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Brand Name :
hemgenix
Synonyms :
etranacogene dezaparvovec
Class :
Anti hemophilic agent,Gene therapy
Dosage Forms & Strengths
Injection
1*103 genome copies/ml Intravenous
Available as 10ml vials
2*1000 genome copies/kg intravenous(2ml/kg)-single dose
Frequency defined:
>10%
AST increased
Infusion-related reactions
Flu-like symptoms
ALT increased
Blood creatinine kinase increased
Headache
Fatigue
1-10%
Hypersensitivity
Nausea
Pregnancy consideration: Not recommended for use in females
Lactation: Not recommended for use in females
Pregnancy category:
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 not 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: etranacogene dezaparvovec
Pronounced: –
Why do we use etranacogene dezaparvovec?
It is used for the treatment of congenital factor IX deficiency (hemophilia B)