GAVRETO Hard capsule (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

GAVRETO 100 mg hard capsules.

2. Qualitative and quantitative composition

Each hard capsule contains 100 mg of pralsetinib. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Hard capsule. Light blue, opaque hard capsule, size 0 (22 mm long x 7 mm wide) with BLU-667 printed on the capsule shell body and 100 mg on the capsule shell cap in white ink.

4.1. Therapeutic indications

Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with ...

4.2. Posology and method of administration

Therapy should be initiated by a physician experienced in the administration of anticancer medicinal products. Patient selection for treatment of RET fusion-positive advanced NSCLC should be based on a ...

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

Pneumonitis / ILD Severe, life-threatening or fatal cases of pneumonitis/ILD have been reported in patients who received pralsetinib in clinical trials (see section 4.8). Patients who present with clinically ...

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

Pharmacokinetic interactions In vitro data indicate that pralsetinib is primarily metabolised by CYP3A4 and transported by P-gp. Therefore, inducers and inhibitors of CYP3A4 and P-gp may alter ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in females and males Women of childbearing potential should be informed that pralsetinib may cause foetal harm (see section 5.3). The pregnancy status of ...

4.7. Effects on ability to drive and use machines

Gavreto has minor influence on the ability to drive and use machines. Caution should be exercised when driving or operating machines as patients may experience fatigue while taking Gavreto (see section ...

4.8. Undesirable effects

Summary of the safety profile The most common adverse reactions were anaemia (47.2%), aspartate aminotransferase increased (46.0%), neutropenia (43.9%), constipation (41.9%), musculoskeletal pain (39.8%), ...

4.9. Overdose

Symptoms No cases of overdose have been reported in clinical trials with pralsetinib. The maximum dose of pralsetinib studied clinically is 600 mg orally once daily. Adverse reactions observed at this ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors ATC code: L01EX23 Mechanism of action Pralsetinib is a potent protein kinase inhibitor that selectively targets ...

5.2. Pharmacokinetic properties

Pralsetinib Cmax and AUC increased inconsistently over the dose range of 60 mg to 600 mg once daily (0.15 to 1.5 times the recommended dose); pharmacokinetics was linear in the dose range of ...

5.3. Preclinical safety data

Repeat-dose toxicity studies In studies of up to 13 weeks duration in rats and cynomolgus monkeys, the primary findings at exposures similar to steady state human exposures (AUC) at 400 mg once daily in ...

6.1. List of excipients

Capsule content: Hypromellose Cellulose microcrystalline Starch, pregelatinised Sodium hydrogen carbonate Citric acid Magnesium stearate Capsule shell: Brilliant blue FCF (E133) 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 temperature storage conditions. Store in the original package in order to protect from moisture.

6.5. Nature and contents of container

High density polyethylene (HDPE) bottle with child-resistant closure (polypropylene) and foiled induction seal liner and desiccant sachet (silica gel). Pack sizes: 60, 90 or 120 capsules. Not all ...

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

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

8. Marketing authorization number(s)

EU/1/21/1555/001 EU/1/21/1555/002 EU/1/21/1555/003

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 18 November 2021

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