EBGLYSS
Generic Name/API: lebrikizumab
Manufacturer: Almirall Limited
Dosage Forms & Strength & Pack Size:
Solution for injection in pre-filled pen 2’s or 3’s
Storage:
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original package in order to protect from light.
Do not use this medicine if you notice that the solution is cloudy or discoloured or if it contains visible particles. Before use, remove the carton from the refrigerator, take the pre-filled pen out of the carton and allow to reach room temperature by waiting for 45 minutes. After removal from the refrigerator, Ebglyss must be stored below 30ºC and used within 7 days or discarded. Once stored out of refrigeration, do not place back in the refrigerator. The date of removal from the refrigerator may be recorded on the carton.
This medicine is for single use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
EBGLYSS™ (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids.
It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg).
Warnings – Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients.
Before using
Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you:
- Have a parasitic (helminth) infection.
- Are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with EBGLYSS.
- Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.
- Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Possible side effects
EBGLYSS can cause serious side effects, including:
- Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:
- 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. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision.
The most common side effects of EBGLYSS include:
- eye and eyelid inflammation, including redness, swelling, and itching
- injection site reactions
- shingles (herpes zoster)
These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
How to take
- See the detailed “Instructions for Use” that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes.
- Use EBGLYSS exactly as prescribed by your healthcare provider.
- EBGLYSS is given as an injection under the skin (subcutaneous injection).
- If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver.
- If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time.
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