ADUHELM™ (aducanumab-avwa) injection
Drug UPDATES: [Drug information (pdf)]
PACKAGE INSERT -Dosing: Click (+) next to Dosage and Administration section (drug info link)
After an initial titration, the recommended dosage of ADUHELM is 10 mg/kg (see TABLE 1). ADUHELM is administered as an intravenous (IV) infusion over approximately one hour every four weeks and at least 21 days apart.
| IV Infusion (every 4 weeks) |
ADUHELM Dosage (administered over approximately one hour) |
| Infusion 1 and 2 | 1 mg/kg |
| Infusion 3 and 4 | 3 mg/kg |
| Infusion 5 and 6 | 6 mg/kg |
| Infusion 7 and beyond | 10 mg/kg |
- Use aseptic technique when preparing the ADUHELM diluted solution for intravenous infusion. Each vial is for single-dose only. Discard any unused portion.
- Calculate the dose, total volume of ADUHELM solution required, and the number of vials needed based on the patient's actual body weight. Each vial contains an ADUHELM concentration of 100 mg per mL. More than one vial may be needed for a full dose.
- Select the correct vial(s) for the required volume [see Dosage Forms and Strengths (3)].
- Check that the ADUHELM solution is clear to opalescent and colorless to yellow solution. Do not use if opaque particles, discoloration, or other foreign particles are present.
- Remove the flip-off cap from the vial. Insert the syringe needle into the vial through the center of the rubber stopper.
- Withdraw the required volume of ADUHELM from the vial(s) and add to an infusion bag of 100 mL of 0.9% Sodium Chloride Injection, USP. Do not use other intravenous diluents to prepare the ADUHELM diluted solution.
- Gently invert the infusion bag containing the ADUHELM diluted solution to mix completely. Do not shake.
- After dilution, immediate use is recommended. If not administered immediately, store the diluted solution of ADUHELM in 0.9% Sodium Chloride Injection, USP refrigerated at 2°C to 8°C (36°F to 46°F) for up to 3 days, or at room temperature up to 30°C (86°F) for up to 12 hours.
- Prior to infusion, allow the ADUHELM diluted solution to warm to room temperature.
- Visually inspect the ADUHELM diluted solution for particles or discoloration prior to administration. Do not use if it is discolored, or opaque or foreign particles are seen.
- Infuse ADUHELM diluted solution intravenously over approximately one hour through an intravenous line containing a sterile, low-protein binding, 0.2 or 0.22 micron in-line filter.
- Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction
Aducanumab-avwa is a recombinant human immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta, and is expressed in a Chinese hamster ovary cell line. Aducanumab-avwa has an approximate molecular weight of 146 kDa.
ADUHELM (aducanumab-avwa) injection is a preservative-free, sterile, clear to opalescent, and colorless to yellow solution for intravenous infusion after dilution supplied in single-dose vials available in concentrations of 170 mg/1.7 mL (100 mg/mL) or 300 mg/3 mL (100 mg/mL) of ADUHELM.
Each mL of solution contains 100 mg of aducanumab-avwa and L-arginine hydrochloride (31.60 mg), L-histidine (0.60 mg), L-histidine hydrochloride monohydrate (3.39 mg), L-methionine (1.49 mg), polysorbate 80 (0.50 mg), and Water for Injection at an approximate pH of 5.5.
Aducanumab-avwa is a human, immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer's disease. ADUHELM reduces amyloid beta plaques
ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
None.
Amyloid Related Imaging Abnormalities (ARIA): Enhanced clinical vigilance for ARIA is recommended during the first 8 doses of treatment with ADUHELM, particularly during titration. If a patient experiences symptoms which could be suggestive of ARIA, clinical evaluation should be performed, including MRI testing if indicated.
Hypersensitivity Reactions: Angioedema and urticaria have occurred. If a hypersensitivity reaction occurs, promptly discontinue the infusion of ADUHELM and initiate appropriate therapy.
