Rystiggo (rozanolixizumab)

Rystiggo generic or biosimilar

Rystiggo is available only as a brand-name biologic medication. It’s not currently available in a biosimilar or generic version.

Biologic medications are made from living cells. It’s not possible to copy these drugs exactly. A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active ingredient in a brand-name medication.

Biosimilars are considered to be just as safe and effective as their parent drug. And like generics, biosimilars tend to cost less than brand-name medications.

Rystiggo dosage

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Rystiggo comes as a solution in a single-dose vial. The drug is prepared and administered by a healthcare professional. It’s given as a subcutaneous infusion, which is a type of injection that’s administered under your skin over a period of time.

Dosage for myasthenia gravis

The typical Rystiggo dosage for myasthenia gravis is one dose given as a subcutaneous infusion once weekly for 6 weeks. The recommended dose depends on your body weight in kilograms (kg), as shown in the dosing table below. For reference, 1 kg equals 2.2 pounds (lbs).

Depending on your response to the medication, your doctor may recommend additional treatment cycles with Rystiggo. You’ll likely take a break for a few weeks before starting the next treatment cycle. Typically, people start their next round of Rystiggo treatment at least 9 weeks (63 days) after starting their previous treatment cycle.

How it’s given

Rystiggo comes as a solution in a single-dose vial. The drug is prepared and administered by a healthcare professional. It’s given as a subcutaneous infusion, which is a type of injection that’s administered under your skin over a period of time.

You’ll likely receive Rystiggo infusions at your doctor’s office or treatment center. Or you may be able to have a nurse or another healthcare professional come to your home to give your infusions.

It typically takes about 15 minutes to receive an infusion of Rystiggo. A healthcare professional will monitor you during and for at least 15 minutes after the infusion. They’ll watch for symptoms of an allergic reaction, such as swelling or rash, and treat the reaction if it occurs.

For more details about what to expect during treatment with Rystiggo, talk with your doctor. You can also visit the manufacturer website for more information.

About receiving Rystiggo

Below you’ll find information about key dosage issues.

• If you miss a dose: If you miss a dose of Rystiggo, call your doctor’s office right away. They can help get your appointment rescheduled.
• Receiving Rystiggo with food: Rystiggo may be administered without regard to the timing of food.
• Length of use: Rystiggo may be used as a short-term or long-term treatment. One treatment cycle of Rystiggo consists of one dose given once weekly for a total of 6 weeks. Depending on your response to the medication, your doctor may recommend additional treatment cycles.
• Length of time to work: Rystiggo starts working from your first dose. It may take 6 weeks or longer to see the full effects of the medication.

Rystiggo side effects

Rystiggo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while receiving Rystiggo. These lists do not include all possible side effects.

For more information about the possible side effects of Rystiggo, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Rystiggo, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Rystiggo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Rystiggo’s prescribing information.

Mild side effects of Rystiggo can include:

• mild headache
• mild infection, such as upper respiratory tract infection
• diarrhea
• fever
• nausea
• infusion site reactions
• abdominal pain
• joint pain

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Rystiggo aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• severe headache, which may be associated with:
  • nausea
  • dizziness
  • sensitivity to light and sound
• serious infection, such as pneumonia, which may include symptoms such as:
  • cough
  • fever
  • weakness
• aseptic meningitis, which may include symptoms such as:
  • stiff neck
  • headache
  • fever
  • chills
  • stomach upset

ALLERGIC REACTION

For some people, Rystiggo can cause an allergic reaction. This side effect was common in the drug’s studies.

In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep using the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Rystiggo, your doctor may recommend using a different medication instead.

Rystiggo uses

The Food and Drug Administration (FDA) approves prescription drugs such as Rystiggo to treat certain conditions. Rystiggo may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Rystiggo for myasthenia gravis

Rystiggo is FDA-approved to treat generalized myasthenia gravis in certain adults. Myasthenia gravis is a chronic (long-term) autoimmune condition that affects your muscles and nerves. Common symptoms include muscle weakness and fatigue. These symptoms can be severe and interfere with a person’s daily activities.

