CIBINQO® (abrocitinib) 6 ADVERSE REACTIONS

(abrocitinib)

Prescribing Information

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

•: Serious Infections [see Warnings and Precautions (5.1)]
•: Mortality [see Warnings and Precautions (5.2)]
•: Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions (5.3)]
•: Major Adverse Cardiovascular Events [see Warnings and Precautions (5.4)]
•: Thrombosis [see Warnings and Precautions (5.5)]
•: Laboratory Abnormalities [see Warnings and Precautions (5.6)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of CIBINQO was evaluated in four randomized, placebo-controlled clinical trials (2 monotherapy, 1 combination therapy with topical corticosteroid, and 1 dose-ranging) and one long-term extension trial in subjects with moderate to severe atopic dermatitis (AD). A total of 1623 subjects with moderate to severe atopic dermatitis were treated with CIBINQO in these clinical trials representing 1428 patient-years of exposure. There were 634 subjects with at least 1 year of exposure to CIBINQO.

In the placebo-controlled clinical trials, a total of 1198 subjects were exposed to CIBINQO with 608 subjects receiving CIBINQO 100 mg once daily and 590 subjects receiving CIBINQO 200 mg once daily for up to 16 weeks. The median age of subjects was 33.0 years, 124 subjects (8.1%) were 12 to less than 18 years old and 94 subjects (6.1%) were 65 years of age or older. The majority of subjects were White (68.7%) and male (53.9%).

Adverse reactions occurring at ≥1% in any of the treated groups and at a higher rate than in the placebo group are presented in Table 3. A total of 61 (5.1%) subjects treated with CIBINQO were discontinued from the trials due to adverse reactions. The safety profile of CIBINQO in the monotherapy and the combination trial(s) were similar.

Table 3. Adverse Reactions from Placebo-Controlled Trials Reported in ≥1% of CIBINQO Treated Subjects with Moderate to Severe Atopic Dermatitis and at Higher Rate than Placebo for up to 16 Weeks
* Study size adjusted percentages † Herpes simplex also includes oral herpes, ophthalmic herpes, herpes dermatitis, genital herpes.
	Weeks 0–16
	CIBINQO 200 mg N=590 n (%*)	CIBINQO 100 mg N=608 n (%*)	Placebo N=342 n (%*)
Nasopharyngitis	51 (8.7)	75 (12.4)	27 (7.9)
Nausea	86 (14.5)	37 (6.0)	7 (2.1)
Headache	46 (7.8)	36 (6.0)	12 (3.5)
Herpes simplex†	25 (4.2)	20 (3.3)	6 (1.8)
Increased blood creatine phosphokinase	17 (2.9)	14 (2.3)	5 (1.5)
Dizziness	17 (2.9)	11 (1.8)	3 (0.9)
Urinary tract infection	13 (2.2)	10 (1.7)	4 (1.2)
Fatigue	8 (1.3)	10 (1.6)	2 (0.5)
Acne	28 (4.7)	10 (1.6)	0 (0.0)
Vomiting	19 (3.2)	9 (1.5)	3 (0.9)
Impetigo	3 (0.5)	9 (1.5)	1 (0.3)
Oropharyngeal pain	6 (1.0)	8 (1.4)	2 (0.6)
Hypertension	5 (0.8)	7 (1.2)	2 (0.7)
Influenza	6 (1.1)	7 (1.2)	0 (0.0)
Gastroenteritis	8 (1.3)	7 (1.1)	2 (0.6)
Dermatitis contact	3 (0.5)	6 (1.1)	1 (0.3)
Abdominal pain upper	11 (1.9)	4 (0.6)	0 (0.0)
Abdominal discomfort	7 (1.2)	3 (0.5)	1 (0.3)
Herpes zoster	7 (1.2)	2 (0.3)	0 (0.0)
Thrombocytopenia	9 (1.5)	0 (0.0)	0 (0.0)

Specific Adverse Reactions

Exposure adjusted incidence rates were adjusted by trial size for all the adverse reactions reported in this section.

Overall Infections

In the placebo-controlled trials, for up to 16 weeks, overall infections were reported in 90 subjects (126.8 per 100 patient-years) treated with placebo, 211 subjects (168.8 per 100 patient-years) treated with CIBINQO 100 mg and 204 subjects (159.5 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, overall infections were reported in 427 subjects (91.8 per 100 patient-years) treated with CIBINQO 100 mg and 394 subjects (103.2 per 100 patient-years) treated with CIBINQO 200 mg.

Serious Infections

In the placebo-controlled trials, for up to 16 weeks, serious infections were reported in 2 subjects (2.6 per 100 patient-years) treated with placebo, 6 subjects (3.9 per 100 patient-years) treated with CIBINQO 100 mg, and 2 subjects (1.3 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, serious infections were reported in 18 subjects (2.3 per 100 patient-years) treated with CIBINQO 100 mg and 16 subjects (2.3 per 100 patient-years) treated with CIBINQO 200 mg. The most commonly reported serious infections were herpes simplex, herpes zoster, and pneumonia.

