Cibinqo

Package leaflet: Information for the patient

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

abrocitinib

This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you may experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

In addition to this package leaflet, your doctor will provide you with a patient card containing important safety information you should be aware of. Keep this patient card with you.
What this leaflet contains

1. What Cibinqo is and what it is used for
2. What you need to know before taking Cibinqo
3. How to take Cibinqo
4. Possible side effects
5. How to store Cibinqo
6. Contents of the pack and other information

1. What Cibinqo is and what it is used for

Cibinqo contains the active substance abrocitinib. It belongs to a group of medicines called Janus kinase inhibitors, which help reduce inflammation. It works by reducing the activity of an enzyme in the body called "Janus kinase", which is involved in inflammation.
Cibinqo is used to treat moderate to severe atopic dermatitis in adults and adolescents aged 12 years and older, also known as atopic eczema. By reducing the activity of Janus kinase enzymes, Cibinqo reduces skin itching and inflammation. This in turn may reduce sleep disturbances and other consequences of atopic eczema such as anxiety or depression, and improves overall quality of life.

2. What you should know before taking Cibinqo

Do not take Cibinqo

• if you are allergic to abrocitinib or to any of the other ingredients of this medicine (listed in section 6).
• if you currently have a serious infection, including tuberculosis.
• if you have severe liver problems.
• if you are pregnant or breastfeeding (see section “Pregnancy, contraception, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before and during treatment with Cibinqo if:

• you have an infection or frequently get infections. Inform your doctor if you experience symptoms such as fever, have wounds, feel unusually tired, or have dental problems, as these may be signs of infection. Cibinqo may reduce your body’s ability to fight infections and could worsen an existing infection or increase the risk of developing a new infection. If you have diabetes or are aged 65 years or older, you may be at higher risk of infections.
• you have had or have had close contact with someone who has tuberculosis. Your doctor will test you for tuberculosis before starting treatment with Cibinqo and may repeat the test during treatment.
• you have previously had herpes infection (Herpes Zoster), as Cibinqo may cause it to recur. Inform your doctor if you develop a painful skin rash with blisters, as this may be a sign of Herpes Zoster.
• you have previously had hepatitis B or hepatitis C.
• you have recently received or plan to receive a vaccination (immunization), as certain vaccines (live vaccines) are not recommended while taking Cibinqo.
• you have previously had blood clots in the veins of your legs (deep vein thrombosis) or in your lungs (pulmonary embolism), or if you are at increased risk of developing them (for example, if you have recently undergone major surgery, if you are using hormonal contraceptives/hormone replacement therapy, or if you or a close family member has been diagnosed with a blood clotting disorder). Your doctor will discuss whether Cibinqo is an appropriate treatment for you. If you suddenly develop shortness of breath or difficulty breathing, chest pain, pain in the upper back, swelling of an arm or leg, pain or tenderness in the legs, or redness or discoloration of an arm or leg, contact your doctor immediately, as these may be signs of blood clots.
• you have or have had heart problems, as your doctor will discuss whether Cibinqo is an appropriate treatment for you.
• you have or have had cancer, smoke or have smoked in the past, as your doctor will discuss whether Cibinqo is an appropriate treatment for you.
• non-melanoma skin cancer has been observed in patients taking Cibinqo. During treatment with Cibinqo, your doctor may recommend regular dermatological examinations. If new skin lesions appear during or after treatment, or if existing lesions change in appearance, inform your doctor.

Additional monitoring tests
Your doctor will perform blood tests before and during treatment with Cibinqo and, if necessary, may adjust your treatment accordingly.

Children
This medicine is not approved for use in children under 12 years of age, as the safety and benefits of Cibinqo have not yet been established.

