Daurismo

Patient Information Leaflet

Daurismo 25 mg film-coated tablets, 100 mg film-coated tablets

glasdegib
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Daurismo is and what it is used for

Daurismo is an anticancer medicine containing the active substance glasdegib.
Daurismo is used in combination with another anticancer medicine, cytarabine, for the treatment of
adult patients with newly diagnosed acute myeloid leukemia (AML), a type of blood cancer.
How Daurismo works
In AML, tumour cells, known as stem cells, continuously produce new leukaemic tumour cells. Daurismo works by blocking a key process in these stem cells called the Hedgehog (Hh) pathway, thereby reducing their ability to generate new tumour cells. By inhibiting the Hh pathway, Daurismo also makes tumour cells more sensitive to cytarabine, an anticancer medicine used to treat AML. The combination of Daurismo with cytarabine may increase patient survival by reducing tumour growth and possibly increasing tumour cell death.
If you have any questions about how Daurismo works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Daurismo

Do not take Daurismo

• if you are allergic to glasdegib or to any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Daurismo:

• if you or your partner are of childbearing age (see section 2 “Pregnancy, breastfeeding and fertility”)
• if you have ever experienced QT interval prolongation (a change in the heart's electrical activity that may cause serious heart rhythm disturbances), or if you know you are at risk for this condition
• if you are taking other medicines that you have been told may prolong the QT interval (see section 2 “Other medicines and Daurismo”)
• if blood tests show abnormal levels of electrolytes (for example: calcium, magnesium, potassium)
• if you have kidney problems
• if you have a history of muscle cramps or muscle weakness.

Inform your doctor immediately while taking this medicine:

• if you experience muscle pain, cramps, or unexplained muscle weakness during treatment with Daurismo. Your doctor may need to adjust the dose or temporarily or permanently discontinue treatment.

You will need to have blood tests before and during treatment to monitor electrolyte levels,
complete blood count, creatine kinase levels, kidney and liver function, as well as
electrocardiograms.
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 purchased without a prescription and herbal products, as Daurismo may affect how other medicines work. In addition, some medicines may affect how Daurismo works.
In particular, the following medicines may increase the risk of side effects when taken 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 imbalances
• 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 certain types of bacterial infections
• methadone, a medicine used to control pain and treat opioid dependence.

The following medicines may reduce the effectiveness of Daurismo:

• carbamazepine, phenytoin – medicines used to treat seizures or convulsions
• rifampicin, a medicine used to treat tuberculosis (TB)
• St John’s wort (Hypericum perforatum), a herbal product 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 in the lungs
• 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
• digoxin, a medicine used to treat heart conditions.

Daurismo with food and drink
During treatment with Daurismo, avoid eating grapefruit or drinking grapefruit juice, as this may alter the amount of Daurismo in your body.
Pregnancy, breastfeeding and fertility
Pregnancy
You must not become pregnant during treatment with Daurismo, and you must not take Daurismo if you are pregnant. Daurismo may cause severe birth defects or fetal death.
Your doctor will provide you with further information about the effects of Daurismo on the fetus and will perform a pregnancy test before you start taking this medicine.
Contact your doctor immediately if you or your partner becomes pregnant or suspects pregnancy during treatment or within 30 days after the last dose of Daurismo. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Contraception in women and men
Women
While taking Daurismo and for at least 30 days after the last dose, you must always use an effective method of contraception (birth control). Speak to your doctor for advice on the most suitable contraceptive methods for you and your partner.
Men
While taking Daurismo and for at least 30 days after the last dose, men must always use an effective method of contraception, 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, you must not donate semen.
These instructions are summarized in the patient checklist, which your doctor should provide at the time of prescription.
Breastfeeding
While taking Daurismo and during the week following the last dose, you must avoid breastfeeding. It is not known whether Daurismo passes into breast milk and could harm the baby.
Fertility
Daurismo may affect male and female fertility. Talk to your doctor about fertility preservation before starting treatment with Daurismo.
Driving and using machines
During treatment with Daurismo, exercise particular caution when driving or operating machinery if you experience fatigue, muscle cramps, pain, or nausea (feeling unwell).
Daurismo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, Daurismo is essentially “sodium-free”.
Daurismo contains lactose
This medicine contains lactose (a sugar found in milk and milk products).
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Daurismo

Take Daurismo once daily, around the same time each day. Always follow your doctor’s or pharmacist’s instructions exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 100 mg tablet taken orally once daily, regardless of meals.
Your doctor may reduce the dose or interrupt treatment temporarily or permanently if you:

• experience certain adverse reactions while taking Daurismo (see section 4 “Possible side effects”);
• show abnormal blood test results (see section 2 “Warnings and precautions”);
• are taking medicines that interfere with the action of Daurismo (see section 2 “Other medicines and Daurismo”).

