Nemolizumab-ilto injection

WHY is this medicine prescribed?

Nemolizumab-ilto injection is used to treat prurigo nodularis (PN; skin disorder where itchy, small lumps form on the body) and certain types of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Nemolizumab-ilto is in a class of medications called monoclonal antibodies. It works by stopping the action of certain substances in the body that cause inflammation, itching and skin regulation.

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?

Nemolizumab-ilto comes as a pre-filled pen to be given subcutaneously (under the skin). It is injected once every 4 or 8 weeks. Your doctor will tell you how often to inject nemolizumab-ilto injection.

Use nemolizumab-ilto exactly as directed. Ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.

Your will be shown how to give nemolizumab-ilto using the pre-filled pen. Read the manufacturer's information for the patient that comes with the medication. Ask your doctor or pharmacist to show you or the person who will be giving the medication how to inject it.

Remove the pen from the refrigerator and allow it to warm to room temperature for 30 to 45 minutes before using it. Look at the contents of the pen closely. There are two chambers in the pen: one with liquid and one with powder. Do not use if liquid is cloudy or contains particles or powder is not white. The liquid and the powder in thepen will have to be mixed before injecting. Please read the patient instructions on how to mix them. After mixing, check the liquid closely and do not use unless clear and free from any particles. Once mixed, nemolizumab-ilto must be injected within 4 hours. If not used within 4 hours, it must be discarded.

Inject nevolizumab-ilto on the front upper thighs (upper legs) or the stomach area at least 2 inches from the belly button. If someone else injects the medication, the back of the upper arm may also be used. To reduce the chances of soreness or redness, use a different injection site for each injection. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

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

What SPECIAL PRECAUTIONS should I follow?

Before using nemolizumab-ilto,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, food, or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving nemolizumab-ilto injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using nemolizumab-ilto injection, call your doctor.

• do not have any vaccinations without talking to your doctor. It is important to have all vaccines appropriate for your age before beginning your treatment with nemolizumab-ilto injection. 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 should I do IF I FORGET to take a dose?

Inject the missed dose as soon as you remember it and then give the next dose as schedule.

What SIDE EFFECTS can this medicine cause?

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

• headache
• muscle or joint pain

Some side effects can be serious. If you experience any of these symptoms, stop using nemolizumab-ilto injection and call your doctor immediately or get emergency medical treatment:

• rash; hives; swelling of the face, eyelids, tongue, or throat; difficulty breathing or wheezing; feeling dizzy or lightheaded; fainting; swollen glands, fever; or fast heartbeat
• nausea, vomiting, or stomach cramps

Nemolizumab-ilto 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Nemolizumab-ilto pre-filled pens should be stored in their original box in a refrigerator until ready to use. Do not freeze or expose to heat or direct sunlight. If needed, you may store nemolizumab-ilto injection at room temperature for up to 90 days in the original carton to protect it from light. Once stored at room temperature, do not return nemolizumab-ilto injection to the refrigerator. Discard nemolizumab-ilto injection if it is not used within 90 days at room temperature.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reachhttps://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.