Other medicines and Cibinqo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist before taking Cibinqo if you are taking medicines for the treatment of:

• fungal infections (such as fluconazole), depression (such as fluoxetine or fluvoxamine), stroke (such as ticlopidine), as these may increase the side effects of Cibinqo.
• stomach acid reflux (such as antacids, famotidine or omeprazole), as these may reduce the amount of Cibinqo in the blood.
• depression (such as citalopram, clobazam or escitalopram), as Cibinqo may increase their effects.
• neurofibromatosis type I (such as selumetinib), as Cibinqo may increase its effects.
• heart failure (such as digoxin) or stroke (such as dabigatran), as Cibinqo may increase their effects.
• seizures (such as S-mephenytoin), as Cibinqo may increase its effects.
• stroke (such as clopidogrel), as Cibinqo may reduce its effects.
• asthma, rheumatoid arthritis or atopic dermatitis (such as biological antibody therapies, medicines that modulate the body’s immune response such as cyclosporine, other Janus kinase inhibitors such as baricitinib, upadacitinib), as these may increase the risk of side effects.

Your doctor may advise you to avoid using or to stop taking Cibinqo if you are taking medicines for the treatment of:

• tuberculosis (such as rifampicin), seizures or convulsions (such as phenytoin), prostate cancer (such as apalutamide, enzalutamide), or HIV infection (such as efavirenz), as these may reduce the effectiveness of Cibinqo.

If any of the conditions described above apply to you or if you have any doubts, consult your doctor or pharmacist before taking Cibinqo.

Pregnancy, contraception, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Contraception in women
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with Cibinqo and for at least one month after the last dose. Your doctor may advise you on suitable contraceptive methods.

Pregnancy
Do not use Cibinqo if you are pregnant, think you may be pregnant, or are planning to have a baby, as it may harm the developing baby. Inform your doctor immediately if you become pregnant or think you may have become pregnant during treatment.

Breastfeeding
Do not use Cibinqo while breastfeeding, as it is unknown whether this medicine is excreted in breast milk and whether it may affect the newborn. You and your doctor must decide whether you will breastfeed or use this medicine.

Fertility
Cibinqo may cause a temporary reduction in fertility in women of childbearing age. This effect is reversible after discontinuation of treatment.

Driving and using machines
Cibinqo does not affect the ability to drive vehicles or operate machinery.

Cibinqo contains lactose monohydrate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

Elderly
Patients aged 65 years or older may be at increased risk of infections, heart attack, and certain types of cancer. Your doctor may decide that Cibinqo is not the appropriate treatment for you.

3. How to take Cibinqo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Cibinqo is a tablet to be taken by mouth. It can be used in combination with other eczema medicines applied to the skin, or it may be used alone.
The recommended starting dose for adults and adolescents (aged 12 to 17 years) weighing 59 kg or more is 100 mg or 200 mg once daily, as prescribed by your doctor. Your doctor may increase or decrease the dose depending on how well the medicine works.

A lower starting dose may be necessary for some patients, and your doctor may prescribe 100 mg once daily if:

• you are 65 years of age or older;
• you have a specific medical history or condition;
• you are an adolescent (aged 12 to 17 years) weighing between 25 kg and 58 kg.

If you have moderate to severe kidney problems or are prescribed certain other medicines, your starting dose may be 50 mg or 100 mg once daily. Your starting dose will be based on your individual needs, medical history, and condition; therefore, you must always take this medicine exactly as instructed by your doctor.

After starting treatment, your doctor may adjust your dose based on how well the medicine works and any side effects you may experience. If the medicine is effective, your dose may be reduced. Additionally, treatment may be temporarily or permanently stopped if blood tests show low white blood cell or platelet counts.

If you have taken Cibinqo for 24 weeks and have not shown any signs of improvement, your doctor may decide to permanently stop treatment.

The tablet must be swallowed whole with water. Do not divide, crush, or chew the tablet before swallowing, as this may alter the amount of medicine absorbed by your body.

The tablet can be taken with or without food. If you feel unwell (nausea) when taking this medicine, taking it with food may help. To help you remember to take the medicine, we recommend taking it at the same time each day.

If you take more Cibinqo than you should
If you take more Cibinqo than prescribed, contact your doctor, as you may experience some of the side effects described in section 4.

If you forget to take Cibinqo

• If you forget a dose, take it as soon as you remember, unless your next dose is due within less than 12 hours.
• If less than 12 hours remain before your next dose, do not take the missed dose; instead, take your next dose at the usual scheduled time.
• Do not take a double dose to make up for a forgotten tablet.

