CIBINQO 50 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

ABROCITINIB

Dostopno od:

PFIZER PHARMACEUTICALS ISRAEL LTD

Koda artikla:

D11AH08

Farmacevtska oblika:

FILM COATED TABLETS

Sestava:

ABROCITINIB 50 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

PFIZER INC, USA

Terapevtsko območje:

ABROCITINIB

Terapevtske indikacije:

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

Datum dovoljenje:

2023-01-02

Navodilo za uporabo

CIBINQO (ABROCITINIB)
PRESCRIBER BROCHURE
THIS PRESCRIBER BROCHURE CONTAINS IMPORTANT SAFETY INFORMATION THAT
YOU NEED TO CONSIDER
WHEN PRESCRIBING AND MAINTAINING PATIENTS ON CIBINQO THERAPY, NAMELY:
•
Venous thromboembolism
•
Potential risk of Infections (including herpes zoster and serious and
opportunistic infections)
•
Potential risk of malignancy
•
Potential risk of Major Adverse Cardiovascular Events
•
Embryofoetal toxicity following exposure in utero
PLEASE READ THIS BROCHURE IN FULL ALONG WITH THE PRESCRIBING
INFORMATION FOR CIBINQO.
Abrocitinib should only be used if no suitable treatment alternatives
are available in patients:
•
65 years of age and older;
•
patients with history of atherosclerotic cardiovascular disease or
other cardiovascular risk
factors (such as current or past long-time smokers);
•
patients with malignancy risk factors (e.g., current malignancy or
history of malignancy)
2
3
ABOUT CIBINQO
Cibinqo is a Janus kinase (JAK) 1 inhibitor.
Cibinqo is indicated for treatment of moderate-to-severe atopic
dermatitis in adults who are
candidates for systemic therapy.
Posology
The recommended starting dose is 100 mg or 200 mg once daily based on
individual patient
characteristics:
•
A starting dose of 100 mg once daily is recommended for patients 65
years of age and older,
those at higher risk of venous thromboembolism (VTE), major adverse
cardiovascular event
(MACE) and malignancy. If the patient does not respond adequately to
100 mg once daily,
the dose can be increased to 200 mg once daily.
•
A dose of 200 mg once daily may be appropriate for patients who are
not at higher risk of
VTE, MACE and malignancy with high disease burden or for patients with
an inadequate
response to 100 mg once daily. Upon disease control, dose should be
decreased to 100 mg
once daily. If disease control is not maintained after dose reduction,
re-treatment with
200 mg once daily can be considered.
The lowest effective dose for maintenance should be considered.
Discontinuation of treatment should

Lastnosti izdelka

Cibinqo LPD CC
090124
1
2022-0076572
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cibinqo 50 mg
Cibinqo 100 mg
Cibinqo 200 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cibinqo 50 mg
Each film-coated tablet contains 50 mg of abrocitinib.
_Excipient with known effect _
Each film-coated tablet contains 1.37 mg of lactose monohydrate.
Cibinqo 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of abrocitinib.
_ _
_Excipient with known effect _
Each film-coated tablet contains 2.73 mg of lactose monohydrate.
Cibinqo 200 mg film-coated tablets
Each film-coated tablet contains 200 mg of abrocitinib.
_Excipient with known effect _
Each film-coated tablet contains 5.46 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Cibinqo 50 mg film-coated tablets
_ _
Oval pink film-coated tablet
debossed with “PFE” on one side and “ABR
50” on
the other.
Cibinqo 100 mg film-coated tablets
_ _
Round pink film-coated tablet
debossed with “PFE” on one side and “
ABR
100” on the other.
Cibinqo 200 mg film-coated tablets
_ _
Oval pink film-coated tablet
debossed with “PFE” on one side and “ABR
200” on
the other.
Cibinqo LPD CC
090124
2
2022-0076572
4.
CLINICAL PARTICULARS
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 100 mg or 200 mg once daily based on
individual patient characteristics:
•
A starting dose of 100 mg once daily is recommended for patients at
higher risk of venous thromboembolism
(VTE), major adverse cardiovascular event (MACE) and malignancy (see
section 4.4). If the patient does not
respond adequately to 100 mg once daily, the dose can be increased