Donanemab

Donanemab is a prescription medication indicated for the treatment of Alzheimer’s disease.

• Donanemab is available under the following different brand names: Kisunla, donanemab-azbt.

Common side effects of Donanemab include:

• swelling in areas of the brain with or without small spots of bleeding in or on the surface of the brain
• headache

Serious side effects of Donanemab include:

• serious allergic reactions: symptoms include swelling of the face, lips, mouth, or eyelids, difficulty breathing, and hives
• infusion-related reactions: symptoms include chills, sweating, irritation of skin, headache, nausea, chest pain, vomiting, problems breathing

Rare side effects of Donanemab 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, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms include sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, 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

Injection, solution

• 350 mg/20 mL (17.5 mg/mL) single-dose vial

Alzheimer disease

Adult dosage

• Initial: 700 mg IV every 4 weeks × 3 doses
• Dose 4 and thereafter: 1,400 mg 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.

• Donanemab has no noted severe interactions with any other drugs
• Donanemab has no noted serious interactions with any other drugs
• Donanemab has no noted moderate interactions with any other drugs
• Donanemab has no noted minor interactions with any 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 product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Known serious hypersensitivity (including anaphylaxis) to Donanemab or excipients

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Amyloid related imaging abnormalities (ARIA)
  • May cause ARIA characterized by ARIA with edema (ARIA-E) which can be observed on MRI as brain edema or sulcal effusions;
  • May also present as ARIA with hemosiderin deposition (ARIA-H), which includes micro hemorrhage and superficial siderosis
  • ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta-amyloid generally occurs in association with an occurrence of ARIA-E
  • ARIA-H of any cause and ARIA-E can occur together
  • Focal neurologic deficits may also occur; symptoms associated with ARIA usually resolve over time; in addition to ARIA, intracerebral hemorrhages above 1 cm in diameter have occurred in patients receiving therapy
  • Neuroimaging findings that may indicate cerebral amyloid angiopathy (CAA) include evidence of prior intracerebral hemorrhage, cerebral microhemorrhages, and cortical superficial siderosis; CAA increases the risk for intracerebral hemorrhage; the presence of an ApoE ε4 allele is also associated with cerebral amyloid angiopathy
  • ARIA can occur spontaneously in Alzheimer disease, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (eg, pretreatment microhemorrhage or superficial siderosis)
  • It is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, rarely can occur
  • Symptoms may include, but are not limited to, headache, confusion, visual changes, dizziness, nausea, and gait difficulty
  • Exercise caution when considering use in patients with factors that indicate an increased risk for intracerebral hemorrhage, particularly those who need to be on anticoagulant therapy or with findings on MRI that are suggestive of cerebral amyloid angiopathy
  • Baseline brain MRI and periodic monitoring with MRI are recommended; enhanced clinical vigilance for ARIA is recommended during the first 24 weeks
• Hypersensitivity reactions
  • Hypersensitivity reactions reported, including anaphylaxis and angioedema
  • Promptly discontinue infusion at first observation of any signs or symptoms consistent with hypersensitivity and initiate appropriate therapy
  • Contraindicated with a history of serious hypersensitivity
• Infusion-related reactions
  • Majority of reactions occurred within the first 4 infusions
  • Infusion reactions typically occur during infusion or within 30 minutes post-infusion
  • Signs and symptoms include chills, erythema, nausea/vomiting, difficulty breathing/dyspnea, sweating, elevated blood pressure, headache, chest pain, and low blood pressure
  • If an infusion-related reaction occurs, may reduce the infusion rate or discontinue
  • Initiate appropriate therapy as clinically indicated
  • Pretreatment with antihistamines, acetaminophen, or corticosteroids before subsequent dosing may be considered

Pregnancy and Lactation

• There are no adequate data regarding use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• No animal studies have been conducted
• Lactation
  • There are no data regarding the presence of Donanemab in human milk, its effects on breastfed infants, or its effects on milk production
  • Data from other monoclonal antibodies generally indicate low passage of monoclonal antibodies into human milk and limited systemic exposure in breastfed infants