RYKINDO EXTENDED-RELEASE INJECTABLE SUSPENSION 37.5MG/VIAL [SIN17184P]

Product Info

RYKINDO EXTENDED-RELEASE INJECTABLE SUSPENSION 37.5MG/VIAL

[SIN17184P]

INDICATIONS AND USAGE

RYKINDO® is indicated:

• for the treatment of acute and chronic schizophrenic, psychoses, hallucinations and delusions.

• To alleviates affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia.

DOSAGE AND ADMINISTRATION

General Administration Information

For patients who have never taken oral risperidone, establish tolerability with oral risperidone prior to initiating RYKINDO®.

RYKINDO® should be administered every 2 weeks by intramuscular (IM) gluteal injection. Each injection should be administered by a health care professional. Do not administer by any other route. Alternate injections between the two buttocks. Do not combine two different dose strengths of RYKINDO® in a single administration.

For detailed preparation and administration instructions, see Dosage and Administration.

Dosage Recommendations

The recommended dosage of RYKINDO® is 25 mg every 2 weeks. Administer the first dose of RYKINDO® along with 7 days of oral risperidone.

Patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg every 2 weeks. No additional benefit was observed with dosages greater than 50 mg of risperidone long-acting injection (intramuscular); however, a higher incidence of adverse reactions was observed. Dose titration should not be made more frequently than every 4 weeks.

Patients Currently Receiving Risperidone Long-acting Injection 2-week Intramuscular Formulation

The RYKINDO® dose for patients receiving a risperidone long-acting injection (intramuscular) every two week formulation should be the same as that of the previous treatment. The first injection of RYKINDO® should be given 4 weeks (no later than 5 weeks) after the last injection of the previous treatment. Supplementation with oral risperidone is not recommended [see Clinical Pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Titration should not be made more frequently than every 4 weeks.

Reinitiation of Treatment in Patients Previously Discontinued

There are no data to specifically address reinitiation of treatment. When restarting patients who have had an interval off treatment with RYKINDO®, the previously established dosage should be reinitiated if there has been no change in the patient’s general medical condition. Supplementation with oral risperidone is also required.

Dosage Recommendations for Patients with Renal or Hepatic Impairment

Patients with renal or hepatic impairment should be treated with titrated oral risperidone prior to initiating treatment with RYKINDO® [see Use in Specific Populations and Clinical Pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. The recommended starting dose is 0.5 mg oral risperidone twice daily during the first week, which can be increased to 1 mg twice daily or 2 mg once daily during the second week. If a total daily dose of at least 2 mg oral risperidone is well tolerated, RYKINDO® 25 mg can be administered every 2 weeks with oral supplementation for 7 days following the first injection [see Dosing and Administration].

Dosage Recommendations for Concomitant Use of RYKINDO® with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inducers

Co-administration of carbamazepine and other CYP3A4 enzyme inducers (e.g., phenytoin, rifampin, phenobarbital) with risperidone would be expected to cause decreases in the plasma concentrations of the sum of risperidone and 9-hydroxyrisperidone combined, which could lead to decreased efficacy of RYKINDO® treatment. The risperidone dose needs to be titrated accordingly for patients receiving these enzyme inducers, especially during initiation or discontinuation of therapy with these inducers [see Drug Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. At the initiation of therapy with carbamazepine or other known CYP3A4 hepatic enzyme inducers, patients should be closely monitored during the first 1 to 2 months because the dose of RYKINDO® may need to be adjusted. A dose increase, or additional oral risperidone, needs to be considered. On discontinuation of carbamazepine or other CYP3A4 hepatic enzyme inducers, the dosage of RYKINDO® should be re-evaluated and, if necessary, decreased. Patients may be placed on a lower dose of RYKINDO® between 2 to 4 weeks before the planned discontinuation of carbamazepine or other CYP3A4 inducers to adjust for the expected increase in plasma concentrations of risperidone plus 9-hydroxyrisperidone. For patients treated with the recommended dose of 25 mg RYKINDO® and discontinuing from carbamazepine or other CYP3A4 enzyme inducers, it is recommended to continue treatment with the 25-mg dose unless clinical judgment necessitates interruption of RYKINDO® treatment.

Fluoxetine and paroxetine, CYP2D6 inhibitors, have been shown to increase the plasma concentration of risperidone by 2.5 to 2.8-fold and 3 to 9-fold, respectively. Fluoxetine did not affect the plasma concentration of 9-hydroxyrisperidone. Paroxetine lowered the concentration of 9-hydroxyrisperidone by about 10%. The dose of risperidone needs to be titrated accordingly when co-administering fluoxetine or paroxetine. When either concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dose of RYKINDO®. When initiation of fluoxetine or paroxetine is considered, patients may be placed on a lower dose of RYKINDO® between 2 to 4 weeks before the planned start of fluoxetine or paroxetine therapy to adjust for the expected increase in plasma concentrations of risperidone. When fluoxetine or paroxetine is initiated in patients receiving the recommended dose of 25 mg RYKINDO® it is recommended to continue treatment with the 25 mg dose unless clinical judgment necessitates to interruption of RYKINDO® treatment. The effects of discontinuation of concomitant fluoxetine or paroxetine therapy on the pharmacokinetics of risperidone and 9-hydroxyrisperidone have not been studied [see Drug Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Preparation and Administration Instructions

• Read the instructions for preparation and administration below.

• For gluteal intramuscular injection only. Do not inject by any other route. Alternate injections between the two buttocks.

• Allow package to come to room temperature (25°C) for at least 30 minutes prior to preparation. Prepare medication when you are ready to administer the dose.

• The components in the single-dose kit are shown in Figure 1.

CONTRAINDICATIONS

RYKINDO® is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone.