DAURISMO Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

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

2. Qualitative and quantitative composition

Daurismo 25 mg film-coated tablets Each film-coated tablet contains glasdegib maleate equivalent to 25 mg of glasdegib. Excipient with known effect: Each film-coated tablet contains 1.3 mg of lactose ...

3. Pharmaceutical form

Film-coated tablet (tablet). Daurismo 25 mg film-coated tablets: 7 mm round, yellow film-coated tablet debossed with Pfizer on one side and GLS 25 on the other side. Daurismo 100 mg film-coated ...

4.1. Therapeutic indications

Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard ...

4.2. Posology and method of administration

Daurismo should only be prescribed by or under the supervision of a physician experienced in the use of anticancer medicinal products. Posology The recommended dose is 100 mg glasdegib once daily in combination ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Embryo-foetal toxicity Based on its mechanism of action and findings from animal embryo-foetal developmental toxicity studies, Daurismo can cause embryo-foetal death or severe birth defects when administered ...

4.5. Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on the pharmacokinetics of glasdegib In vitro, CYP3A4 is responsible for the majority of glasdegib depletion and contributed to the formation of other minor oxidative ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in males and females If Daurismo is used in women of childbearing potential, they should be advised to avoid becoming pregnant. The pregnancy status of female ...

4.7. Effects on ability to drive and use machines

Daurismo has minor influence on the ability to drive and use machines. However, patients experiencing fatigue or other symptoms (e.g., muscle cramps, pain, nausea) affecting the ability to react normally ...

4.8. Undesirable effects

Summary of the safety profile The overall safety profile of Daurismo is based on data from clinical studies, including Study 1 in 84 patients with AML (N=75) and high-risk MDS (N=9). The median exposure ...

4.9. Overdose

There is no specific antidote for Daurismo. Management of Daurismo overdose should consist of symptomatic treatment and ECG monitoring. Glasdegib has been administered in clinical studies up to a dose ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents ATC code: L01XX63 Mechanism of action Glasdegib is an inhibitor of the Hedgehog (Hh) signal transduction pathway that binds ...

5.2. Pharmacokinetic properties

Absorption Following a single 100 mg dose of glasdegib, peak concentration in plasma israpidly reached with the median Tmax of 2 hours. Following repeat 100 mg once daily dosing to steady state, ...

5.3. Preclinical safety data

The primary target organ findings following repeat oral administration of glasdegib in rats and dogs for up to 26 and 39 weeks in duration, respectively, included the kidney (degeneration/necrosis) in ...

6.1. List of excipients

Tablet core: Sodium starch glycolate Microcrystalline cellulose (E460(i)) Calcium hydrogen phosphate (anhydrous) (E341ii) Magnesium stearate (E470b) Film-coating: Lactose monohydrate Hypromellose ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

PVC (polyvinyl chloride) blister sealed with aluminium foil containing 10 film-coated tablets, or high-density polyethylene (HDPE) bottle with polypropylene closure containing 30 or 60 film-coated tablets. ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

8. Marketing authorization number(s)

Daurismo 25 mg film-coated tablets: EU/1/20/1451/001 EU/1/20/1451/002 Daurismo 100 mg film-coated tablets: EU/1/20/1451/003 EU/1/20/1451/004

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 26 June 2020

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