Aduhelm
- Generic Name: aducanumab-avwa injection
- Brand Name: Aduhelm
Aduhelm (Aducanumab-avwa Injection) side effects drug center
What Is Aduhelm?
Aduhelm (aducanumab-avwa) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.
What Are Side Effects of Aduhelm?
Side effects of Aduhelm include:
- amyloid related imaging abnormalities (ARIA) fluid retention (edema),
- headache,
- amyloid related imaging abnormalities due to haemosiderin deposition (ARIA-H) microhemorrhage,
- ARIA-H superficial siderosis,
- falls,
- diarrhea, and
- confusion/delirium/altered mental status/disorientation.
Dosage for Aduhelm
Titration is required for treatment initiation. The recommended maintenance dosage of Aduhelm is 10 mg/kg administered as an intravenous infusion over approximately one hour every four weeks.
Aduhelm In Children
Safety and effectiveness of Aduhelm in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Aduhelm?
Aduhelm may interact with other medicines.
Tell your doctor all medications and supplements you use.
Aduhelm During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Aduhelm; it is unknown how it might affect a fetus. It is unknown if Aduhelm passes into breast milk or how it might affect a nursing infant. Consult your doctor before breastfeeding.
Additional Information
Our Aduhelm (aducanumab-avwa) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Aduhelm Professional Information
SIDE EFFECTS
The following adverse reactions are described elsewhere in the labeling:
- Amyloid Related Imaging Abnormalities [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of ADUHELM has been evaluated in 3,078 patients who received at least one dose of ADUHELM. In two placebo-controlled studies (Studies 1 and 2) in patients with Alzheimer's disease, a total of 1105 patients received ADUHELM 10 mg/kg [see Clinical Studies]. Of these 1105 patients, approximately 52% were female, 76% were White, 10% were Asian, and 3% were of Hispanic or Latino ethnicity. The mean age at study entry was 70 years (range from 50 to 85).
In the combined placebo-controlled and long-term extension periods of Studies 1 and 2, 834 patients received at least one dose of ADUHELM 10 mg/kg once monthly for at least 6 months, 551 patients for at least 12 months, and 309 patients for at least 18 months. In the combined placebo-controlled and long-term extension periods, 5% (66 out of 1386) of patients in the 10 mg/kg dose group withdrew from the study because of an adverse reaction. The most common adverse reaction resulting in study withdrawal in the combined placebo-controlled and long-term extension periods was ARIA-H superficial siderosis. Table 3 shows adverse reactions that were reported in at least 2% of patients treated with ADUHELM and at least 2% more frequently than in patients on placebo.
Table 3: Adverse Reactions Reported in at Least 2% of Patients Treated with ADUHELM 10 mg/kg and at Least 2% Higher Than Placebo in Studies 1 and 2
| Adverse Reaction | ADUHELM 10 mg/kg N=1105 % |
Placebo N=1087 % |
| ARIA-E | 35 | 3 |
| Headachea | 21 | 16 |
| ARIA-H microhemorrhage | 19 | 7 |
| ARIA-H superficial siderosis | 15 | 2 |
| Fall | 15 | 12 |
| Diarrheab | 9 | 7 |
| Confusion/Delirium/Altered Mental Status/Disorientationc | 8 | 4 |
| aHeadache includes the adverse reaction related terms headache, head discomfort, migraine, migraine with aura, and occipital neuralgia. bDiarrhea includes the adverse reaction related terms diarrhea and infectious diarrhea. cConfusion/Delirium/Altered Mental Status/Disorientation includes the adverse reaction related terms confusional state, delirium, altered state of consciousness, disorientation, depressed level of consciousness, disturbance in attention, mental impairment, mental status changes, postoperative confusion, and somnolence. |
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Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other aducanumab products may be misleading.
The immunogenicity of ADUHELM has been evaluated using an in vitro assay for the detection of binding anti-aducanumab-avwa antibodies.
In up to 41 months of treatment in the combined placebo-controlled and long-term extension periods of Studies 1 and 2, up to 0.6% (15/2689) of patients receiving ADUHELM once monthly developed anti-aducanumab-avwa antibodies.
Based on the limited number of patients who tested positive for anti-aducanumab-avwa antibodies, no observations were made concerning a potential effect of neutralizing activity of anti-aducanumab-avwa antibodies on exposure or efficacy; however, the available data are too limited to make definitive conclusions regarding an effect on pharmacokinetics, safety, or efficacy of ADUHELM. Quantification of neutralizing anti-aducanumab-avwa antibodies has not been assessed.
DRUG INTERACTIONS
No Information provided
Read the entire FDA prescribing information for Aduhelm (Aducanumab-avwa Injection)
&Copy; Aduhelm Patient Information is supplied by Cerner Multum, Inc. and Aduhelm Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.