CIBINQO Film-coated tablet Ref.[28174] Active ingredients: Abrocitinib

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.

• A starting dose of 100 mg once daily is recommended for patients ≥65 years of age. For other patients who may benefit from a starting dose of 100 mg, see sections 4.4 and 4.8.
• During treatment, the dose may be decreased or increased based on tolerability and efficacy. The lowest effective dose for maintenance should be considered. The maximum daily dose is 200 mg.

Cibinqo can be used with or without medicated topical therapies for atopic dermatitis.

Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks.

Laboratory monitoring

Table 1. Laboratory measures and monitoring guidance:

Treatment initiation Treatment should not be initiated in patients with a platelet count <150 × 10³/mm³, an absolute lymphocyte count (ALC) <0.5 × 10³/mm³, an absolute neutrophil count (ANC) <1.2 × 10³/mm³ or who have a haemoglobin value <10 g/dL (see section 4.4).

Dose interruption

If a patient develops a serious infection, sepsis or opportunistic infection, dose interruption should be considered until the infection is controlled (see section 4.4).

Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1.

Missed doses

If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose. Thereafter, dosing should be resumed at the regular scheduled time.

Interactions

In patients receiving dual strong inhibitors of CYP2C19 and moderate inhibitors of CYP2C9, or strong inhibitors of CYP2C19 alone (e.g. fluvoxamine, fluconazole, fluoxetine and ticlopidine), the recommended dose should be reduced by half to 100 mg or 50 mg once daily (see section 4.5).

Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin) (see section 4.5).

Special populations

Renal impairment

No dose adjustment is required in patients with mild renal impairment, i.e. estimated glomerular filtration rate (eGFR) of 60 to <90 mL/min.

In patients with moderate (eGFR 30 to <60 mL/min) renal impairment, the recommended dose of abrocitinib should be reduced by half to 100 mg or 50 mg once daily (see section 5.2).

In patients with severe (eGFR <30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose. The maximum daily dose is 100 mg (see section 5.2).

Abrocitinib has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy.

Hepatic impairment

No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Abrocitinib is contraindicated to patients with severe (Child Pugh C) hepatic impairment (see section 4.3).

Elderly

The recommended starting dose for patients aged 65 years or more is 100 mg once daily (see section 4.4).

Paediatric population

The safety and efficacy of Cibinqo in children under 12 years of age have not yet been established. No data are available.

Cibinqo has been studied in adolescents 12 to <18 years of age. However, because of bone findings in juvenile rats (comparable to a 3 month old human) (see section 5.3), additional long-term data in growing adolescents is needed to conclude that the benefits outweigh the risks. Currently available data are described in sections 4.8, 5.1 and 5.2.

Method of administration

This medicinal product is to be taken orally once daily with or without food at approximately the same time each day.

In patients who experience nausea, taking tablets with food may improve nausea.

Tablets should be swallowed whole with water and should not be split, crushed or chewed because these methods have not been studied in clinical trials.

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 identified. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions (see section 4.8). Treatment should be symptomatic and supportive. There is no specific antidote for overdose with this medicinal product.

Pharmacokinetics data up to and including a single oral dose of 800 mg in healthy adult volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 48 hours.

50 mg film-coated tablets:

2 years.

100 mg and 200 mg film-coated tablets:

30 months.

This medicinal product does not require any special storage conditions.

Cibinqo 50 mg film-coated tablets:

High-density polyethylene (HDPE) bottle and polypropylene closure containing 14 or 30 film-coated tablets.

Polyvinylidene chloride (PVDC) blister with aluminium foil lidding film containing 7 film-coated tablets. Each pack contains 14, 28 or 91 film-coated tablets.

Cibinqo 100 mg film-coated tablets:

HDPE bottle and polypropylene closure containing 14 or 30 film-coated tablets.

PVDC blister with aluminium foil lidding film containing 7 film-coated tablets. Each pack contains 14, 28 or 91 film-coated tablets.

Cibinqo 200 mg film-coated tablets:

HDPE bottle and polypropylene closure containing 14 or 30 film-coated tablets.

PVDC blister with aluminium foil lidding film containing 7 film-coated tablets. Each pack contains 14, 28 or 91 film-coated tablets.

Not all pack sizes may be marketed.

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