6 ml zur Infusion). [2 minutes]).

The line should not be flushed after use as the infusion volume has been adjusted to compensate for losses in the line.

The need for further courses of treatment depends on the response. The safety of starting subsequent cycles earlier than 63 days after the start of the previous treatment cycle has not been established.

What happens if I miss a dose?

If a scheduled dose is missed, Rystiggo may be administered up to 4 days after the scheduled time. Thereafter, the original dosage regimen should be continued until the treatment cycle is completed. Call your doctor for instructions if you miss an appointment for your infusion.

What happens if I overdose?

Because Rystiggo is administered by a doctor, an overdose is unlikely.

What should I avoid while taking Rystiggo?

You should avoid live vaccines while being treated with this medicine.

What side effects does Rystiggo have?

Get medical help right away if you notice any signs of an allergic reaction: hives; difficulty breathing; Swelling of your face, lips, tongue, or throat.

Call your doctor immediately if you have:

• Anzeichen einer Infektion – Fieber, Schüttelfrost, Halsschmerzen, Gliederschmerzen, ungewöhnliche Müdigkeit, Appetitlosigkeit, Blutergüsse oder Blutungen.

Common side effects of Rystiggo include:

• Kopfschmerzen
• Infektionen, einschließlich Infektionen der oberen Atemwege
• Durchfall
• Fieber
• Überempfindlichkeitsreaktionen
• Brechreiz
• Reaktionen auf der Verwaltungsseite
• Bauchschmerzen
• Gelenkschmerzen.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rystiggo?

Caution should be exercised when using Rystiggo with other drugs that bind to the human neonatal Fc receptor (FcRn) (e.g. immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass) as this may reduce the effectiveness of these drugs.

Rystiggo may interact with other prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you take and when you start, stop, or change the dose of a medicine.

storage

Store vials refrigerated at 2°C to 8°C in the original carton to protect from light until use. Do not freeze. Don't shake.

If necessary, vials can be stored in the original carton at room temperature up to 25°C for a single period of up to 30 days to protect the vial from light. Once a vial has been stored at room temperature, it should not be placed in the refrigerator. Discard the vial if it is not used within 30 days or the expiration date has expired, whichever comes first.

Ingredients

Injection: Rozanolixizumab-noli 280 mg/2 mL (140 mg/mL) single-dose glass vial.

Manufacturer

UCB, Inc.

References

1. Rystiggo-Produktinformationen

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