Ebglyss injection for moderate-to-severe atopic dermatitis

Ebglyss (lebrikizumab-lbkz) is a subcutaneous injection approved for treating moderate-to-severe atopic dermatitis in adults and children 12 years and older weighing at least 40 kg. It is intended for patients whose disease is not well controlled by topical therapies or when those treatments are not appropriate. Ebglyss works by blocking interleukin-13, a key molecule involved in the inflammation underlying atopic dermatitis.

Ebglyss is used for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients aged 12 years and older weighing at least 40 kg. It is intended for patients whose disease is not adequately controlled with prescription topical therapies or for whom such therapies are not advisable. It may be used with or without topical corticosteroids and topical calcineurin inhibitors reserved for sensitive areas.

lebrikizumab-lbkz

Lebrikizumab-lbkz is a monoclonal antibody that selectively binds to interleukin-13 (IL-13) with high affinity, inhibiting its signaling through the IL-4Rα/IL-13Rα1 receptor complex. IL-13 contributes to type 2 inflammation that plays a central role in atopic dermatitis. By blocking IL-13’s activity, Ebglyss reduces inflammatory responses including the release of proinflammatory cytokines, chemokines, and immunoglobulin E (IgE), which contribute to skin symptoms.

Recommended Dosage

• Initial dose: 500 mg (two 250 mg injections) subcutaneously at Week 0 and Week 2.
• Then 250 mg every 2 weeks until Week 16 or until adequate clinical response.
• Maintenance dose: 250 mg every 4 weeks or every 8 weeks thereafter.

Administration Instructions

• Administer by subcutaneous injection at the abdomen, thigh, or back of the upper arm.
• Alternate injection sites; avoid injection within 2 inches of the navel or on skin that is tender, bruised, red, hard, or affected by dermatitis.
• Adult patients may self-inject after proper training; caregivers may administer for pediatric patients after training.
• No need to warm the prefilled pen or syringe before use.
• Inspect solution visually for particulates or discoloration before use; do not use if liquid is cloudy, discolored, or contains particles.

Vaccinations Before Treatment

Complete all age-appropriate vaccinations per current guidelines prior to starting Ebglyss. Avoid live vaccines during treatment.

Missed Dose

If a dose is missed, administer as soon as possible and then continue on the regular schedule.

Use is contraindicated in patients with prior serious hypersensitivity to lebrikizumab-lbkz or any excipients in Ebglyss.

Hypersensitivity

Serious allergic reactions including angioedema and urticaria may occur. Discontinue treatment immediately if a serious hypersensitivity reaction develops.

Eye Disorders

Conjunctivitis and keratitis have been observed, more frequently than with placebo. Patients should report any new or worsening eye symptoms promptly.

Parasitic Infections

Treat any pre-existing helminth infections before starting therapy. If infection occurs during treatment and does not respond to therapy, discontinue Ebglyss until resolved.

Vaccinations

Avoid live vaccines during treatment. Ebglyss may increase the risk of infection following live vaccines.

Common adverse reactions include conjunctivitis (reported in up to 10% of patients), injection site reactions (3%), and herpes zoster (

Most conjunctivitis and keratitis cases were mild or moderate and resolved without stopping treatment. Injection site reactions decreased over time and were generally mild or moderate.

Treatment discontinuation due to adverse events was uncommon (about 2%).

Transient eosinophilia was reported more frequently than with placebo but did not lead to treatment discontinuation.

No formal drug interaction studies have been conducted. The effects of Ebglyss on other drugs’ pharmacokinetics and vice versa are unknown.

Pregnancy

Data are insufficient to determine risk in human pregnancy. Lebrikizumab crosses the placenta, especially during the third trimester. Animal studies showed no embryo-fetal harm at exposures up to 18 times human levels. A pregnancy exposure registry monitors outcomes and women are encouraged to enroll.

Lactation

No data available on lebrikizumab in human milk. Monoclonal antibodies are transferred in breast milk, but effects on the infant are unknown. Consider benefits of breastfeeding and maternal clinical need when deciding about use.

In case of overdose, contact Poison Control and monitor for any adverse effects. Provide symptomatic treatment as needed.

Store refrigerated at 2°C to 8°C (36°F to 46°F). Can be kept at room temperature up to 30°C (86°F) for a maximum of 7 days in its original carton. Protect from light. Do not freeze. Do not shake or expose to heat or sunlight. Discard if frozen, discolored, cloudy, or containing particulates.

Dispose of used prefilled pens and syringes in puncture-resistant containers.