Nemluvio

Pronunciation: Nem LOO vee oh
Generic name: nemolizumab-ilto
Dosage form: subcutaneous injection pen (30 mg)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 15, 2024.

What is Nemluvio?

Nemluvio (nemolizumab) is a medicine used to treat prurigo nodularis, to help improve itch, skin nodules, and sleep. Nemluvio reduced itch in 41% of patients after 4 weeks of treatment, and by week 16, it showed significant and clinically meaningful improvements in both itch and skin nodules. Nemluvio is given as an injection under the skin (subcutaneous injection) using a pre-filled pen every 4 weeks.

Nemluvio works by inhibiting a signaling protein (cytokine) called IL-31, which is involved in the itch, inflammation, and nodule formation in prurigo nodularis. By inhibiting IL-31 cytokine signaling, Nemluvio helps improve the symptoms of prurigo nodularis. Nemluvio is from a class of medicines called interleukin-31 receptor antagonist.

Nemluvio FDA approval is for the treatment of prurigo nodularis in adults, it was approved on August 13, 2004 for the company Galderma.

What is prurigo nodularis?

Prurigo nodularis is a long-term skin condition that has symptoms of severely itchy red or pink bumps that can later become larger nodules. These itchy areas usually occur on the outer side of your arms and legs, and also the shoulders, chest and buttocks. The cause of prurigo nodularis is unknown, although it is thought that it may be related to changes in the immune system, nerves, and inflammation. Patients with PN have elevated levels of Interleukin 31, a messenger protein (cytokine) that causes severe itching and dermatitis.

How well does Nemluvio work?

How well Nemluvio works was measured in clinical trials (OLYMPIA 1 and OLYMPIA 2).

For itch improvement, 56% of Nemluvio-treated patients in OLYMPIA 1 and 49% in OLYMPIA 2 achieved at least a four-point reduction in itch intensity at Week 16 compared to 16% in both placebo groups;

For skin nodule clearance, 26% of Nemluvio-treated patients in OLYMPIA 1 and 38% in OLYMPIA 2 reached clearance of skin nodules at Week 16 compared to 7% and 11% in the placebo groups; and

For sleep improvement, 50% of Nemluvio-treated patients in OLYMPIA 1 and 52% in OLYMPIA 2 achieved at least a four-point reduction in sleep disturbance at Week 16 compared to 12% and 21% in the placebo groups.

Nemluvio Side Effects

The most common Nemluvio side effects are headache, atopic dermatitis, eczema, and nummular eczema (eczema presenting as scattered circular patches), which occur in ≥1% of patients in clinical trials.

Serious Nemluvio side effects

This medicine may caused allergic reactions (hypersensitivity). You should stop using Nemluvio and tell your healthcare provider or get emergency help right away if you get any of the following hypersensitivity symptoms:

Breathing problems or wheezing
Swelling of the face, lips, mouth, tongue, or throat 
Fainting, dizziness, feeling lightheaded
Fast pulse
Swollen lymph nodes
Joint pain
Fever
Skin rash (red or rough skin)
Nausea or vomiting
General ill feeling
Cramps in your stomach area

Warnings

Do not use this injection if you are allergic to nemolizumab-ilto or to any of the inactive ingredients contained in this medicine.

Before taking this medicine

Before taking Nemluvio, tell your healthcare provider about all of your medical conditions, including if you:

are scheduled to receive any vaccination. You should not receive a live vaccine right before or during the treatment of this injection.
are pregnant or plan to become pregnant as it is not known whether this medicine will harm your unborn baby.
are breastfeeding or plan to breastfeed as it is not known whether this medicine passes into your breast milk and if it can harm your baby.

How should I use this medicine?

See the detailed Instructions for Use that come with Nemluvio for information on how to prepare and inject and how to properly store and throw away (dispose of) used prefilled pens.

Nemluvio is a single-dose prefilled dual chamber pen containing 30 mg of nemolizumab-ilto lyophilized powder and diluent, water for injection.

Before injection, remove the Nemluvio carton from the refrigerator and allow it to reach room temperature (30-45 minutes).

Inspect the pen visually before reconstitution. Nemluvio is supplied in a single-dose prefilled dual-chamber pen with white powder in one chamber and a clear diluent in the other chamber. Do not use if powder is not white, or if diluent is cloudy or contains visible particles.

Nemluvio must be reconstituted prior to administration. Following reconstitution, each prefilled pen delivers 30 mg/0.49 mL as a clear and colorless to slightly yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the reconstituted solution has discoloration or contains particles.

Use Nemluvio pens within 4 hours after reconstitution. Discard unused reconstituted pens after 4 hours.

Discard any unused portions after administration.

Nemluvio is given as an injection under the skin (subcutaneous injection). Use this injection exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much Nemluvio to inject and how often to inject it.

Administer subcutaneous injection into the front upper thighs or abdomen except for the 2 inches (5 cm) around the navel. Injection in the upper arm should only be performed by a caregiver or healthcare professional. You should alternate the injection site with each injection. Do not inject into skin that is tender, inflamed, swollen, damaged, or has bruises, scars, or open wounds.

Refer to the Instructions for Use for complete administration instructions with illustrations.

Nemluvio comes as a single-dose prefilled pen with a needle guard.

If your healthcare provider decides that you or a caregiver can give the injections, you or your caregiver should receive training on how to prepare and inject Nemluvio properly. Do not try to inject this medicine until you have been shown how to do so properly by your healthcare provider.

Your healthcare provider may prescribe other medicines to use with this injection. Use the other prescribed medicines exactly as your healthcare provider tells you to.

Nemluvio Dosing Information

Adult Patients Weighing Less Than 90kg: The recommended dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.

Adult Patients Weighing 90kg or More: The recommended dosage is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks (Q4W).

General dosing information

Nemluvio must be reconstituted prior to administration.
Complete all age-appropriate vaccinations as recommended by current immunization guidelines before Nemluvio treatment.
Nemluvio is available as a single-dose prefilled dual chamber pen containing 30 mg of nemolizumab-ilto lyophilized powder and diluent, water for injection.

What happens if I miss a dose?

If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.

What happens if I overdose?

If you inject too much Nemluvio, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What other drugs will affect this medicine?

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Medications that are Cytochrome P450 (CYP450) Substrates Upon starting or discontinuing Nemluvio, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

Storage

Refrigerator storage

Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the expiration date.
Do not freeze.
Do NOT expose to heat or direct sunlight.

Room temperature storage

Store at room temperature [up to 77°F (25°C)] for up to 90 days.
In the space provided on the inner partition for the pen, write the date the prefilled pen is first removed from the refrigerator.
Do not use the pen beyond the expiration date or 90 days after the date it was first removed from the refrigerator (whichever is earlier).

Ingredients

Dualchamber single-dose, prefilled pen

Chamber one contains 30 mg of nemolizumab-ilto with 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.

Chamber two contains the diluent, water for injection.

Following reconstitution each prefilled pen delivers 30 mg/0.49 mL of nemolizumab-ilto with a pH of 6.7 to 7.3.