IMPORTANT FACTS (continued from previous pages)
What is the most important information I should know about CIBINQO? (see previous pages)
What is CIBINQO?
CIBINQO is a prescription medicine that is a Janus kinase (JAK) inhibitor. CIBINQO is used to treat adults with moderate-to-severe atopic dermatitis (eczema) that did not respond to other treatment and is not well controlled with prescription therapies, including biologic medicines or in adults who cannot tolerate these therapies.
It is not known if CIBINQO is safe and eff ective in children. What medicines should I avoid while taking CIBINQO?
During the fi rst 3 months of treatment with CIBINQO, do not take CIBINQO with other medicines that prevent blood clots. You can take low-dose aspirin up to a dose of 81 mg each day during this time if prescribed by your healthcare provider.
What should I tell my healthcare provider before taking CIBINQO?
Tell your healthcare provider about all of your medical conditions, including if you: • See “What is the most important information I should know about CIBINQO?” on previous pages
• have an infection. • are a current or past smoker. • have had a heart attack, other heart problems, or stroke. • have kidney problems or liver problems. • have low platelet counts or white blood cell counts. • have any eye problems, including cataracts or retinal detachment.
• You can take CIBINQO with or without food. • CIBINQO can be used with or without prescribed topical medicines for atopic dermatitis. Prescribed topical medicine are lotions, creams, or ointments applied to your skin.
• If you miss a dose, take the dose as soon as possible. If it is less than 12 hours before the next dose, skip the dose. Take the next dose at your usually scheduled time.
• If you take too much CIBINQO, call the Poison Control Center at 1-800-222-1222 right away.
What are the possible side eff ects of CIBINQO?
• have recently received or are scheduled to receive an immunization (vaccine). People who take CIBINQO should not receive live vaccines.
CIBINQO may cause serious side eff ects, including: • See “What is the most important information I should know about CIBINQO?” on previous pages The most common side eff ects of CIBINQO include: See “What is the most important information I should know about CIBINQO?” on previous pages • common cold • nausea • headache • herpes simplex including cold sores • increased blood level of creatinine phosphokinase • dizziness • urinary tract infection • tiredness • acne • vomiting • mouth and throat pain • fl u • stomach fl u • bacterial skin infection (impetigo) • high blood pressure • allergic skin rash to something you came into contact with • stomach-area pain • shingles • low platelet count
• are breastfeeding or plan to breastfeed. It is not known if CIBINQO passes into your breast milk. You and your healthcare provider should decide if you will take CIBINQO or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CIBINQO and other medicines may aff ect each other causing side eff ects.
Especially tell your healthcare provider if you take aspirin or any antiplatelet therapies. See “Do not take CIBINQO if you.” Ask your healthcare provider if you are unsure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist whenever you get a new medicine.
How should I take CIBINQO?
• Take CIBINQO exactly as your healthcare provider tells you to take it.
• Take CIBINQO 1 time each day, at about the same time each day. • Swallow CIBINQO tablets whole with water. Do not split, crush, or chew the tablets.
• are pregnant or plan to become pregnant. It is not known if CIBINQO will harm your unborn baby. − Pregnancy Exposure Registry. Pfi zer has a registry for women who take CIBINQO during pregnancy. The purpose of this registry is to check the health of you and your baby. If you are pregnant or become pregnant during treatment with CIBINQO, talk to your healthcare provider about how you can join this pregnancy registry, or you may contact the registry at 1-877-311-3770.
CIBINQO may cause fertility problems in females, which may aff ect your ability to get pregnant. Talk to your healthcare provider if you have concerns about fertility.
Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with CIBINQO. Call your healthcare provider right away if you have any sudden changes in your vision during treatment with CIBINQO.
These are not all the possible side eff ects of CIBINQO.
Call your doctor for medical advice about side eff ects. You may report side eff ects to the FDA at 1-800-FDA-1088. You may also report side eff ects to Pfi zer at 1-800-438-1985.
General information about the safe and eff ective use of CIBINQO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CIBINQO for a condition for which it was not prescribed. Do not give CIBINQO to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about CIBINQO that is written for health professionals.
What are the ingredients in CIBINQO?
Active ingredient: abrocitinib Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.
CIBINQO is available in 50 mg, 100 mg, and 200 mg pills.
Please see full Prescribing Information, including BOXED WARNING, and Medication Guide available at
CIBINQOPI.com
A personalized savings and support program Learn more about fi nancial assistance options and other resources by talking to a Patient Support Representative.
Call 1-833-956-DERM (1-833-956-3376) Monday-Friday, 8:00 AM-8:00 PM ET
This brief summary is based on the CIBINQO Prescribing Information LAB-1423-1.0 and Medication Guide LAB-1424-1.0. Issued January 2022 © 2022 Pfi zer Inc. All rights reserved. October 2022. PP-CIB-USA-0232
© PARADE Publications 2022. All rights reserved.
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