Remestemcel-L: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 22, 2025🚩 Report this page

Remestemcel-L

Active ingredient

Sold as PROCHYMAL

CA Health Canada

Drug class: -
Availability: See label
Routes: Intravenous
Markets covered: 1
Products on record: 1

Overview

Remestemcel-L is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	1	March 22, 2025

CACanada· Health Canada

1 product

Uses

CAOfficial regulatory label· revised March 22, 2025[1]

AND CLINICAL USE ............................................................................. 5 CONTRAINDICATIONS .................................................................................................. 5 WARNINGS AND PRECAUTIONS .................................................................................
5 ADVERSE REACTIONS................................................................................................... 7 DRUG INTERACTIONS .................................................................................................
11 DOSAGE AND ADMINISTRATION ............................................................................. 11 STORAGE AND STABILITY ......................................................................................... 13 SPECIAL HANDLING INSTRUCTIONS ......................................................................
13 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 13 OVERDOSAGE ............................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY ...........................................................

Sources & citations

[1]Health Canada (DPD) · 02386380 · revised March 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

The long term effects of PROCHYMAL in growing children are unknown. BEFORE you use PROCHYMAL talk to your doctor if: you are allergic to bovine (cow) or porcine (pig) products. INTERACTIONS WITH THIS MEDICATION Drug interactions between PROCHYMAL and other drugs have not been tested.
There are currently no known drug interactions with PROCHYMAL.
PROPER USE OF THIS MEDICATION Usual dose:
PROCHYMAL should only be administered under the supervision of a health care professional. The dose of PROCHYMAL that is recommended is 2 million cells per kg of body weight. It is recommended that PROCHYMAL be infused at a rate of 4-6 mL per minute.
PROCHYMAL should be delivered 2 times per week and at least 3 days apart for the first 4 weeks. Then PROCHYMAL should be administered 1 time per week for the following 4 weeks if indicated. If a recurrence of aGvHD occurs outside the treatment window, the treatment cycle for PROCHYMAL should be repeated.
Overdose:
Overdose has not been reported and the maximum tolerated dose of PROCHYMAL has not been established in humans. If an overdose does occur, then the patient should be monitored and treated for symptoms. SIDE EFFECTS AND WHAT TO DO ABOUT THEM PROCHYMAL should only be administered under the supervision of a health care professional.
IMPORTANT:
PLEASE READ Prochymal® Product Monograph – NOC/c Page 32 of 33 It is recommended that oxygen saturation (SaO2/SAT) is monitored by pulse oximetry during infusion of the product. Your infusion will be stopped if needed. Undesirable effects, such as allergic reactions or difficulty breathing should be communicated immediately to your caregiver.
ca/medeffect.
NOTE:
Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. HOW TO STORE IT PROCHYMAL should be handled by a health care professional and must be stored at ≤ -135oC in an ultra low temperature freezer.
Cryoprotective gloves should be worn when handling PROCHYMAL at extremely cold temperatures. When PROCHYMAL arrives in a cryoshipper, it can be transferred to a liquid nitrogen freezer for longer term storage if needed. The stem cells will die if storage instructions are not carefully followed.
IMPORTANT:
PLEASE READ Prochymal® Product Monograph – NOC/c Page 33 of 33 MORE INFORMATION A copy of this document plus the full product monograph, prepared for health professionals, can be attained by contacting the sponsor, Mesoblast International Sàrl, at 1-212-880-2060.
This leaflet was prepared by Mesoblast International Sàrl Last revised:
March 6, 2014

This is not medical advice. Consult a qualified healthcare professional.