fects on ability to drive and use machines
Revestive has minor influence on the ability to drive and use machines. However, cases of syncope have been reported in clinical studies. Such events might impact the ability to drive and use machines.
Undesirable effects
The most commonly reported adverse reactions (≥ 10%) were abdominal pain and distension, respiratory tract infections, nausea, injection site reactions, headache, vomiting and oedema peripheral. Approximately 38% of the treated patients with a stoma experienced gastrointestinal stoma complications.
Overdose
In the event of an overdose, the patient should be carefully monitored by the medical professional
Pharmacodynamic properties
Teduglutide is an analogue of GLP-2. In several nonclinical studies, teduglutide has been shown to preserve mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth.
List of excipients
Powder: L-histidine, mannitol. sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment); hydrochloric acid (pH adjustment)
Solvent: Water for injections
To report suspected adverse reactions, contact NPS Pharma Holdings Ltd at +800 67744357
Marketing Authorization Holder: NPS Pharma Holdings Limited
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New Drugs Online Report for teduglutide
Information
Generic Name: teduglutide
Trade Name: Revestive (EU), Gattex (US)
Synonym: ALX 0600, [gly2]-recombinant human glucagon-like peptide, Gattex
Entry Type: New molecular entity
Development and Regulatory status
UK: Launched
EU: Launched
US: Launched
UK launch Plans: Available only to registered users
Actual UK launch date: September 2014
Comments
Sep 14: Launched in the UK. 5mg vial plus solvent, 28=£14,615.39 [33].
17/09/2014 13:15:10
Mar 14: Marketed in the US [32]
24/03/2014 16:21:00
Nov 13: Supplemental New Drug Application submitted in the US to include long-term data from STEPS 2 in the product label. A decision by the FDA is expected by June 28, 2014 [31].
17/11/2013 17:16:44
Aug 13: The company plans to launch in Europe in the first half of 2014 [29]
26/08/2013 11:02:53
Mar 13: NPS Pharmaceuticals has re-gained the full worldwide rights to teduglutide. The cost of teduglutide in the US is $295,000 a year. NPS will be marketing the drug in Europe [28].
20/03/2013 19:28:06
Dec 12: Approved in US for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support. Gattex will be available in Q1 2013. [27]
23/12/2012 19:01:28
Oct 12: FDA panel vote in favour of approval [26].
18/10/2012 08:17:37
Oct 12: FDA staff issue a favourable review prior to the advisory panel meeting and endorse the company´s risk mitigation strategy. The FDA review notes that there are three key safety concerns, gastrointestinal obstructions, the growth of polyps and pancreatic disorders, but concludes that the drug´s use would not need to be restricted due to these concerns. Under the proposed REMS, doctors would be advised against prescribing the drug to any patient with active cancer, patients would need to be cancer-free for 5 years, all patients would have to undergo a colonoscopy within 6 months of beginning treatment and any polyps found should b |
