Rozanolixizumab-noli (Subcutaneous)

Rozanolixizumab-noli injection is used to treat a nerve and muscle problem called generalized myasthenia gravis (gMG) in patients who have a positive test for anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibodies.

This medicine is to be given only by or under the direct supervision of a doctor.

It is very important that your doctor checks your progress during regular visits to ensure that this medicine is working properly. Blood tests may be needed to look for unwanted effects.

This medicine may increase your risk of infection. Contact your doctor right away if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Talk to your doctor if you have a fever, headache, nausea, stiff neck or back, or vomiting. These may be signs of aseptic meningitis (swelling of the brain).

This medicine may cause a serious allergic reaction, including angioedema and rash, which can be life-threatening and require immediate medical attention. Contact your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.

While you are being treated with rozanolixizumab-noli injection, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Rozanolixizumab-noli may lower your body's resistance, and there is a chance you might get the infection the vaccine is meant to prevent. Additionally, you should not be around others in your household who receive live virus vaccines because they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Avoid close contact with them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies to determine how age affects the effects of rozanolixizumab-noli injection in children. Safety and effectiveness have not been established.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the usefulness of rozanolixizumab-noli injection.

Breast Feeding

There are no adequate studies on women to assess the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. When you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The following interactions are based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Infection, active—Use with caution. This medicine may reduce your body's ability to fight infections.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bladder pain
• bloody or cloudy urine
• body aches or pain
• burning or stinging of the skin
• chills
• cough
• difficult, burning, or painful urination
• ear congestion
• fast heartbeat
• fever
• frequent urge to urinate
• headache
• lower back or side pain
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• skin itching, rash, or redness
• sneezing
• sore throat
• stuffy or runny nose
• swelling of the face, throat, or tongue
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Nausea
• stiff neck or back
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• diarrhea
• difficulty in moving
• joint pain
• muscle pain or stiffness
• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Rystiggo

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Rozanolixizumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under the skin of your stomach once a week for 6 weeks.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.