Patient leaflet - Aumseqa 55 mg film-coated tablets
1. What Aumseqa is and what it is used for
Aumseqa contains the active substance aumolertinib which belongs to a group of medicines called protein kinase inhibitors, which are used to treat cancer. Aumseqa is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer’. If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR’ (epidermal growth factor receptor), your cancer is likely to respond to treatment with Aumseqa. Aumseqa can be prescribed for you:
z as the first medicine you receive for your cancer
which has spread to other parts of the body, or z in certain circumstances if you have been treated
for your cancer before with other protein kinase inhibitor medicines.
How Aumseqa works
Aumseqa works by blocking EGFR and may help to slow or stop your lung cancer from growing. It may also help reduce the size tumour.
If Aumseqa is the first protein kinase inhibitor medicine you are receiving, it means that your cancer contains defects in the EGFR gene, for example ‘exon 19 deletion’ or ‘exon 21 substitution mutation’.
If your cancer has progressed while you were being treated with other protein kinase inhibitor medicines, it means that your cancer contains a gene defect called ‘T790M’. Because of this defect, other protein kinase medicines may no longer work.
If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you take Aumseqa
Do not take Aumseqa
If you are allergic to aumolertinib or any of the other ingredients of this medicine (listed in section 6). The following medicines will affect how well Aumseqa works. Do not use with Aumseqa. These are some examples. Please ask your doctor, nurse or pharmacist about the medicines you are taking: z Strong CYP3A4 inhibitors
- grapefruit juice
- ritonavir, ritonavir in combination with other medicines, cobicistat, nelfinavir, lopinavir – – used to treat infection caused by human immunodeficiency virus (HIV)
- posaconazole, itraconazole, voriconazole, ketoconazole – used to treat fungal infection – clarithromycin – used to treat bacterial infections – nefazodone – used to treat depression z Strong CYP3A4 inducers
- phenytoin sodium, carbamazepine – used for seizures.
- rifampicin, rifabutin – used for tuberculosis (TB) and used to treat meningitis bacteria. – St. John’s wort (Hypericum perforatum) – an herbal medicine used for depression.
- mitotane – used to treat Cushing disease
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Aumseqa if:
z you have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease’). z you have ever had heart problems or raised blood pressure – your doctor may want to keep a close eye on you.
z you have had a blood clot (thrombus) in a blood vessel.
Tell your doctor straight away while taking this medicine if:
z you have sudden difficulty in breathing together with a cough or fever.
z you have rapid or irregular heartbeats, dizziness, light-headedness, chest discomfort, shortness of breath or fainting.
z You have unexplained muscle pain, tenderness, or weakness, trouble moving arms or legs, dark tea-coloured urine, or decreased urination.
Your doctor may routinely perform blood tests to monitor your liver function, renal function, and electrolytes. Tell your doctor if you are experiencing abdominal pain, nausea, confusion, and fatigue. Your doctor will inform you of what to do.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking this medicine.
Children and adolescents
Do not give Aumseqa to children or adolescents under the age of 18 years.
Other medicines and Aumseqa
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription. This is because Aumseqa can affect the way some other medicines work. Also, some other medicines can affect the way Aumseqa works. Aumseqa may affect how well the following medicines work and/or increase side effects of these medicines or side effects of Aumseqa:
z verapamil – used for high blood pressure and to control chest pain z fluconazole – used to treat fungal infection z statins such as rosuvastatin, atorvastatin – used to lower cholesterol.
z dabigatran – used to prevent blood clots. z digoxin – used for irregular heartbeat or other heart problems.
The following medicines may reduce how well Aumseqa works:
z phenobarbital – used for seizures.
z bosentan – used for high blood pressure in the lungs. z efavirenz – used to treat HIV infections /AIDS. There is no affect expected when taking Aumseqa with famotidine or omeprazole, usually given for stomach ulcers or heartburn.
If you are taking any of the medicines listed above, tell your doctor before taking Aumseqa.
Your doctor will discuss appropriate treatment options with you.
