Safety in Lactation: Drugs for hypertension

23 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Many of the drugs covered by…
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Medicine Compliance Aid Stability

VolibrisGlaxoSmithKline UK

GlaxoSmithKline UK
Tablets f/c 5mg, 10mg
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special precautions for storage
9 November 2015

Lactation Safety Information

No published evidence of safety
Although low levels anticipated in milk due to the drug’s properties, serious adverse effects have been reported in adults
16 January 2017

New Medicines

Volibris (EU), Letairis (US)Pulmonary arterial hypertension (PAH) in children aged 8 - <18 years, including use in combination treatment


Volibris (EU), Letairis (US)
New formulation and licence extension / variation

Development and Regulatory status

Phase II Clinical Trials
Nov 21This product is no longer an orphan medicine in the EU. Volibris was withdrawn from the Community register of orphan medicinal products in April 2018 at the end of the 10-year period of market exclusivity [6].
Sep 21Licence extension and new 2.5mg strength approved in EU [6].
Jul 21EU CHMP issues a positive opinion recommending a new strength (2.5 mg film coated tablets) and an extension to the existing indication - this is treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease [5].
Apr 05Granted orphan drug status in EU [4].


Endothelin receptor antagonist in a 2.5mg tablet strength.
Idiopathic PAH is rare.The prevalence of PAH is estimated at 15-50 per million. The incidences is estimated to be 1-3.3 per million per year for idiopathic PAH [1]. The only centre in the UK that treats paediatric patients has approximately 134 patients, of which 27 would fall within the proposed licence indication [4].
Pulmonary arterial hypertension (PAH) in children aged 8 - <18 years, including use in combination treatment

Trial or other data

Oct 20Long-term PII study (NCT01342952) is ongoing but has finished recruitment [2].
Sep 19Results posted for PII study (NCT01332331) [2].
Nov 13PII study completes (NCT01332331). This study is part of a Paediatric Investigational Plan (PIP; EMEA-000434-PIP01-08) agreed with the European Medicines Agency´s Paediatric Committee (PDCO) [2].
Jun 11Long-term PII study starts (NCT01342952). It is extension to study AMB112529 (NCT01332331). The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population. Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters [2].
Jan 11PII study starts (NCT01332331). It is a 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in 41 subjects aged 8 years up to 18 years with PAH. Patients will be recruited in countries including the US and Europe (not UK). Primary comparison will be the safety and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH population The secondary comparison will be the change from baseline for the efficacy parameters between the two treatment groups [2].