EVRENZO Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Evrenzo 20 mg film-coated tablets. Evrenzo 50 mg film-coated tablets. Evrenzo 70 mg film-coated tablets. Evrenzo 100 mg film-coated tablets. Evrenzo 150 mg film-coated tablets.

2. Qualitative and quantitative composition

Evrenzo 20 mg film-coated tablets: Each tablet contains 20 mg of roxadustat. Evrenzo 50 mg film-coated tablets: Each tablet contains 50 mg of roxadustat. Evrenzo 70 mg film-coated tablets: ...

3. Pharmaceutical form

Film-coated tablets (tablets). Evrenzo 20 mg tablets: Red, oval tablets (approximately 8 mm × 4 mm) with 20 debossed on one side. Evrenzo 50 mg tablets: Red, oval tablets (approximately 11 ...

4.1. Therapeutic indications

Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).

4.2. Posology and method of administration

Treatment with roxadustat should be initiated by a physician experienced in the management of anaemia. All other causes of anaemia should be evaluated prior to initiating therapy with Evrenzo, and when ...

4.3. Contraindications

Evrenzo is contraindicated in the following conditions: Hypersensitivity to the active substance, peanut, soya or to any of the excipients listed in section 6.1. Third trimester of pregnancy (see sections ...

4.4. Special warnings and precautions for use

Cardiovascular and mortality risk Overall, the cardiovascular and mortality risk for treatment with roxadustat has been estimated to be comparable to the cardiovascular and mortality risk for ESA therapy ...

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

Effect of other medicinal products on roxadustat Phosphate binders and other products containing multivalent cations Co-administration of roxadustat with phosphate binders sevelamer carbonate or calcium ...

4.6. Fertility, pregnancy and lactation

Pregnancy, women of childbearing potential and contraception There are no data on the use of roxadustat in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Roxadustat ...

4.7. Effects on ability to drive and use machines

Roxadustat has minor influence on the ability to drive and use machines. Seizures have been reported during treatment with Evrenzo (see section 4.4). Therefore, caution should be exercised when driving ...

4.8. Undesirable effects

Summary of the safety profile The safety of Evrenzo was evaluated in 3542 non-dialysis dependent (NDD) and 3353 dialysis dependent (DD) patients with anaemia and CKD who have received at least one dose ...

4.9. Overdose

Single supratherapeutic doses of roxadustat 5 mg/kg (up to 510 mg) in healthy subjects were associated with a transient increase in heart rate, an increased frequency of mild to moderate musculoskeletal ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: anti-anaemic preparations, other anti-anaemic preparations ATC code: B03XA05 Mechanism of action Roxadustat is a hypoxia-inducible factor, prolyl hydroxylase inhibitor ...

5.2. Pharmacokinetic properties

Roxadustat plasma exposure (area under the plasma drug concentration over time curve [AUC] and maximum plasma concentrations [Cmax]) is dose-proportional within the recommended therapeutic dose ...

5.3. Preclinical safety data

Repeat-dose toxicity studies In the 26-week intermittent repeat dose study in Sprague-Dawley or Fisher rats, roxadustat at approximately 4 to 6-fold the total AUC at Maximum Recommended Human Dose (MRHD) ...

6.1. List of excipients

Tablet core: Lactose monohydrate Cellulose, microcrystalline (E460 (i)) Croscarmellose sodium (E468) Povidone (E1201) Magnesium stearate (E470b) Film-coating: Poly(vinyl alcohol) (E1203) ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

4 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/aluminium perforated unit dose blisters in a carton containing 12 1 film-coated tablets.

6.6. Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

8. Marketing authorization number(s)

EU/1/21/1574/001 EU/1/21/1574/002 EU/1/21/1574/003 EU/1/21/1574/004 EU/1/21/1574/005

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