CIBINQO 200 mg FILM-COATED TABLETS

2. What you need to know before you take Cibinqo

Do not take Cibinqo

• if you are allergic to abrocitinib or any of the other ingredients of 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

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

• you have an infection or if you get infections often. Tell your doctor if you have symptoms such as fever, wounds, feeling more tired than usual, or dental problems, as these 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 you 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 do a tuberculosis test before starting treatment with Cibinqo and may do this test again during treatment;
• you have ever had a herpes infection (shingles), because Cibinqo may cause it to come back. Tell 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 C;
• you have recently been vaccinated or plan to get a vaccine (immunization); this is because certain vaccines (live vaccines) are not recommended while taking Cibinqo;

• you have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) or are at a higher risk of developing them (for example, if you have recently had major surgery, use hormonal contraceptives/hormone replacement therapy, or if you or your close relatives have been identified as having a coagulation abnormality). Your doctor will discuss with you whether Cibinqo is suitable for you. Tell your doctor if you suddenly have difficulty breathing or have chest pain or pain in the upper back, swelling in your legs or arms, pain or tenderness in your legs, or redness or discoloration 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;
• non-melanoma skin cancer has been observed in patients taking Cibinqo. Your doctor may recommend that you have your skin checked regularly while taking Cibinqo. If new skin lesions appear during or after treatment, or if existing lesions change in appearance, tell your doctor.

Additional tests

Your doctor will do blood tests before and during treatment with Cibinqo and may adjust your treatment if necessary.

Children

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

Other medicines and Cibinqo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist before taking Cibinqo if you are taking any of the following medicines:

• for fungal infections (e.g., fluconazole), depression (e.g., fluoxetine or fluvoxamine), stroke (e.g., ticlopidine), as they may increase the adverse effects of Cibinqo;
• for acid reflux in the stomach (such as antacids, famotidine, or omeprazol), as they may reduce the amount of Cibinqo in your blood;
• for depression (e.g., citalopram, clobazam, or escitalopram), as Cibinqo may increase their effects;
• for neurofibromatosis type 1 (e.g., selumetinib), as Cibinqo may increase their effects;
• for heart failure (e.g., digoxin) or stroke (e.g., dabigatran), as Cibinqo may increase their effects;
• for seizures (e.g., S-mephenytoin), as Cibinqo may increase their effects;
• for stroke (e.g., clopidogrel), as Cibinqo may decrease their effects;
• for asthma, rheumatoid arthritis, or atopic dermatitis (e.g., treatments with biologic antibodies, medicines that control the body's immune response, such as cyclosporin, other Janus kinase inhibitors, such as baricitinib, upadacitinib), as they may increase the risk of adverse effects.

Your doctor may ask you to avoid taking or stop taking Cibinqo if you are taking any of the following medicines:

• for tuberculosis (e.g., rifampicin), seizures or fits (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 if you are not sure, talk to your doctor or pharmacist before taking Cibinqo.

Pregnancy, contraception, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Contraception in women

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

Pregnancy

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

Breastfeeding

Do not take Cibinqo during breastfeeding, as it is not known whether this medicine passes into breast milk and affects the baby. You and your doctor will decide whether to breastfeed or take 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 using machines

Cibinqo has no effect on your ability to drive or use machines.

Cibinqo contains lactose monohydrate and sodium

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

Elderly patients

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

3. How to take Cibinqo

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Cibinqo is a tablet that is taken by mouth. It can be used with other medicines for eczema that are applied to the skin or used alone.

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

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

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

If you have moderate to severe kidney problems, or if you are prescribed other medicines, the initial dose may be 50 mg or 100 mg once daily. The initial dose prescribed for you will be based on your needs and medical history or conditions, so you should always take this medicine exactly as your doctor has told you.

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

If you have taken Cibinqo for 24 weeks and still show no improvement, your doctor may decide to permanently stop treatment.

Swallow the tablet whole with water. Do not break, crush, or chew the tablet before swallowing, as this may change the amount of medicine that enters your body.

You can take the tablet with or without food. If you feel sick (nauseous) while taking this medicine, it may help to take it with food. To help you remember to take your medicine, 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 side effects described in section 4.

If you forget to take Cibinqo

• If you miss a dose, take it as soon as you remember, unless it is less than 12 hours until your next dose.
• If it is less than 12 hours until your next dose, simply miss the missed dose and take the next scheduled dose when it is time.
• Do not take a double dose to make up for missed doses.

If you stop taking Cibinqo

Do not stop taking Cibinqo without talking to your doctor.

If you have any further questions on the use of 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

Talk to your doctor and seek medical help immediately 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 side effects

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

• 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 a blood test

Uncommon(may affect up to 1 in 100 people)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in the Appendix. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 label after “EXP”. The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Cibinqo Composition

• 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 ingredients are:

Tablet core: microcrystalline cellulose (E460i), anhydrous calcium hydrogen phosphate (E341ii), sodium starch glycolate, 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").

Product Appearance and Package Contents

Cibinqo 50 mg tablets are oval, 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, 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 available in polyvinylidene chloride (PVDC) blisters with an aluminum foil or high-density polyethylene (HDPE) bottles with a polypropylene cap. Each blister contains 14, 28, or 91 tablets. Each bottle contains 14 or 30 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the last revision of this prospectus:

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.