TGA
The Prescription Medicines in Pregnancy database has now been updated to include the following new entries:
| Medicine | Pregnancy Category |
|---|---|
| abaloparatide | B3 |
| abrocitinib | D |
| atogepant | B3 |
| ceftazidime / avibactam | B3 |
| belumosudil | D |
| calcifediol | B3 |
| cipaglucosidase alfa / miglustat | D |
| crizanlizumab | B1 |
| danicopan | B3 |
| datopotamab deruxtecan | D |
| deutetrabenazine | B3 |
| doravirine | B1 |
| efgartigimod alfa | C |
| elafibranor | D |
| etranacogene dezaparvovec | B2 |
| fedratinib | D |
| fenfluramine | D |
| foslevodopa / foscarbidopa | B3 |
| fruquintinib | D |
| futibatinib | D |
| gilteritinib | D |
| inavolisib | D |
| inebilizumab | C |
| insulin icodec | B3 |
| lazertinib | D |
| leniolisib | D |
| letibotulinumtoxinA | B3 |
| linaclotide | B3 |
| linzagolix | D |
| lumasiran | B1 |
| luspatercept | D |
| marstacimab | D |
| mavacamten | D |
| nemolizumab | B1 |
| odevixibat | D |
| palopegteriparatide | B3 |
| pegunigalsidase alfa | B3 |
| respiratory syncytial virus (RSV) F protein mRNA | B1 |
| ritlecitinib | D |
| rozanolixizumab | D |
| sipavibart | B2 |
| sodium iodide [131I] | X |
| sotatercept | D |
| spesolimab | B1 |
| talazoparib | D |
| talquetamab | C |
| tebentafusp | C |
| teprotumumab | X |
| tezepelumab | B1 |
| tirbanibulin | D |
| toripalimab | D |
| tremelimumab | D |
| triamcinolone acetonide (ocular) | B3 |
| turoctocog alfa | B2 |
| ublituximab | C |
| velmanase alfa | D |
| vonicog alfa | B2 |
| vutrisiran | D |
| zilucoplan | D |
| apadamtase alfa / cinaxadamtase alfa | B1 |
| seladelpar | B1 |
The following database entries have been amended:
| Medicine | Safety Statement | Classification 1 | Classification 2 | Classification 3 |
|---|---|---|---|---|
| anacaulase-bcdb | From “Dermatology” to “Drugs Used in Dermatology” | From “Topical debridement drug” to “Topical” | Removed “Proteolytic enzyme enriched in bromelain” | |
| belantamab mafodotin | From “Based on the mechanism of action of the cytotoxic component monomethyl auristatin F, belantamab mafodotin can cause embryo-fetal harm when administered to a pregnant woman. The cytotoxic component kills rapidly dividing cells, which would affect a developing embryo. There is also a potential risk of heritable changes via aneuploidy in female germ cells” to “Based on its mechanism of action, belantamab mafodotin may cause embryofetal harm (embryotoxicity and teratogenicity) when administered to a pregnant woman” | |||
| vanzacaftor / tezacaftor / deutivacaftor | From “Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators” to “Inhalational agents” | |||
| From “delgocitinib” to “delgocitinib (dermal)” | From “Immunomodulating” to “Allergy and Immune System” | From “Topical kinase inhibitor for chronic hand eczema” to “Immunomodifiers” | ||
| baricitinib | From “Musculoskeletal System” to “Allergy and Immune System” | From “Antirheumatoid agents” to “Immunomodifiers” |
/Public Release. View in full here.
