DAURISMO 100 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Daurismo 25 mg Film-Coated Tablets

Daurismo 100 mg Film-Coated Tablets

glasdegib

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Daurismo and what is it used for
2. What you need to know before you take Daurismo
3. How to take Daurismo
4. Possible side effects
5. Storage of Daurismo
6. Contents of the pack and other information

1. What is Daurismo and what is it used for

Daurismo is a cancer medicine that contains the active substance glasdegib.

Daurismo is used together with another cancer medicine, cytarabine, to treat adults who have been newly diagnosed with a type of blood cancer called acute myeloid leukemia (AML).

How Daurismo works

In AML, cancer cells called stem cells constantly produce new leukemia cancer cells. Daurismo works by blocking a key process in these stem cells called the “Hedgehog (Hh) pathway”. This reduces their ability to produce new cancer cells. By blocking the Hh pathway, Daurismo may also make cancer cells more sensitive to a cancer medicine, cytarabine, used to treat AML. The combination of Daurismo with cytarabine may increase the life span of patients by reducing cancer growth and possibly increasing cancer cell death.

If you have any questions about how Daurismo works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Daurismo

Do not take Daurismo

• If you are allergic to glasdegib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Daurismo:

Tell your doctor immediately while taking this medicine:

Children and adolescents

Daurismo must not be used in patients under 18 years of age.

Other medicines and Daurismo

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Daurismo may affect the way other medicines work. Other medicines may affect the way Daurismo works.

In particular, the following medicines may increase the risk of side effects with Daurismo:

• Boceprevir - a medicine used to treat hepatitis C.
• Cobicistat, ritonavir, telaprevir - medicines used to treat HIV infection.
• Itraconazole, ketoconazole, voriconazole, posaconazole - medicines used to treat fungal infections.
• Troleandomycin - a medicine used to treat bacterial infections.
• Conivaptan - a medicine used to regulate water and salt imbalance.
• Amiodarone, disopyramide, dofetilide, ibutilide, sotalol, quinidine – medicines used to treat heart problems.
• Droperidol, haloperidol, pimozide – medicines used to treat psychotic disorders.
• Moxifloxacin – a medicine used to treat a certain type of bacterial infection.
• Methadone – a medicine used to treat pain and for the treatment of opioid addiction.

The following medicines may reduce the effectiveness of Daurismo:

• Carbamazepine, phenytoin, antiepileptics – medicines used to treat seizures or fits.
• Rifampicin – a medicine used to treat tuberculosis (TB).
• St. John's Wort (Hypericum perforatum) – a herbal medicine used to treat mild depression and anxiety.
• Enzalutamide – a medicine used to treat prostate cancer.
• Mitotane – a medicine used to treat adrenal gland cancer.
• Bosentan – a medicine used to treat high blood pressure.
• Efavirenz, etravirine – medicines used to treat HIV infection.
• Modafinil – a medicine used to treat sleep disorders.
• Nafcillin – a medicine used to treat certain types of bacterial infections.

Taking Daurismo with food and drinks

Do not take grapefruit juice or grapefruit while being treated with Daurismo, as it may change the amount of Daurismo in your body.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must not become pregnant while taking Daurismo and must not take it if you are pregnant.

Daurismo may cause serious birth defects in babies or death of the fetus.

Your doctor will give you more information about the effects of Daurismo on the fetus and will perform a pregnancy test before you start treatment with the medicine.

Tell your doctor immediately if you or your partner become pregnant or think you may have become pregnant during treatment or in the 30 days after the last dose of Daurismo. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Contraception in women and men

Women

You must always use effective contraception (birth control) while taking Daurismo and for at least 30 days after the last dose of Daurismo. Talk to your doctor about the suitable contraceptive methods for you and your partner.

Men

Men must always use effective contraceptive methods, including condoms (with spermicide, if available), even if they have had a vasectomy, while taking Daurismo and for at least 30 days after the last dose of Daurismo.

Do not donate semen at any time while taking Daurismo and for at least 30 days after the last dose.

