DAURISMO 25 mg Tabletki Powlekane

Treść ulotki

1. Daurismo 25 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Daurismo and what is it 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
2. Daurismo 25 mg film-coated tablets: each film-coated tablet contains
3. Daurismo 100 mg film-coated tablets: each film-coated tablet contains

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

glasdegib

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Daurismo and what is it used for

Daurismo is an antineoplastic medicine containing the active substance glasdegib.
Daurismo is used in association with another antineoplastic medicine, cytarabine, for the treatment of
adult patients with newly diagnosed blood cancer called acute myeloid leukemia (AML).

How Daurismo works
In AML, cancer cells, called stem cells, constantly produce new
leukemic cancer cells. Daurismo works by blocking a key process in these stem cells,
called the Hedgehog (Hh) pathway, reducing their ability to create new cancer cells. By blocking
the Hh pathway, Daurismo is also able to make cancer cells more sensitive to an antineoplastic
medicine, cytarabine, used to treat AML. The combination of Daurismo with the medicine
cytarabine may increase patient survival by reducing tumor growth and,
possibly, increasing cancer cell death.
If you have any questions about how Daurismo works or why this medicine has been
prescribed to you, please ask your doctor.

2. What you need to know before taking Daurismo

Do not take Daurismo

• if you are allergic to glasdegib or 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 potential (see section 2 “Pregnancy, breastfeeding and fertility”)
• if you have ever experienced a prolongation of the QT interval (a change in the electrical activity of the heart that can cause serious heart rhythm problems) or if you are known to be 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 (e.g. calcium, magnesium, potassium)
• if you have kidney problems
• if you have a history of cramps or muscle weakness.

Tell your doctor immediately while taking this medicine:

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

You will need to undergo blood tests before and during treatment to check electrolytes,
blood cell counts, creatine kinase levels, kidney and liver function, as well as
electrocardiograms.

Children and adolescents
Daurismo should 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 you bought without a prescription and
herbal medicines, as Daurismo can affect how other medicines work. Also,
some medicines can affect how Daurismo works.
In particular, the following medicines may increase the risk of side effects if 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 some types of bacterial infections
• methadone, a medicine used to control pain and for the treatment of opioid dependence.

The following medicines may reduce the effectiveness of Daurismo:

• carbamazepine, phenytoin, medicines used to treat seizures or fits
• 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
• efavirenz, etravirine - medicines used to treat HIV infection
• modafinil, a medicine used to treat sleep disorders
• nafcillin, a medicine used to treat some types of bacterial infections
• digoxin, a medicine used to treat heart conditions.

Daurismo with food and drink
During treatment with Daurismo, you should avoid eating grapefruit and drinking grapefruit juice, as it may change the amount of Daurismo in your body.

Pregnancy, breastfeeding and fertility
Pregnancy
During therapy with Daurismo, you should not become pregnant and should not take it if you are
pregnant. Daurismo can cause serious birth defects in newborns or lead to 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 the medicine.
You should immediately tell your doctor if you or your partner becomes pregnant or suspects a
pregnancy during treatment and for 30 days after the last dose of Daurismo. If you are pregnant, suspect you are or are planning a pregnancy, ask your doctor or pharmacist for advice
before taking this medicine.
Contraception in women and men

Women
During the intake of Daurismo, and for at least 30 days after the last dose of Daurismo, you must
always use an effective contraceptive measure (contraception). Consult your doctor for
advice on the most suitable contraceptive methods for you and your partner.

Men
During the intake of Daurismo, and for at least 30 days after the last dose of Daurismo, men
must always use an effective contraceptive measure, including condoms (with spermicide,
if available), even if they have already had a vasectomy.
During the intake of Daurismo, and for at least 30 days after the last dose, you should never donate
semen.
This information is summarized in the patient leaflet, which the doctor must give you at the
time of prescription.
Breastfeeding
During the intake of Daurismo, or during the week following the last dose of Daurismo,
you should avoid breastfeeding. It is not known whether Daurismo can pass into breast milk and harm
the baby.
Fertility
Daurismo can affect male and female fertility. Before taking Daurismo, talk to your
doctor about preserving fertility.

Driving and operating machinery
During treatment with Daurismo, if you experience fatigue or muscle cramps, pain or nausea
(feeling unwell), be particularly careful when driving and using machinery.

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

Daurismo contains lactose
This medicine contains lactose (present in milk or milk derivatives).
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking
this medicine.

3. How to take Daurismo

Take Daurismo once a day, around the same time each day. Take this medicine
always exactly as your doctor or pharmacist has instructed. If you have any doubts, consult your doctor
or pharmacist.
The recommended dose is one 100 mg tablet taken orally once a day,
independently of meals.
The doctor may reduce the dose or interrupt the treatment, temporarily or permanently. If
you:

• during the intake of Daurismo experience some undesirable effects (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 one and take the next dose
at the usual time.

If you take more Daurismo than you should
If you accidentally take too many tablets, immediately inform your doctor, pharmacist or nurse. Urgent medical attention may be necessary.

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 dose. Do not take a double
dose to make up for a missed dose.

If you stop taking Daurismo
Do not stop taking Daurismo unless instructed by your doctor.
It is important to take Daurismo every day, as long as prescribed by your doctor. If you are unable
to take the medicine as prescribed by your doctor or if you feel you no longer need it, contact
your doctor immediately.
If you have any further questions on 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 can cause serious birth defects and can also cause the death of a baby before
birth or shortly after birth. During the intake of this medicine you must avoid the start of a
pregnancy (see paragraph 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 haemoglobin)
• bleeding (haemorrhage)
• temperature above normal (fever)
• feeling sick (nausea)
• loss of appetite (anorexia)
• muscle pain (myalgia)
• feeling tired (fatigue)
• decrease in the number of platelets in the blood (thrombocytopenia)
• loose or watery stools (diarrhoea)
• infection in the lungs that makes it difficult to breathe (pulmonary infection)
• altered taste
• swelling of arms and legs
• difficulty passing stools (constipation)
• abdominal pain (stomach ache)
• skin rash
• shortness of breath (dyspnoea)
• 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 electrical activity of the heart (electrocardiogram)
• heart beating too fast, too strong or missing beats (heart palpitations)
• blood infection
• burning sensation when urinating or a frequent and urgent need to urinate (may be symptoms of a urinary tract infection)
• mouth irritation

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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 which is stated on the package and on the blister or the
bottle after “Exp.” The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Daurismo contains

• The active ingredient 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 dibasic calcium 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 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 tablets, round in shape, yellow in colour, 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 tablets, round in shape, light orange in colour, 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 Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108Freiburg Im Breisgau
Germany
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. + 370 52 51 4000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: +36-1-488-37-00

Česká republika
Pfizer, spol. s r.o.
Tel.: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel. +356 21344610

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055 51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel.: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785 800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel.: + 386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel.: + 421 2 3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh./Tel: +358 (0)9 43 00 40

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Kύπρος
Pfizer Ελλάς A.E. (Cyprus Branch)
Τηλ: +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. Also, links to other websites on rare diseases and related therapeutic treatments are provided.