Lebrikizumab

Lebrikizumab is a prescription medication indicated for moderate-to-severe atopic dermatitis in patients aged 12 years and older (weight 40 kg and above) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

• Lebrikizumab is available under the following different brand names: Ebglyss, lebrikizumab-lbkz.

Common side effects of Lebrikizumab include:

• eye and eyelid inflammation, including redness, swelling, and itching
• injection site reactions
• shingles (herpes zoster)

Serious side effects of Lebrikizumab include:

• allergic reaction symptoms include breathing problems or wheezing, swelling of the face, lips, mouth, tongue, or throat, hives, itching, fainting, dizziness, feeling lightheaded, skin rash, cramps in your stomach area (abdomen)
• eye problems

Rare side effects of Lebrikizumab 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

Solution for SC injection

• 250 mg/2 mL (single-dose prefilled pen or syringe)

Atopic dermatitis

Adult dosage

• Initial dose
  • 500 mg SC (two 250-mg injections) at weeks 0 and 2, then
  • 250 mg SC every 2 weeks until week 16 or later, when adequate clinical response is achieved
• Maintenance dose
  • 250 mg SC every 4 weeks

Pediatric dosage

• Children younger than 12 years: Safety and efficacy not established
• Children aged 12 years and older and weighing 40 kg and above
• Initial dose
  • 500 mg SC (two 250-mg injections) at weeks 0 and 2, then
  • 250 mg SC every 2 weeks until Week 16 or later, when adequate clinical response is achieved
• Maintenance dose
  • 250 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.

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

• Serious hypersensitivity to lebrikizumab or any excipients

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Hypersensitivity
  • Hypersensitivity reactions (e.g., angioedema, and urticaria) reported
  • Discontinue for serious hypersensitivity reaction, institute appropriate therapy
• Conjunctivitis and keratitis
  • Conjunctivitis and keratitis may occur
  • Most patients recover during the treatment period
  • Advise patients to report new onset or worsening eye symptoms to their healthcare provider
• Parasitic (helminth) infections
  • May increase the risk of helminth infections due to IL-13 signaling inhibition
  • Treat pre-existing helminth infections before initiating lebrikizumab
  • If patients become infected during lebrikizumab treatment and do not respond to antihelminth treatment, discontinue lebrikizumab until the infection resolves
• Vaccinations
  • Lebrikizumab may alter immunity and increase the risk of infection following the administration of live vaccines
  • Before initiating, complete all age-appropriate vaccinations according to current immunization guidelines
  • Avoid use of live vaccines immediately before or during treatment
  • No data are available on response to live vaccines

Pregnancy and Lactation

• Available data on lebrikizumab use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, Lebrikizumab may be transmitted from mother to developing fetus
• Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979)
• Lactation
  • No data are available regarding the presence of lebrikizumab in human milk, its effects on breastfed infants, or milk production
  • Endogenous IgG and monoclonal antibodies are transferred in human milk
  • Effects of local gastrointestinal exposure and limited systemic exposure in breastfed infants are unknown