ADUHELM

Generic Name/API: aducanumab-avwa

Manufacturer: Biogen Inc.

Dosage Forms & Strength & Pack Size:
Injection:
• 170 mg/1.7 mL (100 mg/mL) solution in a single-dose vial
• 300 mg/3 mL (100 mg/mL) solution in a single-dose vial

Storage:
Unopened Vial
• Store in original carton until use to protect from light.
• Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Do not freeze or shake.
• If no refrigeration is available, ADUHELM may be stored unopened in its original carton to
protect from light at room temperature up to 25°C (77°F) for up to 3 days.
• Prior to dilution, unopened vials of ADUHELM may be removed from and returned to the
refrigerator if necessary, when kept in the original carton. Total combined time out of
refrigeration with protection from light should not exceed 24 hours at room temperature up to
25°C (77°F).

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
ADUHELM is indicated for the treatment of Alzheimer’s disease. ADUHELM should be started in patients with mild cognitive impairment or mild dementia stage of disease, the population studied in clinical trials. ADUHELM is approved under accelerated approval based on reduction in amyloid plaques as seen in patients treated with ADUHELM. Continued approval of ADUHELM may require verification of clinical benefit in a confirmatory study

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ADUHELM?
ADUHELM can cause serious side effects, including:

Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. It is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur
Most people with this type of swelling in the brain do not get symptoms, however some people may have symptoms, such as: headache, nausea, confusion, difficulty walking, dizziness, seizures, and vision changes
Some people have a genetic risk factor (homozygous apolipoprotein E gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor
Some medicines may increase the risk for larger areas of bleeding in the brain in patients taking ADUHELM. Talk to your healthcare provider to see if you are on any medicines that increase this risk
Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with ADUHELM to check you for ARIA
Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

Before receiving ADUHELM, tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if ADUHELM will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with ADUHELM
are breastfeeding or plan to breastfeed. It is not known if aducanumab-avwa (the active ingredient in ADUHELM) passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving ADUHELM
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). Ask your healthcare provider for a list of these medicines if you are not sure
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacists when you get a new medicine.

What are the possible side effects of ADUHELM?
ADUHELM can cause serious side effects, including:

See above “What is the most important information I should know about ADUHELM?”
Serious allergic reactions. Swelling of the face, lips, mouth, or tongue and hives have happened during an ADUHELM infusion. Tell your healthcare provider if you have any of the symptoms of a serious allergic reaction during or after ADUHELM infusion
The most common side effects of ADUHELM include:

swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA)
headache
fall
These are not all the possible side effects of ADUHELM. For more information, ask your healthcare provider or pharmacist.

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