Rystiggo 280mg/2ml Inj, 2ml
It is used to treat myasthenia gravis.
Drug Class
Immunosuppressant
Pharmacologic Class
Neonatal Fc Receptor (FcRn) Blocker
Pregnancy Category
Not available
FDA Approved
Jun 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Rystiggo is a medicine given by injection that helps reduce the levels of certain antibodies in your blood that cause muscle weakness in generalized myasthenia gravis (gMG). By lowering these antibodies, it can help improve your muscle strength and reduce your gMG symptoms.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an infusion into the fatty tissue under the skin over a period of time. You will be closely monitored during and after the infusion. Be sure to discuss any questions or concerns with your doctor.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an infusion into the fatty tissue under the skin over a period of time. You will be closely monitored during and after the infusion. Be sure to discuss any questions or concerns with your doctor.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Report any signs of infection (fever, chills, cough, sore throat) immediately to your doctor.
- Discuss vaccination plans with your doctor, as live vaccines may not be recommended during treatment.
- Attend all scheduled appointments for infusions and monitoring tests.
- Maintain good hygiene to reduce the risk of infection.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
7 mg/kg intravenous infusion once weekly for 6 weeks. Subsequent treatment cycles are based on clinical evaluation.
Condition-Specific Dosing:
generalizedMyastheniaGravis:
7 mg/kg IV infusion over approximately 15 minutes, once weekly for 6 weeks. Subsequent cycles should be individualized based on clinical response and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Dialysis:
No specific recommendations; not expected to be significantly removed by dialysis due to large molecular size.
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Pharmacology
Mechanism of Action
Rozanolixizumab is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn). This binding prevents FcRn from recycling IgG antibodies, leading to increased catabolism and reduced serum levels of total IgG, including pathogenic autoantibodies (e.g., anti-AChR, anti-MuSK) that drive generalized myasthenia gravis (gMG).
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
End of infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 5.5 L
ProteinBinding:
Not applicable (binds to FcRn, not plasma proteins in the typical sense)
CnssPenetration:
Limited (large molecule, but can reduce autoantibodies in CNS if present)
Elimination:
HalfLife:
Approximately 10-11 days
Clearance:
Approximately 0.38 L/day
ExcretionRoute:
Degraded into amino acids and peptides, which are then recycled or excreted.
Unchanged:
Not applicable (undergoes catabolism)
Pharmacodynamics
OnsetOfAction:
Reduction in total IgG levels observed within days of first dose.
PeakEffect:
Maximum reduction in total IgG levels typically observed within 2-3 weeks of treatment initiation.
DurationOfAction:
Effects on IgG levels persist for several weeks after the last dose, gradually returning to baseline.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Symptoms of aseptic meningitis, a severe brain problem, such as:
+ Headache
+ Fever
+ Chills
+ Severe nausea or vomiting
+ Stiff neck
+ Rash
+ Sensitivity to bright lights
+ Drowsiness
+ Confusion
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:
Headache
Common cold symptoms
Stomach pain or diarrhea
Mild fever
Upset stomach
Joint pain
Irritation at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Symptoms of aseptic meningitis, a severe brain problem, such as:
+ Headache
+ Fever
+ Chills
+ Severe nausea or vomiting
+ Stiff neck
+ Rash
+ Sensitivity to bright lights
+ Drowsiness
+ Confusion
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:
Headache
Common cold symptoms
Stomach pain or diarrhea
Mild fever
Upset stomach
Joint pain
Irritation at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of infection: fever, chills, body aches, fatigue, cough, sore throat, painful urination, skin redness or swelling.
- Signs of allergic reaction: rash, hives, itching, difficulty breathing, swelling of your face, lips, tongue, or throat, dizziness, feeling faint.
- Headache, diarrhea, nausea, vomiting (common side effects).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you currently have an infection.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you currently have an infection.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or the flu.
Before receiving any vaccinations, consult with your doctor, as the use of certain vaccines in combination with this medication may increase the risk of infection or reduce the vaccine's effectiveness. Ensure that you are up to date with all recommended vaccinations before initiating treatment with this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or the flu.
