A-broe-SYE-ti-nib
REMS
Contraindicated in:
Active infection;
↑risk for thrombosis;
Use Cautiously in:
Patients who are >50 yr old and have ≥1 cardiovascular risk factor (↑ risk of all-cause mortality, cardiovascular death, MI, stroke, and thrombosis);
Chronic or recurrent infection;
Previously exposed to tuberculosis (TB);
History of serious or opportunistic infection;
Resided or traveled in areas of endemic tuberculosis or endemic mycoses;
Underlying conditions that predispose to infection;
Malignancy (other than successfully treated nonmelanoma skin cancer);
Current or previous smoker (↑ risk of malignancy);
CV: CARDIOVASCULAR DEATH, DEEP VEIN THROMBOSIS (DVT), hypertension, MI
Derm: acne, contact dermatitis, impetigo
EENT: nasopharyngitis, retinal detachment
GI: nausea, abdominal pain, oropharyngeal pain, vomiting
Hemat: lymphopenia, thrombocytopenia
MS: ↑CK
Neuro: dizziness, fatigue, headache, STROKE
Resp: PULMONARY EMBOLISM (PE)
Misc: INFECTION (INCLUDING SERIOUS BACTERIAL, FUNGAL, VIRAL, OR OPPORTUNISTIC INFECTIONS, INCLUDING TB), MALIGNANCY (INCLUDING NONMELANOMA SKIN CANCER)
Drug-drug:
Renal Impairment
Absorption: Well absorbed following oral administration.
Distribution: Extensively distributed to tissues.
Half-Life: 3–5 hr.
Advise patient to notify health care professional if signs and symptoms of infection (fever, sweating, or chills; blood in phlegm; diarrhea or stomach pain; muscle aches; weight loss; burning during urination or urinating more often than usual; cough or shortness of breath; warm, red, or painful skin or sores on body; feeling very tired) occur.
Caution patients with signs and symptoms of a heart attack or stroke (discomfort in the center of chest that lasts for more than a few minutes or that goes away and comes back; severe tightness, pain, pressure, or heaviness in chest, throat, neck, or jaw; pain or discomfort in arms, back, neck, jaw, or stomach; weakness in one part or on one side of the body; slurred speech; shortness of breath with or without chest discomfort; breaking out in a cold sweat; nausea or vomiting; light-headedness) to notify health care professional immediately.
Inform patient of ↑ risk of DVT and pulmonary embolism. If signs and symptoms (swelling, pain, or tenderness in one or both legs; sudden, unexplained chest or upper back pain; shortness of breath or difficulty breathing) occur, stop therapy and get immediate medical care. Advise patient to notify health care professional if they have had blood clots in the legs or lungs in the past.
May ↑ risk of cancer. Advise patient to have skin checked for skin cancer during therapy. Limit amount of time spent in sunlight. Avoid using tanning beds or sunlamps. Wear protective clothing and use sunscreen with a high protection factor (SPF 30 and above); especially important for patients with very fair skin or with a family history of skin cancer. Instruct patient to notify health care professional if they have ever had any type of cancer.
NDC Code