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Dawnzera
donidalorsen
Adult Dosing .
Dosage forms: INJ (auto-injector): 80 mg
hereditary angioedema prophylaxis
- [80 mg SC q4-8wk]
renal dosing
- [see below]
- eGFR >60: no adjustment; eGFR <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin <1.5x ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
- Dosage forms: INJ (auto-injector): 80 mg
hereditary angioedema prophylaxis
- [12 yo and older]
- Dose: 80 mg SC q4-8wk
renal dosing
- [see below]
- eGFR >60: no adjustment; eGFR <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin <1.5x ULN: no adjustment; bilirubin >1.5x ULN: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
Drug Interactions .
Overview
donidalorsen
antisense oligonucleotide
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
Common Reactions
- injection site rxn
- URI
- UTI
- abdominal discomfort
- platelets decr.
- LFTs incr.
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of fetal harm based on animal data at 2.5x and 5x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver; CYP450: none
Excretion: urine (<1% unchanged); Half-life: 1mo
Subclass: Hereditary Angioedema
Mechanism of Action
selectively inhibits plasma prekallikrein production, decreasing inflammatory mediators
Formulary .
No Formulary Selected
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