Donidalorsen: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026🚩 Report this page

Donidalorsen

Drugs Used In Hereditary Angioedema

Sold as Dawnzera

GB MHRAEU EMA

Drug class: Drugs Used In Hereditary Angioedema
Availability: See label
Markets covered: 2
Products on record: 2

B06ACDrugs Used In Hereditary Angioedema

Overview

Donidalorsen is an active pharmaceutical ingredient in the Drugs Used In Hereditary Angioedema group (B06AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	May 22, 2026
EU European Union	EMA	1	February 20, 2026

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised May 22, 2026[1]

Dawnzera is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised February 20, 2026[2]

Dawnzera is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

How to take

Sources & citations

[1]MHRA (UK) · PLGB506970036 · revised May 22, 2026
[2]European Medicines Agency · EMEA/H/C/006554 · revised February 20, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment is to be initiated under the supervision of a physician experienced in the diagnosis and management of patients with HAE. Posology The recommended starting dose in adult and adolescent patients aged 12 years and older is 80 mg donidalorsen by subcutaneous injection once monthly.
, attack free) for at least 3 months while receiving Dawnzera. Based on the clinical data, a gradual reduction in attack rate is seen as early as Week 1 after the initial dose of donidalorsen with an expected maximum effect after 1 month.
1). 4). Missed dose If a dose is missed, the patient or caregiver should be instructed to administer the dose as soon as possible. Thereafter, dosing should be resumed at the prescribed dosing frequency (once monthly or once every 2 months) from the date of the most recently administered dose.
2). 2). Dawnzera has not been studied in patients with moderate or severe impairment. Donidalorsen should only be used in these patients if the anticipated clinical benefit outweighs the risk. Renal impairment No dose adjustment of donidalorsen is required for patients with mild renal impairment.
Dawnzera has not been studied in patients with moderate or severe impairment or end stage renal disease. Donidalorsen should only be used in these patients if the anticipated clinical benefit outweighs the risk. Paediatric population The safety and efficacy of donidalorsen in children aged < 12 years have not yet been established.
No data are available. 1. 1).
Table 1:
Treatment schedule for patients changing from other prophylactic therapy to Dawnzera. Other prophylactic therapy Recommended treatment schedule when changing to Dawnzera Berotralstat Continue taking the current dose of berotralstat for 14 days after initiating treatment with Dawnzera.
C1 esterase inhibitor Continue taking the current dose of C1 esterase inhibitor for 14 days after initiating treatment with Dawnzera. Lanadelumab Administer last dose of lanadelumab 14 days prior to initiating treatment with Dawnzera.
Method of administration Dawnzera is intended for subcutaneous use only. Dawnzera is to be administered as a subcutaneous injection in the abdomen, upper thigh region, or for caregivers only, the back of the upper arm. Rotation of the injection site is recommended.
Dawnzera must not be injected into areas where the skin is tender, bruised, red, hard, infected or discoloured. After proper training on correct subcutaneous injection technique, a patient or caregiver may inject Dawnzera if their physician determines it is appropriate.
Comprehensive instructions for administration using the pre-filled pen are provided in the package leaflet and the instructions for use. 6.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]

4 %). Tabulated list of adverse reactions Adverse reactions associated with donidalorsen obtained from clinical trials are tabulated below. All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 2:
Adverse drug reactions to donidalorsen System organ class Adverse drug reaction Frequency Immune system disorders Hypersensitivity (including anaphylaxis) Common General disorders and administration site conditions Injection site reactions a Very common Investigations Hepatic enzyme increased b Very common a Injection site reactions include also: erythema, discolouration, pain, pruritus, induration, haematoma, bruising, exfoliation, hypersensitivity and swelling.
b mainly mild, and mostly in alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Description of selected adverse reactions Hypersensitivity including anaphylaxis In clinical trials, a serious hypersensitivity reaction of anaphylaxis was reported in one patient.
4). Injection site reactions During double-blinded, placebo-controlled trials, injection site reactions were observed. All injection site reactions were non serious, mild to moderate in severity, and generally resolved over time. In some patients, the injection site reactions such as injection site erythema, injection site pruritus, and injection site discolouration persisted for 2 or more days.
In one patient who received higher than labelled doses in accordance with the protocol, injection site discoloration led to permanent discontinuation of treatment. Paediatric population The safety of donidalorsen was evaluated in a double-blind placebo-controlled clinical trial in a subset of 7 adolescent patients aged 12 to 17 years.
The safety profile in these adolescent patients was similar to the profile observed in adult patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]

8). In case of a severe hypersensitivity reaction, administration of donidalorsen must be stopped immediately and appropriate treatment must be initiated. Patients must be advised on the signs and symptoms of hypersensitivity reactions and instructed to promptly seek medical attention and to discontinue use of donidalorsen if serious hypersensitivity reactions occur.
General Dawnzera is not intended for treatment of acute HAE attacks. In case of a breakthrough HAE attack, individualised treatment should be initiated with an approved rescue medicinal product. 1). Patients with HAE nC1-INH having mutations that are not associated with the kallikrein-kinin system (KKS) pathway are not expected to respond to Dawnzera.
1). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.

Treatment is to be initiated under the supervision of a physician experienced in the diagnosis and management of patients with HAE. Posology The recommended starting dose in adult and adolescent patients aged 12 years and older is 80 mg donidalorsen by subcutaneous injection once monthly.
, attack free) for at least 3 months while receiving Dawnzera. Based on the clinical data, a gradual reduction in attack rate is seen as early as Week 1 after the initial dose of donidalorsen with an expected maximum effect after 1 month.
1). 4). 3 Missed dose If a dose is missed, the patient or caregiver should be instructed to administer the dose as soon as possible. Thereafter, dosing should be resumed at the prescribed dosing frequency (once monthly or once every 2 months) from the date of the most recently administered dose.
2). 2). Dawnzera has not been studied in patients with moderate or severe impairment. Donidalorsen should only be used in these patients if the anticipated clinical benefit outweighs the risk. Renal impairment No dose adjustment of donidalorsen is required for patients with mild renal impairment.
Dawnzera has not been studied in patients with moderate or severe impairment or end stage renal disease. Donidalorsen should only be used in these patients if the anticipated clinical benefit outweighs the risk. Paediatric population The safety and efficacy of donidalorsen in children aged < 12 years have not yet been established.
No data are available. 1. 1).
Table 1:
Treatment schedule for patients changing from other prophylactic therapy to Dawnzera. Other prophylactic therapy Recommended treatment schedule when changing to Dawnzera Berotralstat Continue taking the current dose of berotralstat for 14 days after initiating treatment with Dawnzera.
C1 esterase inhibitor Continue taking the current dose of C1 esterase inhibitor for 14 days after initiating treatment with Dawnzera. Lanadelumab Administer last dose of lanadelumab 14 days prior to initiating treatment with Dawnzera.
Method of administration Dawnzera is intended for subcutaneous use only. 4 Dawnzera is to be administered as a subcutaneous injection in the abdomen, upper thigh region, or for caregivers only, the back of the upper arm. Rotation of the injection site is recommended.
Dawnzera must not be injected into areas where the skin is tender, bruised, red, hard, infected or discoloured. After proper training on correct subcutaneous injection technique, a patient or caregiver may inject Dawnzera if their physician determines it is appropriate.
Comprehensive instructions for administration using the pre-filled pen are provided in the package leaflet and the instructions for use. 6.