Prospect: information for the patient

Cibinqo 50 mg film-coated tablets

Cibinqo 100 mg film-coated tablets

Cibinqo 200 mg film-coated tablets

abrocitinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may have. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

In addition to this prospect, your doctor will give you a patient card, which contains important safety information that you should know. Carry this patient card with you.

Cibinqo contains the active ingredient abrocitinib. It belongs to a group of medications called Janus kinase inhibitors, which help reduce inflammation. It acts by reducing the activity of an enzyme in the body called “Janus kinase”, which is involved in inflammation.

Cibinqo is used to treat adultsand adolescents aged 12yearsor older with moderate to severe atopic dermatitis, also known as atopic eczema. By reducing the activity of Janus kinases, Cibinqo decreases 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.

Do not take Cibinqo

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

Warnings and precautions

Consult your doctor or pharmacist before and during treatment with Cibinqo if:

• you have an infection or frequently get infections. Inform your doctor if you have symptoms such as fever, wounds, feeling more tired than usual, or dental problems, as they may be signs of infection. Cibinqo may reduce your body's ability to fight infections and may worsen an existing infection or increase the likelihood of getting a new infection. If you have diabetes or are 65 years of age or older, you may be more likely to get infections;
• you have or have had tuberculosis or have been in close contact with someone with tuberculosis. Your doctor will make you undergo a tuberculosis test before starting treatment with Cibinqo and may repeat the test during treatment;
• you have ever had herpes (cold sore), as Cibinqo may cause it to reappear. Inform your doctor if you have a painful skin rash with blisters, as this may be a sign of herpes;
• you have ever had hepatitis B or hepatitis C;
• you have recently been vaccinated or plan to receive a vaccine (immunization); this is because certain vaccines (vaccines made with live microorganisms) are not recommended while taking Cibinqo;

• you have had previous blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) or have a higher risk of developing them (for example: if you have recently undergone major surgery, if you use hormonal contraceptives/hormone replacement therapy, if you have been identified or your close relatives have a coagulation disorder). Your doctor will discuss with you whether Cibinqo is suitable for you. Inform your doctor if you suddenly lack breath or have difficulty breathing, chest pain or upper back pain, swelling in your legs or arms, pain or tenderness in your legs, or redness or change in color in your legs or arms, as these may be signs of blood clots in the veins;

• you have or have had heart problems because your doctor will discuss with you whether Cibinqo is suitable for you;
• you have or have had cancer, smoke or have smoked in the past, because your doctor will discuss with you whether Cibinqo is suitable for you;
• skin cancer (non-melanoma) has been observed in patients taking Cibinqo. Your doctor may recommend that you undergo skin exams periodically while taking Cibinqo. If new skin lesions appear during or after treatment or if existing lesions change in appearance, inform your doctor.

Additional laboratory tests

Your doctor will perform blood tests before and during treatment with Cibinqo, and may adjust the treatment as needed.

Children

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

Other medicines and Cibinqo

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Particularly, inform your doctor or pharmacist before taking Cibinqo if you are taking some of the medicines to treat:

• fungus infections (e.g., fluconazole), depression (e.g., fluoxetine or fluvoxamine), stroke (e.g., ticlopidine), as they may increase the adverse effects of Cibinqo;
• acid reflux from the stomach (such as antacids, famotidine, or omeprazole), as they may reduce the amount of Cibinqo in your blood;
• depression (e.g., citalopram, clobazam, or escitalopram), as Cibinqo may increase their effects;
• neurofibromatosis type I (e.g., selumetinib), as Cibinqo may increase their effects;
• heart failure (e.g., digoxin) or stroke (e.g., dabigatran), as Cibinqo may increase their effects;
• seizures (e.g., S-mefenitoína), as Cibinqo may increase their effects;
• stroke (e.g., clopidogrel), as Cibinqo may reduce their effects;
• asthma, rheumatoid arthritis, or atopic dermatitis (e.g., treatments with biologic antibodies, medicines that control the body's immune response, such as ciclosporin, other Janus kinase inhibitors, such as baricitinib, upadacitinib), as they may increase the risk of adverse effects.

Your doctor may ask you to avoid using or stop taking Cibinqo if you are taking some of the medicines to treat:

• tuberculosis (e.g., rifampicin), seizures or attacks (e.g., phenytoin), prostate cancer (e.g., apalutamide, enzalutamide), or HIV infection (e.g., efavirenz), as they may reduce the effectiveness of Cibinqo.

If you are in any of the above situations or are unsure, speak with your doctor or pharmacist before taking Cibinqo.

Pregnancy, contraception, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Contraception in women

If you are a woman of childbearing age, you should use an effective contraceptive method during treatment with Cibinqo and for at least one month after your last dose of treatment. Your doctor may advise you on suitable contraceptive methods.

Pregnancy

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

Breastfeeding

Do not use Cibinqo during breastfeeding, as it is unknown whether this medicine passes into breast milk and affects the baby. You and your doctor should decide whether to breastfeed or use this medicine.

Fertility

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

Driving and operating machinery

Cibinqo has no effect on your ability to drive or operate machinery.

Cibinqo contains lactose monohydrate and sodium

If your doctor has told you that you have a certain sugar intolerance, contact them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

Older patients

Patients 65 years of age and older may have a higher risk of infections, heart attack, and certain types of cancer. Your doctor may decide that Cibinqo is not suitable for you.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Cibinqo is an oral tablet that is administered orally. It can be used with other medications for eczema that are applied to the skin or it can be used alone.

The recommended initial dose for adults and adolescents (12 to 17 years old) with a body weight of at least 59 kg is 100 mg or 200 mg once a day as prescribed by your doctor. Your doctor may increase or decrease your dose depending on the effect of the medication.

Some patients need a lower initial dose and your doctor may prescribe 100 mg once a day if:

• you are 65 years old or older;
• you have a medical history or any medical condition, or
• you are an adolescent (12 to 17 years old) with a body weight of 25 to 58 kg.

If you have moderate to severe kidney problems, or if you are taking other medications, the initial dose may be 50 mg or 100 mg once a day. The initial dose prescribed to you will be based on your needs and medical history or medical conditions, therefore, you must take this medication exactly as your doctor has indicated.

After starting treatment, your doctor may adjust the dose based on the efficacy of the medication and any adverse effects you experience. If the medication works well, the dose may be reduced. The treatment may also be temporarily or permanently interrupted if blood tests show a low white blood cell or platelet count.

If you have taken Cibinqo for 24 weeks and still do not show improvement, your doctor may decide to permanently discontinue treatment.

You must swallow the tablet whole with water. Do not break, crush, or chew the tablet before swallowing it, as this may change the amount of medication that enters your body.

You can take the tablet with or without food. If you experience discomfort (nausea) while taking this medication, it may be helpful to take it with food. To help you remember to take your medication, it is suggested that you take it at the same time every day.

If you take more Cibinqo than you should

If you take more Cibinqo than you should, contact your doctor. You may experience some of the adverse 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 in less than 12 hours.
• If there are less than 12 hours until your next dose, simply omit the missed dose and take the next dose at the usual time.
• Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Cibinqo

You must not stop taking Cibinqo without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Severe Adverse Effects

Consult your doctor and seek immediate medical help if you notice any signs of:

• Shingles (herpes zoster), a painful skin rash with blisters and fever
• Blood clots in the lungs, legs, or pelvis with symptoms such as a painful and swollen leg, chest pain, or difficulty breathing

Other Adverse Effects

Very Common(may affect more than 1 in 10 people)

• Discomfort (nausea)

Common(may affect up to 1 in 10 people)

• Herpes labial and other types of simple herpes infections
• Vomiting
• Stomach pain
• Headache
• Dizziness
• Acne
• Increased levels of an enzyme called creatine phosphokinase, observed in a blood test

Uncommon(may affect up to 1 in 100 people)

• Pneumonia (lung infection)
• Low platelet count observed in a blood test
• Low white blood cell count observed in a blood test
• High levels of fat in the blood (cholesterol) observed in a blood test (see section 2 “Warnings and precautions”)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, bottle, and blister pack label after “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cibinqo

• The active ingredient 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 glycolate starch, magnesium stearate (E470b).

Coating: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol (E1521), triacetin (E1518), red iron oxide (E172) (see section 2 "Cibinqo contains lactose and sodium").

Appearance of the product and contents of the package

Cibinqo 50 mg tablets are oval-shaped, pink tablets, approximately 11 mm long and 5 mm wide, engraved with "PFE" on one side and "ABR 50" on the other.

Cibinqo 100 mg tablets are round, pink tablets, approximately 9 mm in diameter, engraved with "PFE" on one side and "ABR 100" on the other.

Cibinqo 200 mg tablets are oval-shaped, pink tablets, approximately 18 mm long and 8 mm wide, engraved with "PFE" on one side and "ABR 200" on the other.

The 50 mg, 100 mg, and 200 mg tablets are presented in blister packs of polyvinyl chloride (PVC) with an aluminum foil or high-density polyethylene (HDPE) bottles with a polypropylene closure. Each blister pack contains 14, 28, or 91 tablets. Each bottle contains 14 or 30 tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu .