ALUNBRIG Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Alunbrig 30 mg film-coated tablets. Alunbrig 90 mg film-coated tablets. Alunbrig 180 mg film-coated tablets.

2. Qualitative and quantitative composition

Alunbrig 30 mg film-coated tablets Each film-coated tablet contains 30 mg of brigatinib. Excipient with known effect: Each film-coated tablet contains 56 mg of lactose monohydrate. Alunbrig 90 mg ...

3. Pharmaceutical form

Film-coated tablet (tablet). Alunbrig 30 mg film-coated tablets: Round, white to off-white film-coated tablet of approximately 7 mm in diameter with debossed U3 on one side and plain on the other ...

4.1. Therapeutic indications

Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. ...

4.2. Posology and method of administration

Treatment with Alunbrig should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. ALK-positive NSCLC status should be known prior to initiation of Alunbrig ...

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

Pulmonary adverse reactions Severe, life-threatening, and fatal pulmonary adverse reactions, including those with features consistent with ILD/pneumonitis, can occur in patients treated with Alunbrig (see ...

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

Agents that may increase brigatinib plasma concentrations CYP3A inhibitors In vitro studies demonstrated that brigatinib is a substrate of CYP3A4/5. In healthy subjects, coadministration of multiple 200 ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in males and females Women of childbearing age being treated with Alunbrig should be advised not to become pregnant and men being treated with Alunbrig should ...

4.7. Effects on ability to drive and use machines

Alunbrig has minor influence on the ability to drive and use machines. However, caution should be exercised when driving or operating machines as patients may experience visual disturbance, dizziness, ...

4.8. Undesirable effects

Summary of the safety profile The most common adverse reactions (≥25%) reported in patients treated with Alunbrig at the recommended dosing regimen were increased AST, increased CPK, hyperglycaemia, increased ...

4.9. Overdose

There is no specific antidote for overdose with Alunbrig. In the event of an overdose, monitor the patient for adverse reactions (see section 4.8) and provide appropriate supportive care.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitors ATC code: L01XE43 Mechanism of action Brigatinib is a tyrosine kinase inhibitor that targets ALK, c-ros oncogene ...

5.2. Pharmacokinetic properties

Absorption In Study 101, following administration of a single oral dose of brigatinib (30-240 mg) in patients, the median time to peak concentration (Tmax) was 1-4 hours postdose. After a single ...

5.3. Preclinical safety data

Safety pharmacology studies with brigatinib identified potential for pulmonary effects (altered respiration rate; 1-2 times the human Cmax), cardiovascular effects (altered heart rate and blood ...

6.1. List of excipients

Tablet core: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate (type A) Silica colloidal hydrophobic Magnesium stearate Tablet coating: Talc Macrogol Polyvinyl alcohol ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Alunbrig 30 mg film-coated tablets: Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap closures with foil induction seal liner, containing ...

6.6. Special precautions for disposal and other handling

Patients should be advised to keep the desiccant canister in the bottle and not to swallow it. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. ...

7. Marketing authorization holder

Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark

8. Marketing authorization number(s)

Alunbrig 30 mg film-coated tablets: EU/1/18/1264/001 – 60 tablets in bottle EU/1/18/1264/002 – 120 tablets in bottle EU/1/18/1264/011 – 28 tablets in carton EU/1/18/1264/003 – 56 tablets in carton ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 22 November 2018

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