If you vomit after taking Daurismo
If you vomit after taking a dose of Daurismo, do not take another tablet; take the next dose at the usual time.
If you take more Daurismo than you should
If you accidentally take too many tablets, inform your doctor, pharmacist, or nurse immediately. Urgent medical attention may be required.
If you forget to take Daurismo
If you forget to take a tablet, take it as soon as you remember, unless more than 10 hours have passed since the scheduled time, in which case skip the missed dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Daurismo
Do not stop taking Daurismo unless instructed by your doctor.
It is important to take Daurismo every day for as long as prescribed by your doctor. If you are unable to take the medicine as prescribed or if you think you no longer need it, contact your doctor immediately.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Daurismo can cause severe birth defects and may also cause the death of a child before birth or shortly after birth. While taking this medicine, you must avoid becoming pregnant (see section 2 "What you need to know before taking Daurismo").
Other side effects associated with Daurismo, in combination with cytarabine, include:
Very common: may affect more than 1 in 10 people

• reduced ability to carry oxygen in the blood (low hemoglobin)
• bleeding
• body temperature above normal (fever)
• feeling the need to vomit (nausea)
• reduced appetite (anorexia)
• muscle pain (myalgia)
• feeling of tiredness (fatigue)
• decrease in the number of platelets in the blood (thrombocytopenia)
• watery or loose stools (diarrhea)
• lung infection making breathing difficult (pulmonary infection)
• altered taste
• swelling of arms and legs
• difficulty passing stools (constipation)
• abdominal pain (stomach pain)
• skin rash
• shortness of breath (dyspnea)
• vomiting
• weight loss
• decrease in the number of white blood cells (leucopenia)
• decrease in the number of a type of white blood cells (neutrophils) (neutropenia)
• joint pain
• hair loss (alopecia)

Common: may affect up to 1 in 10 people

• changes in the heart's electrical activity (electrocardiogram)
• heart beating too fast, too hard, or skipping beats (palpitations)
• blood infection
• burning sensations during urination or frequent and urgent need to urinate (these could be symptoms of a urinary tract infection)
• mouth irritation

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Daurismo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Daurismo contains

• 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 components are: tablet core: sodium starch glycolate, microcrystalline cellulose, anhydrous dibasic calcium phosphate, and magnesium stearate. See section 2 “Daurismo contains sodium”; coating: monohydrate lactose, hypromellose, titanium dioxide, macrogol, triacetin, yellow iron oxide, and red iron oxide (only 100 mg tablets). See section 2 “Daurismo contains lactose”.

Description of the appearance of Daurismo and contents of the pack
Film-coated tablet (tablet).
Daurismo 25 mg film-coated tablets

• Film-coated, round, yellow tablets with the inscription “Pfizer” on one side and “GLS 25” on the other side.
• 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

• Film-coated, round, light orange tablets with the inscription “Pfizer” on one side and “GLS 100” on the other side.
• 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 Authorization Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel. + 370 52 51 4000
Tél/Tel: +32 (0)2 554 62 11
България Magyarország
Pfizer Luxembourg SARL, Klon Balgaria Pfizer Kft.
Tel.: +359 2 970 4333 Tel.: +36-1-488-37-00
Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel.: +420 283 004 111 Tel. +356 21344610
Danmark Nederland
Pfizer ApS Pfizer bv
Tlf.: +45 44 20 11 00 Tel: +31 (0)800 63 34 636
Deutschland Norge
Pfizer Pharma GmbH Pfizer AS
Tel: +49 (0)30 550055 51000 Tlf: +47 67 52 61 00
Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel.: +372 666 7500 Tel: +43 (0)1 521 15-0
Ελλάδα Polska
Pfizer Hellas A.E. Pfizer Polska Sp. z o.o.
Tel.: +30 210 6785 800 Tel.: +48 22 335 61 00
España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500
France România
Pfizer Pfizer Romania S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0) 21 207 28 00
Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: +385 1 3908 777 Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: + 386 (0)1 52 11 400
Ireland Slovenská republika
Pfizer Healthcare Ireland Unlimited Company Pfizer Luxembourg SARL, organizačná zložka
Tel: 1800 633 363 (toll free) Tel.: + 421 2 3355 5500
+44 (0)1304 616161
Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh./Tel: +358 (0)9 43 00 40
Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00
Kýpros
Pfizer Hellas A.E. (Cyprus Branch)
Tel: +357 22 817690
Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: + 371 670 35 775

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu. In addition, links to other websites on rare diseases and related therapeutic treatments are provided.