Nemolizumab

Nemolizumab is used in adults to treat prurigo nodularis (a skin condition that leads to hard and raised bumps on your skin).

Nemolizumab may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Doses are based on weight. Your dose may change if you gain or lose weight.

Nemolizumab is injected under the skin in the stomach, thigh, or upper arm, usually once every 4 weeks. Your first dose may be given in 2 injections to receive the total dose.

A healthcare provider may teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare an injection only when you are ready to give it. Leave the needle cap on until you are ready to inject your dose. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Be sure you understand how to properly mix this medicine. Mixed medicine should be kept at room temperature and must be used within 4 hours.

Do not inject within 2 inches of your navel (belly button) or areas where the skin is swollen, tender, bruised, has scars, or has open wounds. Do not inject into the same place two times in a row.

Throw away a pen after one use, even if there is still medicine left inside. Do not reuse a needle, syringe, or pen. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Store this medicine in the original container in the refrigerator. Protect from light and do not freeze or shake.

Take the medicine out of the refrigerator and let it reach room temperature for 30 to 45 minutes before injecting your dose. Do not heat the medicine with hot water, sunlight, or a microwave.

You may store this medicine at room temperature for up to 90 days. Throw the medicine away if not used within 90 days. Do not put it back into the refrigerator.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use nemolizumab if you are allergic to it.

Tell your doctor if you have or have ever had:

• if you are scheduled to receive a vaccine.

Make sure you are up to date on all vaccines before you start using nemolizumab.

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

Tell your baby's doctor if you used nemolizumab during pregnancy. It could affect your baby's vaccination schedule during the first 3 months of life.

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

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

Nemolizumab may cause serious side effects. Call your doctor right away if you have:

• fever;
• skin rash (red or rough skin);
• fainting, feeling light-headed, feeling weak or tired;
• wheezing, trouble breathing;
• fast pulse, swollen glands, nausea or vomiting, stomach cramps; or
• joint pain.

Common side effects of nemolizumab may include:

• headache; or
• skin rash, skin inflammation such as eczema or atopic dermatitis.

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.

Usual Adult Dose for Prurigo Nodularis:

Weight less than 90 kg:-Initial dose: 60 mg subcutaneously (two 30 mg injections) once-Maintenance dose: 30 mg subcutaneously every 4 weeksWeight at least 90 kg:-Initial dose: 60 mg subcutaneously (two 30 mg injections) once-Maintenance dose: 60 mg subcutaneously every 4 weeksComments:-Complete all age-appropriate vaccinations following immunization guidelines before starting treatment with this drug.Use: Treatment of adults with prurigo nodularis

Usual Adult Dose for Atopic Dermatitis:

Initial dose: 60 mg subcutaneously (two 30 mg injections) onceMaintenance dose: 30 mg subcutaneously every 4 weeks; for patients who achieve clear or almost clear skin after 16 weeks of treatment, 30 mg subcutaneously every 8 weeks is recommendedComments:-Complete all age-appropriate vaccinations following immunization guidelines before starting treatment with this drug.-Discontinue topical therapies when the disease has sufficiently improved.Use: Treatment of adults with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies

Usual Pediatric Dose for Atopic Dermatitis:

12 years and older:-Initial dose: 60 mg subcutaneously (two 30 mg injections) once-Maintenance dose: 30 mg subcutaneously every 4 weeks; for patients who achieve clear or almost clear skin after 16 weeks of treatment, 30 mg subcutaneously every 8 weeks is recommendedComments:-Complete all age-appropriate vaccinations following immunization guidelines before starting treatment with this drug.-Discontinue topical therapies when the disease has sufficiently improved.Use: Treatment of pediatric patients 12 years and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies

Use the medicine as soon as you remember, and then return to your usual schedule. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while you are being treated or just before starting treatment with nemolizumab. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

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