Elglustat(Cerdelga)
Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection
Reference price:
Manufacturer:
Sanofi
Formulation:
CAPSULE
Validity period:
24 months
Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

Eliglustat is a medication designed for the treatment of Gaucher disease type 1, a genetic disorder characterized by the accumulation of glucocerebroside due to a deficiency in the enzyme glucocerebrosidase. It is a synthetic compound that inhibits the glucocerebrosidase enzyme’s activity, thus reducing the buildup of harmful substrates in the lysosomes. Eliglustat is available in capsules, with a typical dosage of 84 mg per capsule.

The drug is considered bioequivalent and therapeutically equivalent to the reference product Cerdelga, developed by Genzyme Corporation. As of the date of the document, Eliglustat has achieved tentative approval by the U.S. FDA for the treatment of this condition, pending resolution of patent-related issues. The tentative approval is contingent upon the expiration of certain patents and the outcome of ongoing litigation, particularly related to patent infringement claims.

Generic name

Elglustat(Cerdelga)
English name
Elglustat
Alternative Names
Cerdelga
Drug prices
Indications

CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who have been identified as CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) via an FDA-cleared test. It is not recommended for ultra-rapid metabolizers (URMs) or indeterminate metabolizers.

Therapeutic Target
Glucosylceramide synthase (GCS)
Active Ingredients
Eliglustat
Dosage form
CAPSULE
specifications
84mg * 56 capsules/box
Description

Eliglustat is an oral medication designed to treat Gaucher disease type 1. It works by inhibiting the enzyme glucocerebrosidase, thus reducing the accumulation of glucocerebroside in the body. By decreasing the buildup of this substance, Eliglustat helps to alleviate symptoms such as organ enlargement (hepatosplenomegaly) and bone pain, as well as improving quality of life for patients. Eliglustat is bioequivalent to the reference drug Cerdelga and has been tentatively approved by the FDA, subject to patent expiration and ongoing litigation.

Dosage and Administration

EMs and IMs: 84 mg twice daily

PMs: 84 mg once daily

Dosage adjustments are required when co-administered with CYP2D6 or CYP3A inhibitors, or in patients with hepatic impairment.

Capsules must be swallowed whole; do not crush, dissolve, or open.

May be taken with or without food.

Avoid grapefruit products.

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