Nemolizumab-ilto injection

Nemolizumab-ilto injection is used to treat prurigo nodularis (PN; skin disorder where itchy, small lumps form on the body). 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.

Nemolizumab-ilto comes as a pre-filled pen to be given subcutaneously (under the skin). It is usually given every 4 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use nemolizumab-ilto exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor or nurse will show you or your caregiver how to give nemolizumab-ilto using the pre-filled pen. Before you use nemolizumab-ilto injection yourself the first time, 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.

You can give nevolizumab-ilto to the front upper thighs or into the abdomen at least 2 inches from the belly button. The upper arm should only be used if being given by a caregiver or a healthcare professional. Every time you give nevolizumab-ilto, you should use a different injection site. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Before giving nemolizumab-ilto, remove the prefilled syringe from the refrigerator and allow it to warm to room temperature for 30 to 45 minutes. Look at the contents of the pre-filled syringe 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 chambers of the pre-filled syringe will have to be mixed before injecting. Please read the patient instructions on how to mix them. After mixed, 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.

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

Before using nemolizumab-ilto,

• tell your doctor and pharmacist if you are allergic to nemolizumab-ilto, any other medications, or any of the ingredients in nemolizumab-ilto injection. Ask your pharmacist or check the Medication Guide 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 while receiving nemolizumab-ilto. 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 taking nemolizumab-ilto, call your doctor.
• do not have any vaccinations without talking to your doctor. There are certain vaccines you should not get while receiving nemolizumab-ilto.

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

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

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

• headache
• dry, itchy skin

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

• swelling of the face, eyelids, tongue, or throat
• rash, hives, or blistering skin
• difficulty breathing or shortness of breath or wheezing

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).

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

Keep all appointments with your doctor.

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.

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