Rozanolixizumab

Generic name: rozanolixizumab
Brand name: Rystiggo
Dosage form: subcutaneous solution (noli 140 mg/ml)
Drug class: Selective immunosuppressants

Medically reviewed by Drugs.com on Dec 15, 2023. Written by Cerner Multum.

What is rozanolixizumab?

Rozanolixizumab is used to treat myasthenia gravis in adults.

Your doctor will make sure you have the correct type to be treated with rozanolixizumab.

Rozanolixizumab may also be used for purposes not listed in this medication guide.

Rozanolixizumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

You may get infections more easily. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;

• mouth sores, red or swollen gums;

• pale skin, easy bruising, unusual bleeding;

• chest discomfort, wheezing, dry cough or hack, rapid weight loss; or

• signs of meningitis--headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness.

Your treatments may be delayed if you have certain side effects.

Common side effects of rozanolixizumab may include:

• headache;

• diarrhea;

• fever;

• nausea;

• pain, bruising, swelling, or irritation where the medicine was injected; or

• any type of infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

You may get infections more easily. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

Before taking this medicine

Tell your doctor if you have or have ever had:

• use any other medications;

• if you are scheduled to receive a vaccine; or

• an active or recent infection.

Tell your doctor if you recently received a vaccine.

Make sure you are current on all vaccines before you start using rozanolixizumab.

It is not known if rozanolixizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using rozanolixizumab.

How is rozanolixizumab given?

Your doctor will perform tests to make sure rozanolixizumab is the right treatment for you.

Rozanolixizumab is given once a week for 6 weeks. Your doctor will determine how many treatment cycles you will receive of this medicine.

Rozanolixizumab is given as an infusion under the skin. A healthcare provider will give you this injection.

After receiving an injection, you will be watched closely to make sure you do not have an allergic reaction or serious side effects.

You may get infections more easily. You may need frequent medical tests.

Rozanolixizumab dosing information

Usual Adult Dose for Myasthenia Gravis:

Usual dose: Body weight based dosing
-Less than 50 kg: 420 mg (3 mL) as a subcutaneous infusion once weekly
-50 kg to less than 100 kg: 560 mg (4 mL) as a subcutaneous infusion once weekly
-100 kg and above: 840 mg (6 mL) as a subcutaneous infusion once weekly

Duration of therapy: 6 weeks

Comments:
-Administer the prescribed dose of this medication as a subcutaneous infusion using an infusion pump. The infusion should be set at a rate of up to 20 mL per hour.
-The decision to proceed with additional treatment cycles should be based on clinical assessment. The safety of initiating subsequent cycles within a period shorter than 63 days from the beginning of the previous treatment cycle has not been confirmed.

Use: For the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your rozanolixizumab injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving rozanolixizumab?

Avoid receiving rozanolixizumab injection into skin that is hard, red, bruised, swollen, or tender.

Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using rozanolixizumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect rozanolixizumab?

Other drugs may affect rozanolixizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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