If you stop taking Cibinqo
Do not stop taking Cibinqo without talking to your doctor.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Contact your doctor immediately if you experience signs of:

• Herpes zoster, a painful rash with blisters and fever
• Blood clots in the lungs, legs, or pelvis, with symptoms such as a swollen and painful leg, chest pain, or shortness of breath

Other side effects
Very common (may affect more than 1 in 10 people)

• Feeling unwell (nausea)

Common (may affect up to 1 in 10 people)

• Cold sores and other types of herpes simplex infections
• Vomiting
• Stomach pain
• Headache
• Dizziness
• Acne
• Increased levels of an enzyme called creatine phosphokinase, seen in blood tests

Uncommon (may affect up to 1 in 100 people)

• Pneumonia (lung infection)
• Low platelet count, seen in blood tests
• Decreased white blood cell count (lymphocytes and neutrophils), seen in blood tests
• High levels of fats in the blood (cholesterol), seen in blood tests (see section 2 Warnings and precautions)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Cibinqo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, bottle and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cibinqo contains
The active substance is abrocitinib.
Each 50 mg tablet contains 50 mg of abrocitinib.
Each 100 mg tablet contains 100 mg of abrocitinib.
Each 200 mg tablet contains 200 mg of abrocitinib.
The other components are:
Tablet core: microcrystalline cellulose (E460i), anhydrous calcium hydrogen phosphate (E341ii), sodium starch glycolate, magnesium stearate (E470b).
Film coating: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol (E1521), triacetin (E1518), red iron oxide (E172) (see section 2: Cibinqo contains lactose and sodium).

Description of the appearance of Cibinqo and contents of the pack
Cibinqo 50 mg tablets are pink oval tablets, approximately 11 mm long and 5 mm wide, imprinted with “PFE” on one side and “ABR 50” on the other.
Cibinqo 100 mg tablets are pink round tablets, approximately 9 mm in diameter, imprinted with “PFE” on one side and “ABR 100” on the other.
Cibinqo 200 mg tablets are pink oval tablets, approximately 18 mm long and 8 mm wide, imprinted with “PFE” on one side and “ABR 200” on the other.
The 50 mg, 100 mg, and 200 mg tablets are available in polyvinylidene chloride (PVDC) blisters with an aluminum foil lid or in high-density polyethylene (HDPE) bottles with polypropylene caps. Each blister contains 14, 28, or 91 tablets. Each bottle contains 14 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Česká republika
Pfizer, spol. s r.o.
Tel.: +420 283 004 111

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785 800

España
Pfizer S.L.
Tel: +34 91 490 99 00

France
Pfizer
Tél: +33 (0)1 58 07 34 40

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Ísland
Icepharma hf.
Sími: +354 540 8000

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22 817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 52 51 4000

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 52 51 4000

Luxembourg/Luxemburg
Pfizer Luxembourg SARL
Tél/Tel: +32 (0)2 554 62 11

Magyarország
Pfizer Kft.
Tel.: +36-1-488-37-00

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 43 00 40

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION OF THE TERMS OF THE MARKETING AUTHORISATION

Scientific conclusions
Taking into account the assessment by the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for abrocitinib, the PRAC's scientific conclusions are as follows:
In light of the available data on neutropenia, including two reported cases with positive dechallenge and rechallenge, as well as two additional reports with positive dechallenge, together with clinical study data and non-clinical study data showing an effect on neutrophil count in rats, and considering the potential class effect, the PRAC concluded that the product information for abrocitinib should be amended accordingly.

Having reviewed the PRAC's recommendation, the Committee for Human Medicinal Products (CHMP) agrees with the overall conclusions and the rationale of the recommendation.

Reasons for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on abrocitinib, the CHMP considers that the benefit-risk balance of the medicinal product(s) containing abrocitinib remains unchanged, subject to the proposed amendments to the product information.
The CHMP recommends a variation to the terms of the marketing authorisation.