Aducanumab

Aducanumab is a prescription medication used for the treatment of Alzheimer’s disease.

• Aducanumab is available under the following different brand names: Aduhelm, aducanumab-avwa 

Common side effects of Aducanumab include:

• changes in mental state, 
• confusion, 
• vomiting, 
• nausea, 
• tremor, 
• gait disturbances, 
• headache, and 
• falls

Serious side effects of Aducanumab include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• headaches, 
• dizziness, 
• confusion, 
• nausea, and
• vision changes

Rare side effects of Aducanumab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 100 mg/mL (1.7-mL, 3-mL single-dose vials) 

Alzheimer Disease

Adult dosage

• Administered as an IV infusion every 4 weeks and at least 21 days apart
• Infusions 1-2: 1 mg/kg IV every 4 weeks
• Infusions 3-4: 3 mg/kg IV every 4 weeks
• Infusions 5-6: 6 mg/kg IV every 4 weeks
• Infusion 7 and beyond: 10 mg/kg IV every 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Aducanumab has severe interactions with no other drugs.
• Aducanumab has serious interactions with no other drugs.
• Aducanumab has moderate interactions with no other drugs.
• Aducanumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist about all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Aducanumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Aducanumab?”

Cautions

• Angioedema and urticaria reported; promptly discontinue infusion upon first observation of any signs or symptoms consistent with a hypersensitivity reaction, and initiate appropriate therapy

Amyloid-related imaging abnormalities (ARIA)

• May cause ARIA-E; observed on MRI as brain edema, sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis
• ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time; other symptoms include headache, confusion, dizziness, vision changes, or nausea
• The majority of ARIA was observed during the first 8 doses, particularly during titration; enhanced clinical vigilance recommended
• Safety in patients with any pretreatment localized superficial siderosis, greater than 10 brain microhemorrhages, and/or with a brain hemorrhage  more than 1 cm within 1 year of treatment initiation has not been established
• For ARIA-E or mild/moderate ARIA-H, continue treatment
• If dosing is temporarily suspended, resume at the same dose and titration schedule
• There are no systematic data on continued dosing following the detection of radiographically moderate or severe ARIA
• Refer to prescribing information for ARIA MRI classification criteria

Pregnancy and Lactation

• There are no adequate data on use in pregnant females to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Lactation

• No data are available on the presence of aducanumab in human milk, effects on breastfed infants, or effects on milk production