Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypertension [see Warnings and Precautions (5.1) ] .
Hemorrhagic Events [see Warnings and Precautions (5.2) ] .
Infections [see Warnings and Precautions (5.3) ] .
Gastrointestinal Perforation [see Warnings and Precautions (5.4) ] .
Hepatotoxicity [see Warnings and Precautions (5.5) ].
Proteinuria [see Warnings and Precautions (5.6) ] .
Palmar-Plantar Erythrodysesthesia (PPE) [see Warnings and Precautions (5.7) ] .
Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.8) ] .
Most common adverse reactions (incidence ≥20%) are hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc.
WARNINGS AND PRECAUTIONS Hypertension: Control blood pressure prior to treatment and monitor during treatment.
Manage with anti-hypertensive medications and adjustment of the dose of FRUZAQLA, if necessary.
Withhold, dose reduce, or permanently discontinue based on severity of hypertension.
( 2.2 , 5.1 ) Hemorrhagic Events: Closely monitor patients who are at risk for bleeding.
Withhold, reduce dose, or permanently discontinue FRUZAQLA based on severity and persistence of hemorrhage.
Like all medications, Fruzaqla can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: