Abrocitinib

What is Abrocitinib?

• Abrocitinib (Cibinqo) is a Janus kinase (JAK) inhibitor used to treat refractory, moderate-to-severe atopic dermatitis.

What are the uses of this medicine?

• Abrocitinib (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.

Limitation of Use:

• Cibinqo is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

How does this medicine work?

Cibinqois a Janus kinase (JAK) inhibitor.

• Abrocitinib reversibly inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site.
• The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. 
• Both the parent compound and the active metabolites inhibit JAK1 activity in vitro with similar levels of selectivity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.

What drug interactions can this medicine cause?

• Dosage reduction of Cibinqo is recommended when coadministered with strong CYP2C19 inhibitors. The recommended dose is 50 mg daily or 100 mg once daily for those patients who are not responding to 50 mg once daily.
• Avoid concomitant use of Cibinqo with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9.
• Avoid concomitant use of Cibinqo with strong CYP2C19 or CYP2C9 inducers.
• Monitor appropriately or dose titrate P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities when coadministered with CIBINQO.
• Antiplatelet drugs, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment are contraindicated with CIBINQO.

Is this medicine FDA approved?

• In January 2022, the United States Food and Drug Administration (FDA) approved abrocitinib for adults with moderate-to-severe atopic dermatitis.

How should this medicine be used?

Perform the following tests and evaluations prior to Cibinqo initiation:

• Tuberculosis (TB) infection evaluation
• Viral hepatitis screening
• A complete blood count (CBC)

Recommended dosage:

• Recommended dosage is 100 mg orally once daily.
• 200 mg orally once daily is recommended for those patients who are not responding to 100 mg once daily.
• Moderate renal impairment: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily.
• CYP2C19 poor metabolizer: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily.

Administration:

• Take Cibinqo1 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 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 50 mg, 100 mg, and 200 mg

This medicine is available in fallowing brand namesː

• CIBINQO

What side effects can this medication cause?

The most common side effects of this medicine include:

• 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
• 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

Cibinqo may cause serious side effects, including:

• Serious infections
• 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
• Cancer and immune system problems
• Increased risk of major cardiovascular events such as heart attack, stroke or death
• Blood clots
• Changes in certain laboratory test results

What special precautions should I follow?

• The most frequent serious infections reported in clinical studies with Cibinqo for atopic dermatitis were herpes simplex, herpes zoster, and pneumonia. Avoid use of Cibinqo in patients with active, serious infection including localized infections.
• Treatment with Cibinqo was associated with an increased incidence of hematologic abnormalities and lipid elevations. Laboratory monitoring is recommended due to potential changes in platelets, lymphocytes, and lipids.
• Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines including prophylactic herpes zoster vaccinations. Avoid use of live vaccines prior to, during, and immediately after Cibinqo treatment.
• In a large, randomized, postmarketing safety study of another JAK inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO.
• Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical studies with Cibinqo for atopic dermatitis. Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.
• Major adverse cardiovascular events were reported in clinical studies of Cibinqo for atopic dermatitis. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO.
• Deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in patients receiving CIBINQO. Avoid Cibinqo in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue Cibinqo and evaluate and treat patients appropriately.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is no experience regarding human overdosage with CIBINQO.

Management of overdosage:

• There is no specific antidote for overdose with CIBINQO.
• If you take too much CIBINQO, call the Poison Control Center at 1-800-222-1222 right away.

Can this medicine be used in pregnancy?

• It is not known if Cibinqo will harm your unborn baby.
• 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.

Can this medicine be used in children?

• The safety and effectiveness of Cibinqo have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

• Packager: Pfizer Laboratories Div Pfizer Inc

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Abrocitinib
• FDA Abrocitinib

Abrocitinib Resources
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