CIBINQO® (abrocitinib) 8 USE IN SPECIFIC POPULATIONS

(abrocitinib)

Prescribing Information

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770.

Risk Summary

Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug‑associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of abrocitinib to pregnant rats and rabbits during organogenesis at exposure 11 or 4 times the maximum recommended human dose (MRHD) based on AUC comparison, respectively, resulted in maternal dystocia and skeletal variations in rats and no adverse effects in rabbits (see Data).

The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The background risks in the U.S. general population of major birth defects and miscarriages are 2–4% and 15–20% of clinically recognized pregnancies, respectively.

Data

Animal Data

In an embryofetal development study, abrocitinib was administered orally to pregnant rats at doses of 10, 30, or 60 mg/kg/day during the period of organogenesis. No fetal malformations were observed. Abrocitinib increased the incidence of skeletal variations of short 13th ribs at 30 mg/kg/day (11 times the MRHD based on AUC comparison). Increased embryofetal lethality and additional skeletal variations (cervical arches with reduced ventral processes, thickened ribs, and unossified metatarsals) were noted at 60 mg/kg/day (17 times the MRHD based on AUC comparison).

In an embryofetal development study, abrocitinib was administered orally to pregnant rabbits at doses of 10, 30, or 75 mg/kg/day during the period of organogenesis. No abrocitinib-related maternal or developmental toxicity was noted at doses up to 75 mg/kg/day (4 times the MRHD based on AUC comparison).

In a prenatal and postnatal development study, abrocitinib was administered orally to pregnant rats at doses of 10, 30, and 60 mg/kg/day beginning on gestation day 6 and continuing through lactation day 20. Dystocia with prolonged parturition and reduced offspring body weights were noted at 30 mg/kg/day (11 times the MRHD based on AUC comparison). Postnatal survival was markedly decreased at 60 mg/kg/day (17 times the MRHD based on AUC comparison). No maternal toxicity was observed at 10 mg/kg/day (2.4 times the MRHD based on AUC comparison). No abrocitinib-related effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring was noted at doses up to 30 mg/kg/day (11 times the MRHD based on AUC comparison).

8.2 Lactation

Risk Summary

There are no data on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Abrocitinib was secreted in milk of lactating rats (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the serious adverse findings in adults, including risks of serious infections, malignancy, and thrombosis, advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose (approximately 5–6 elimination half-lives).

Data

Animal Data

Lactating female rats were orally administered a single dose of 10 mg/kg abrocitinib on lactation day 12. Abrocitinib AUC was approximately 5 times greater in milk than in plasma.

8.3 Females and Males of Reproductive Potential

Infertility

Females

Based on the findings in rats, oral administration of CIBINQO may impair female fertility. Impaired fertility in female rats was reversible 1 month after cessation of abrocitinib oral administration [see Nonclinical Toxicology (13.1)].

8.4 Pediatric Use

The safety and effectiveness of CIBINQO in pediatric patients 12 years of age and older with atopic dermatitis have been established.

In trials Trial-AD-1 and Trial-AD-2, 124 pediatric subjects 12 to less than 18 years old weighing 25 kg or more with moderate-to-severe atopic dermatitis were enrolled and randomized to receive either CIBINQO 100 mg (N=51), 200 mg (N=48), or matching placebo (N=25) in monotherapy. Additional 284 pediatric subjects 12 to less than 18 years of age weighing 25 kg or more with moderate-to-severe atopic dermatitis, were enrolled and randomized to receive either CIBINQO 100 mg (N=95) or 200 mg (N=94) or matching placebo (N=95) in combination with topical corticosteroids in Trial-AD-4. Efficacy and adverse reaction profile were comparable between the pediatric patients and adults [see Clinical Studies (14) and Adverse Reactions (6.1)].

The safety and effectiveness of CIBINQO have not been established in pediatric patients below 12 years of age.

Juvenile Animal Toxicity Data

In a juvenile animal toxicity study, abrocitinib was administered orally to juvenile rats at doses of 5, 25, and 75 mg/kg/day from postnatal day 10 (approximately equivalent to a human infant) through postnatal day 63 (approximately equivalent to an adolescent). Abrocitinib caused a reversible, dose‑related decrease in the primary spongiosa in the metaphysis of the proximal tibia and distal femur and adverse effects on bone development at all dose levels. Abrocitinib caused irreversible dose-related small or misshapen femoral heads at doses ≥5 mg/kg/day (0.8 times the MRHD based on AUC comparison); irreversibly decreased femur size and caused paw malrotation and limb impairment at doses ≥25 mg/kg/day (7.2 times the MRHD based on AUC comparison); and fractures at 75 mg/kg/day (27 times the MRHD based on AUC comparison).