Specifically, the drug is approved for adults with this condition who’ve tested positive for having a certain antibody (protein) in their body: anti-acetylcholine receptor (anti-AChR) or anti-muscle-specific tyrosine kinase (anti-MuSK). Most people with myasthenia gravis have one or the other (not both). These antibodies contribute to the symptoms of myasthenia gravis.

Rystiggo and children

Rystiggo is approved for use in certain adults. The safety and effectiveness of this medication has not been studied in children.

Rystiggo interactions

Rystiggo can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Before starting treatment with Rystiggo, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications

Below is a list of medications that may interact with Rystiggo. This list does not contain all drugs that may interact with Rystiggo. It isn’t known whether Rystiggo could interact with supplements. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

Alcohol is not known to interact with Rystiggo.

Talk with your doctor if you have questions about how much (if any) alcohol is safe for you to drink during Rystiggo treatment.

Rystiggo cost and coupons

As with all medications, the cost of Rystiggo can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Rystiggo, or if you need help understanding your insurance coverage, help is available.

A program called Onward is available for Rystiggo. For more information and to find out if you’re eligible for support, call 844-669-2731 or visit the program website.

Generic version:Rystiggo is a brand-name biologic drug. It isn’t available in a biosimilar or generic version. Biosimilars tend to cost less than brand-name biologic drugs.

To learn more about saving money on prescriptions, check out this article.

Similar drugs

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Rystiggo, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Rystiggo:

• efgartigimod alfa (Vyvgart)
• efgartigimod alfa and hyaluronidase (Vyvgart Hytrulo)
• ravulizumab (Ultomiris)
• eculizumab (Soliris)
• immune globulin (Asceniv, Octagam, others)

Things to consider when receiving Rystiggo

If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.

Rystiggo and pregnancy

It’s not known whether Rystiggo should be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before starting Rystiggo treatment. As a precaution, they may suggest birth control options to use during treatment with Rystiggo.

Rystiggo and birth control

It’s not known if Rystiggo is safe to use during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs during treatment with Rystiggo.

Rystiggo and breastfeeding

It’s not known whether Rystiggo should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before starting Rystiggo treatment.

Common questions about Rystiggo

Here are answers to some frequently asked questions about Rystiggo.

Does Rystiggo cause fatigue?

It’s not likely. Fatigue wasn’t reported as a side effect of Rystiggo in clinical trials of the drug.

Keep in mind that fatigue is a common symptom of myasthenia gravis, the condition that Rystiggo is used to treat. The goal of Rystiggo treatment is to lower the symptoms of your condition. As the medication starts to work, some people may notice a reduction in their symptoms. This may include feeling less fatigued than usual.

Talk with your doctor if you have questions about what to expect with Rystiggo treatment.

How does Rystiggo work?

Rystiggo works by blocking a receptor called FcRn.* This receptor is an attachment site for certain antibodies (proteins). These antibodies include anti-acetylcholine receptor (anti-AChR) and anti-muscle-specific tyrosine kinase (anti-MuSK).

When these antibodies attach to FcRn, it interferes with the signaling process between nerve and muscle cells. This interference leads to symptoms of myasthenia gravis, such as muscle weakness and fatigue. These symptoms can be severe and interfere with daily activities.

When Rystiggo blocks this receptor, it reduces the effects of anti-AChR and anti-MuSK. This allows better signaling between nerve and muscle cells, which can help reduce the symptoms of myasthenia gravis.

For more information about how Rystiggo works, talk with your doctor or pharmacist. You can also visit the manufacturer website.

* FcRn stands for neonatal Fc receptor.

Should I continue taking my other medications for myasthenia gravis during Rystiggo treatment?

Yes, as long as your doctor recommends it.

The clinical trials of Rystiggo included adults who were already taking a stable regimen of medications for myasthenia gravis. These regimens included one or more of the following types of medications:

• acetylcholinesterase (AChE) inhibitors, such as pyridostigmine (Mestinon)
• steroids, such as prednisone
• nonsteroidal immunosuppressants, such as azathioprine (Imuran)

Trial participants continued taking these medications during Rystiggo treatment. No interactions or safety concerns were reported.

Still, it’s important to talk with your doctor about all prescription, over-the-counter, and other drugs you take before starting Rystiggo. Sharing this information can help prevent potential interactions.