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Drug overview for ADUHELM (aducanumab-avwa):
Generic name: aducanumab-avwa (A-due-KAN-ue-mab)
Drug class: Alzheimer's Disease Agents - Amyloid Directed MC Antibody
Therapeutic class: Cognitive Disorder Therapy
No enhanced Introduction information available for this drug.
No enhanced Uses information available for this drug.
Generic name: aducanumab-avwa (A-due-KAN-ue-mab)
Drug class: Alzheimer's Disease Agents - Amyloid Directed MC Antibody
Therapeutic class: Cognitive Disorder Therapy
No enhanced Introduction information available for this drug.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ADUHELM (aducanumab-avwa) have been approved by the FDA:
Indications:
Mild to moderate Alzheimer's type dementia
Professional Synonyms:
None.
Indications:
Mild to moderate Alzheimer's type dementia
Professional Synonyms:
None.
The following dosing information is available for ADUHELM (aducanumab-avwa):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ADUHELM (aducanumab-avwa):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Aducanumab/Anticoagulants; Fibrinolytics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Microhemorrhage has been reported with the use of aducanumab. Radiographic changes on brain MRI have been noted as amyloid related imaging abnormalities-hemosiderin deposition (ARIA-H) which included microhemorrhage.(1) CLINICAL EFFECTS: Concurrent use of aducanumab with either anticoagulants or fibrinolytics may increase the risk of hemorrhage.(1-3) PREDISPOSING FACTORS: The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. thrombocytopenia). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs). PATIENT MANAGEMENT: Evaluate concurrent use of aducanumab with anticoagulants or fibrinolytics.(1-3) Patients receiving concurrent therapy with aducanumab and anticoagulants or fibrinolytics should be closely monitored for signs and symptoms of bleeding and changes in platelet count or International Normalized Ratio (INR).(1) Enhanced observation is recommended for the first 8 doses of aducanumab, particularly with dose titration. MRI should be considered if a patient develops clinical symptoms of microhemorrhage.(1) If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of microhemorrhage, including headache, nausea/vomiting, confusion, dizziness, visual disturbance, gait difficulties, and loss of coordination. General signs of blood loss include decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. When applicable, perform agent-specific laboratory tests (e.g. INR, aPTT) to monitor efficacy and safety of anticoagulation. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as confusion, headache, dizziness, nausea, visual changes, unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. DISCUSSION: In two phase 3 studies, aducanumab was observed to increase ARIA-H, including microhemorrhage. Radiographic changes were classified as mild (<=4 new incidences), moderate (5 to 9 new incidences), or severe (10 or more new incidences. Patients were excluded from clinical trials if taking concurrent anticoagulants or anti-platelets.(1) In Studies 1 and 2, ARIA was observed in 41% of patients treated with aducanumab with a planned dose of 10 mg/kg, compared to 10% of patients on placebo.(1) |
ACD-A, ACTIVASE, ANISINDIONE, ARGATROBAN, ARGATROBAN-0.9% NACL, ARIXTRA, BIVALIRUDIN, CATHFLO ACTIVASE, CITRATE PHOSPHATE DEXTROSE, DABIGATRAN ETEXILATE, DEFITELIO, DICUMAROL, ELIQUIS, ELMIRON, ENOXAPARIN SODIUM, ENOXILUV, FONDAPARINUX SODIUM, FRAGMIN, HEPARIN SODIUM, HEPARIN SODIUM IN 0.45% NACL, HEPARIN SODIUM-0.45% NACL, HEPARIN SODIUM-0.9% NACL, HEPARIN SODIUM-D5W, JANTOVEN, LMD 10% WITH 0.9% SOD CHLORIDE, LMD 10% WITH 5% DEXTROSE, LOVENOX, PENTOSAN POLYSULFATE SODIUM, PHENINDIONE, PRADAXA, RIVAROXABAN, SAVAYSA, TNKASE, WARFARIN SODIUM, XARELTO |
| IgG Antibodies and Derivatives/Efgartigimod-alfa SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3) |
VYVGART, VYVGART HYTRULO |
| IgG Antibodies and Derivatives/Nipocalimab-aahu SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
IMAAVY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Rozanolixizumab-noli SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3) DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3) |
RYSTIGGO |
The following contraindication information is available for ADUHELM (aducanumab-avwa):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Brain aneurysm |
| Intracerebral hemorrhage |
There are 0 moderate contraindications.
The following adverse reaction information is available for ADUHELM (aducanumab-avwa):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 8 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Amyloid-related imaging abnormality Amyloid-related imaging abnormality with edema |
Accidental fall Amyloid-related imaging abnormality with microhemorrhage Amyloid-related imaging abnormality with superficial siderosis |
| Rare/Very Rare |
|---|
|
Angioedema Intracerebral hemorrhage Urticaria |
There are 6 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Headache disorder |
Acute cognitive impairment Diarrhea Dizziness Nausea Visual changes |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ADUHELM (aducanumab-avwa):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ADUHELM (aducanumab-avwa):
WARNING: This medication may increase your risk of serious (possibly fatal) side effects such as temporary swelling of the brain, or small spots of bleeding in or on the surface of the brain. These side effects are also known as amyloid-related imaging abnormalities (ARIA). Your doctor may order a genetic test to measure your risk for ARIA before you start this medication.
If the genetic test shows you are at greater risk, your doctor should discuss with you the risks and benefits of starting aducanumab. Your doctor will do magnetic resonance imaging (MRI) scans before and during treatment to check for these side effects. If you are also taking medications that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran), your doctor will monitor you more closely for bleeding.
ARIA usually go away over time. They do not always cause symptoms, but tell your doctor right away if you develop symptoms such as headache, dizziness, nausea, confusion, seizures, trouble walking, or vision changes.
WARNING: This medication may increase your risk of serious (possibly fatal) side effects such as temporary swelling of the brain, or small spots of bleeding in or on the surface of the brain. These side effects are also known as amyloid-related imaging abnormalities (ARIA). Your doctor may order a genetic test to measure your risk for ARIA before you start this medication.
If the genetic test shows you are at greater risk, your doctor should discuss with you the risks and benefits of starting aducanumab. Your doctor will do magnetic resonance imaging (MRI) scans before and during treatment to check for these side effects. If you are also taking medications that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran), your doctor will monitor you more closely for bleeding.
ARIA usually go away over time. They do not always cause symptoms, but tell your doctor right away if you develop symptoms such as headache, dizziness, nausea, confusion, seizures, trouble walking, or vision changes.
The following icd codes are available for ADUHELM (aducanumab-avwa)'s list of indications:
| Mild to moderate alzheimer's type dementia | |
| G30 | Alzheimer's disease |
| G30.0 | Alzheimer's disease with early onset |
| G30.1 | Alzheimer's disease with late onset |
| G30.8 | Other alzheimer's disease |
| G30.9 | Alzheimer's disease, unspecified |
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