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Articles

Safety in lactation: Drugs for chronic bowel disorders

21 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Aminosalicylates for chronic bowel disorders Mesalazine…
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Lactation Safety Information

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Analogue of human glucagon-like peptide-2 (GLP-2) indicated for short bowel syndrome after surgery
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract
A potentially serious adverse effect has been found in animals, although not confirmed in human studies. This suggests teduglutide should be used with caution until more evidence is available
5 February 2017

New Medicines

Revestive (UK/EU), Gattex (US) Short bowel syndrome in infants aged 4 to 12 months

Information

Revestive (UK/EU), Gattex (US)
Licence extension / variation
Takeda
Takeda

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
None
Yes
Jan 22Has orphan drug status in EU (EU/3/01/077) [3].
Dec 21Currently pre-registration in EU [3].

Category

Analogue of human glucagon-like peptide-2 (GLP-2), a peptide secreted by L cells of the intestine which is known to increase intestinal and portal blood flow, inhibit gastric acid secretion, and decrease intestinal motility. Injected once daily.
Estimates of the incidence and prevalence of SBS vary, in part because of differences in the case definition used across studies. Using a variety of definitions, the incidence of SBS has been estimated at approximately 0.02 to 0.1% among all live births, 0.5 to 2.0% among neonatal intensive care unit admissions, and 0.7% among very low birth weight infants. Approximately 80% of pediatric SBS cases develop during the neonatal period. Necrotizing enterocolitis is the most common cause of SBS [1].
Short bowel syndrome in infants aged 4 to 12 months
Subcutaneous injection

Trial or other data

Apr 21Results posted for PIII study (NCT03571516), although primary outcome result seems to be missing [2].
Sep 20PIII study (NCT03571516) completes [2].
Aug 18PIII study to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support starts (NCT03571516). 10 infants aged 4-12 months will be recruited in Finland, France, Italy and the UK. Participants will receive 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection of teduglutide into abdomen or into either the thigh or arm once daily (QD) in addition to standard medical therapy for 24 weeks, or will receive standard medical therapy for 24 weeks. Primary outcome is number of participants who achieved at least 20% reduction from baseline in weight-normalised PS volume at EOT/ET (up to Week 24) [2].

Evidence based evaluations

Revestive (UK/EU), Gattex (US) Short bowel syndrome - pre-filled pen formulation

Information

Revestive (UK/EU), Gattex (US)
New formulation
Takeda
Takeda

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

Analogue of human glucagon-like peptide-2 (GLP-2), a peptide secreted by L cells of the intestine which is known to increase intestinal and portal blood flow, inhibit gastric acid secretion, and decrease intestinal motility. Injected once daily.
The most common aetiology in adults is currently Crohns disease. Extrapolated figures of home parenteral nutrition centres and single-centre studies suggest an incidence of 2-5 per million [1].
Short bowel syndrome - pre-filled pen formulation
Subcutaneous injection