Rystiggo 840mg/6ml Sdv Inj, 6ml

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 reduced serum IgG levels, including pathogenic autoantibodies that drive generalized myasthenia gravis (gMG).

Urgent Side Effects: Seek Medical Attention 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, 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 discolored sputum
+ 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

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, 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 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.

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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have.

To ensure your safety, carefully review all your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.

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 conjunction 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.

• Signs of infection (fever, chills, sore throat, cough, unusual fatigue, localized pain/swelling)
• Signs of hypersensitivity reactions (rash, hives, itching, difficulty breathing, swelling of face/lips/tongue/throat, dizziness, lightheadedness)
• Symptoms of infusion-related reactions (headache, dizziness, nausea, vomiting, abdominal pain, diarrhea, fatigue, chills, muscle pain, joint pain, back pain, chest pain, flushing, rash, pruritus, dyspnea, hypertension, hypotension, tachycardia, bradycardia, palpitations, paresthesia, tremor, blurred vision, dry mouth, throat irritation, nasal congestion, sneezing, cough, dysphagia, dyspepsia, flatulence, constipation, urinary frequency, dysuria, peripheral edema, asthenia, malaise, feeling hot, feeling cold)
• Signs of worsening myasthenia gravis symptoms (e.g., increased muscle weakness, difficulty breathing, swallowing, or speaking)

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. Consider monitoring IgG levels in infants exposed in utero.

Rozanolixizumab is a humanized IgG4 monoclonal antibody, and human IgG is known to be present in breast milk. The effects of rozanolixizumab on the breastfed infant and on milk production are unknown. 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. Monitor breastfed infants for signs of infection.

Safety and effectiveness in pediatric patients have not been established.

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.

• Rystiggo is specifically approved for generalized myasthenia gravis (gMG) and is administered by IV infusion.
• Patients should be monitored for signs and symptoms of infection throughout treatment and for several weeks after the last dose, as FcRn blockers can increase infection risk.
• Infusion-related reactions are common; patients should be monitored during and after infusion. Pre-medication may be considered for patients who experience these reactions.
• Live attenuated vaccines should not be given concurrently with Rystiggo. Discuss vaccination status and plans with patients.
• The treatment cycle is 6 weeks, with subsequent cycles based on clinical response and physician discretion.
• Rystiggo significantly reduces IgG levels, including pathogenic autoantibodies, which is the basis of its therapeutic effect in gMG.

• Efgartigimod (Vyvgart) - another FcRn blocker for gMG
• Eculizumab (Soliris) - C5 complement inhibitor for gMG
• Ravulizumab (Ultomiris) - C5 complement inhibitor for gMG
• Intravenous Immunoglobulin (IVIg)
• Plasma Exchange (PLEX)
• Corticosteroids (e.g., Prednisone)
• Immunosuppressants (e.g., Azathioprine, Mycophenolate Mofetil, Cyclosporine, Tacrolimus)

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 for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs; your pharmacist can provide information on these programs. Some medications may come with an additional patient information leaflet; consult your pharmacist if you have questions. If you have any concerns or questions 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.