Applies to abrocitinib: oral tablet.
Warning
Oral route (Tablet)
Serious InfectionsPatients treated with abrocitinib may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infection reported with abrocitinib were herpes simplex, herpes zoster, and pneumonia.If a serious or opportunistic infection develops, discontinue abrocitinib and control the infection.Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions:Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized disease.Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.Avoid use of abrocitinib in patients with an active, serious infection including localized infections. The risks and benefits of treatment with abrocitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.MortalityIn a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Abrocitinib is not approved for use in RA patients.MalignanciesMalignancies were reported in patients treated with abrocitinib. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risks.Major Adverse Cardiovascular EventsMajor adverse cardiovascular events were reported in patients treated with abrocitinib. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue abrocitinib in patients that have experience a myocardial infarction or stroke.ThrombosisDeep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with abrocitinib. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid abrocitinib in patients at risk. If symptoms of thrombosis occur, discontinue abrocitinib and treat appropriately.
Serious side effects of Abrocitinib
Along with its needed effects, abrocitinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking abrocitinib:
Less common
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- burning or stinging of skin
- chills
- cough
- diarrhea
- fever
- general feeling of discomfort or illness
- headache
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- painful blisters on the trunk of the body
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pinpoint red spots on the skin
- runny nose
- shivering
- sore throat
- stomach pain
- sweating
- trouble sleeping
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Rare
- Blistering, burning, crusting, dryness, or flaking of the skin
- blurred vision
- dizziness
- itching, scaling, severe redness, soreness, or swelling of the skin
- nervousness
- pounding in the ears
- red rash with watery, yellow-colored, or pus filled blisters
- slow or fast heartbeat
- thick yellow to honey-colored crusts
Incidence not known
- Chest pain or tightness
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
- white, yellow or waxy scar-like area
- shiny bump
Other side effects of Abrocitinib
Some side effects of abrocitinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Stuffy nose
Less common
- Bladder pain
- blemishes on the skin
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- pimple
For Healthcare Professionals
Applies to abrocitinib: oral tablet.
General
The most common adverse reactions were headache, dizziness, fatigue, nausea, vomiting, oropharyngeal pain, upper abdominal pain, abdominal discomfort, nasopharyngitis, gastroenteritis, impetigo, influenza, hypertension, acne, contact dermatitis, herpes simplex infection, herpes zoster infection, increased blood creatine phosphokinase, urinary tract infection, and thrombocytopenia.[Ref]
Cardiovascular
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Pulmonary embolism, deep venous thrombosis, major adverse cardiovascular events[Ref]
Other
Herpes simplex also included oral herpes, ophthalmic herpes, herpes dermatitis, genital herpes.[Ref]
Very common (10% or more): Overall infection (up to 26%)
Common (1% to 10%): Fatigue, serious infection, herpes simplex, herpes zoster, influenza, creatinine phosphokinase elevations[Ref]
Oncologic
Uncommon (0.1% to 1%): Malignancies[Ref]
Hematologic
Common (1% to 10%): Lymphopenia
Uncommon (0.1% to 1%): Thrombocytopenia[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 14.5%)
Common (1% to 10%): Abdominal discomfort, abdominal pain upper, gastroenteritis, vomiting[Ref]
Dermatologic
Common (1% to 10%): Acne, impetigo, contact dermatitis[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infections[Ref]
Ocular
Uncommon (0.1% to 1%): Retinal detachment[Ref]
Metabolic
Common (1% to 10%): Lipid elevations[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (up to 13%)
Common (1% to 10%): Oropharyngeal pain
Uncommon (0.1% to 1%): Pneumonia[Ref]
Nervous system
Common (1% to 10%): Headache, dizziness[Ref]
