Cibinqo - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Cibinqo 50 mg film-coated tablets

Cibinqo 100 mg film-coated tablets

Cibinqo 200 mg film-coated tablets

abrocitinib

VThis medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist.This includes any possible side

effects not listed in this leaflet. See section 4.

In addition to this leaflet, your doctor will give you a patient card, which contains important safety information that you need to be aware of. Keep this patient card with you.

What is in this leaflet

• 1. What Cibinqo is and what it is used for

• 2. What you need to know before you take 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 to 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 adults with moderate-to-severe atopic dermatitis, also known as atopic eczema. By reducing the activity of Janus kinase enzymes, Cibinqo lessens itching and inflammation of the skin.This in turn can reduce sleep disturbances and other consequences of atopic eczema such as anxiety or depression and improves overall quality of life.

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 serious infection ongoing, including tuberculosis.

• – if you have severe liver problems.

• – if you are pregnant or breast-feeding (see the “pregnancy, contraception, breast-feeding and

fertility” section).

Warnings and precautions

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

• – have an infection (shown by signs such as fever, sweating, or chills, muscle aches, cough or

shortness of breath, blood in your phlegm, weight loss, diarrhoea or stomach pain, burning when you urinate or urinating more often than usual, feeling very tired) – Cibinqo can reduce your body’s ability to fight infections and so may worsen an infection that you already have, or make it more likely for you to get a new infection.

• – have, or have had, tuberculosis or have been in close contact with someone with tuberculosis.

Your doctor will test you for tuberculosis before starting Cibinqo and may retest during treatment.

• – have ever had a herpes infection (shingles), because Cibinqo may allow it to come back. Tell

your doctor if you get a painful skin rash with blisters as this can be a sign of shingles.

• – have ever had hepatitis B or hepatitis C.

• – have recently had or plan to have a vaccination (immunisation) – this is because certain vaccines

(live vaccines) are not recommended while using Cibinqo.

• – have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary

embolism). Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins.

• – have elevated blood cholesterol or other medical conditions that make you more likely to

develop heart disease – it is not clear if Cibinqo increases the risk of heart disease, and your doctor will discuss with you if treatment with this medicine is appropriate or if you need additional tests when taking this medicine.

• – have cancer or have had any cancer – it is not clear if Cibinqo increases the risk of cancer, and

your doctor will discuss with you if treatment with this medicine is appropriate and whether check-ups will be necessary during treatment.

Additional monitoring tests

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

Children

This medicine is not approved for use in children below the age of 18 years because the safety and benefits of Cibinqo are not yet fully 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 some of the medicines to treat:

• – fungal infections (such as fluconazole), depression (such as fluoxetine or fluvoxamine), stro­ke

(such as ticlopidine), as they may increase the side effects of Cibinqo.

• – stomach acid reflux (such as antacids, famotidine or omeprazole), as they may alter the amount

of Cibinqo in your blood.

• – depression (such as bupropion, duloxetine), sleep disorders (such as ramelteon), seizures (such

as S-mephenytoin), irritable bowel syndrome (such as alosetron), muscle spasms (such as tizanidine), as Cibinqo may alter the amount of these medicines in your blood.

• – heart failure (such as digoxin) or stroke (such as dabigatran), as Cibinqo may increase their

effects.

• – asthma, rheumatoid arthritis, or atopic dermatitis (such as biologic antibody therapies,

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 side effects.

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

• – tuberculosis (such as rifampicin), seizures or fits (such as phenytoin), prostate cancer (such as apalutamide, enzalutamide), or HIV infection (such as efavirenz), as these may reduce how well Cibinqo works.

If any of the above apply to you or if you are not sure, talk to your doctor or pharmacist before taking Cibinqo.

Pregnancy, contraception, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 potential, you should use an effective method of contraception during treatment with Cibinqo, and for at least one month after your last treatment dose. Your doctor can advise you on suitable methods of contraception.

Pregnancy

Do not use Cibinqo if you are pregnant, think you may be pregnant or are planning to have a baby since it can harm the developing baby. Tell your doctor right away if you become pregnant or think you might have become pregnant during treatment.

Breast-feeding

Do not use Cibinqo while breast-feeding as it is not known if this medicine passes into breast milk and affects the baby. You and your doctor should decide if you will breast-feed or use this medicine.

Fertility

Cibinqo may cause temporary reduced fertility in woman of childbearing potential. This effect is reversible after stopping treatment.

Driving and using machines

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

Cibinqo contains lactose monohydrate and sodium

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Cibinqo

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Cibinqo is a tablet to be taken by mouth. It may be used with other eczema medicines that you apply on the skin or it may be used on its own.

The recommended starting dose is 200 mg once a day. Some patients need a lower starting dose and your doctor may give you 100 mg once a day if you are over 65 years of age, or if you have a certain medical history or medical condition. If you have moderate-to-severe kidney problems, or if you are prescribed certain other medicines the starting dose can be either 50 mg or 100 mg once a day. You will get a starting dose based on your need and medical history, and therefore you should always take this medicine exactly as your doctor has told you.

Maximum daily dose is 200 mg.

After starting treatment, your doctor can adjust the dose based on how well the medicine works and any side effect you get. If the medicine is working well, the dose may be reduced. Treatment may also be stopped temporarily or permanently if blood tests show low white blood cell or platelet counts.

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

You should swallow your tablet whole with water. Do not split, crush or chew the tablet before swallowing as it may change how much medicine that gets into your body.

You can take the tablet either with or without food. If you feel sick (nausea) when 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 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 get 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 your next dose is due in less than

• 12 hours.

• – If there is less than 12 hours before your next dose, just skip the missed dose and take your next

usual dose when it is due.

• – Do not take a double dose to make up for a forgotten tablet.

If you stop taking Cibinqo

You should not stop taking Cibinqo without discussing this with 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 get medical help straight away if you get 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 swollen leg, chest pain

or shortness of breath

Other side effects

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

• – Feeling sick (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

• – Increase in an enzyme called creatine phosphokinase, shown by blood test

Uncommon (may affect up to 1 in 100 people)

• – Pneumonia (lung infection)

• – Low platelet count shown by blood test

• – Low white blood cell count shown by blood test

• – High blood fat (cholesterol) shown by blood test (see section 2 Warnings and precautions)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you 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 foil after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 ingredients are:

What Cibinqo looks like and contents of the pack

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

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

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

The 50 mg, 100 mg and 200 mg tablets are provided in polyvinylidene chloride (PVDC) blisters with aluminum foil lidding film or high-density polyethylene (HDPE) bottles with polypropylene closure. Each blister pack 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 Bruxelles

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/ Belgien Luxembourg/Lu­xemburg Pfizer NV/SA

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

Tél/Tel: +32 (0)2 554 62 11

Efc^rapufl n$aň3ep ^roKCCMOypr C’ÀPÂ Know Etnrapua Ten.: +359 2 970 4333	Magyarország Pfizer Kft. Tel.: +36–1–488–37–00
Česká republika Pfizer, spol. s r.o. Tel.: +420 283 004 111	Malta Vivian Corporation Ltd. Tel: +356 21344610
Danmark Pfizer ApS Tlf: +45 44 20 11 00	Nederland Pfizer bv Tel: +31 (0)10 406 43 01
Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055–51000	Norge Pfizer AS Tlf: +47 67 52 61 00
Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500	Österreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15–0
EMáóa Pfizer EZZàç A.E. Tql: +30 210 6785 800	Polska Pfizer Polska Sp. z o.o. Tel.:+48 22 335 61 00

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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