Dose Information

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Switching from Oral RISPERDAL®

Consistent with the RISPERDAL® Prescribing Information:

• RISPERDAL® is an atypical antipsychotic indicated for the treatment of schizophrenia.
• RISPERDAL® can be administered once or twice daily. The initial dose of RISPERDAL® for treatment of schizophrenia in adults is 2 mg/day. May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2 mg per day, as tolerated, to a recommended dose of 4 to 8 mg per day. Doses above 6 per day were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended.

Consistent with the INVEGA SUSTENNA® Prescribing Information:

• There are no systematically collected data to specifically address switching patients with schizophrenia or schizoaffective disorder from other antipsychotics to INVEGA SUSTENNA®, or concerning concomitant administration with other antipsychotics.
• For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNA®.
• Previous oral antipsychotics can be gradually discontinued at the time of initiation of treatment with INVEGA SUSTENNA®.
• All patients transitioning from oral antipsychotics must follow the recommended initiation dosing of 234 mg (day 1), 156 mg (day 8) both administered in the deltoid muscle.)
• The initiation regimen (234 mg followed by 156 mg one week later both in the deltoid muscle) rapidly attains steady-state paliperidone concentrations with no need for oral antipsychotic supplementation.
• The recommended maintenance dose of INVEGA SUSTENNA® for treatment of schizophrenia is 117 mg. Some patients may benefit from lower or higher maintenance doses within the additional available strengths (39 mg, 78 mg, 156 mg, and 234 mg).
• Patients stabilized on risperidone tablets can attain similar steady-state exposure with INVEGA SUSTENNA® as depicted in Table. The INVEGA SUSTENNA® Prescribing Information does not specifically address conversion of RISPERDAL® tablets to INVEGA SUSTENNA®. This information is based on pharmacokinetic (PK) modeling performed to compare steady-state exposure during maintenance treatment between RISPERDAL® tablets and INVEGA SUSTENNA® (after both the 234 mg/156 mg deltoid starting doses).*

Table: Doses of RISPERDAL® and INVEGA SUSTENNA® Needed to Attain Similar Steady-State Palliperidone Exposure During Maintenance Treatment.*

Formulation	RISPERDAL® Tablet	INVEGA SUSTENNA® Injection
Dosing Frequency	Total Daily Dose	Every 4 Weeks
Dose (mg)	6	234
	4	156
	3	117
	2	78
	1	39

*Russu A, Sliwa JK, Ravestijn P, et al. Maintenance dose conversion between oral risperidone and paliperidone palmitate 1 month: Practical guidance based on pharmacokinetic simulations. Int J Clin Pract. 2018;e13089.

• Administration: Each injection must be administered only by a healthcare professional. INVEGA SUSTENNA® is intended for intramuscular use only. Do not administer by any other route. Avoid inadvertent injection into a blood vessel.

INVEGA SUSTENNA® Prescribing Information [http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVEGA+SUSTENNA-pi.pdf]

RISPERDAL® Prescribing Information [http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RISPERDAL-pi.pdf]