vestronidase alfa

REMS

Contraindicated in:

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant.

CV: peripheral edema

Derm: pruritus, rash

GI: diarrhea

Local: extravasation, infusion site reactions

Misc: ANAPHYLAXIS

Drug-drug:

Mepsevii

Recombinant form of human beta-glucuronidase, which is taken up by lysosomes and causing catabolism of accumulated glycosaminoglycans in affected tissues.

Therapeutic effects:

Therapeutic Classification: replacement enzyme

Pharmacologic Classification: enzymes

Absorption: IV administration results in complete bioavailability.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Eliminated by proteolytic degradation into small peptides and amino acids.

Half-Life: 2.6 hr

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Explain purpose of medication to patient.
Instruct patient to notify health care professional immediately if signs and symptoms of anaphylaxis (rash, pruritus, hives, swelling of face and neck, dyspnea, fainting, dizziness, feeling light-headed) occur.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

ves-TRON-i-dase al-FA

NDC Code

69794- Ultragenyx Pharmaceutical Inc.
- 69794-001- MEPSEVII
  - 69794-001-01- 1 VIAL, SINGLE-USE in 1 CARTON (69794-001-01) / 5 mL in 1 VIAL, SINGLE-USE