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CIBINQO Film-coated tablet (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Cibinqo 50 mg film-coated tablets. Cibinqo 100 mg film-coated tablets. Cibinqo 200 mg film-coated tablets.

2. Qualitative and quantitative composition

Cibinqo 50 mg film-coated tablets Each film-coated tablet contains 50 mg of abrocitinib. <u>Excipient with known effect:</u> Each film-coated tablet contains 1.37 mg of lactose monohydrate. Cibinqo 100 ...

3. Pharmaceutical form

Film-coated tablet (tablet). <u>Cibinqo 50 mg film-coated tablets:</u> Pink, approximately 11 mm long and 5 mm wide oval tablet debossed with PFE on one side and ABR 50 on the other. <u>Cibinqo 100 mg ...

4.1. Therapeutic indications

Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

4.2. Posology and method of administration

Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. Posology The recommended starting dose is 200 mg once daily. ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active serious systemic infections, including tuberculosis (TB) (see section 4.4). Severe hepatic impairment ...

4.4. Special warnings and precautions for use

Serious infections Serious infections have been reported in patients receiving abrocitinib. The most frequent serious infections in clinical studies were herpes simplex, herpes zoster and pneumonia (see ...

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

Potential for other medicines to affect pharmacokinetics of abrocitinib Abrocitinib is metabolised predominantly by CYP2C19 and CYP2C9 enzymes, and to a lesser extent by CYP3A4 and CYP2B6 enzymes, and ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential Women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the final dose of Cibinqo. Pregnancy planning ...

4.7. Effects on ability to drive and use machines

Cibinqo has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions are nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting ...

4.9. Overdose

Cibinqo was administered in clinical studies up to a single oral dose of 800 mg and 400 mg daily for 28 days. Adverse reactions were comparable to those seen at lower doses and no specific toxicities were ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Other dermatological preparations, agents for dermatitis, excluding corticosteroids <b>ATC code:</b> D11AH08 Mechanism of action Abrocitinib is a Janus kinase (JAK)1 inhibitor. ...

5.2. Pharmacokinetic properties

Absorption Abrocitinib is well-absorbed with over 91% extent of oral absorption and absolute oral bioavailability of approximately 60%. The oral absorption of abrocitinib is rapid and peak plasma concentrations ...

5.3. Preclinical safety data

General toxicity Decreased lymphocyte counts and decreased size and/or lymphoid cellularity of organs/tissues of the immune and haematopoietic systems were observed in nonclinical studies and were attributed ...

6.1. List of excipients

<u>Tablet core:</u> Microcrystalline cellulose (E460i) Calcium hydrogen phosphate anhydrous (E341ii) Sodium starch glycolate Magnesium stearate (E470b) <u>Film-coat:</u> Hypromellose (E464) Titanium dioxide ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

<u>50 mg film-coated tablets:</u> 2 years. <u>100 mg and 200 mg film-coated tablets:</u> 30 months.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

<U>Cibinqo 50 mg film-coated tablets:</u> High-density polyethylene (HDPE) bottle and polypropylene closure containing 14 or 30 film-coated tablets. Polyvinylidene chloride (PVDC) blister with aluminium ...

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)

<u>Cibinqo 50 mg film-coated tablets:</u> EU/1/21/1593/001 EU/1/21/1593/002 EU/1/21/1593/003 EU/1/21/1593/004 EU/1/21/1593/005 <u>Cibinqo 100 mg film-coated tablets:</u> EU/1/21/1593/006 EU/1/21/1593/007 ...

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