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vestronidase alfa
Overview
What is MEPSEVII?
Vestronidase alfa-vjbk is a recombinant human lysosomal beta glucuronidase which is a purified human enzyme produced by recombinant DNA technology in a Chinese hamster ovary cell line.
Purified vestronidase alfa-vjbk exists as a homotetramer, with each monomer consisting of 629 amino acids. The calculated isotope average molecular mass of each non-glycosylated peptide chain is 72,562 Da.
The amino acid sequence for vestronidase alfa-vjbk is the same as the amino acid sequence for human beta-glucuronidase (GUS).
MEPSEVII (vestronidase alfa-vjbk) injection for intravenous infusion is a sterile, preservative-free, non-pyrogenic, colorless to slightly yellow liquid supplied in a single-dose vial. Each mL of solution contains vestronidase alfa-vjbk (2 mg), L-histidine (3.1 mg), polysorbate 20 (0.1 mg), sodium chloride (7.88 mg) and sodium phosphate monobasic dihydrate (3.12 mg). The pH of the solution is 6.0.
What does MEPSEVII look like?
What are the available doses of MEPSEVII?
Injection: 10 mg/5 mL (2 mg/mL) in a single-dose vial ()
What should I talk to my health care provider before I take MEPSEVII?
How should I use MEPSEVII?
MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).
Limitations of Use
The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined.
MEPSEVII should be administered under the supervision of a healthcare professional with the capability to manage anaphylaxis. Premedication is recommended 30 to 60 minutes prior to the start of the infusion
The recommended dosage of MEPSEVII is 4 mg/kg administered by intravenous infusion every two weeks.
Administer the infusion over approximately 4 hours. Infuse the first 2.5% of the total volume over the first hour. After the first hour, increase the infusion rate as tolerated in order to complete infusion over the following 3 hours according to the recommended rate guidelines in Table 1
What interacts with MEPSEVII?
Sorry No Records found
What are the warnings of MEPSEVII?
Sorry No Records found
What are the precautions of MEPSEVII?
Sorry No Records found
What are the side effects of MEPSEVII?
Sorry No records found
What should I look out for while using MEPSEVII?
None.
What might happen if I take too much MEPSEVII?
Sorry No Records found
How should I store and handle MEPSEVII?
Store Axumin at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Axumin does not contain a preservative. Store Axumin within the original container in radiation shielding.This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.Store Axumin at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Axumin does not contain a preservative. Store Axumin within the original container in radiation shielding.This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.MEPSEVII (vestronidase alfa-vjbk) injection is a colorless to slightly yellow liquid supplied as a carton containing one 10 mg/5 mL (2 mg/mL) single-dose vial (NDC 69794-001-01). Store under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. MEPSEVII (vestronidase alfa-vjbk) injection is a colorless to slightly yellow liquid supplied as a carton containing one 10 mg/5 mL (2 mg/mL) single-dose vial (NDC 69794-001-01). Store under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mucopolysaccharidosis VII (MPS VII or Sly syndrome) is a lysosomal disorder characterized by the deficiency of GUS that results in GAG accumulation in cells throughout the body leading to multisystem tissue and organ damage.
Vestronidase alfa-vjbk is a recombinant form of human GUS and is intended to provide exogenous GUS enzyme for uptake into cellular lysosomes. Mannose-6-phosphate (M6P) residues on the oligosaccharide chains allow binding of the enzyme to cell surface receptors, leading to cellular uptake of the enzyme, targeting to lysosomes and subsequent catabolism of accumulated GAGs in affected tissues.
Non-Clinical Toxicology
None.Caution should be exercised when the following drugs are administered concomitantly with carbidopa and levodopa extended-release.
Symptomatic postural hypotension has occurred when carbidopa and levodopa preparations were added to the treatment of patients receiving some antihypertensive drugs. Therefore, when therapy with carbidopa and levodopa extended-release is started, dosage adjustment of the antihypertensive drug may be required.
For patients receiving MAO inhibitors (Type A or B), see . Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone (see ).
There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa and levodopa preparations.
Dopamine D receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa. In addition, the beneficial effects of levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with carbidopa and levodopa extended-release should be carefully observed for loss of therapeutic response.
Use of carbidopa and levodopa extended-release with dopamine-depleting agents (e.g., reserpine and tetrabenazine) or other drugs known to deplete monoamine stores is not recommended.
Carbidopa and levodopa extended-release and iron salts or multivitamins containing iron salts should be coadministered with caution. Iron salts can form chelates with levodopa and carbidopa and consequently reduce the bioavailability of carbidopa and levodopa.
Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.
Anaphylaxis to MEPSEVII was reported in 2 of 20 patients in the clinical program . These reactions occurred during MEPSEVII infusion and were observed as early as the first dose of MEPSEVII for one patient. Manifestations included respiratory distress, cyanosis, decreased oxygen saturation, and hypotension. The two patients with anaphylaxis to MEPSEVII during the clinical trials had one occurrence each and tolerated subsequent infusions of MEPSEVII, without recurrence.
Anaphylaxis can be life-threatening. MEPSEVII should be administered under the supervision of a healthcare professional with the capability to manage anaphylaxis. Patients should be observed for 60 minutes after MEPSEVII administration. If severe systemic reactions occur, including anaphylaxis, immediately discontinue the MEPSEVII infusion and provide appropriate medical treatment. Prior to discharge, inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care if symptoms occur. Consider the risks and benefits of re-administering MEPSEVII following anaphylaxis.
The following serious adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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