Details: Drug information (pdf)
Most common adverse reactions (at least 10% and higher incidence compared to placebo): ARIA-Edema, headache, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and fall.
To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-833-425-9360 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
After an initial titration, the recommended dosage of ADUHELM is 10 mg/kg (see TABLE 1). ADUHELM is administered as an intravenous (IV) infusion over approximately one hour every four weeks and at least 21 days apart.
| IV Infusion (every 4 weeks) |
ADUHELM Dosage (administered over approximately one hour) |
| Infusion 1 and 2 | 1 mg/kg |
| Infusion 3 and 4 | 3 mg/kg |
| Infusion 5 and 6 | 6 mg/kg |
| Infusion 7 and beyond | 10 mg/kg |
Obtain recent (within one year) brain magnetic resonance imaging (MRI) prior to initiating treatment. Obtain MRIs prior to the 7th infusion (first dose of 10 mg/kg) and 12th infusion (sixth dose of 10 mg/kg). If 10 or more new incident microhemorrhages or > 2 focal areas of superficial siderosis (radiographic severe ARIA-H) is observed, treatment may be continued with caution only after a clinical evaluation and a follow-up MRI demonstrates radiographic stabilization (i.e., no increase in size or number of ARIA-H) [see Warnings and Precautions (5.1)].
If an infusion is missed, resume administration at the same dose as soon as possible [see Dosage and Administration (2.1)]. Infusions are to be administered every 4 weeks and at least 21 days apart.
- Use aseptic technique when preparing the ADUHELM diluted solution for intravenous infusion. Each vial is for single-dose only. Discard any unused portion.
- Calculate the dose, total volume of ADUHELM solution required, and the number of vials needed based on the patient's actual body weight. Each vial contains an ADUHELM concentration of 100 mg per mL. More than one vial may be needed for a full dose.
- Select the correct vial(s) for the required volume [see Dosage Forms and Strengths (3)].
- Check that the ADUHELM solution is clear to opalescent and colorless to yellow solution. Do not use if opaque particles, discoloration, or other foreign particles are present.
- Remove the flip-off cap from the vial. Insert the syringe needle into the vial through the center of the rubber stopper.
- Withdraw the required volume of ADUHELM from the vial(s) and add to an infusion bag of 100 mL of 0.9% Sodium Chloride Injection, USP. Do not use other intravenous diluents to prepare the ADUHELM diluted solution.
- Gently invert the infusion bag containing the ADUHELM diluted solution to mix completely. Do not shake.
- After dilution, immediate use is recommended. If not administered immediately, store the diluted solution of ADUHELM in 0.9% Sodium Chloride Injection, USP refrigerated at 2°C to 8°C (36°F to 46°F) for up to 3 days, or at room temperature up to 30°C (86°F) for up to 12 hours.
- Prior to infusion, allow the ADUHELM diluted solution to warm to room temperature.
- Visually inspect the ADUHELM diluted solution for particles or discoloration prior to administration. Do not use if it is discolored, or opaque or foreign particles are seen.
- Infuse ADUHELM diluted solution intravenously over approximately one hour through an intravenous line containing a sterile, low-protein binding, 0.2 or 0.22 micron in-line filter.
- Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction
ADUHELM is a clear to opalescent and colorless to yellow solution, available as:
Injection: 170 mg/1.7 mL (100 mg/mL) in a single-dose vial
Injection: 300 mg/3 mL (100 mg/mL) in a single-dose vial
ADUHELM (aducanumab-avwa) injection is a preservative-free, sterile, clear to opalescent, and colorless to yellow solution. ADUHELM is supplied one vial per carton as follows:
170 mg/1.7 mL (100 mg/mL) single-dose vial (with red flip cap) – NDC 64406-101-01
300 mg/3 mL (100 mg/mL) single-dose vial (with blue flip cap) – NDC 64406-102-02
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).
