
Imaavy
Imaavy (nipocalimab) is FDA approved to treat generalized myasthenia gravis (gMG). It's for people 12 years and older who have antibodies against AChR or MuSK proteins in the body. It works as a neonatal Fc receptor blocker to help your nerves and muscles work together better. Imaavy (nipocalimab) is given as an infusion through the vein at a clinic or medical center. You’ll get the infusion once every 2 weeks. Common side effects include respiratory infections, swelling in the hands or feet, and muscle spasms.
What is Imaavy (nipocalimab)?
What is Imaavy (nipocalimab) used for?
- Generalized myasthenia gravis (gMG) in people 12 years and older with anti‑AChR or anti‑MuSK antibodies
How Imaavy (nipocalimab) works
Imaavy (nipocalimab) is an FcRn blocker. It attaches to a protein in the body called the neonatal Fc receptor (FcRn). This lowers levels of certain antibodies in your blood. Some of these antibodies attack proteins called AChR and MuSK, which are essential for your nerves and muscles to work together.
When these harmful antibodies go down, your nerves and muscles can communicate better. This can help improve your strength and daily function.
Drug facts
| Common Brands | Imaavy |
|---|---|
| Drug Class | Neonatal Fc receptor blocker |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Imaavy (nipocalimab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Respiratory tract infection (18%)
- Muscle spasm (12%)
- Swelling in the arms, legs, or feet (12%)
- Stomach pain (8%)
- Back pain (8%)
- Allergic reaction, such as rash or hives (8%)
- Fever (7%)
- Diarrhea (7%)
- Cough (7%)
Less Common Side Effects
- Urinary tract infection
- Shingles or cold sores
- Infection in the mouth
- Anemia
- Dizziness
- Nausea
- High blood pressure
- Trouble sleeping
Imaavy (nipocalimab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infections: fever, chills, cough, sore throat, burning or frequent urination, skin that’s warm or painful, shingles rash
- Severe allergic reaction: rash, hives, itching, swelling of the face or throat, trouble breathing, chest or throat tightness, feeling faint
- Infusion‑related reactions: headache, flushing, nausea, chills, fever, dizziness
The following Imaavy (nipocalimab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Back pain
- Diarrhea
- Muscle spasms
- Nausea
- Stomach pain
- Swelling of the ankles, hands, or feet
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Pros and cons of Imaavy (nipocalimab)
Pros
- FDA approved for people 12 years and older
- Given once every 2 weeks
- Few interactions with other medications
Cons
- Given only by IV infusion at a clinic, not at home for self‑injection
- Might raise your risk of infections and shingles
- Not recommended to get any live vaccines during treatment
Pharmacist tips for Imaavy (nipocalimab)
- Talk to your prescriber or primary care provider about keeping your vaccines up to date. Before getting any vaccine, tell the healthcare professional that you're receiving Imaavy (nipocalimab). You can get non-live vaccines, like most flu shots, during treatment. But live vaccines, such as MMR (measles, mumps, and rubella), are not recommended. It's not clear if this medication can make live vaccines less safe or work less well.
- Plan your schedule around your Imaavy (nipocalimab) infusion plan. You’ll get the infusion once every 2 weeks. Write down these dates on your calendar to help you remember. If you miss an appointment, reschedule as soon as you can.
- During your visit, a nurse will place an IV in one of your veins and run the Imaavy (nipocalimab) infusion over a set amount of time. The first infusion takes at least 30 minutes, and the rest take at least 15 minutes. After the infusion ends, they'll watch you for 30 minutes to make sure you feel okay.
- Imaavy (nipocalimab) can cause infusion reactions. They can include headache, flushing, nausea, chills, fever, or dizziness. It can also cause chest tightness, swelling in the face, and trouble breathing. If this happens during your visit, tell your nurse right away. They might slow or stop the infusion and treat your symptoms. If you have these symptoms after you go home, call your care team or get medical help.
- Swelling in your hands, ankles, or feet are common side effects of Imaavy (nipocalimab). Elevating your legs, gentle movement, and limiting salty foods might help. But let your care team know if swelling is new or gets worse.
- Tell your care team if you get sick or have had a recent infection. Imaavy (nipocalimab) can raise your risk of infections. Call your care team if you have a fever, chills, cough, sore throat, burning with urination, or a shingles‑like rash. They might pause your infusions until you feel better. This can help your body fight the infection as best it can.
- Share a full list of all the medications you take with your prescriber and pharmacist. Imaavy (nipocalimab) can interact with medications that are monoclonal antibodies or immunoglobulin products. Imaavy (nipocalimab) might make them work less well.
Risks and warnings for Imaavy (nipocalimab)
Imaavy (nipocalimab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of infections
- Risk factors: Active, long-term, or recurrent infection | Incomplete vaccination
Imaavy (nipocalimab) can raise your chances of getting infections. In studies, respiratory infections and urinary tract infections (UTIs) were common. Some infections can be serious. Certain old viral infections, like shingles or cold sores, can also come back.
Watch for signs of infection while you're taking Imaavy (nipocalimab). This can include fever, cough, trouble breathing, burning with urination, and new rashes. If you notice any signs of infection, tell your prescriber. They might pause treatment until the infection goes away.
Allergic reactions
In rare cases, some people who received Imaavy (nipocalimab) had allergic reactions. Most were mild or moderate and happened within an hour to 2 weeks of the infusion.
Allergic reactions can cause a rash, hives, itching, swelling of the face or throat, trouble breathing, or chest tightness. Some people have had severe reactions like anaphylaxis or angioedema (serious swelling).
Your care team will watch you during your Imaavy (nipocalimab) infusion and for 30 minutes after it ends. If you have a reaction during the infusion, they'll stop the infusion and treat your symptoms. If you have signs of an allergic reaction after you go home, get medical help right away. If it's serious, you won't receive Imaavy (nipocalimab) again to be safe.
Infusion-related reactions
- Risk factors: History of an infusion reaction to other medications
Some people feel unwell during or within 2 days after an Imaavy (nipocalimab) infusion. You might have a headache, fever, chills, flushing, or nausea. You might also feel tired or dizzy. Most of these reactions are mild to moderate.
Your care team will watch you during the infusion and for 30 minutes after. If you have a mild reaction, they might slow the infusion and give you medications to help. But for more severe reactions, they'll stop the infusion and treat your symptoms. If you have these symptoms after you go home, call your care team.
Imaavy (nipocalimab) dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1.62ml of 300mg/1.62ml | 1 vial | $3,001.45 | $3,001.45 |
| 6.5ml of 1,200mg/6.5ml | 2 vials | $23,967.85 | $11,983.93 |
Typical dosage for Imaavy (nipocalimab)
This medication is given as an infusion through a vein, or an intravenous (IV) infusion. It's given by a trained healthcare professional at a clinic or infusion center.
Your prescriber will calculate the dose based on your weight.
The typical starting dose is 30 mg/kg of body weight given IV once.
Then, a maintenance dose of 15 mg/kg IV is given 2 weeks after the first dose and every 2 weeks after that.
How much does Imaavy (nipocalimab) cost?
$3,001.45
What are alternatives to Imaavy (nipocalimab)?
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