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.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] Evacuation of gallstones [see Warnings and Precautions ( 5.2 )] Adverse reactions with intravenous injection [see Warnings and Precautions ( 5.3 )] Preterm labor or spontaneous abortion [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of Kinevac were identified in clinical trials or postmarketing reports.
Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.
The most frequent adverse reactions (20% or greater) are gastrointestinal: abdominal discomfort or pain, and nausea;
these may not necessarily indicate an abnormality of the biliary tract unless there is other clinical or radiologic evidence of disease.
Less common adverse reactions include: Hypersensitivity reactions : anaphylaxis and anaphylactic shock, hypotension, throat tightness, bradycardia, shortness of breath, nausea, abdominal cramping, diaphoresis, hives, rash, itching;
and numbness of face, lips and eyes [see Contraindications ( 4 ), ( 5.1 )] .
Neurological reactions : seizures, headache.
Vasovagal reactions : dizziness, loss of consciousness, nausea, diaphoresis, syncope and hypotension (generally self-limiting).
Other: nausea, vomiting, flushing, hypertension, urge to defecate, diarrhea, sneezing.
Most common adverse reactions (≥20%) are: abdominal discomfort or pain, and nausea.
5 WARNINGS AND PRECAUTIONS Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions : Contains sodium metabisulfite.
Serious reactions may occur during or soon after administration.
If symptoms occur, discontinue the drug.
( 4 , 5.1 ) Evacuation of Gallstones : Stimulation of gallbladder contraction in patients with small gallbladder stones could lead to the evacuation of the stones from the gallbladder, resulting in their lodging in the cystic duct or in the common bile duct.
( 5.2 ) Gastrointestinal Adverse Reactions with Intravenous Injection : Administration as an intravenous injection may cause transient nausea, vomiting, abdominal pain or cramping, dizziness or flushing.
Like all medications, Kinevac 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: