ENSARTINIB

Other

Brand names: ENSACOVE

Oral

Mechanism of Action

12.1 Mechanism of Action Ensartinib is a kinase inhibitor of anaplastic lymphoma kinase (ALK) and inhibits other kinases including MET and ROS1. In vitro, ensartinib inhibited phosphorylation of ALK and its downstream signaling proteins AKT, ERK, and S6, thereby blocking ALK-mediated signaling pathways and inhibiting proliferation in cell lines harboring ALK fusions and mutations. In vivo, ensartinib showed anti-tumor activity in a mouse xenograft model of human NSCLC harboring an ALK fusion.

Indications

2.1 )

Contraindications

• 4 CONTRAINDICATIONS ENSACOVE is contraindicated in patients who have experienced a severe hypersensitivity reaction to ENSACOVE
• FD&C Yellow No. 5 (tartrazine)
• or to any of its components [see Warnings and Precautions ( 5.10 )] . Hypersensitivity reaction to ENSACOVE
• FD&C Yellow No. 5 (tartrazine)
• or to any of its components. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Interstitial Lung Disease (ILD)/Pneumonitis : Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis
Advise patients of the potential risk to a fetus and to use effective contraception
Advise pregnant women and females of reproductive potential of the potential risk to a fetus

Known Side Effects

3 documented side effects by frequency

Drug Not Working

>10%

Constipation

1-10%

Condition Worsened

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral