40 mg, 80 mg film-coated tablets
osimertinib
What TAGRISSO is and what it is used for
TAGRISSO contains the active substance osimertinib, which belongs to a group of medicines called protein kinase inhibitors and is used to treat cancer. TAGRISSO 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 the gene “EGFR” ( epidermal growth factor receptor), your cancer will likely respond to treatment with TAGRISSO. TAGRISSO can be prescribed:
- after complete removal of your cancer, as a treatment after surgery ( adjuvant treatment)
or - as the first drug cancer treatment, you receive for your cancer that has spread to other parts of the body
- in some cases, if you have previously been treated with other protein kinase inhibitors for your cancer.
How TAGRISSO works
TAGRISSO works by blocking EGFR and can help slow or stop the growth of your lung cancer. It can also help to shrink the size of the tumor and prevent the tumor from coming back after surgical removal.
- If you receive TAGRISSO after complete removal of your cancer, it means that your cancer contained a defect ( mutation ) in the EGFR gene, “exon 19 deletion” or “exon 21 substitution mutation”.
- If TAGRISSO is the first protein kinase inhibitor you receive, it means that your cancer has a defect ( mutation ) in the EGFR gene, so-called “exon 19 deletions” or “exon 21 substitution”.
- If your cancer worsened while you were taking other protein kinase inhibitors, it means that your cancer has a gene defect ( mutation ) called “T790M”. This defect can render other protein kinase inhibitors no longer effective.
If you have any questions about how this medicine works or why you have been prescribed this medicine, ask your doctor.
What you need to know before you take TAGRISSO
Do not take TAGRISSO:
- if you are allergic to osimertinib or any of the other ingredients of this medicine (listed in section 6).
- if you take St. John’s wort ( Hypericum perforatum ).
If you are not sure, talk to your doctor, pharmacist, or nurse before taking TAGRISSO.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TAGRISSO:
- if you have had inflammation of the lungs (a condition called interstitial lung disease).
- if you’ve ever had heart problems – your doctor may want to monitor you.
- if you have had eye problems.
If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Tell your doctor immediately while you are taking this medicine if:
- you suddenly have difficulty breathing along with a cough or fever.
- you have widespread scaling of the skin.
- you experience fast or irregular heartbeats, dizziness, lightheadedness, chest discomfort, shortness of breath, and fainting.
- you have watery eyes, sensitivity to light, eye pain, red eyes, or vision changes.
See “Serious side effects” in section 4 for more information.
Children and young people
TAGRISSO has not been studied in children or adolescents. Do not give this medicine to children or adolescents under 18 years of age.
Other medicines and TAGRISSO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes (traditional) herbal and herbal medicines and medicines bought without a prescription. The reason for this is that TAGRISSO can affect the function of certain other medicines. Some other medicines can also affect how TAGRISSO works.
Tell your doctor if you are taking any of the following medicines before taking TAGRISSO:
The following medicines may reduce how well TAGRISSO works:
- phenytoin, carbamazepine, or phenobarbital – used for epileptic seizures.
- rifabutin or rifampicin – used for tuberculosis (TB).
- St. John’s wort ( Hypericum perforatum ) – is a (traditional) herbal medicine used to treat mild depression and mild anxiety.
TAGRISSO can affect how well the following medicines work and/or increase the side effects of these medicines:
- Rosuvastatin – used to lower cholesterol
- Birth control pills – used to prevent pregnancy
- Bosentan – used for high blood pressure in the lungs
- Efavirenz and etravirine – used to treat HIV infections/AIDS
- Modafinil – used for sleep disorders.
- Dabigatran – is used to prevent blood clots.
- Digoxin – used for irregular heartbeats or other heart problems.
- Aliskiren – used for high blood pressure.
Tell your doctor if you are taking any of the medicines listed above before taking TAGRISSO. Your doctor will discuss appropriate treatment options with you.
Pregnancy information for women
- If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. If you become pregnant during treatment, tell the doctor immediately. Your doctor will decide whether you should continue taking TAGRISSO or not.
- You should not become pregnant while taking this medicine. If you are fertile, you must use effective contraception. See “Contraceptives – information for women and men” below.
- Ask your doctor for advice if you plan to become pregnant after you have taken the last dose of this medicine. This is because a certain amount of medicine may remain in your body (see advice on contraception below).
Pregnancy information for men
- If your partner becomes pregnant while you are taking this medicine, tell your doctor immediately.
Contraceptives – information for women and men
You must use effective contraception during treatment.
- TAGRISSO can interfere with the function of birth control pills. Discuss the most appropriate birth control methods with your doctor.
- TAGRISSO can be transferred to semen. Therefore, it is important that men also use an effective contraceptive.
You must also do this after finishing treatment with TAGRISSO:
- Women – continue to use contraception for 2 months afterward.
- Men – continue to use contraception for 4 months afterward.
Breast-feeding
Do not breastfeed while taking this medicine. This is because it has not been determined whether there is a risk to your child.
Driving ability and use of machinery
TAGRISSO has no or no apparent effect on the ability to drive and use machines.
TAGRISSO contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. is almost “sodium-free”.
How to take TAGRISSO
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How much should you take?
- The recommended dose is one 80 mg tablet a day.
- If necessary, your doctor can reduce your dose to one 40 mg tablet a day.
How to take TAGRISSO
- TAGRISSO is taken orally. Swallow the tablet whole with water. The tablet should not be crushed, split, or chewed.
- Take TAGRISSO every day at the same time.
- You can take this medicine with or without food.
If you have trouble swallowing the tablet, you can mix it with water:
- Place the tablet in a glass.
- Add 50ml (about two-thirds of a drinking glass) of still water. Do not use any other liquids.