Herpes Zoster

In the placebo-controlled trials, for up to 16 weeks, opportunistic infections were generally cases of multidermatomal cutaneous herpes zoster. Herpes zoster was reported in 0 subjects treated with placebo, 3 subjects (1.9 per 100 patient-years) treated with CIBINQO 100 mg and 8 subjects (5.1 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, herpes zoster was reported in 16 subjects (2.0 per 100 patient-years) treated with CIBINQO 100 mg and 35 subjects (5.2 per 100 patient-years) treated with CIBINQO 200 mg.

Malignancy

In the placebo-controlled trials, for up to 16 weeks, no malignancy was reported in subjects treated with placebo or CIBINQO 100 mg and in 1 patient (0.65 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, malignancy was reported in 4 subjects (0.5 per 100 patient-years) treated with CIBINQO 100 mg and 2 subjects (0.3 per 100 patient-years) treated with CIBINQO 200 mg.

Thrombosis

In all clinical trials, including the long-term extension trial, pulmonary embolism was reported in 3 subjects (0.4 per 100 patient-years), who were treated with CIBINQO 200 mg. Deep vein thrombosis was reported in 2 subjects (0.3 per 100 patient-years) who were treated with CIBINQO 200 mg. No thrombosis occurred in subjects treated with CIBINQO 100 mg.

Major Adverse Cardiovascular Events

In the placebo-controlled trials, for up to 16 weeks, major adverse cardiovascular event (MACE) was reported in 1 subject (0.6 per 100 patient-years) treated with CIBINQO 100 mg. In all 5 clinical trials, including the long-term extension trial, MACE was reported in 1 patient (0.1 per 100 patient-years) treated with CIBINQO 100 mg and 2 subjects (0.3 per 100 patient-years) treated with CIBINQO 200 mg.

Thrombocytopenia

In the placebo-controlled trials, for up to 16 weeks, treatment with CIBINQO was associated with a dose-related decrease in platelet count. Maximum effects on platelets were observed within 4 weeks, after which the platelet count returned towards baseline despite continued therapy. In all 5 clinical trials, including the long-term extension trial, 6 subjects (0.9 per 100 patient-years) treated with CIBINQO 200 mg had adverse reactions of thrombocytopenia; no subjects treated with CIBINQO 100 mg had an adverse reaction of thrombocytopenia.

Lymphopenia

In the placebo-controlled trials, for up to 16 weeks, confirmed ALC <500/mm3 occurred in 2 subjects (1.2 per 100 patient-years) treated with CIBINQO 200 mg and 0 subjects treated with CIBINQO 100 mg or placebo. Both cases occurred in the first 4 weeks of exposure.

Lipid Elevations

In the placebo-controlled trials, for up to 16 weeks, there was a dose-related percent increase in low-density lipoprotein cholesterol (LDL-c), total cholesterol, and high-density lipoprotein cholesterol (HDL-c) relative to placebo at Week 4 which remained elevated through the final visit in the treatment period. Adverse reactions related to hyperlipidemia occurred in 1 subject (0.6 per 100 patient-years) exposed to CIBINQO 100 mg, 3 subjects (2.0 per 100 patient-years) exposed to CIBINQO 200 mg.

Retinal Detachment

In the placebo-controlled trials, for up to 16 weeks, retinal detachment occurred in 1 subject (0.6 per 100 patient-years) treated with CIBINQO 100 mg. In all 5 clinical trials, including the long-term extension trial, retinal detachment occurred in 2 subjects (0.3 per 100 patient-years) treated with CIBINQO 100 mg.

Creatine Phosphokinase Elevations (CPK)

In the placebo-controlled trials, for up to 16 weeks, events of blood CPK increased were reported in 6 subjects (7.5 per 100 patient-years) treated with placebo, 11 subjects (6.9 per 100 patient-years) treated with 100 mg of CIBINQO and 19 subjects (12.3 per 100 patient-years) treated with 200 mg of CIBINQO. Most elevations were transient, there were no reported adverse reactions of rhabdomyolysis.

Pediatric Subjects (12 to less than 18 years of age)

The safety of CIBINQO was assessed in a trial of 284 subjects 12 to less than 18 years of age with moderate-to-severe atopic dermatitis (Trial-AD-4). The safety profile of CIBINQO in these subjects, assessed through the initial treatment period of 12 weeks and the long-term period (213 with at least 52 weeks of abrocitinib exposure), was comparable to the safety profile from trials in adults with atopic dermatitis.

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. 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 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-1424-3.0

This Medication Guide has been approved by the U.S. Food and Drug Administration. Approved: 12/2023

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