INDICATION AND IMPORTANT SAFETY INFORMATION
What is ALLSENSA®?
ALLSENSA® (CE CLASS III) injection is a prescription medicine used to treat adults with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ALLSENSA® can be used with or without topical corticosteroids.
It is not known if ALLSENSA® is safe and effective in children.
Do not use ALLSENSA® if you are allergic to CE or to any of its ingredients.
What should I discuss with my healthcare provider before starting ALLSENSA®?
Tell your healthcare provider about all your medical conditions, including if you:
have eye problems.
have a parasitic (helminth) infection.
are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ALLSENSA®.
are pregnant or plan to become pregnant. It is not known whether ALLSENSA® will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known whether ALLSENSA® passes into your breast milk and if it can harm your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use ALLSENSA®?
See the detailed “Instructions for Use” that comes with ALLSENSA® for information on how to prepare and inject ALLSENSA® and how to properly store and throw away (dispose of) used ALLSENSA® prefilled syringes.
Use ALLSENSA® exactly as prescribed by your healthcare provider.
Your healthcare provider will tell you how much ALLSENSA® to inject and when to inject it.
ALLSENSA® comes as a single-dose (150 mg) prefilled syringe with needle guard.
ALLSENSA® is given as an injection under the skin (subcutaneous injection).
If your healthcare provider decides that you or a caregiver can give the injection of ALLSENSA®, you or your caregiver should receive training on the right way to prepare and inject ALLSENSA®. Do not try to inject ALLSENSA® until you have been shown the right way by your healthcare provider.
If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
If you inject more ALLSENSA® than prescribed, call Poison Control at 1-800-222-1222.
Your healthcare provider may prescribe other medicines to use with ALLSENSA®. Use the other prescribed medicines exactly as your healthcare provider tells you to.
What are the possible side effects of ALLSENSA®?
ALLSENSA® can cause serious side effects, including:
Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ALLSENSA® and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
breathing problems
itching
skin rash
swelling of the face, mouth, and tongue
fainting, dizziness, feeling lightheaded (low blood pressure)
hives
Eye problems. Tell your healthcare provider if you have any worsening eye problems, including eye pain or changes in vision.
The most common side effects of ALLSENSA® include:
Eye and eyelid inflammation, including redness, swelling, and itching
Injection site reactions
High count of a certain white blood cell (eosinophilia)
These are not all of the possible side effects of ALLSENSA®. Call your doctor for medical advice about side effects. You may report side effects to CE at 1014.