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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…
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Refrigerated Storage

Risperdal ConstaJanssen-Cilag

Janssen-Cilag
Risperdal Consta
25mg/ 37.5mg / 50 mg powder and solvent for prolonged-release suspension for intramuscular injection

If refrigeration is unavailable, RISPERDAL CONSTA can be stored at temperatures not exceeding 25°C for no more than 7 days prior to administration.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

 Contact Janssen-Cilag in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Yes - reduce to 7 days from date of excursion as above
No
12 June 2020
London MI Service

Medicine Compliance Aid Stability

genericConsilient Health Ltd

Consilient Health Ltd
generic
Tablets orodispersible 1mg, 2mg, 3mg, 4mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Orodispersible tablet therefore hygroscopic
1 October 2015

genericAccord Healthcare Ltd

Accord Healthcare Ltd
generic
Tablets f/c 0.5mg, 1mg, 2mg, 3mg, 6mg
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 requirements for storage.
1 October 2015

Risperdal QuickletsJanssen-Cilag Ltd

Janssen-Cilag Ltd
Risperdal Quicklets
Tablets orodispersible 500 micrograms, 1mg, 2mg, 3mg, 4mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Keep in original package and protect from light. Orodispersible tablets therefore hygroscopic.
1 October 2015

RisperdalJanssen-Cilag Ltd

Janssen-Cilag Ltd
Risperdal
Tablets f/c 500 micrograms, 1mg, 2mg, 3mg, 4mg, 6mg
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.
Protect from light
Protect from light.
1 October 2015

Lactation Safety Information

Oral

Oral
Quetiapine, Haloperidol
Limited evidence that maternal oral doses up to 6mg daily produce low levels in milk
Long half-life of active metabolite increases risk of accumulation in breastfed infants
Monitor infant for sedation, poor feeding, behavioural effects, extrapyramidal symptoms, and developmental milestones
22 January 2020

Depot injection

Depot injection
No published evidence of safety for use as depot injection. However maternal oral doses of up to 6mg daily produce low levels in milk
Long half-life of active metabolite increases risk of accumulation in breastfed infants
Monitor infant for sedation, poor feeding, behavioural effects, extrapyramidal symptoms, and developmental milestones
22 January 2020

New Medicines

Dorianex (EU), Doria (US) Schizophrenia, acute exacerbations - in situ microimplants

Information

Dorianex (EU), Doria (US)
New formulation
Rovi
Rovi

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase III Clinical Trials
Jan 20Rovi plans to file in the US in H2 2020 [5].
Jan 20Filed in the EU using the centralised procedure for treatment of schizophrenia [5].
Jul 19Rovi announces the conclusion of the PRISMA-31 and BORIS2 studies, thus completing the clinical research program for risperidone ISM®. All data collected and analysed will be included in the registration dossier to apply for marketing authorisation for Doria® for treatment of schizophrenia in the EU & US, in a first phase, and, subsequently, in other countries [4].
Jul 18Rovi plans to file in the US in H2 2019 [3].

Category

Second generation, intramuscular, sustained release, microparticle formulation of risperidone using a ISM [In Situ Microparticles] drug delivery system. Administered once-monthly.
An English study reported an incidence of 15.2 per 100,000 person-years and a systematic review reported a prevalence of 7.2 per 1,000 persons [1].
Schizophrenia, acute exacerbations - in situ microimplants
Intramuscular

Trial or other data

Dec 18PIII PRISMA-3 trial completes [2].
May 17PIII PRISMA-3 trial to evaluate the safety and efficacy of intramuscular injections of extended-release risperidone in patients with acute exacerbations of schizophrenia starts (NCT03160521). Positive and Negative Syndrome Scale (PANSS) total score, assessed at 12 weeks, will be the primary endpoint of this trial. 438 patients will be recruited in the US & Ukraine [2].
Jul 16Results from PRISMA-1 and PRISMA-2 trials and the design of a PIII programme had been reviewed by the US FDA and EMA. The population pharmacokinetic model will be used to predict the steady-state pharmacokinetic exposure of extended release risperidone active moiety after drug administration, and for simulations helping to provide a dosing rationale for the drug [3].
Mar 15PII PRISMA-2 trial that investigated the pharmacokinetics, safety and tolerability of four intramuscular injections of extended-release risperidone (75mg) at 28-day intervals in 70 patients with schizophrenia in the US completes (NCT02086786) [3].

PerserisSchizophrenia - once monthly subcutaneous formulation

Information

Perseris
New formulation
Not Known
Indivior

Development and Regulatory status

None
None
Launched
Nov 20No plans for EU/UK development of Perseris or collaborations with other companies announced [8].
Nov 20Approved for use in Canada (as 90 mg and 120 mg subcutaneous injection) for the treatment of schizophrenia in adults [7].
Aug 19HLS Therapeutics, which has an agreement with Indivior, intends to file a regulatory submission for risperidone sustained-release in Canada by end 2019, & launch in Canada in H2 2020 [5].
Mar 19In its latest annual report, Indivior does not discuss plans for EU development [6].
Nov 18Launched in US [4].
Jul 18Approved by FDA [3].
Oct 17Filed in US based on results of RB-US13-0005 (NCT02203838) study [2].

Category

Dopamine D2 receptor antagonist and serotonin 2A receptor antagonist in a controlled-release formulation using the ATRIGEL delivery system.
In England there are about 800 per 100,000 people with schizophrenia.
Schizophrenia - once monthly subcutaneous formulation
Subcutaneous

Trial or other data

Sep 16Reckitt Benckiser completes a PIII study that assessed the long-term safety and tolerability of subcutaneously administered risperidone sustained-release formulation in patients with schizophrenia (NCT02203838).
May 15Positive Top-Line Results from pivotal PIII multicentre, double-blind, placebo-controlled study (NCT02109562) of RBP-7000 to assess efficacy, safety and tolerability of RBP-7000 in 354 pts experiencing acute exacerbation of Schizophrenia. The trial included adult pts with Schizophrenia and a PANSS total score between 80 and 120 at baseline and hallucinatory behaviour, delusions, conceptual disorganization or suspiciousness. Pts were randomised to receive once-monthly subcutaneous injections 90 mg or 120 mg of RBP-7000 or a matching placebo injection for 8 wks. The primary efficacy endpoint of the study was the mean change from baseline at Week 8 in PANSS total score; scores were -9.2 points for placebo; -15.4 points for RBP-7000, 90 mg, p=0.0004 vs. placebo; and -16.4 points for RBP-7000, 120 mg, p<0.0001 vs. placebo. Pre-specified key secondary endpoint of improvement on the Clinical Global Impression-Severity of Illness (CGI-S) scale were also met; for each RBP-7000 group vs. placebo at Week 8 (p=0.0002 vs. placebo for RBP-7000, 90 mg; and p<0.0001 vs. placebo for RBP-7000, 120 mg). RBP-7000 was generally well tolerated in the study, and the observed safety profile of RBP-7000 was similar to that reported with oral risperidone [1].