Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Loerrach, Germany
Aumseqa as monotherapy is indicated for:
Treatment with Aumseqa should be initiated by a physician experienced in the use of anticancer medicinal products.
EGFR mutation status in tumour or plasma specimens should be assessed by a CE-marked IVD with the corresponding intended purpose. If the CE-marked IVD is not available, an alternative validated test should be used (see section 4.4).
The recommended dose of Aumseqa is 110 mg (2 tablets of 55 mg) once a day.
This medicinal product should be continued until disease progression or unacceptable toxicity.
If a dose of Aumseqa is missed, it should be taken within the same day as soon as the patient remembers. However, if the next scheduled dose is due within 12 hours, then the missed dose must be skipped. The patient should not take two doses together to make up for a missed dose.
An electrocardiogram (ECG) must be performed prior to treatment initiation, at least once during the first 3 weeks of therapy, and periodically thereafter as clinically indicated. QTc interval abnormalities should be managed promptly (see Table 1 and section 4.4).
For patients with known cardiovascular risk factors and conditions which may affect left ventricular ejection fraction (LVEF), cardiac function should be monitored, with at least LVEF assessment prior to treatment initiation and during treatment with Aumseqa (see section 4.4).
If concurrent use of strong CYP3A4 inhibitors (such as grapefruit juice, clarithromycin, itraconazole or lopinavir) cannot be avoided, the dose of Aumseqa should be reduced from 110 mg to 55 mg (see section 4.5).
Dosing interruption and/or dose reduction or permanent discontinuation may be required based on individual safety and tolerability.
If dose reduction is necessary, then the dose should be reduced from 110 mg (2 tablets) to 55 mg (1 tablet) taken once daily.
Dose modification guidelines for adverse reactions are provided in Table 1.
Table 1. Recommended Aumseqa dose modifications due to adverse reactions:
| Adverse reaction | Severity | Dose modification |
| Interstitial lung disease | Any grade | Permanently discontinue Aumseqa. |
| QTc interval prolongation | QTc interval prolongation > 480 to ≤ 500 msec (Grade 2) | Withhold Aumseqa for up to 2 weeks. If QTc interval has not recovered to ≤ 480 msec, permanently discontinue Aumseqa. If QTc interval recovers to ≤ 480 msec or within 30 msec of baseline, resume treatment at 110 mg. Monitor ECGs at least weekly for 2 weeks following return to ≤ 480 msec. Monitor and supplement electrolyte levels as clinically indicated. Review and adjust concomitant medicinal products with known QTc interval prolonging effects (see section 4.5). |
| QTc interval prolongation > 500 msec or > 60 msec from baseline (Grade 3) | Withhold Aumseqa for up to 2 weeks. If QTc interval has not recovered to ≤ 480 msec or within 30 msec of baseline, permanently discontinue Aumseqa. If QTc interval recovers to ≤ 480 msec: • resume treatment at 110 mg dose for the first occurrence. • resume treatment at 55 mg dose for the second occurrence or the first occurrence in patients with risk factors (see section 4.4). Permanently discontinue Aumseqa if symptoms/signs recur at any time on the reduced dose (55 mg). Monitor ECGs at least weekly for 2 weeks following return of QTc interval to ≤ 480 msec. Monitor and supplement electrolyte levels as clinically indicated. Review and adjust concomitant medicinal products with known QTc interval prolonging effects (see section 4.5). | |
| Prolongation associated with torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of other serious arrhythmias | Permanently discontinue Aumseqa. | |
| Cardiac failure | Asymptomatic, absolute decrease in LVEF > 10% from baseline or to below 50% | Withhold Aumseqa for up to 2 weeks. If LVEF returns to baseline or ≥ 50%: • resume treatment at 110 mg dose for the first occurrence. • resume treatment at 55 mg dose for the second occurrence. Permanently discontinue Aumseqa if symptoms/signs recur at any time on the reduced dose (55 mg). |
| Symptomatic congestive heart failure | Permanently discontinue Aumseqa. | |
| Blood creatine phosphokinase (CPK) increased / rhabdomyolysis | Grade 3 with muscular symptoms (e.g. muscle tenderness, muscle twitches or myalgia) | Withhold Aumseqa for up to 2 weeks. If muscular symptoms resolve and blood CPK increase is ≤ Grade 3: • resume treatment at 110 mg dose for the first occurrence. • resume treatment at 55 mg for the second occurrence. Permanently discontinue Aumseqa if symptoms/signs recur at any time on the reduced dose (55 mg). If muscular symptoms do not resolve and CPK increase does not improve to ≤ Grade 2, permanently discontinue Aumseqa. |
| Grade 4 with or without muscular symptoms (e.g. muscle tenderness, muscle twitches or myalgia) | Withhold Aumseqa for up to 2 weeks. If muscular symptoms resolve and blood CPK increase is ≤ Grade 3, resume treatment at 55 mg dose for the first occurrence. Permanently discontinue Aumseqa if symptoms/signs recur at any time on this dose. If muscular symptoms do not resolve and CPK increase remains ≥ Grade 3, permanently discontinue Aumseqa. | |
| Other adverse reactions | ≥ Grade 3 | Withhold Aumseqa for up to 2 weeks. If adverse reaction recovers to ≤ Grade 2: • resume treatment at 110 mg dose for the first occurrence • resume treatment at 55 mg dose for the second occurrence. Permanently discontinue Aumseqa if symptoms/signs recur at any time on the reduced dose (55 mg). If adverse reaction does not recover to ≤ Grade 2, permanently discontinue Aumseqa. |
Grade = Severity graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) CPK = creatine phosphokinase, ECG = electrocardiogram, LVEF = left ventricular ejection fraction, QTc = corrected QT
No dose modification is required due to patient age, body weight, gender, ethnicity, or smoking status (see section 5.2).
No dose modification is required for the elderly (see section 5.2).
Based on clinical studies, no dose modification is required in patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment (see section 5.2).
Based on clinical studies and population pharmacokinetic (PK) analysis, no dose modification is required in patients with mild or moderate renal impairment. Aumolertinib has not been evaluated in patients with severe renal impairment (creatinine clearance [CLc] <30 mL/min) or end-stage renal disease. Caution should be exercised when using Aumseqa in patients with severe or end-stage renal impairment (see section 5.2).
The safety and efficacy of Aumseqa in children or adolescents under the age of 18 years have not been established. No data are available.
This medicinal product is for oral use.
Two 55 mg tablets should be swallowed whole with water without chewing or crushing.
Aumseqa should be taken approximately at the same time each day. It can be taken with or without food (see section 5.2).
Human experience of accidental overdose with Aumseqa is limited. The highest dose studied was 260 mg once daily. The potential toxicity of Aumseqa at doses of 260 mg and above is unknown. The adverse reactions observed at 260 mg dose were primarily nausea and anaemia.
There is no specific treatment for Aumseqa overdose. In the event of an overdose or suspected overdose, the patient should be closely monitored, Aumseqa treatment should be withheld, and symptomatic treatment should be provided as clinically required.
3 years.
Do not store above 30°C.
Store in the original bottle in order to protect from moisture.
White, high density polyethylene (HDPE) bottle with an aluminium heat-induction sealed child-resistant closure, a silica gel desiccant cannister inside, and a white polypropylene (PP) cap.
Each bottle contains 60 film-coated tablets.
Each carton contains one bottle.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.