Product Dossier
CAFNEA
Product Dossier for CAFNEA (caffeine citrate, Phebra). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Phebra
- Active ingredient: caffeine citrate
- Therapeutic area: Rare Disease
- Same area: ORKAMBI
- Same area: BYLVAY
What it is
Cafnea is available as an oral solution containing caffeine citrate 25 mg/5 mL and as an injection containing caffeine citrate 40 mg/2 mL for intravenous administration.
Approved indications
— Short-term treatment of apnoea of prematurity in infants of gestational age 28 to less than 33 weeks.
Key safety warnings
Nonclinical studies indicated potential long-term neurological and cardiac effects in neonatal animals exposed to caffeine at clinically relevant levels.
Regulatory history
Cafnea oral solution and injection were first listed on the ARTG on 9 April 2010. The TGA approved Cafnea on 17 March 2010 for the short-term treatment of apnoea of prematurity in infants of gestational age 28 to less than 33 weeks. This decision was made based on acceptable quality, safety, and efficacy data, with the TGA's quality evaluation finding the chemistry, quality control, and bioavailability of Cafnea acceptable. However, the nonclinical evaluation identified deficiencies in the sponsor's literature search and reliance on outdated data. An export-only formulation of Cafnea oral solution was subsequently listed on the ARTG on 17 May 2017.