Donanemab
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: AMYLOID RELATED IMAGING ABNORMALITIES Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events can occur. ARIA can be fatal. Serious intracerebral hemorrhages >1 cm, some of which have been fatal, have been observed in patients treated with this class of medications.
Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with KISUNLA [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )] . ApoE ε4 Homozygotes Patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer's disease patients) treated with this class of medications, including KISUNLA, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers [see Warnings and Precautions ( 5.1 )] .
Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, the risk of ARIA across genotypes and the implications of genetic testing results should be discussed with patients. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with KISUNLA; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA [see Warnings and Precautions ( 5.1 )] .
Consider the benefit of KISUNLA for the treatment of Alzheimer's disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with KISUNLA [see Warnings and Precautions ( 5.1 ) and Clinical Studies ( 14 )] . WARNING: AMYLOID RELATED IMAGING ABNORMALITIES See full prescribing information for complete boxed warning. Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). ARIA is usually asymptomatic, although serious and life-threatening events can occur. ARIA can be fatal.
Serious intracerebral hemorrhages >1 cm have occurred in patients treated with this class of…
Dosing in kidney impairment
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Preparation and administration
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Dosing Instructions Administer KISUNLA every four weeks as an intravenous infusion over approximately 30 minutes with the recommended dosage and dosing schedule described in Table 1 . KISUNLA must be diluted prior to administration ( see Table 4 ). [See table below.] Consider stopping dosing with KISUNLA based on reduction of amyloid plaques to minimal levels on amyloid PET imaging.
In Study 1 and Study 2, dosing was stopped based on a reduction of amyloid levels below predefined thresholds on PET imaging [see Clinical Studies] . If an infusion is missed, resume administration every 4 weeks at the same dose as soon as possible.
Dilution Instructions Prior to administration, KISUNLA must be diluted with 0.9% sodium chloride injection ( see Table 4 ). Use aseptic technique when preparing the diluted KISUNLA solution for intravenous infusion. Allow KISUNLA to equilibrate to room temperature before preparation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
KISUNLA solution is clear to opalescent, colorless to slightly yellow to slightly brown. Do not use if particulate matter or discolorations are present. Withdraw required volume of KISUNLA and mix with 0.9% sodium chloride injection, to the recommended total volume for a final concentration of 4 mg/mL to 10 mg/mL ( see Table 4 ).
Use only 0.9% sodium chloride injection for dilution. [See table below.] Each vial is for one-time use only. Discard any unused portion left in the vial. Gently invert the diluted KISUNLA solution to mix completely. Do not shake. After dilution, immediate use is recommended [see Description] . If the diluted KISUNLA solution is not administered immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 72 hours or at room temperature (20°C to 25°C [68°F to 77°F]) for up to 12 hours.
Do not freeze the diluted KISUNLA solution. Storage times include the duration of infusion.
Administration Instructions Visually inspect the diluted KISUNLA solution for particles or discoloration prior to administration. Do not use if it is discolored, or opaque or foreign particles are seen. Prior to infusion, if the diluted solution has been stored under refrigeration, allow the diluted KISUNLA solution to warm to room temperature.
Administer the entire diluted solution intravenously over approximately 30 minutes. Flush the line only with 0.9% sodium chloride injection at the end of the infusion per access specific line maintenance protocol. Observe the patient post-infusion for a minimum of 30 minutes, and consider longer periods of observation if clinically indicated, to evaluate for infusion reactions and hypersensitivity reactions.
The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy administered as clinically indicated. Consider pre-medication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids [see Warnings and Precautions] .
| *Dosing Regimen 2 [see Warnings and Precautions (5.1) and Clinical Studies (14)] | |
| Intravenous Infusion (every 4 weeks) | KISUNLA Dosage (administered over approximately 30 minutes) |
| Infusion 1 | 350 mg |
| Infusion 2 | 700 mg |
| Infusion 3 | 1,050 mg |
| Infusion 4 and beyond | 1,400 mg |
| a final concentration of 4 mg/mL to 10 mg/mL | ||||
| b 2 vials of KISUNLA | ||||
| c 3 vials of KISUNLA | ||||
| d 4 vials of KISUNLA | ||||
| KISUNLA Dose (mg) | KISUNLA Volume (mL) | Volume of 0.9% Sodium Chloride Injection Diluent (mL) | Final Volume of Diluted Solution to be Infused (mL) | Final Concentration of Diluted Solution (mg/mL)a |
| 350 mg | 20 mL | 15 mL to 67.5 mL | 35 mL to 87.5 mL | 350 mg/87.5 mL (4 mg/mL) to 350 mg/35 mL (10 mg/mL) |
| 700 mg | 40 mLb | 30 mL to 135 mL | 70 mL to 175 mL | 700 mg/175 mL (4 mg/mL) to 700 mg/70 mL (10 mg/mL) |
| 1,050 mg | 60 mLc | 45 mL to 202.5 mL | 105 mL to 262.5 mL | 1,050 mg/262.5 mL (4 mg/mL) to 1,050 mg/105 mL (10 mg/mL) |
| 1,400 mg | 80 mLd | 60 mL to 270 mL | 140 mL to 350 mL | 1,400 mg/350 mL (4 mg/mL) to 1,400 mg/140 mL (10 mg/mL) |
Contraindications
4 CONTRAINDICATIONS KISUNLA is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.2 )] . KISUNLA is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. ( 4 , 5.2 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on KISUNLA 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 to assess the potential reproductive or developmental toxicity of KISUNLA. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
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