In a follow-up study, abrocitinib (25 mg/kg/day, at least 4.5 times the MRHD based on AUC comparison) was orally administered to juvenile rats from postnatal day (PND) 10, 15, 21, or 30 through PND day 63. Administration beginning PND 10 caused adverse macroscopic and microscopic bone findings consistent with the previous juvenile animal study. However, administration beginning PND 15 (approximately equivalent to a 6- to 12-month old infant) caused non-adverse reversible microscopic bone findings. No bone findings were noted when administration began on PND 21 or 30 (approximately equivalent to 2- and 6-year old children, respectively).

8.5 Geriatric Use

A total of 145 (4.6%) subjects 65 years of age and older, while 25 (0.8%) were 75 years of age and older, were enrolled in CIBINQO clinical trials. Clinical trials of CIBINQO did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

A higher proportion of subjects 65 years of age and older discontinued from clinical trials compared to younger subjects. Among all subjects exposed to CIBINQO, including the long-term extension trial, confirmed ALC <500/mm3 occurred only in subjects 65 years of age and older. A higher proportion of subjects 65 years of age and older had platelet counts <75,000/mm3. The incidence rate of herpes zoster in subjects 65 years of age and older treated with CIBINQO (7.40 per 100 patient-years) was higher than that of subjects 18 to less than 65 years of age (3.44 per 100 patient-years).

8.6 Renal Impairment

In patients with severe (eGFR <30 mL/min) and moderate (eGFR 30–59 mL/min) renal impairment, the combined exposure (AUCinf,u) of abrocitinib and its two active metabolites, M1 and M2, is increased compared to patients with normal renal function (eGFR ≥90 mL/min) [see Clinical Pharmacology (12.3)]. This may increase the risk of adverse reactions such as infections.

CIBINQO is not recommended for use in patients with severe renal impairment and ESRD including those on renal replacement therapy [see Dosage and Administration (2.3)].

A dosage reduction in patients with moderate renal impairment is recommended. No dosage adjustment is required in patients with mild renal impairment (eGFR 60–89 mL/min) [see Dosage and Administration (2.3)].

CIBINQO has not been studied in subjects on renal replacement therapy. In Phase 3 clinical trials, CIBINQO was not evaluated in subjects with atopic dermatitis with baseline creatinine clearance values less than 40 mL/min.

8.7 Hepatic Impairment

Avoid use of CIBINQO in patients with severe (Child Pugh C) hepatic impairment. In clinical trials, CIBINQO was not evaluated in subjects with severe (Child Pugh C) hepatic impairment.

Dosage adjustment is not required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment based on similar combined exposure (AUCinf,u) of abrocitinib and its two active metabolites, M1 and M2 compared to patients with normal hepatic function [see Clinical Pharmacology (12.3)].

8.8 CYP2C19 Poor Metabolizers

In patients who are CYP2C19 poor metabolizers, the AUC of abrocitinib is increased compared to CYP2C19 normal metabolizers due to reduced metabolic clearance. Dosage reduction of CIBINQO is recommended in patients who are known or suspected to be CYP2C19 poor metabolizers based on genotype or previous history/experience with other CYP2C19 substrates [see Dosage and Administration (2.4) and Clinical Pharmacology (12.5)].

