Ibruxen 140 mg is identified as a capsule containing 140 mg of ibrutinib and manufactured by Everest Pharmaceuticals Ltd.
Ibrutinib is an oral covalent inhibitor of Bruton tyrosine kinase, or BTK.
Ibruxen contains ibrutinib. The applicable uses depend on the product's authorization and country. Current U.S. ibrutinib labeling includes CLL/SLL, WM and cGVHD, while European authorization includes additional disease settings.
Ibrutinib covalently inhibits BTK, disrupting signaling involved in B-cell survival, proliferation, trafficking and adhesion.
It indicates that one Ibruxen capsule contains 140 mg of ibrutinib.
Not necessarily. Current U.S. adult CLL/SLL and WM dosing is 420 mg once daily, which corresponds to three 140 mg capsules when that formulation is used.
The available product information states that capsules should be swallowed whole and not opened, broken or chewed.
Common adverse reactions include diarrhea, fatigue, musculoskeletal pain, thrombocytopenia, neutropenia, rash, anemia, bruising and nausea.
Yes. Serious and fatal bleeding events have occurred. The risk may increase when anticoagulant or antiplatelet medicines are used concurrently.
Yes. Serious arrhythmias, atrial fibrillation, cardiac failure and sudden cardiac death have been reported.
Yes. CYP3A inhibitors can increase ibrutinib exposure, while strong CYP3A inducers can decrease exposure.
Current U.S. labeling advises avoiding grapefruit and Seville oranges because they can inhibit CYP3A and increase ibrutinib exposure.
Ibrutinib can cause embryo-fetal harm. Pregnancy considerations should be discussed with the treating healthcare professional.
Current U.S. labeling advises against breastfeeding during IMBRUVICA treatment.
Everest Pharmaceuticals Ltd. is identified as the manufacturer in available product information.
No. Ibruxen and IMBRUVICA are separate products that contain the same active ingredient, ibrutinib. Their manufacturers and product-specific characteristics can differ.
IMBRUVICA is the established branded ibrutinib product associated with the original U.S. approval of ibrutinib.
Current U.S. labeling includes CLL/SLL and WM, while cGVHD is also approved as a non-cancer indication. European authorization includes specified MCL and other settings.
The answer depends on jurisdiction. The former U.S. accelerated MCL indication was voluntarily withdrawn, while current EMA information includes specified MCL treatment.
Complete blood counts are monitored during treatment because cytopenias can occur. The frequency and additional laboratory monitoring depend on the patient's clinical circumstances.
Current U.S. labeling permits taking a missed dose later on the same day, without taking an extra dose the following day.
Yes. Hepatotoxicity, including drug-induced liver injury, has been reported.
The reported terminal half-life is approximately 4 to 6 hours.