Action and Spectrum

Drug Interaction

Adverse Reaction

Adverse drug reactions  

Frequency Defined  

>10%  

Elevated transaminases (13%)  

Nausea (27%)  

Injection-site reactions (25%)  

Rash (17%)  

Increased serum creatinine (15%)  

1-10%  

Fatigue (10%)  

<1%  

Anaphylaxis  

Black Box Warning

Contraindication / Caution

Pregnancy / Lactation

Pregnancy warnings:   
US FDA pregnancy category: Not assigned 

Lactation:  

Excreted into human milk is unknown  

Pregnancy Categories:        

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.   

Category B: there was no evidence of risk to the fetus in animal studies, and there were no enough studies on pregnant women.  

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category  

Pharmacology

Adminstartion

Patient Information Leaflet

Patient Information Leaflet    

Generic Name: givosiran 

Why do we use givosiran?  

givosiran is a RNAi Agents used to treat Acute Hepatic Porphyria.