Nemolizumab

Nemolizumab is a prescription medication used for the treatment of adults with prurigo nodularis.

• Nemolizumab is available under the following different brand names: Nemluvio, nemolizumab-ilto.

Common side effects of nemolizumab include:

• headache
• skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)

Serious side effects of nemolizumab include:

• allergic reactions (hypersensitivity) symptoms include 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 the stomach area

Rare side effects of nemolizumab include:

none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, powder for reconstitution

• 30 mg/0.49 mL after reconstitution (dual chamber prefilled pen)

Prurigo nodularis

Adult dosage

• Weighing less than 90 kg
  • 60 mg SC (two 30-mg injections), then
  • 30 mg SC every 4 weeks
• Weighing more than or equal to 90 kg
  • 60 mg SC (two 30-mg injections), then
  • 60 mg SC every 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Nemolizumab has no noted severe interactions with any other drugs
• Nemolizumab has no noted serious interactions with any other drugs
• Nemolizumab has no noted moderate interactions with any other drugs
• Nemolizumab has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Known hypersensitivity to drugs or excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nemolizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nemolizumab?”

Cautions

• Hypersensitivity
  • Hypersensitivity reactions (eg, facial angioedema) reported
  • If a significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue nemolizumab
• Vaccinations
  • Complete all age-appropriate vaccinations as recommended by current immunization guidelines before initiating
  • Avoid live vaccines during treatment
  • Unknown if administration of live vaccines during treatment will affect vaccine efficacy
• Drug interaction overview
  • CYP450 substrates
    • Monitor or modify the dose
    • Formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL10, TNFα, IFN) during chronic inflammation
    • Consider modifying the dose for substrates with narrow therapeutic indexes

Pregnancy and Lactation

• Data are insufficient to evaluate drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• May be transferred from mother to developing fetus; transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester
• Clinical considerations
  • May interfere with the immune response to infections; consider risks and benefits before administering live vaccines to infants exposed in utero
  • Data are not available regarding infant serum levels at birth and the duration of persistence of nemolizumab in infant serum after birth
  • Consider delaying live vaccines a minimum of 3 months after birth owing to product half-life
• Lactation
  • Data are unavailable regarding the presence  of nemolizumab in human milk, its effects on breastfed infants, or milk production
  • Detected in the breast milk of monkeys
  • Endogenous maternal IgG and monoclonal antibodies are transferred in human milk
  • Effects of local gastrointestinal exposure and limited systemic exposure in breastfed are unknown
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy with potential adverse effects in a breastfed child or from the underlying maternal condition