Pregnancy, Breast-feeding, and Fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
Pregnancy z You should not become pregnant while taking this medicine.
z If you are able to become pregnant, you must use effective contraception. See ‘Contraception – information for women and men’ below.
z If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
z If you do become pregnant during treatment, tell your doctor straight away. Your doctor will decide with you whether you should carry on taking Aumseqa. z If you plan to become pregnant after taking the last dose of this medicine, ask your doctor for advice. This is because some medicine may remain in your body, (see advice on contraception below).
Contraception – information for women and men z Both women and men must use effective contraception during treatment and for 4 weeks after completing treatment with Aumseqa.
z Aumseqa may pass into semen.
Breast-feeding
Do not breast-feed while taking this medicine. This is because it is not known if there is a risk to your baby. Breast-feeding should be discontinued during treatment with Aumseqa and for 4 weeks after completion of treatment with Aumseqa.
Driving and using machines
Aumseqa has minor influence on the ability to drive and use machines. You may experience fatigue and dizziness. If you experience fatigue and/or dizziness, do not drive or use machines until symptoms resolve.
Aumseqa contains lactose
Aumseqa contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Aumseqa contains sodium
This medicine contains less than 1 mmol sodium (23.3 mg) 110 mg dose (2 tablets of 55 mg), that is to say essentially “sodium free”.
3. How to take Aumseqa
Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist, or nurse if you are not sure.
How much to take
The recommended starting dose is two 55 mg tablets once a day.
If necessary, your doctor may reduce your dose to one 55 mg tablet each day or temporarily stop your treatment. It is important to tell your doctor about the side effects that you are experiencing.
Packaging Company Veristat
Format: 351 × 229 mm
A
Print colors:: Black
Product name: AUMSEQA
Fo S fo
C
Binningerstrasse 116, CH-4123 Allschwil Tel. ++41 61 486 98 00, Fax ++41 61 486 98 08 info@proacteam.ch
File Path: /Medien01/Proacteam01/Ablage/2025/25-0108_Solutions f
umseqa 55 mg film-coated tablets nt type: Expressway mallest nt size: 8.5 Point
ountry code: UK or Life Sciences SFL_Aumseqa PIL und Foldingbox
User: Nicolaus Computer: on Date: 07/05/2025 – 10:34 Print Scale: 100% Handling#: 3 4.4
mm 4.4
mm 4.4 mm 4.4 mm
78.95 mm
351 mm mm 4.4 mm 4.4 mm 4.4 mm
How to take
z Aumseqa is taken by mouth. Swallow the tablet whole with some water. Do not crush or chew the tablet. z Aumseqa can be taken with or without food. z Take Aumseqa every day at the same time. Do not swallow the desiccant canister contained in the bottle. Please tell your doctor, nurse or pharmacist if you have difficulty swallowing tablets.
If you take more Aumseqa than you should If you take more tablets than you should, tell your doctor or pharmacist straight away. You may need medical help.
If you forget to take Aumseqa
If you forget a dose, take it as soon as you remember it. However, if it is less than 12 hours until your next dose is due, skip the missed dose. Take your next normal dose at its scheduled time.
Do not take a double dose (4 tablets) to make up for a forgotten dose.
If you stop taking Aumseqa
It is important to take this medicine every day, for as long as your doctor prescribes it for you.
Do not stop taking this medicine without talking to your doctor first.
Your doctor may adjust your dosage based on side effects. It is important to tell your doctor about the side effects that you are experiencing.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience any of the following side effects stop taking the medicine and seek medical help immediately:
Inflammation of the lungs
Aumseqa can cause lung inflammation (interstitial lung disease, pneumonitis), which in some people can be fatal. You will be checked for any lung problems while you are taking Aumseqa.
Lung inflammation symptoms may include: z sudden difficulty in breathing together with a cough and fever
z shortness of breath at rest or aggravated by exertion z dry cough that will not go away.
Seek medical help immediately if you get any of these symptoms. Your doctor will stop Aumseqa if you get this side effect. This side effect is common: it may affect up to 1 in 10 people.
