Rozanolixizumab-noli

WHY is this medicine prescribed?

Rozanolixizumab-noli is used to treat certain types of myasthenia gravis(MG; a disorder of the nervous system that causes muscle weakness). Rozanolixizumab is in a class of medications called Fc receptor blockers. It works by reducing the amount of IgG (an antibody that attacks neuromuscular receptors in patients with myasthenia gravis) circulating in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Rozanolixizumab-noli comes as a solution (liquid) to be given by subcutaneous (under the skin) infusion by a doctor or a nurse in a hospital or a clinic. It is usually given once weekly for at least 6 weeks. Your doctor will determine if and how frequently you will continue to receive rozanolixizumab after that.

Your doctor or nurse will monitor you during and for 15 minutes after finishing the infusion.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving Rozanolixizumab-noli,

• tell your doctor and pharmacist if you are allergic to rozanolixizumab, any other medications, or any of the ingredients in rozanolixizumab-noli injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have a history of current infection or chronic infection such as hepatitis B or C, HIV, herpes.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving rozanolixizumab-noli, call your doctor.

• before starting rozanolixizumab-noli infusions, your doctor will make sure you have received all necessary vaccines. Once you have started receiving rozanolixizumab-noli, do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Rozanolixizumab-noli may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea
• rash
• nausea
• stomach pain
• joint pain
• bruising, swelling or redness at site of injection

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever
• pain or burning on urination, increased frequency of urination
• cough, shortness of breath, difficulty breathing
• headache, fatigue, stiff neck, drowsiness, unresponsiveness, sensitivity to bright lights, seziures

Rozanolixizumab-noli may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and for infusions. If you miss a scheduled appointment for an infusion, you can still receive it up to 4 days after the original scheduled time. If its been more than 4 days, then skip that does and resume the regular schedule.

Ask your pharmacist any questions you have about rozanolixizumab-noli.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.