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Paliperidone

Published
Topics: CCG commissioned new medicinesMental health and illnessNew Medicines · PaliperidonePatent expiriesPre-registration new medicines (UK/EU)Safety in BreastfeedingStability in dosette boxes ·
Contents
  1. dm+d
  2. Articles
  3. Medicine Compliance Aid Stability
    1. Invega · Janssen-Cilag Ltd
  4. Lactation Safety Information
    1. Oral
    2. Depot injection · as palmitate salt
  5. New Medicines
    1. Byannli (EU), Invega Hafyera (US) · Schizophrenia, prevention of relapse - 6-monthly IM formulation

dm+d

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Articles

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…

Which medicines are considered safe for use in the acute porphyrias?

29 May 2020This updated Medicines Q&A presents a table of the medicines considered safe for use in the acute porphyrias. Inclusion of a drug does not guarantee…
Search Articles

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
Usage of Medicines in Compliance Aids

Lactation Safety Information

Oral

Oral
Caution
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
Safety in Lactation: Antipsychotics
9 November 2018
Bibliography

Depot injection as palmitate salt

Depot injection
as palmitate salt
Caution
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
Safety in Lactation: Antipsychotics
9 November 2018
Bibliography

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

None
Pre-registration (Filed)
Approved (Licensed)
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

US label