- March 15, 2022
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Brand Name :
Givlaari
Synonyms :
givosiran
Class :
RNAi Agents
Dosage Forms & Strengths
Solution
189mg/mL
2.5
mg/kg
Subcutaneous (SC)
every month
it enhances by affecting the hepatic enzyme CYP2C9 metabolism
it enhances by affecting the hepatic enzyme CYP2D6 metabolism
may increase the level by affecting the hepatic enzyme CYP3A4 metabolism
givosiran affect the hepatic enzyme CYP1A2 metabolism to increase the level or effect of melatonin
the effects of givosiran may be increased with caffeine by altering CYP1A2 metabolism
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
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
Patient Information Leaflet
Generic Name: givosiran
Why do we use givosiran?
givosiran is a RNAi Agents used to treat Acute Hepatic Porphyria.
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