Rystiggo 420mg/3ml Sdv Inj, 3ml
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 an injectable medicine used to treat adults with generalized myasthenia gravis (gMG). It works by reducing the levels of certain antibodies in your blood that cause the muscle weakness in gMG.
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 immediately to your healthcare provider.
- Stay up-to-date on your vaccinations, but discuss live vaccines with your doctor before receiving them.
- Avoid close contact with people who are sick or have infections.
- Maintain good hygiene, including frequent hand washing.
- Follow your doctor's instructions for scheduled doses and follow-up appointments.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose is 7 mg/kg (actual body weight) administered as a subcutaneous infusion over approximately 15 minutes once weekly for 6 weeks. Subsequent doses are based on body weight: 420 mg (for patients < 65 kg) or 840 mg (for patients ≥ 65 kg) administered once weekly for 6 weeks. After the initial 6-week treatment period, subsequent treatment cycles are administered based on clinical response and tolerability.
Dose Range:
420 - 840 mg
Condition-Specific Dosing:
Generalized Myasthenia Gravis (gMG):
Initial: 7 mg/kg (actual body weight) SC once weekly for 6 weeks. Subsequent: 420 mg (<65 kg) or 840 mg (≥65 kg) SC once weekly for 6 weeks, followed by individualized cycles based on clinical response.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No dose adjustment necessary. Rozanolixizumab is not expected to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Pharmacology
Mechanism of Action
Rozanolixizumab is a humanized monoclonal antibody that binds to the neonatal Fc receptor (FcRn). This binding prevents FcRn from recycling immunoglobulin G (IgG), leading to increased catabolism and reduced serum levels of IgG, including pathogenic autoantibodies that drive generalized myasthenia gravis (gMG).
Pharmacokinetics
Absorption:
Bioavailability:
Not available (subcutaneous administration)
Tmax:
2-3 days (subcutaneous)
FoodEffect:
No known food effect
Distribution:
Vd:
Approximately 7.5 L
ProteinBinding:
Not applicable (binds to FcRn, not plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 13-14 days
Clearance:
Approximately 0.39 L/day
ExcretionRoute:
Degradation products excreted via general metabolic pathways
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Reduction in total IgG levels observed within days; clinical improvement in gMG symptoms can be seen within 1-2 weeks.
PeakEffect:
Peak reduction in IgG levels typically occurs within 2-3 weeks of initiation.
DurationOfAction:
Effects on IgG levels persist for several weeks after cessation of treatment, with levels returning to baseline over several months.
Confidence:
High
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
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, seek medical attention right away:
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 minor ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects or any other unusual symptoms, seek medical attention:
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 about side effects, consult 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, seek medical attention right away:
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 minor ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects or any other unusual symptoms, seek medical attention:
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 about side effects, consult 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, sore throat, cough, body aches, unusual fatigue, painful urination, skin redness or swelling.
- Symptoms of aseptic meningitis: severe headache, stiff neck, fever, nausea, vomiting, sensitivity to light, confusion.
- Signs of allergic reaction: rash, hives, itching, swelling of your face, lips, tongue, or throat, difficulty breathing.
- Any new or worsening muscle weakness or breathing difficulties.
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 adjust the dosage of any medication without first consulting 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 adjust the dosage of any medication without first consulting your doctor.
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 at a higher risk of developing infections. To minimize this risk, practice good hygiene by washing your hands frequently. Additionally, try to avoid close contact with individuals who have infections, colds, or the flu.
Before receiving any vaccinations, consult with your doctor. Certain vaccines may not be effective when taken with this medication, or they may increase your risk of infection. Ensure that you are up to date with all recommended vaccinations before starting 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 at a higher risk of developing infections. To minimize this risk, practice good hygiene by washing your hands frequently. Additionally, try to avoid close contact with individuals who have infections, colds, or the flu.