- Stir the water until the tablet crumbles into very small pieces. The tablet will not dissolve completely.
- Drink the liquid immediately.
- To make sure you have taken all the medicine, rinse the glass thoroughly with another 50 ml of water and drink it.
If you have taken too much TAGRISSO
If you take more than your normal dose, contact your doctor or nearest hospital immediately.
If you forget to take TAGRISSO
If you forget to take a dose, take it as soon as you remember. However, if it is less than 12 hours until the next dose is due, skip the missed dose. Take the next normal dose at the scheduled time.
If you stop taking TAGRISSO
Do not stop taking this medicine without talking to your doctor first. You must take this medicine every day, for as long as your doctor prescribes it for you.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Tell your doctor immediately if you experience any of the following serious side effects (see also section 2):
- Sudden difficulty breathing along with cough or fever. This may be a sign of inflammation in the lungs (a condition called interstitial lung disease). Most cases can be treated but some cases have been fatal. Your doctor may stop your treatment with TAGRISSO if you experience this side effect. This side effect is common: it may affect up to 1 in 10 users.
- Stevens-Johnson syndrome, which may appear as a red-violet target-like rash or as round spots on the trunk often with central blistering, scaling of the skin, sores in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. This side effect is rare: it may affect up to 1 in 1,000 users.
- Changes in the electrical activity of the heart (QTc prolongation) such as fast or irregular heartbeats, dizziness, lightheadedness, chest discomfort, shortness of breath, or fainting. This side effect is less common: it may affect up to 1 in 100 users.
- If you get watery eyes, sensitivity to light, eye pain, redness in the eye or vision changes. This side effect is less common: it may affect up to 1 in 100 users.
Tell your doctor immediately if you experience any of the serious side effects listed above.
Other side effect ar
Very common (may affect more than 1 in 10 users)
- Diarrhea – may come and go during treatment. Tell your doctor if the diarrhea does not go away or becomes severe.
- Skin and nail problems – signs may include pain, itching , dry skin, rash and redness around the fingernails. This is more common in areas exposed to sunlight. Regular use of moisturizing cream on skin and nails can help. Tell your doctor if your skin and nail problems get worse.
- Stomatitis – inflammation of the mouth or ulcers that form in the mouth.
- Loss of appetite.
- Reduction in the number of white blood cells ( leukocytes, lymphocytes, or neutrophils ).
- Reduction in the number of platelets in the blood.
Common (may affect up to 1 in 10 users)
- Epistaxis ( epistaxis ).
- Hair loss ( alopecia ).
- Hives ( urticaria ) – itchy, raised patches anywhere on the skin. These can be pink or red and round in shape. Tell your doctor if you experience this side effect.
- Hand-foot syndrome – this may include redness , swelling, stinging or burning with cracking of the skin on the palms of the hands and/or soles of the feet.
- Increase in a substance in the blood called creatinine (made by the body and removed by the kidneys).
- Abnormal blood test results related to blood creatine phosphokinase (an enzyme released into the blood when muscles are damaged).
Uncommon (may affect up to 1 in 100 users)
- Target-like rash, which are ring-like skin reactions (suggesting erythema multiforme).
- Inflammation of the blood vessels in the skin. It may look like bruises or redness of the skin that does not fade in color when pressed.
Rare (may affect up to 1 in 1,000 users)
- Inflammation of the muscles that can cause muscle pain or weakness
How to store TAGRISSO
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister and carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if the package is damaged or shows signs of having been opened.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is osimertinib (as mesylate). Each 40 mg film-coated tablet contains 40 mg osimertinib. Each 80 mg film-coated tablet contains 80 mg osimertinib.
- Other ingredients are mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide and black iron oxide (see section 2 “TAGRISSO contains sodium”).
Appearance and package sizes of the medicine
TAGRISSO 40 mg is supplied as beige, film-coated, round and biconvex tablets, marked with “AZ” and “40” on one side and blank on the other.
TAGRISSO 80 mg is supplied as beige, film-coated, oval and biconvex tablets, marked with “AZ” and “80” on one side and blank on the other.
TAGRISSO is supplied in blisters containing 30 x 1 film-coated tablets, packaged in cartons containing 3 blisters of 10 tablets each.
TAGRISSO is supplied in blisters containing 28 x 1 film-coated tablets, packaged in cartons containing 4 blisters of 7 tablets each.
Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienAstraZeneca SA/NVPhone: +32 2 370 48 11 | LithuaniaUAB AstraZeneca LietuvaPhone: +370 5 266 0550 |
| BulgariaAstraZeneca Bulgaria EOODTel.: +359 244 55 000 | Luxembourg/LuxembourgAstraZeneca SA/NVTél/Tel: +32 2 370 48 11 |
| Czech RepublicAstraZeneca Czech Republic s.r.oPhone: +420 222 807 111 | MagyarországAstraZeneca Kft.Phone: +36 1 883 6500 |
| DenmarkAstraZeneca A/SPhone: +45 43 66 64 62 | MaltaAssociated Drug Co. LtdPhone: +356 2277 8000 |
| DeutschlandAstraZeneca GmbHPhone: +49 40 80 90 34100 | The NetherlandsAstraZeneca BVPhone: +31 79 363 2222 |
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| SpainAstraZeneca Farmacéutica Spain, SAPhone: +34 91 301 91 00 | PolishAstraZeneca Pharma Poland Sp. z o. iPhone: +48 22 245 73 00 |
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| IrelandAstraZeneca Pharmaceuticals (Ireland) DACPhone: +353 1609 7100 | SlovenijaAstraZeneca UK LimitedPhone: +386 1 51 35 600 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovenian RepublicAstraZeneca AB, ozone: +421 2 5737 7777 |
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