25 mg or 100 mg film-coated tablets 
glass dough

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Daurismo is and what it is used for 
2. What you need to know before using Daurismo 
3. How to use Daurismo 
4. Possible side effects 
5. How to store Daurismo 
6. Contents of the packaging and other information 

1. What Daurismo is and what it is used for

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

Daurismo is used in combination with another cancer drug, cytarabine, to treat adults who have recently been diagnosed with a type of blood cancer called acute myeloid leukemia (AML).

This is how Daurismo works

In AML, there are cancer cells called stem cells, which constantly create new leukemic cancer cells. Daurismo works by blocking a key process, called the Hedgehog (Hh) signaling pathway, in these stem cells. In this way, their ability to create new cancer cells is weakened. By blocking the Hh signaling pathway, Daurismo can also make cancer cells more sensitive to a cancer drug, cytarabine, which is used to treat AML. When you combine Daurismo with the drug cytarabine, you can increase the patient’s life expectancy, as it reduces the growth of cancer and possibly kills more cancer cells.

Contact your doctor if you have any questions about how Daurismo works or why you have been given this medicine.

2. What you need to know before using Daurismo

Do not use Daurismo

– if you are allergic to glass dough or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Daurismo

  • if you or your partner may become pregnant (see section Pregnancy, breast-feeding and fertility )
  • if you have ever had a prolonged QT interval (a change in the electrical activity of the heart that can cause severe irregular heart rhythms) or know that you are at risk for this condition
  • if you are taking any other medicines that you have been informed prolong QT et
  • if blood tests show that you have abnormal levels of electrolytes (eg calcium, magnesium, or potassium )
  • if you have kidney problems
  • if you have previously had muscle cramps or muscle weakness.

Tell your doctor immediately when you take this medicine

  • if you have muscle pain or unexplained muscle cramps or muscle weakness during treatment with Daurismo. Your doctor may need to change your dose or stop your treatment temporarily or permanently.

Children and young people

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 over-the-counter medicines and herbal medicines. This is because Daurismo may affect the way other medicines work. Some other medicines may affect the way Daurismo works.

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

  • boceprevir – a drug used to treat hepatitis C.
  • cobicistat, ritonavir, telaprevir – drugs used to treat HIV – infection.
  • itraconazole, ketoconazole, voriconazole, posaconazole – medicines used to treat fungal infections.
  • troleandomycin – a drug used to treat bacterial infections.
  • conivaptan – a drug used to regulate the imbalance of water and salt.
  • amiodarone, disopyramide, dofetilide, ibutilide, sotalol, quinidine – medicines used to treat heart problems.
  • droperidol, haloperidol, pimozide – medicines used to treat psychotic illnesses.
  • moxifloxacin – a drug used to treat certain types of bacterial infections.
  • methadone – a drug used to treat pain and to treat opioid dependence.

The following medicines may reduce the effect of Daurismo:

  • carbamazepine, phenytoin, antiepileptic drugs – drugs used to treat seizures or seizures.
  • rifampicin – a drug used to treat tuberculosis (TB).
  • St. John’s wort ( Hypericum perforatum ) – an herbal medicine used to treat mild depression and mild anxiety.
  • enzalutamide – a drug used to treat prostate cancer.
  • mitotane – a drug used to treat adrenal cancer.
  • bosentan – a drug used to treat high blood pressure.
  • efavirenz, etravirine – drugs used to treat HIV – infection.
  • modafinil – a drug used to treat sleep disorders.
  • nafcillin – a drug used to treat certain types of bacterial infections.

Daurismo with food, drink, and alcohol

Do not drink grapefruit juice or eat grapefruit during treatment with Daurismo, as this may affect the amount of Daurismo in your body.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must not become pregnant while taking Daurismo and you must not take the medicine if you are pregnant. Daurismo can cause serious congenital malformations in infants or lead to fetal death.

Your doctor will give you more information about the effects of Daurismo on the fetus. You will also have to do a pregnancy test before you start taking the medicine.

You must tell your doctor immediately if you or your partner become pregnant or are thought to be pregnant during your treatment and for 30 days after your last dose of Turismo. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Contraceptives in women and men

Women

You should always use effective contraception while you are taking Daurismo and for at least 30 days after your last dose of Daurismo. Talk to your doctor about which contraceptive methods are right for you and your partner.

Men

You should always use effective contraception, including condoms (with spermicides, if available), even if you have undergone a vasectomy, while you are taking Daurismo and for at least 30 days after your last dose of Daurismo.

You should not donate semen while taking Daurismo and at least 30 days after your last dose.

Breast-feeding

Do not breast-feed while you are taking Daurismo or for a week after your last dose of Daurismo. It is not known if Daurismo passes into breast milk and harms your baby.

Fertility

Daurismo can affect the fertility of both men and women. Talk to your doctor about fertility preservation measures before taking Daurismo.

Driving and using machines

If you feel tired or experience muscle cramps, pain, or nausea during your treatment with Daurismo, you should be especially careful when driving or using machines.

Daurismo contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

Daurismo contains lactose

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

3. How to use Daurismo

Take Daurismo once a day at about the same time each day.