Blood clots
Pulmonary embolism
Aumseqa may cause a clot in your lung, symptoms can vary greatly. Some common signs and symptoms include: z shortness of breath
z chest pain
z cough with blood
Other signs and symptoms of blood clots include: z rapid or irregular heartbeat,
z lightheadedness,
z excessive sweating,
z fever,
z leg pain or swelling,
z clammy skin.
Seek medical help immediately if you get any of these symptoms. This side effect is common: it may affect 1 in 10 people.
Heart conditions
The risks of these problems may be higher for people with an existing heart problem, or who are taking other medicines. You will be checked for any heart problems while you are taking Aumseqa.
Heart failure or problem with your heart
Aumseqa can affect how well your heart pumps blood. Signs and symptoms include:
z increased heart beats
z shortness of breath at rest
z tiredness and fatigue
z swelling in the legs, ankles and feet.
Seek medical help immediately if you get any of these symptoms. This side effect is uncommon: it may affect 1 in 100 people.
Changes in heart rhythm (QTc prolongation) Aumseqa can affect electrical activity in the heart which in some people can develop into a potentially serious heart condition. This can result in a: z very fast or irregular heartbeat causing fainting z dizziness
z light-headedness
z chest discomfort
z shortness of breath.
Seek medical help immediately if you get any of these symptoms. This side effect is common: it may affect up to 1 in 10 people.
Other side effects
Very common (may affect more than 1 in 10 people) z abnormal level of liver enzymes known as aspartate aminotransferase increased (AST) - AST is an enzyme that helps metabolise amino acids. AST is normally present in blood at low levels.
z abnormal level of liver enzyme known as alanine aminotransferase increased (ALT) - ALT is an enzyme found in the liver that helps convert proteins into energy for the liver cells. ALT is normally present in blood at low levels.
z anaemia (condition in which you lack enough healthy red blood cells to carry adequate oxygen to your body’s tissue)
z cough z decreased platelet count - blood cells that help blood clot.
z decreased white blood cell count - decreased disease-fighting cells z diarrhoea z increased blood bilirubin – an increase may be sign of an unhealthy or damaged liver.
z increased blood creatine phosphokinase (CPK) z low level of sodium in the blood z low level of potassium in the blood z mouth sores z rash
Common (may affect up to 1 in 10 people) z blood pressure that is higher than normal z blood clots in the veins especially in the legs z an abnormally high level of uric acid in the blood z decreased appetite z eye symptoms including dry eye; tearing; sensitivity to light; blurred vision; eye pain; redness in the eye; vision changes increased blood pressure z increased blood lactate dehydrogenase - you have some type of tissue damage or disease. z lymphocyte count decreased - count in your bloodstream is lower than normal. Severe or chronic low counts can indicate a possible infection or other significant illness.
z nausea z proteinuria – increased level of protein in the urine. May be a sign of kidney problem.
z pruritis - an unpleasant sensation that provokes the desire to scratch.
z vomiting
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Aumseqa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 30ºC.
Store in the original bottle in order to protect from moisture.
The bottle of tablets should contain a ‘desiccant’ which helps keep the tablets dry. If this is missing or the aluminium seal is open under the cap when opening the bottle for the first time, please contact your pharmacist who will advise you on what to do.
Do not swallow desiccant. Do not remove desiccant from bottle.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Aumseqa contains z The active substance is aumolertinib. Each tablet contains 55 mg of aumolertinib as mesilate. z The other ingredients are microcrystalline cellulose, sodium starch glycolate, anhydrous lactose, sodium stearyl fumarate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide yellow (E172).
What Aumseqa looks like and contents of the pack The 55 mg tablets are 7 mm round biconvex yellow film-coated tablet debossed with “E1” on one side and plain on the reverse.
Pack size: 1 bottle of 60 film-coated tablets
Marketing Authorisation Holder:
SFL Pharmaceuticals Deutschland GmbH Marie-Curie-Strasse 8
79539 Loerrach
Germany
Manufacturer:
Manufacturing Packaging Farmaca (MPF) B.V. Neptunus 12, Heerenveen, 8448CN
The Netherlands