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Safety in Lactation: Antipsychotics

22 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral and non-depot antipsychotics with less…

Medicines that are considered safe for use in the acute porphyrias

29 May 2020The UK Porphyria Medicines Information Service (UKPMIS) and Cardiff Porphyria Service produce a list of medicines that are considered to be safe for use in…
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Medicine Compliance Aid Stability

InvegaJanssen-Cilag Ltd

Janssen-Cilag Ltd
Invega
Tablets m/r 3mg, 6mg, 9mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Protect from light. Protect from moisture and packed with a desiccant.
1 October 2015

Lactation Safety Information

Oral

Oral
Quetiapine, Haloperidol
Active metabolite of risperidone
No published evidence of safety
Long half-life increases risk of accumulation in breastfed infants
Monitor infant for sedation, poor feeding, behavioural effects, extrapyramidal symptoms, and developmental milestones
9 November 2018

Depot injection as palmitate salt

Depot injection
as palmitate salt
Risperidone depot injection
Active metabolite of risperidone
No published evidence of safety
Long half-life increases risk of accumulation in breast fed infants
Monitor infant for sedation, poor feeding, behavioural effects, extrapyramidal symptoms, and developmental milestones
9 November 2018

New Medicines

Byannli (EU), Invega Hafyera (US)Schizophrenia, prevention of relapse - 6-monthly IM formulation

Information

Byannli (EU), Invega Hafyera (US)
New formulation
Janssen
Janssen

Development and Regulatory status

Launched
Launched
Launched
February 2022
Feb 22Licence changes were also approved by the EMA in Nov 21 [13].
Feb 22Byannli Prolonged-release suspension for injection in prefilled syringe available in the UK. Price for 1 x 700mg PFS=£1884.42; 1 x 1,000mg PFS = £2355.54 [12].
Feb 22MHRA approves 6-monthly paliperidone palmitate (Byannli) for the maintenance treatment of schizophrenia in adults [11].
Nov 21Invega Hafyera is available in the US [10].
Sep 21Recommended for EU approval by CHMP – “for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1‑monthly or 3‑monthly paliperidone palmitate injectable products”. Byannli will be available as prolonged-release suspension for injection (700 or 1,000mg) for 6-monthly administration [9].
Sep 21Approved in US [8].
Jan 21Johnson & Johnson also filed in the US, in Oct 20 [7].
Dec 20Filed in EU [6].
Jan 20Company plans to file in EU & US before end of 2020 [4].

Category

Dopamine D2 receptor and serotonin 5HT2 receptor antagonist
In England there are about 800 per 100,000 people with schizophrenia.
Schizophrenia, prevention of relapse - 6-monthly IM formulation
Intramuscular

Trial or other data

May 20PIII trial (NCT03345342) completes [5].
Nov 19PIII trial (NCT03345342) has finished recruiting and expects to complete collection of primary outcome data in Jul 20 [3].
Nov 18PIII trial (NCT03345342) is still recruiting; timescales unchanged [2].
Nov 17PIII trial to assess the non-inferiority in the efficacy of paliperidone palmitate 6-month formulation to the 3-month formulation, in preventing the relapse in patients with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month starts (NCT03345342). 765 patients will be recruited in countries around the world including the US and EU. Collection of primary outcome data (time to relapse) is expected to finish in Jul 20 [1].

Evidence based evaluations