Before receiving any vaccinations, consult with your doctor, as the use of certain vaccines in combination with this medication may increase the risk of infection or reduce the vaccine's effectiveness. Ensure that you are up to date with all recommended vaccinations before initiating treatment with this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well established, but may include exaggerated adverse effects such as increased risk of infection or severe hypersensitivity reactions.
What to Do:
In case of suspected overdose, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention immediately. Management should be supportive and directed at treating any clinical manifestations.
Drug Interactions
Moderate Interactions
- Live attenuated vaccines (due to potential for reduced vaccine efficacy and increased risk of infection)
Monitoring
Baseline Monitoring
Total IgG levels
Rationale: To establish baseline and monitor the extent of IgG reduction, which correlates with efficacy and potential for infection.
Timing: Prior to initiation of treatment.
Signs and symptoms of infection
Rationale: Patients are at increased risk of infection due to reduced IgG levels.
Timing: Prior to initiation of treatment.
Routine Monitoring
Total IgG levels
Frequency: Periodically during treatment cycles and before subsequent cycles.
Target: Not a specific target range, but monitor for significant reduction and consider clinical status.
Action Threshold: Consider delaying or discontinuing treatment if IgG levels fall below 5 g/L or if clinically significant infection occurs.
Signs and symptoms of infection (e.g., fever, chills, malaise, localized symptoms)
Frequency: Regularly during treatment and for several weeks after the last dose.
Target: Absence of infection
Action Threshold: Promptly evaluate and treat any suspected infection. Consider interrupting treatment if a serious infection develops.
Hypersensitivity reactions (e.g., rash, urticaria, dyspnea, hypotension)
Frequency: During and after infusion.
Target: Absence of reaction
Action Threshold: Stop infusion immediately and initiate appropriate medical management if a reaction occurs.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, cough, dysuria, skin redness/swelling)
- Symptoms of hypersensitivity reactions (rash, hives, itching, shortness of breath, dizziness, swelling of face/lips/tongue)
- Worsening of myasthenia gravis symptoms (though this is the target of treatment, monitor for paradoxical worsening or lack of improvement)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Rystiggo in pregnant women. IgG antibodies are known to cross the placental barrier. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal exposure to IgG antibody.
Second Trimester:
Potential for fetal exposure to IgG antibody.
Third Trimester:
Potential for fetal exposure to IgG antibody; may affect neonatal IgG levels.
Lactation
It is unknown whether rozanolixizumab is excreted in human milk. Maternal IgG is known to be present in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Rystiggo and any potential adverse effects on the breastfed infant from Rystiggo or from the underlying maternal condition.
Infant Risk:
Unknown; potential for infant exposure to rozanolixizumab and reduced IgG levels in breastfed infant.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients. Dose adjustment is not required based on age.
Clinical Information
Clinical Pearls
- Rystiggo is an FcRn blocker, a novel mechanism for treating gMG by reducing pathogenic IgG autoantibodies.
- Patients should be monitored for signs and symptoms of infection due to the reduction in total IgG levels.
- Live attenuated vaccines are generally not recommended during treatment with Rystiggo due to the immunosuppressive effects.
- Administered as an intravenous infusion, typically in a healthcare setting.
- Individualized treatment cycles are based on clinical response and tolerability after the initial 6-week course.
Alternative Therapies
- Efgartigimod (Vyvgart) - another FcRn blocker
- Eculizumab (Soliris) - C5 complement inhibitor
- Ravulizumab (Ultomiris) - C5 complement inhibitor
- Rituximab (Rituxan) - CD20 B-cell depleter (off-label for gMG)
- Corticosteroids (e.g., prednisone)
- Immunosuppressants (e.g., azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus)
- Intravenous Immunoglobulin (IVIg)
- Plasma Exchange (PLEX)
Cost & Coverage
Average Cost:
High (specialty drug) per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, may have step therapy)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.