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is a 100 mg tablet taken orally once a day, with or without food.

If you get some side effects is when you take Daurismo (see section 4, “Possible side effects”) may be the doctor will lower your dose or stop treatment, either temporarily or permanently.

If you vomit after taking Daurismo

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

If you use more Daurismo than you should  

If you happen to take too many tablets, tell your doctor, pharmacist, or nurse immediately. You may need to seek emergency medical attention.

If you forget to use 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 dosing time. In such cases, skip dose one. Do not take a double dose to make up for a forgotten dose.

If you stop using Daurismo

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

You must take Daurismo every day, as long as your doctor prescribes it for you. If you are unable to take the medicine as prescribed by your doctor or if you feel you no longer need it, talk to your doctor straight away.

If you have any further questions on the use of this product, 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 congenital malformations. It can also lead to the death of the fetus or the death of the baby shortly after birth. You should not become pregnant while taking this medicine (see section 2, “What you need to know before taking Daurismo”).

Other side effects of Daurismo, in combination with cytarabine, include:

Very common: may affect more than 1 user in 10

  • low hemoglobin value
  • bleeding
  • fever
  • nausea
  • decreased appetite
  • muscle pain
  • feeling tired
  • decreased number of platelets ( platelets ) in the blood
  • diarrhea
  • pneumonia
  • taste changes
  • swelling of the arms and legs
  • constipation
  • abdominal pain (stomach pain)
  • rash
  • respiratory distress
  • vomiting
  • weight loss
  • decreased white blood cell count
  • decreased number of a certain type of white blood cell ( neutrophils )
  • joint pain
  • hair loss

Common: may affect up to 1 in 10 users

  • changes in the electrical activity of the heart
  • palpitation
  • infection in the blood
  • burning sensation when urinating and frequent and urgent need to urinate (may be a symptom of a urinary tract infection)
  • irritation in the mouth

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 carton and blister or can 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 appears to have been tampered with.

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

6. Contents of the packaging and other information

Content declaration

  • The active substance is glasdegib. Daurismo 25 mg film-coated tablets: Each film-coated tablet contains glass begin maleate equivalent to 25 mg glass begin.Daurismo 100 mg film-coated tablets: Each film-coated tablet contains glass begin maleate equivalent to 100 mg glass begin.
  • Other ingredients are Tablet core: sodium starch glycolate, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), and magnesium stearate. See section 2, “Daurismo contains sodium”.Film coating: lactose monohydrate, hypromellose, titanium dioxide, macrogol, triacetin, yellow iron oxide, and red iron oxide (100 mg tablets only). See section 2, “Daurismo contains lactose”.

What the medicine looks like and the contents of the pack

Daurismo 25 mg film-coated tablets

  • Round, yellow film-coated tablets with “Pfizer” embossed on one side and “GLS 25” on the other side.
  • Available in blisters of 10 tablets. Each pack contains 60 tablets in either 6 blisters or a plastic jar.

Daurismo 100 mg film-coated tablets 

  • Round, slightly orange film-coated tablets with “Pfizer” embossed on one side and “GLS 100” on the other side.
  • Available in blisters of 10 tablets. Each pack contains 30 tablets in either 3 blisters or a plastic jar.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Company Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgique / België / BelgienPfizer SA / NVTel: +32 (0) 2 554 62 11 LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000
BulgariaPfizer Luxembourg SAARЛ, Clone of BulgariaTel: +359 2 970 4333 Luxembourg / LuxemburgPfizer SATel: +32 (0) 2 554 62 11
Czech RepublicPfizer, spol. s roTel .: +420 283 004 111 HungaryPfizer Kft.Tel .: + 36-1-488-37-00
DenmarkPfizer ApSTel: +45 44 20 11 00 MaltaVivian Corporation Ltd.Tel. +356 21344610
GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055 51000 The NetherlandsPfizer bvTel: +31 (0) 10 406 43 01
EestiPfizer Luxembourg SARL Eesti subsidiaryTel .: +372 666 7500 NorwayPfizer ASTel: +47 67 52 61 00
GreecePfizer Aλλάς AE.:Ηλ .: +30 210 6785 800 AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0
SpainPfizer, SLTel: +34 91 490 99 00 PolandPfizer Polska Sp.zooTel .: +48 22 335 61 00
FrancePfizerTel: +33 (0) 1 58 07 34 40 PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500
CroatiaPfizer Croatia dooTel: +385 1 3908 777 RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00
IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 SloveniaPfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel .: + 386 (0) 1 52 11 400
IcelandIcepharma hf.Phone: +354 540 8000 Slovak RepublicPfizer Luxembourg SARL, organizerTel .: + 421 2 3355 5500
ItalyPfizer SrlTel: +39 06 33 18 21 Finland / FinlandPfizer OyPuh./Tel: +358 (0) 9 43 00 40
LatviaPfizer Luxembourg SARL subsidiary LatvijāTel .: + 371 670 35 775 United KingdomPfizer LimitedTel: +44 (0) 1304 616161

Muhammad Nadeem

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