Abrocitinib

Abrocitinib is a prescription medication used for the treatment of atopic dermatitis.

• Abrocitinib is available under the following different brand names: Cibinqo

Common side effects of Abrocitinib include:

• cold or flu symptoms, 
• nausea, 
• headache, 
• cold sores, 
• abnormal lab results (increased blood creatinine phosphokinase or CPK), 
• dizziness, 
• pain or burning while urinating, 
• tiredness, 
• acne, 
• vomiting, 
• mouth or throat pain, 
• diarrhea, 
• high blood pressure, 
• abdominal pain,
• red or itchy skin, 
• low blood platelet level,  
• skin infection (impetigo), and 
• herpes simplex (oral, ophthalmic, dermatitis or genital)

Serious side effects of Abrocitinib include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• fever, 
• sweating, 
• chills, 
• muscle aches, 
• cough, 
• shortness of breath, 
• blood in the phlegm, 
• weight loss, 
• diarrhea, 
• abdominal pain, 
• increased urination, 
• pain or discomfort when urinating, 
• tiredness, 
• red, irritated, or painful skin or sores, 
• chest pain or pressure, 
• pain spreading from the jaw to the arm, 
• weakness (especially in one side of the body), 
• slurred speech, 
• nausea, 
• vomiting, 
• lightheadedness, and
• swelling, pain or tenderness in one or both legs

Rare side effects of Abrocitinib include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablets

• 50 mg
• 100 mg
• 200 mg

Atopic Dermatitis

Adult dosage

• 100 mg orally every day
• If adequate response not achieved after 12 weeks, consider increasing to 200 mg every day
• Discontinue 200-mg dose if adequate response not achieved

Pediatric dosage

• Aged below 12 years: Safety and efficacy not established
• Aged above 12 years
  • 100 mg orally every day
  • If adequate response is not achieved after 12 weeks, consider increasing to 200 mg every day
  • Discontinue 200-mg dose if an adequate response is not achieved
  • Use with or without topical corticosteroids

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Abrocitinib has severe interactions with the following drugs:
  • abciximab
  • anagrelide
  • aspirin
  • cangrelor
  • cilostazol
  • clopidogrel
  • dipyridamole
  • eptifibatide
  • prasugrel
  • ticagrelor
  • ticlopidine
  • tirofiban
  • upadacitinib
  • vorapaxar
• Abrocitinib has serious interactions with at least 41 other drugs.
• Abrocitinib has moderate interactions with the following drugs:
  • chloramphenicol
  • clonidine
  • colchicine
  • digoxin
  • fluvoxamine
  • isoniazid
  • modafinil
  • omeprazole
  • sirolimus
  • sitaxentan
  • temsirolimus
  • ticlopidine
  • ublituximab
• Abrocitinib has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Concomitant antiplatelet therapies, except for low-dose aspirin (below 81 mg every day), during the initial 3 months of treatment

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Abrocitinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Abrocitinib?”

Cautions

• Malignancies reported; consider risks and benefits of treatment before initiating in patients with known malignancy, other than previously treated nonmelanoma skin cancer; screen for malignancies during treatment according to guidelines
• Perform periodic skin examinations for patients who are at increased risk for skin cancer; limit exposure to sun and ultraviolet (UV) light by wearing protective clothing and using a broad-spectrum sunscreen
• Higher rate of major adverse cardiovascular events (MACE; defined as cardiovascular death, myocardial infarction, and stroke) reported with another JAK inhibitor vs TNF blockers in RA patients
• Thrombosis reported, including deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis; avoid therapy in patients who may be at increased risk of thrombosis
• In patients with rheumatoid arthritis (RA) aged ≥50 years with at least 1 cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed; not approved for RA
• May cause neutropenia, lymphopenia, anemia, elevated lipids, or elevated liver enzymes; monitor for abnormal laboratory values, and assess the need to interrupt dosing
• Serious and fatal infections
  • Serious and fatal infections reported
  • Most frequent infections reported included herpes zoster, herpes simplex, and pneumonia
  • Avoid use in patients with active serious infections, including localized infections
  • Closely monitor for developing signs and symptoms of infection during and after treatment
  • Discontinue therapy if a serious or opportunistic infection develops
  • Initiate prompt and complete diagnostic testing appropriate for an immunocompromised patient if a new infection develops; initiate appropriate antimicrobial therapy
  • Carefully consider the risks and benefits of treatment before restarting
  • Screen patients for opportunistic infections (eg, TB), and treat them according to guidelines
• Tuberculosis (TB)
  • Not recommended for use in patients with active TB
  • Before initiating, start preventive therapy for latent TB in newly diagnosed patients with latent TB, patients with previously untreated latent TB, or patients with a negative test for latent TB but who are at high risk for TB infection
  • Monitor for developing signs and symptoms of TB
• Viral reactivation
  • Viral reactivation, including cases of herpes virus reactivation (eg, herpes zoster) and hepatitis B virus reactivation, was reported
  • If herpes zoster develops, consider temporarily interrupting therapy until the episode resolves
  • Screen for viral hepatitis and monitor for reactivation in accordance with clinical guidelines before starting and during therapy
  • Consider the risks and benefits of treatment before initiating it in the following patients
  • With chronic or recurrent infection
  • Who has been exposed to TB
  • With a history of serious or opportunistic infection
  • Who have resided or traveled in areas of endemic tuberculosis or endemic mycoses
  • With underlying conditions that may predispose them to infection
• Drug interaction overview
  • Substrate of CYP2C9 and CYP2C19
  • Inhibitor of P-glycoprotein (P-gp)
  • Strong CYP2C19 inhibitors
  • Reduce abrocitinib dose
  • Strong CYP2C19 inhibitors increase systemic exposure to abrocitinib and its metabolites
  • Moderate-to-strong inhibitors of both CYP2C9 and CYP2C19
  • Avoid coadministration
    • Moderate-to-strong CYP2C9 and CYP2C19 inhibitors increase systemic exposure and adverse reactions of abrocitinib and its metabolites
    • Strong CYP2C9 or CYP2C19 inducers
  • Avoid coadministration
    • Strong CYP2C9 or CYP2C19 inducers decrease the systemic exposure of abrocitinib and its metabolites
    • Sensitive P-gp substrates
    • Monitor and titrate the dose of P-gp substrates accordingly
    • Abrocitinib increases plasma concentrations and adverse reactions of P-gp substrates where small concentration changes may lead to serious or life-threatening toxicities (eg, digoxin)
• Antiplatelet therapy
  • Contraindicated, except for low-dose aspirin (less than 81 mg every day), during the initial 3 months of treatment
  • Abrocitinib may increase bleeding risk with thrombocytopenia
• Vaccines
  • Use of live attenuated vaccines during or immediately before initiating is not recommended
  • Before initiating, assess vaccination history, including prophylactic zoster vaccinations
  • Ensure vaccinations are current before initiating

Pregnancy and Lactation

• Data are insufficient to evaluate the drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Pregnancy exposure registry
  • Monitors outcomes in females exposed to the drug during pregnancy
  • Contact 1-877-311-3770 to register
• Infertility
  • May impair female fertility
  • Impaired fertility in female rats was reversible 1 month after discontinuing abrocitinib
• Lactation
  • No data is available on the presence in human milk, its effects on breastfed infants, or its effects on milk production
  • Abrocitinib secreted in the milk of lactating rats
  • If a drug is present in animal milk, it is likely the drug will be present in human milk
  • Advise patients that breastfeeding is not recommended during treatment and for 1 day (~5-6 half-lives) after the last dose