Is miglustat a generic drug?
Miglustat, the generic, will be available in 100 mg oral capsules, a formulation equivalent to Zavesca. Miglustat, like Zavesca, is indicated to treat adults with mild to moderate type 1 Gaucher disease who cannot use enzyme replacement therapy.
What is Zavesca used for?
ZAVESCA ® is a prescription medicine used alone for adults with mild to moderate type 1 Gaucher disease. ZAVESCA is used only in people who cannot be treated with enzyme replacement therapy. ZAVESCA ® can make a difference when used alone to treat adults who have mild to moderate type 1 Gaucher disease.
Who makes Zavesca?
ZAVESCA patient support is provided by Actelion Pharmaceuticals US, Inc., the company that makes ZAVESCA, and by Accredo, a specialty pharmacy that ensures patients have continued access to their medication.
Is miglustat FDA approved?
The U.S. Food and Drug Administration (FDA) approved the use of Zavesca in 2003, followed by the approval of generic miglustat in 2018.
Who makes miglustat?
It was developed by Oxford GlycoSciences and is marketed by Actelion. Miglustat has been approved in the EU, Japan, and Canada for treating progressive neurological complications in people with Niemann–Pick disease, type C (NPC)….Miglustat.
| Clinical data | |
|---|---|
| Identifiers | |
| show IUPAC name | |
| CAS Number | 72599-27-0 |
| PubChem CID | 51634 |
Which type of Gaucher disease is the most treatable?
How Is Gaucher Disease Treated? Gaucher disease type 1, the most common form of Gaucher disease in western countries, is treatable. The non-neurological symptoms associated with type 3, the most common form of the disease worldwide, are also treatable.
Which diseases can be treated with enzyme therapy?
The most common conditions treated by ERT are lysosomal storage diseases (LSDs)….Pompe Disease
- Poor muscle development.
- Trouble eating, breathing, and/or hearing.
- Respiratory problems.
- Enlarged liver and/or heart.
- Problems with motor function.
What chromosome is the GBA gene located on?
GBA is located on chromosome 1q21 and there is a highly homologous pseudogene sequence located only 16 kb downstream. There are approximately 300 described mutations in GBA, some of which originate from pseudogene sequences. The N370S mutation accounts for about 70% of mutant alleles in the Ashkenazi Jewish population.
What does Bradykinesia mean?
Bradykinesia means slowness of movement and is one of the cardinal manifestations of Parkinson’s disease. Weakness, tremor and rigidity may contribute to but do not fully explain bradykinesia.
What is the life expectancy of someone with Gaucher disease?
From the International Collaborative Gaucher Group (ICGG) Gaucher Registry, the mean life expectancy at birth of patients with Gaucher disease Type 1 has been reported as 68.2 years (63.9 years for splenectomised patients and 72.0 years for non-splenectomised patients), compared with 77.1 years in a reference …
What is the half life of Miglustat 50 mg?
The effective half-life of Miglustat is approximately 6 to 7 hours, which predicts that steady-state will be achieved by 1.5 to 2 days following the start of three times daily dosing. Miglustat, dosed at 50 and 100 mg three times daily in Gaucher patients, exhibits dose-proportional pharmacokinetics.
How many Miglustat capsules are in a carton?
Miglustat is supplied in hard gelatin capsules containing 100 mg Miglustat. Miglustat 100 mg capsules are white opaque with “OGT 918” printed in black on the cap and “100” printed in black on the body. Miglustat 100 mg capsules are packed in blister cards. Six blister cards of 15 capsules are supplied in each carton.
How to take Miglustat at the same time every day?
1 Take Miglustat exactly as your healthcare provider tells you to. 2 Take Miglustat at the same time each day. 3 If you miss a dose of Miglustat, skip that dose. Take the next Miglustat capsule at the usual time.
Is it safe to take Miglustat with imiglucerase?
While co-administration of Miglustat appeared to increase the clearance of imiglucerase by 70%, these results are not conclusive because of the small number of patients studied and because patients took variable doses of imiglucerase [see Clinical Pharmacology (12.3) ].