What is Rystiggo?
Rystiggo (rozanolixizumab-noli) is a subcutaneous (under the skin) injection for infusion that may be used to improve muscle weakness in adults with generalized myasthenia gravis who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. The rare disease generalized myasthenia graveis can cause severe, life-threatening muscular weakness. Symptoms include difficulty breathing, double sight, drooping eyes, difficulty chewing and speaking, as well as difficulties swallowing and chewing. Globally, there are 100–350 cases for every 1,000,000 people. It can affect any age group, race, or gender. Rystiggo (rozanolixizumab-noli) works by binding to and inhibiting an important protein called neonatal Fc receptor, known as FcRn, that plays an essential role in controlling autoantibody levels. Autoantibodies produced by people with generalized MG damage acetylcholine receptors. This prevents them from being activated by acetylcholine. Acetylcholine from the nerve end must attach to receptors for a muscle to contract. Autoantibodies can damage these receptors and cause muscle weakness. Rozanolixizumab is a monoclonal IgG4 antibody that has been humanized. Rystiggo's FDA approval date is June 27, 2023. Rystiggo is the first FDA-approved treatment for two of the most common subtypes of gMG in adults: anti-AChR antibody-positive and anti-MuSK antibody-positive gMG.
Warnings
Rystiggo may increase your infection risk. Do not take it if you are currently infected. If you experience fever, chills or sore throats, body aches, unusual fatigue, loss of appetite, bruising, or bleeding, call your doctor immediately. Aseptic meningitis has been linked to serious events. Your doctor will monitor your symptoms and treat you if needed. Rystiggo has been associated with hypersensitivity reactions, including angioedema. During your infusion, your doctor will monitor for hypersensitivity reactions. If you experience any type of allergic reaction after the infusion, seek medical attention.
Similar/related drugs
pyridostigmine, Mestinon, Neostigmine, Soliris, Ultomiris, and Vyvgart
Before you take this drug
Tell your doctor about any of the following to ensure that Rystiggo will be safe for you:
- Have you recently had an infection?
- Received or scheduled to receive an immunization. Before starting Rystiggo, all immunizations appropriate to the child's age should be completed. It is not recommended to administer live or live-attenuated vaccines during treatment.
- Are You Pregnant or Planning on Becoming Pregnant? If this is true for you then congratulations - that means it's likely you have or plan to become pregnant in the near future!
- Are you breastfeeding or planning to breastfeed?
According to animal studies, Rystiggo could cause harm to a fetus. Rystiggo may pass into breast milk, but this is not known.
How to take Rystiggo?
Your healthcare provider will administer Rystiggo in their clinic. The infusion pump will deliver Rystiggo subcutaneously, which means beneath the skin. It is administered in the lower right and lower left areas of your abdomen, but not near your navel. Infusion times vary depending on the dose, but most will last between 1 and 2 minutes. You will be closely monitored during and after the infusion for any hypersensitivity reactions.
Rystiggo is usually administered in a 6-week treatment cycle, which is given once per week. The dosage is determined by the body weight.
- Less than 50kg : 420mg (3 mL infused in 1 minute)
- 50kg to less than 100kg: 560mg (4 mL infused in 1.3 minutes)
- 100kg and more: 840mg (6 mL infused in 2 minutes).
After use, the line does not need to be flushed as the volume of infusion has already been adjusted for the loss in the line. It is dependent on the patient's response to whether or not they need to continue treatment. It has not been proven that it is safe to initiate subsequent cycles earlier than 63 days after the last treatment cycle.
What happens if I miss the dose?
Rystiggo can be given up to four days after a missed dose. The original schedule of dosing should then be followed until the entire treatment cycle has been completed. If you miss your appointment for an infusion, call your doctor to get instructions.
What happens if I overdose?
Rystiggo will be administered by a healthcare professional, so it is unlikely you will overdose.
What should be avoided?
Avoid receiving live vaccines if you are taking this medication.
Side effects of Rystiggo?
If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives, difficulty breathing, swelling of the face, lips, or tongue, or throat swelling.
If you experience:
- Signs of infection include fever, chills, and a sore throat. Body aches. Loss of appetite.
Rystiggo is commonly associated with the following side effects:
- Headache
- Infections, including upper respiratory tract infections
- Diarrhea
- Fever
- Hypersensitivity reactions
- Nausea
- Site reactions to administration
- Abdominal pain
- Joint pain.
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Interaction with other drug
Rystiggo may decrease the effectiveness of other medications that bind the neonatal FcRn (such as monoclonal antibodies, immunoglobulins, or antibodies derived from the IgG-subclass human Fc domain). Rystiggo can interact with prescription and non-prescription medicines, vitamins, and herbal products. Inform your doctor of all the other medications you take, as well as when you change or stop taking any medication.
