Rystiggo 560mg/4ml Sdv Inj, 4ml
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 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. It is given as an injection under the skin.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. Take this medication exactly as directed. It is administered as an infusion into the subcutaneous tissue over a specified period. You will be closely monitored during and after the infusion. 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 to you. Take this medication exactly as directed. It is administered as an infusion into the subcutaneous tissue over a specified period. You will be closely monitored during and after the infusion. 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 (e.g., fever, chills, sore throat, cough) to your doctor immediately.
- Stay up-to-date on all recommended vaccinations. Discuss any live vaccines with your doctor before receiving them.
- Maintain good hygiene to reduce the risk of infection.
- Follow your doctor's instructions for self-injection technique if you are administering the medication at home.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial treatment cycle: 560 mg (for patients < 50 kg) or 720 mg (for patients ≥ 50 kg) administered subcutaneously once weekly for 6 weeks. Subsequent treatment cycles are based on clinical response and may be initiated no sooner than 63 days (9 weeks) after the start of the previous cycle.
Dose Range:
560 - 720 mg
Condition-Specific Dosing:
generalized_myasthenia_gravis:
560 mg (for patients < 50 kg) or 720 mg (for patients ≥ 50 kg) SC once weekly for 6 weeks. Subsequent cycles based on clinical response, no sooner than 63 days after previous cycle start.
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 specific dose adjustment recommended, as it is a large protein not significantly cleared 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 specifically binds to the neonatal Fc receptor (FcRn). By blocking FcRn, rozanolixizumab prevents FcRn from recycling immunoglobulin G (IgG) antibodies, leading to increased catabolism and reduced serum levels of pathogenic IgG autoantibodies, which are implicated in the pathophysiology of generalized myasthenia gravis (gMG).
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 65% (subcutaneous)
Tmax:
Approximately 2-3 days
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 6.5 L
ProteinBinding:
Binds specifically to FcRn; not extensively bound to other plasma proteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 13-14 days
Clearance:
Approximately 0.35 L/day
ExcretionRoute:
Catabolism/cellular degradation
Unchanged:
Not applicable (protein degradation)
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 after the start of a treatment cycle.
DurationOfAction:
Effects on IgG levels persist for several weeks after the last dose, gradually returning towards baseline.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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 do not heal
Symptoms of aseptic meningitis, a severe brain problem, such as:
+ Headache
+ Fever
+ Chills
+ Severe nausea or vomiting
+ Stiff neck
+ Rash
+ Sensitivity to light
+ Drowsiness
+ Confusion
Other Possible Side Effects
Most people taking this medication do not experience severe side effects. However, some may occur. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Headache
Common cold symptoms
Stomach pain or diarrhea
Mild fever
Upset stomach
Joint pain
Irritation at the injection site
This is not a comprehensive list of all possible 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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 do not heal
Symptoms of aseptic meningitis, a severe brain problem, such as:
+ Headache
+ Fever
+ Chills
+ Severe nausea or vomiting
+ Stiff neck
+ Rash
+ Sensitivity to light
+ Drowsiness
+ Confusion
Other Possible Side Effects
Most people taking this medication do not experience severe side effects. However, some may occur. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Headache
Common cold symptoms
Stomach pain or diarrhea
Mild fever
Upset stomach
Joint pain
Irritation at the injection site
This is not a comprehensive list of all possible 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, body aches, cough, sore throat, unusual fatigue, painful urination, skin redness/swelling)
- Signs of allergic reaction (rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, dizziness, feeling faint)
- Headache that is severe or persistent
- Diarrhea that is severe or persistent
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 whether 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 whether 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 flu.
Before receiving any vaccinations, consult with your doctor, as certain vaccines may not be effective or may increase your risk of infection when taken with this medication. Ensure 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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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 flu.
Before receiving any vaccinations, consult with your doctor, as certain vaccines may not be effective or may increase your risk of infection when taken with this medication. Ensure 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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established for monoclonal antibodies. High doses may lead to excessive reduction in IgG levels, potentially increasing infection risk.
What to Do:
In case of suspected overdose, contact a poison control center or emergency medical services immediately. Management should be supportive and directed at the patient's symptoms. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Immunoglobulin G (IgG) levels
Rationale: To establish baseline and monitor therapeutic effect (reduction in IgG).
Timing: Prior to initiation of treatment.
Signs and symptoms of infection
Rationale: To assess baseline infection status, as treatment may increase infection risk.
Timing: Prior to initiation of treatment.
Vaccination status
Rationale: To ensure patients are up-to-date on immunizations prior to treatment.
Timing: Prior to initiation of treatment.
Routine Monitoring
Signs and symptoms of infection (e.g., fever, chills, malaise, localized signs)
Frequency: Regularly throughout treatment and for several weeks after the last dose.
Target: Absence of infection
Action Threshold: Prompt evaluation and management of any suspected infection.
Immunoglobulin G (IgG) levels
Frequency: Not routinely required for efficacy monitoring, but may be considered if clinical response is atypical or to guide subsequent cycles.
Target: Not specified for routine monitoring, but significant reduction is expected.
Action Threshold: Consideration of treatment modification if IgG levels remain high despite adequate dosing and clinical response is poor.
Signs and symptoms of hypersensitivity reactions (e.g., rash, urticaria, dyspnea, hypotension)
Frequency: During and after administration, especially with initial doses.
Target: Absence of hypersensitivity
Action Threshold: Discontinue infusion and provide appropriate medical management.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, cough, fatigue, localized pain/swelling)
- Symptoms of hypersensitivity reactions (rash, hives, itching, shortness of breath, swelling of face/lips/tongue, dizziness, fainting)
- Headache
- Diarrhea
- Nausea
- Abdominal pain
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, particularly in the third trimester. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data; potential for maternal IgG reduction.
Second Trimester:
Limited data; potential for maternal IgG reduction.
Third Trimester:
Increased placental transfer of IgG, potential for neonatal IgG reduction and theoretical increased risk of infection in the neonate.
Lactation
There are no data on the presence of rozanolixizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered 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. Consider the infant's age and the potential for oral absorption.
Infant Risk:
L3 (Moderate risk - no human data, but large molecule, likely low oral bioavailability for infant; theoretical risk of reduced infant IgG if absorbed).
Pediatric Use
The safety and effectiveness of Rystiggo 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. No dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Rystiggo is administered subcutaneously and can be self-administered by patients or caregivers after proper training.
- Patients should be monitored for signs and symptoms of infection throughout treatment and for several weeks after the last dose, as the mechanism of action involves reducing IgG levels, which can increase infection risk.
- Vaccinations should be administered according to immunization guidelines prior to initiating Rystiggo. Live-attenuated vaccines are not recommended during treatment.
- Hypersensitivity reactions, including anaphylaxis, have been reported. Patients should be monitored during and after administration, especially for initial doses.
- The dosing regimen is weight-based for the initial cycle, and subsequent cycles are based on clinical response, not sooner than 63 days after the start of the previous cycle.
Alternative Therapies
- Efgartigimod (Vyvgart) - another FcRn blocker
- Eculizumab (Soliris) - C5 complement inhibitor
- Ravulizumab (Ultomiris) - C5 complement inhibitor
- Corticosteroids (e.g., prednisone)
- Immunosuppressants (e.g., azathioprine, mycophenolate mofetil, cyclosporine)
- Intravenous Immunoglobulin (IVIg)
- Plasma Exchange (PLEX)
Cost & Coverage
Average Cost:
Very high (e.g., tens of thousands of dollars per cycle) per 6-week cycle
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy and quantity limits)
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 reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or drain. If you are unsure about the correct 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 it occurred.