Ebglyss 250mg/ 2ml Pre-Filled Pen (Refrigerator)

Product Name

EBGLYSS Injection for Subcutaneous Use 250 mg/2 mL
Active ingredient: Lebrikizumab

Product Description

EBGLYSS is a prescription medicine containing lebrikizumab, used for the treatment of moderate-to-severe atopic dermatitis (eczema) in adults and adolescents 12 years of age and older who weigh at least 40 kg, when topical prescription treatments are not enough or cannot be used.

It works by blocking a protein involved in inflammation that plays a major role in atopic dermatitis. EBGLYSS may be used with or without topical corticosteroids.

Uses

EBGLYSS is used for:

• Treatment of moderate-to-severe atopic dermatitis (eczema)


• Adults and adolescents 12 years and older


• Patients whose condition is not well controlled with topical prescription therapies


• Patients who cannot use topical therapies

How to Use

• Use exactly as prescribed by your healthcare provider


• EBGLYSS is given as a subcutaneous injection


• Initial dose: 500 mg at Week 0 and Week 2
  
  
  
  • This means two 250 mg injections each time
  
  
  
  


• Then 250 mg every 2 weeks until Week 16 or later, once adequate response is achieved


• Maintenance dose: 250 mg every 4 weeks


• Some patients may maintain response with 250 mg every 8 weeks


• If a dose is missed, take it as soon as possible, then continue with the regular schedule


• In patients under 18 years, injection should be given by an adult


• Injection sites:
  
  
  
  • Abdomen
  
  
  • Thigh
  
  
  • Back of the upper arm (if given by a caregiver)
  
  
  
  

Warnings and Precautions

Before using EBGLYSS, tell your doctor if you:

• Are scheduled to receive any vaccinations


• Are pregnant or planning pregnancy


• Are breastfeeding or planning to breastfeed


• Are using any other prescription or non-prescription medicines, vitamins, or herbal supplements

Important precautions:

• Do not receive live vaccines while using EBGLYSS


• This medicine may rarely cause serious allergic reactions


• Tell your doctor if you have new or worsening eye problems, such as:
  
  
  
  • Eye redness
  
  
  • Eye discomfort
  
  
  • Eye pain
  
  
  • Changes in vision
  
  
  
  


• Keep a record of the batch number (Lot) each time you receive a new pack

Pregnancy and Breastfeeding

• The effects during pregnancy are not known


• It is better to avoid use during pregnancy unless your doctor advises otherwise


• It is not known whether lebrikizumab passes into breast milk


• You and your doctor should decide whether to breastfeed or use EBGLYSS, but not both

Possible Side Effects

Most Common Side Effects

• Eye and eyelid inflammation, including:
  
  
  
  • Redness
  
  
  • Swelling
  
  
  • Itching
  
  
  
  


• Injection site reactions


• Shingles (herpes zoster)


• High count of certain white blood cells

Serious Side Effects

Stop using EBGLYSS and seek medical help immediately if you notice signs of an allergic reaction such as:

• Breathing problems


• Swelling of the face, mouth, or tongue


• Fainting


• Dizziness


• Feeling lightheaded


• Hives, itching, or skin rash

Storage

• Store in a refrigerator at 2°C to 8°C


• Keep in the original carton to protect from light


• If needed, it may be kept at room temperature below 30°C for up to 7 days


• If not used within 7 days at room temperature, it should be discarded


• Do not freeze


• Do not shake


• Discard used prefilled pens in a puncture-resistant container

Active Ingredient

• Lebrikizumab 250 mg/2 mL

Inactive Ingredients

• Glacial acetic acid


• L-histidine


• Polysorbate 20


• Sucrose


• Water for Injection

Dosage Form

• Sterile, preservative-free solution for subcutaneous injection


• Clear, colorless to slightly yellow solution


• Available in single-dose prefilled pen