Before receiving any vaccinations, consult with your doctor. Certain vaccines may not be effective when taken with this medication, or they may increase your risk of infection. Ensure that you are up to date with all recommended vaccinations before starting 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. High doses may lead to excessive reduction in IgG levels, potentially increasing infection risk.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Call 911 or a poison control center (1-800-222-1222). Management is supportive.
Drug Interactions
Moderate Interactions
- Live attenuated vaccines (administer at least 4 weeks prior to or after a treatment cycle)
- Other immunosuppressants (potential for increased infection risk, though not a direct pharmacokinetic interaction)
Monitoring
Baseline Monitoring
Infection screening (e.g., Hepatitis B, Tuberculosis)
Rationale: To assess risk of infection before initiating immunosuppressive therapy.
Timing: Prior to first dose
Immunization status review
Rationale: To ensure patient is up-to-date on vaccinations and to plan for live vaccine administration.
Timing: Prior to first dose
Signs and symptoms of aseptic meningitis
Rationale: To establish baseline and educate patient on potential adverse event.
Timing: Prior to first dose
Routine Monitoring
Signs and symptoms of infection
Frequency: Throughout treatment and for several months after last dose
Target: Absence of signs/symptoms
Action Threshold: Prompt evaluation and treatment if infection suspected
Signs and symptoms of aseptic meningitis (e.g., headache, fever, stiff neck, photophobia, vomiting, confusion)
Frequency: Especially during the first 4 days after infusion
Target: Absence of signs/symptoms
Action Threshold: Discontinue treatment and evaluate if symptoms occur
Headache severity and frequency
Frequency: Regularly, especially post-infusion
Target: Tolerable or absent
Action Threshold: Consider symptomatic treatment or dose modification if severe/persistent
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, cough, unusual fatigue, painful urination)
- Symptoms of aseptic meningitis (severe headache, stiff neck, fever, nausea, vomiting, photophobia, confusion)
- Signs of hypersensitivity reactions (rash, hives, itching, shortness of breath, swelling of face/lips/tongue)
- Headache, diarrhea, nausea, abdominal pain, fatigue, dizziness
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of rozanolixizumab 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. Consider the potential for transient reduction in infant IgG levels.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of altered immune development.
Second Trimester:
IgG transfer increases, potential for fetal exposure and impact on immune system.
Third Trimester:
Significant IgG transfer, potential for transient neonatal IgG reduction and increased infection risk in the newborn.
Lactation
Human IgG is known to be present in human milk. The effects of rozanolixizumab on the breastfed infant or on milk production are unknown. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for rozanolixizumab and any potential adverse effects on the breastfed infant from rozanolixizumab or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk - no human data, but large molecule, likely low oral bioavailability for infant; potential for transient reduction in infant IgG levels if absorbed).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients. No dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Rystiggo is administered via subcutaneous infusion, which can be done at home by the patient or caregiver after proper training, or in a healthcare setting.
- Patients should be monitored for signs and symptoms of infection, especially during and after treatment cycles, due to the mechanism of action reducing IgG levels.
- Aseptic meningitis is a rare but serious adverse event; patients should be educated on symptoms and instructed to seek immediate medical attention if they occur.
- Headache is a very common side effect, often occurring within 48 hours of infusion. Patients should be advised on symptomatic management.
- Vaccination status should be reviewed prior to initiation; live attenuated vaccines should be avoided during treatment and for a period before/after.
Alternative Therapies
- Efgartigimod (Vyvgart, Vyvgart Hytrulo) - another FcRn inhibitor
- Eculizumab (Soliris) - C5 complement inhibitor
- Ravulizumab (Ultomiris) - C5 complement inhibitor
- Rituximab (Rituxan) - CD20 B-cell depleting antibody
- Intravenous Immunoglobulin (IVIg)
- Plasma Exchange (PLEX)
- Corticosteroids (e.g., Prednisone)
- Non-steroidal immunosuppressants (e.g., Azathioprine, Mycophenolate Mofetil, Cyclosporine)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per vial/dose per 420mg/3ml vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to 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 detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.
Proper disposal of unused or expired medications is crucial. Do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to 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 detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.