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Hepatic Impairment Articles & Analysis

9 news found

Tris Pharma Reports Positive Topline Data from Clinical Study of Investigational Pain Therapy Cebranopadol Showing Significantly Less Potential for Abuse Versus Tramadol and Oxycodone

Tris Pharma Reports Positive Topline Data from Clinical Study of Investigational Pain Therapy Cebranopadol Showing Significantly Less Potential for Abuse Versus Tramadol and Oxycodone

Cebranopadol is being studied with once daily dosing and has shown no need for dose adjustment in patients with renal or hepatic impairment or with food. About Tris Pharma Tris Pharma is a privately held, fully integrated and innovation-driven CNS company that provides a differentiated approach to target unmet medical needs, including the application of novel ...

ByTris Pharma, Inc.


Citrine Medicine Announces Approval of Wakix (pitolisant) for Named Patient Program in China

Citrine Medicine Announces Approval of Wakix (pitolisant) for Named Patient Program in China

Pitolisant is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and in women breastfeeding their children. ...

ByRareStone Group


BioXcel Therapeutics Announces FDA Approval of IGALMI (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults

BioXcel Therapeutics Announces FDA Approval of IGALMI (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults

Reduction in dosage of IGALMI or the concomitant medication should be considered. USE IN SPECIFIC POPULATIONS Hepatic Impairment and Geriatric Patients (≥65 years old): A lower dose is recommended in patients with hepatic impairment and geriatric patients. ...

ByBioXcel Therapeutics, Inc.


Ascelia Pharma successfully completes Orviglance Hepatic Impairment Study

Ascelia Pharma successfully completes Orviglance Hepatic Impairment Study

Orviglance is Ascelia Pharma’s oral investigational MRI imaging agent used in the visualization of cancer in the liver and is currently in Phase 3 development. The Hepatic Impairment Study evaluates if patients with different degrees of hepatic impairment can tolerate Orviglance since Orviglance is selectively taken up and ...

ByAscelia Pharma AB


AVEO Oncology Presents Three Posters for Tivozanib/Immunotherapy Combinations at the 2022 ASCO GI Cancers Symposium

AVEO Oncology Presents Three Posters for Tivozanib/Immunotherapy Combinations at the 2022 ASCO GI Cancers Symposium

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA. Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. ...

ByAVEO Pharmaceuticals, Inc.


Cara Therapeutics Announces Difelikefalin (KORSUVA) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients

Cara Therapeutics Announces Difelikefalin (KORSUVA) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients

Risk of Driving and Operating Machinery: Dizziness, somnolence, and mental status changes have occurred in patients taking KORSUVA. KORSUVA may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car and operating machinery. ...

ByCara Therapeutics.


AVEO Oncology Highlights Recent Progress and 2022 Outlook

AVEO Oncology Highlights Recent Progress and 2022 Outlook

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA. Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. ...

ByAVEO Pharmaceuticals, Inc.


Thermo Fisher Scientific and Daiichi Sankyo to Co-Develop Global Companion Diagnostic for Patients with Non-Small Cell Lung Cancer

Thermo Fisher Scientific and Daiichi Sankyo to Co-Develop Global Companion Diagnostic for Patients with Non-Small Cell Lung Cancer

Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock. ...

ByThermo Fisher Scientific, LIMS & Laboratory Software


FDA Approves BAVENCIO (avelumab) plus Axitinib Combination for Patients with Advanced Renal Cell Carcinoma

FDA Approves BAVENCIO (avelumab) plus Axitinib Combination for Patients with Advanced Renal Cell Carcinoma

BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC) The special warnings and precautions for use for BAVENCIO include infusion-related reactions and immune-related adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, and other adverse reactions). ...

BySiemens AG

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