What is Nemluvio®?

Nemluvio is a biologic medication. Its generic name is nemolizumab-ilto. It is in a drug class known as a monoclonal antibody.

Nemluvio is FDA-approved to treat moderate-to-severe atopic eczema (atopic dermatitis) and prurigo nodularis, a chronic skin disorder. It is given as an injection under the skin. Patients have the option of taking Nemluvio in a doctor’s office or clinic, or self-administering it at home using an injectable pen or pre-filled syringe.

Nemluvio is designed to reduce itching of the skin, skin inflammation, and skin rashes associated with eczema. It also promotes skin healing that lasts.

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What is Nemluvio used for?

Nemluvio is a prescription medication used to treat moderate-to-severe atopic dermatitis and prurigo nodularis. (Prurigo nodularis is a chronic skin disorder.) It is approved for adults and children 12 years of age or older in combination with topical corticosteroids or topical calcineurin inhibitors when eczema symptoms are not well controlled with topical therapies.

How does Nemluvio work for treating atopic dermatitis?

Nemluvio works by targeting the part of the immune system that causes itching and inflammation of the skin. Some people with eczema have an immune system that tends to overreact and make too much of a protein called interleukin-31 (IL-31). IL-31 is known to drive itch symptoms in eczema and prurigo nodularis.

Nemluvio blocks the signaling of IL-31 for itch and inflammation. This relieves the urge to scratch. Nemluvio significantly improved itch and inflammation, allowing time for the skin to heal. It also promotes clear skin.

Nemluvio is used along with topical corticosteroids and/or topical calcineurin inhibitors when symptoms are not adequately controlled with topical therapies alone. When eczema symptoms have cleared up, the patient can stop taking the topical corticosteroid and/or topical calcineurin inhibitor.

If you’re prescribed Nemluvio, work together with your doctor on a treatment plan. Follow it closely, as the combination of medications you are prescribed may vary based on the severity of your condition. Regular appointments and open communication with your doctor can ensure your treatment plan is effective. Always follow your doctor’s instructions to get the best results.

What is the dosage for Nemluvio?

Nemluvio has an initial dose (known as a loading dose) that introduces the medication into your body. This dose is 60 mg (two 30 mg injections). Then this is followed by a maintenance dose of 30 mg given every four weeks.

After the loading dose and four months of injections, patients who have clear or almost-clear skin can take the 30 mg dose every eight weeks.

Nemluvio dosing is the same for adult and pediatric patients 12 and older.

How is Nemluvio administered?

The Nemluvio loading dose is typically given in the doctor’s office or clinic. After that, you can continue to take the injection in the doctor’s office or clinic, or you can self-administer it at home (either as the patient or as a caregiver of someone prescribed the medication). Your healthcare provider can show you how to take the medication correctly.

Nemluvio is a subcutaneous injection, meaning it’s injected under the skin. It is administered as a single-dose, prefilled auto-injector pen. Nemluvio has white powder in one chamber and clear diluent in another chamber. Do not use the medicine if the powder is not white or the diluent is it’s cloudy or has visible particles.

The primary injection sites are the front upper thighs and the abdomen. Do not inject within 2 inches of the naval or into areas where the skin is tender, bruised, swollen, damaged, or is an eczema area. Injection in the back of the upper arm is another option but should only be done by a healthcare professional or caregiver. Rotate the location of the injection site each time a dose is given.

Children should receive the injections under the supervision of an adult.

Nemluvio can be administered at home by the patient or a trained caregiver. Administering at home can offer flexibility in managing treatment. If you’re uncomfortable administering it yourself, talk to your doctor about other options.

Self-administration gives patients the freedom and empowerment to take the medication on their own schedule without going to the doctor’s office every four weeks. Follow the specific instructions provided by your healthcare provider. Get training from your doctor on how to correctly administer the injection, know the proper injection sites, and use the right technique. Talk with your doctor regularly to make sure you are injecting Nemluvio safely and effectively.

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What are the ingredients of Nemluvio?

Nemluvio is a single-dose, prefilled auto-injector pen. It contains white powder in one chamber and a clear diluent in another chamber. The product is preservative-free and latex-free.

  • Active ingredient: nemolizumab-ilto
  • Inactive ingredients: arginine hydrochloride (9.5 mg), poloxamer 188 (0.15 mg), sucrose (25.8 mg), trometamol (0.10 mg), and tris hydrochloride for pH adjustment.

What are Nemluvio side effects?

The most common side effects from taking Nemluvio include:

  • headache
  • hives on the skin
  • joint pain
  • muscle aches
  • injection site reaction

Some people may experience an allergic reaction after the Nemluvio injection. Tell your healthcare provider or get emergency help right away if the allergic reaction is severe. This is anaphylaxis, a potentially life-threatening condition. Symptoms of anaphylaxis may include:

  • hives on the skin
  • swelling of your face, mouth and/or tongue
  • breathing problems
  • nausea, abdominal cramps or vomiting
  • low blood pressure
  • fainting, dizziness, feeling lightheaded

If you take Nemluvio at home, you will need a prescription for epinephrine. Epinephrine is the first-line treatment for anaphylaxis. Take it at the first sign of symptoms.

Before taking Nemluvio, tell your doctor or healthcare provider about all of your medical conditions. Provide a list of any other medications you’re taking that could cause drug interactions. Do not stop taking other medications unless instructed to do so by your healthcare provider.

Regular check-ups with your doctor are recommended to monitor side effects and ensure Nemluvio is working safely. Always inform your healthcare provider about any changes in your health.

How much does Nemluvio cost?

Biologics are expensive medications due to their complex production process and clinical trials. The list price for Nemluvio is $4,240 for one prefilled, 30 mg pen. The actual cost may vary depending on if your commercial insurance provider covers Nemluvio. You can find out the actual cost by calling your insurance provider or speaking with your pharmacist.

What if you don’t have insurance for Nemluvio or you are uninsured? Galderma, the manufacturer of the drug, offers a Patient Assistance Program that offers access support for eligible patients. You may be able to access a $0 copay, receive complimentary doses during insurance transitions or delays, or gain access too Nemluvio if your insurance does not cover it. Once enrolled in Galderma Patient Services (GPS), you’ll work with a support team led by a nurse navigator to help you understand insurance benefits and financial assistance. You can enroll online or by phone at 1-855-NEMLUVIO.

In general, Medicare prescription drug plans (Part B and Part D) do not cover Nemluvio. Check with your specific Medicare plan to confirm whether these medications are covered.

For Medicaid, coverage for Nemluvio varies by state, as each state sets its own rules for drug coverage. Many states may require prior authorization for these medications, particularly if they are newer or more expensive. Patients should consult their state’s Medicaid program or their healthcare provider to understand the specific requirements and coverage options available to them.

Charitable organizations such as The Assistance Fund, Inc., Patient Advocate Foundation and The Healthwell Foundation are dedicated to offering financial support to patients with specific medical conditions, irrespective of their chosen treatment. People with commercial or government insurance, including those under Medicare and Medicaid, can reach out directly to these foundations for financial assistance.