Breastfeeding

Do not breastfeed while taking Daurismo or for 1 week after the last dose of Daurismo. It is not known if Daurismo passes into breast milk and may harm your baby.

Fertility

Daurismo may affect male and female fertility. Talk to your doctor about preserving fertility before taking Daurismo.

Driving and using machines

If you feel tired or have muscle cramps, pain, or nausea (feeling sick) during treatment with Daurismo, be careful while driving and using machines.

Daurismo contains sodium

This medicine contains less than 1 mmol of sodium (less than 23 mg) per tablet; this is, essentially “sodium-free”.

Daurismo contains lactose

This medicine contains lactose (found in milk and other dairy products).

If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

3. How to take Daurismo

Take Daurismo once a day, approximately at the same time every day. Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again.

The recommended dose is one 100 mg tablet by mouth once a day with or without food.

If you experience certain side effects while taking Daurismo (see section 4 “Possible side effects”), your doctor may reduce your dose or interrupt treatment temporarily or permanently.

If you vomit after taking Daurismo

If you vomit after taking a dose of Daurismo, do not take an additional dose, just take the next dose at the usual time.

If you take more Daurismo than you should

If you accidentally take too many tablets, tell your doctor, pharmacist, or nurse immediately. You may need urgent medical attention.

If you forget to take Daurismo

If you forget to take a tablet, take it as soon as you remember, unless it is more than 10 hours since the scheduled dose time, in which case you should omit the dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Daurismo

Do not stop taking Daurismo unless your doctor tells you to.

It is important that you take Daurismo every day, and for as long as your doctor has prescribed it. If you cannot take the medicine as your doctor has prescribed, or if you think you no longer need it, talk to your doctor immediately.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Daurismo may cause serious birth defects. It may also cause the death of the fetus or baby soon after birth. You must not become pregnant while taking this medicine (see section 2 “What you need to know before you take Daurismo”).

Other side effects of Daurismo in combination with cytarabine include:

Very common: may affect more than 1 in 10 people

• low hemoglobin levels
• bleeding
• fever
• nausea
• loss of appetite
• muscle pain
• fatigue
• reduced platelet count in the blood

• diarrhea
• pneumonia
• changes in taste
• swelling of arms and legs
• constipation
• abdominal pain (belly)
• rash
• shortness of breath
• vomiting
• weight loss
• reduced white blood cell count
• reduced neutrophil count (a type of white blood cell)
• joint pain
• hair loss

Common: may affect up to 1 in 10 people

• changes in heart electrical activity
• heart palpitations
• blood infection
• burning sensation while urinating and frequent and urgent need to urinate (may be symptoms of urinary tract infection)
• mouth irritation

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Daurismo

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 on the blister or bottle after “EXP”. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not use this medicine if the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Daurismo

• The active substance is glasdegib.

Daurismo 25 mg film-coated tablets: each film-coated tablet contains glasdegib maleate equivalent to 25 mg of glasdegib.

Daurismo 100 mg film-coated tablets: each film-coated tablet contains glasdegib maleate equivalent to 100 mg of glasdegib.

• The other ingredients are:

Tablet core: sodium starch glycolate, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, and magnesium stearate. See section 2 “Daurismo contains sodium”. Coating: lactose monohydrate, hypromellose, titanium dioxide, macrogol, triacetin, yellow iron oxide, and red iron oxide (only the 100 mg tablets). See section 2 “Daurismo contains lactose”.

Appearance of the product and packaging

Daurismo 25 mg film-coated tablets

• Yellow, round, film-coated tablets engraved with “Pfizer” on one side and “GLS 25” on the other.
• Available in blisters of 10 tablets. Each pack contains 60 tablets in 6 blisters or in a plastic bottle.

Daurismo 100 mg film-coated tablets

• Light orange, round, film-coated tablets engraved with “Pfizer” on one side and “GLS 100” on the other.
• Available in blisters of 10 tablets. Each pack contains 30 tablets in 3 blisters or in a plastic bottle.

Not all pack sizes may be marketed.

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.