Medication Guide

MEDICATION GUIDE

Medication Guide CIBINQO (Si BINK oh) (abrocitinib) tablets, for oral use
What is the most important information I should know about CIBINQO? CIBINQO may cause serious side effects, including: 1. Serious infections CIBINQO is a medicine that affects your immune system. CIBINQO can lower the ability of your immune system to fight infections. Some people have had serious infections while taking CIBINQO or other similar medicines, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. • Your healthcare provider should test you for TB before starting treatment with CIBINQO. • Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with CIBINQO. You should not start taking CIBINQO if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). Before starting CIBINQO, tell your healthcare provider if you: • are being treated for an infection • have had an infection that does not go away or that keeps coming back • have diabetes, chronic lung disease, HIV, or a weak immune system • have TB or have been in close contact with someone with TB • have had shingles (herpes zoster) • have had hepatitis B or hepatitis C • live or have lived or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use CIBINQO. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. • think you have an infection or have symptoms of an infection such as:
	o fever, sweating, or chills o muscle aches o cough or shortness of breath	o blood in your phlegm o weight loss o warm, red, or painful skin or sores on your body o diarrhea or stomach pain o burning when you urinate or urinating more often than usual o feeling very tired
After starting CIBINQO, call your healthcare provider right away if you have any symptoms of an infection. CIBINQO can make you more likely to get infections or make any infections that you have worse. If you get a serious infection, your healthcare provider may stop treatment with CIBINQO until your infection is controlled. 2. Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. CIBINQO is a JAK inhibitor medicine. 3. Cancer and immune system problems CIBINQO may increase your risk of certain cancers by changing the way your immune system works. • Lymphoma and other cancers, including skin cancers, can happen in people taking CIBINQO. • People taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. • Follow your healthcare provider's advice about having your skin checked for skin cancer during treatment with CIBINQO. Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. Wear protective clothing when you are in the sun and use a sunscreen with a high protection factor (SPF 30 and above). This is especially important if your skin is very fair or of you have a family history of skin cancer. Tell your healthcare provider if you have ever had any type of cancer. 4. Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Some people taking CIBINQO have had major cardiovascular events. Get emergency help right away if you develop any symptoms of a heart attack or stroke during treatment with CIBINQO, including: • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw • pain or discomfort in your arms, back, neck, jaw, or stomach • weakness in one part or on one side of your body • slurred speech • shortness of breath with or without chest discomfort • breaking out in a cold sweat • nausea or vomiting • feeling lightheaded 5. Blood clots Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking CIBINQO. This may be life-threatening. Blood clots in the veins of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. • Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past. • Stop taking CIBINQO and get medical help right away if you have any signs and symptoms of blood clots during treatment with CIBINQO, including: o swelling, pain or tenderness in one or both legs o sudden, unexplained chest or upper back pain o shortness of breath or difficulty breathing 6. Low blood sugar in people with diabetes If you have diabetes, your healthcare provider may instruct you to check your blood sugar levels more often during treatment with CIBINQO. Call your healthcare provider if you have any problems with low blood sugar (hypoglycemia). 7. Changes in certain laboratory test results Your healthcare provider should do blood tests before you start taking CIBINQO and during treatment with CIBINQO to check for the following: • low lymphocyte count. Lymphocytes are white blood cells that help the body fight off infections. • low neutrophil count. Neutrophils are white blood cells that help the body fight off infections. • low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired. • low platelet count. Platelets help form clots and stop or prevent bleeding. You should not take CIBINQO if your lymphocyte counts, neutrophil counts, red blood cell counts, or platelet counts are too low. Your healthcare provider may stop your CIBINQO treatment for a period of time if needed because of changes in these blood test results. Increased cholesterol levels. You may also have increases in the amount of fat found in your blood. Your healthcare provider should check your cholesterol about 4 weeks after you start CIBINQO, and then as needed. See "What are the possible side effects of CIBINQO?" for more information about side effects.
What is CIBINQO? CIBINQO is a prescription medicine that is a Janus Kinase (JAK) inhibitor. CIBINQO is used to treat adults and children 12 years of age and older 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 when these medicines cannot be tolerated. It is not known if CIBINQO is safe and effective in children under 12 years of age.
Who should not take CIBINQO? Do not take CIBINQO if you take medicines that prevent blood clots (antiplatelet medicines), except for low-dose aspirin up to a dose of 81 mg each day during the first 3 months of CIBINQO treatment.
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?" • 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 diabetes • have low platelet counts or white blood cell counts • have high levels of fat in your blood (high cholesterol) • have any eye problems, including cataracts or retinal detachment. • have recently received or are scheduled to receive an immunization (vaccine). People who take CIBINQO should not receive live vaccines. • are pregnant or plan to become pregnant. It is not known if CIBINQO will harm your unborn baby. o Pregnancy Exposure Registry. Pfizer 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 or www.cibinqopregnancyregistry.com. • 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 affect each other causing side effects. Especially tell your healthcare provider if you take aspirin or any antiplatelet therapies (See the "Who should not take CIBINQO?" section). 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. • You can take CIBINQO with or without food. • CIBINQO can be used with or without prescribed topical steroid 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. • In case of overdose, get medical help or contact a Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.
What are the possible side effects of CIBINQO? CIBINQO may cause serious side effects. See "What is the most important information I should know about CIBINQO?" The most common side effects of CIBINQO include: • See "What is the most important information I should know about CIBINQO."
• common cold • nausea • headache • herpes simplex including cold sores • increased blood level of creatine phosphokinase • dizziness • urinary tract infection • tiredness • acne • vomiting			• mouth and throat pain • flu • stomach flu • bacterial skin infection (impetigo) • high blood pressure • allergic skin rash to something you came into contact with • stomach-area pain • shingles • low platelet count
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. CIBINQO may cause fertility problems in females, which may affect your ability to get pregnant. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of CIBINQO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.
How should I store CIBINQO? • Store CIBINQO at room temperature between 68°F to 77°F (20°C to 25°C). • Store CIBINQO in the original package. • The container has a child resistant closure. Keep CIBINQO and all medicines out of the reach of children.
General information about the safe and effective 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. LAB-1424-4.0

This Medication Guide has been approved by the U.S. Food and Drug Administration. Approved: 6/2026

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