Invega Sustenna Dosage/Direction for Use

Administration Instructions: Each injection must be administered only by a healthcare professional.
Parenteral drug products should be inspected visually for foreign matter and discoloration prior to administration, whenever product and container permit.
INVEGA SUSTENNA is intended for intramuscular use only. Do not administer by any other route. Avoid inadvertent injection into a blood vessel. Administer the dose in a single injection; do not administer the dose in divided injections. Inject slowly, deep into the deltoid or gluteal muscle.
INVEGA SUSTENNA must be administered using only the needles that are provided in the INVEGA SUSTENNA kit.
The recommended needle size for administration of INVEGA SUSTENNA into the deltoid muscle is determined by the patient's weight: For patients weighing less than 90 kg, the 1-inch, 23 gauge needle is recommended.
For patients weighing 90 kg or more, the 1½-inch, 22 gauge needle is recommended.
Deltoid injections should be alternated between the two deltoid muscles.
The recommended needle size for administration of INVEGA SUSTENNA into the gluteal muscle is the 1½-inch, 22 gauge needle regardless of patient weight.
Administer into the upper-outer quadrant of the gluteal muscle. Gluteal injections should be alternated between the two gluteal muscles.
Schizophrenia and Schizoaffective Disorder: For patients who have never taken oral paliperidone or oral or injectable risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNA.
The recommended dosing of INVEGA SUSTENNA for each approved indication is displayed in Table 4. The recommended initiation of INVEGA SUSTENNA is with a dose of 150 mg on treatment day 1 and 100 mg one week later, both administered in the deltoid muscle. Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. (See Table 4.)

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Adjustment of the maintenance dose may be made monthly. When making dose adjustments, the prolonged-release characteristics of INVEGA SUSTENNA should be considered (see Pharmacology: Pharmacokinetics under Actions), as the full effect of the dose adjustment may not be evident for several months.
Missed Doses: Avoiding Missed Doses: It is recommended that the second initiation dose of INVEGA SUSTENNA be given one week after the first dose. To avoid a missed dose, patients may be given the second dose 4 days before or after the one-week time point. Similarly, the third and subsequent injections after the initiation regimen are recommended to be given monthly. To avoid a missed monthly dose, patients may be given the injection up to 7 days before or after the monthly time point.
Management of a Missed Second Initiation Dose: If the target date for the second INVEGA SUSTENNA injection (one week ± 4 days) is missed, the recommended reinitiation depends on the length of time which has elapsed since the patient's first injection. In case of a missed second initiation dose follow the dosing instructions provided in Table 5. (See Table 5.)

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Management of a Missed Maintenance Dose: In case of a missed maintenance dose follow the dosing instructions provided in Table 6. (See Table 6.)

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Use with Risperidone or with Oral Paliperidone: Since paliperidone is the major active metabolite of risperidone, caution should be exercised when INVEGA SUSTENNA is coadministered with risperidone or with oral paliperidone for extended periods of time. Safety data involving concomitant use of INVEGA SUSTENNA with other antipsychotics is limited.
Dosage Adjustments: Renal Impairment: INVEGA SUSTENNA has not been systematically studied in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions). For patients with mild renal impairment (creatinine clearance ≥ 50 mL/min to < 80 mL/min [Cockcroft-Gault Formula]), initiate INVEGA SUSTENNA with a dose of 100 mg on treatment day 1 and 75 mg one week later. Administer both doses in the deltoid muscle. Thereafter, follow with monthly injections of 50 mg in either the deltoid or gluteal muscle (see Use in Specific Populations: Renal Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions).
INVEGA SUSTENNA is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) (see Use in Specific Populations: Renal Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions).
Coadministration with Strong CYP3A4/P-glycoprotein (P-gp) Inducers: Avoid using a strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John's Wort) during the 1-month dosing interval for INVEGA SUSTENNA, if possible. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended release tablets (see Drugs Having Clinically Important Interactions with INVEGA SUSTENNA under Interactions and Pharmacology: Pharmacokinetics under Actions).
Switching from Other Antipsychotics: 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.
Switching from Oral 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. Recommended initiation of INVEGA SUSTENNA is with a dose of 150 mg on treatment day 1 and 100 mg one week later, both administered in the deltoid muscle (see Schizophrenia and Schizoaffective Disorder as previously mentioned). Patients previously stabilized on different doses of INVEGA Extended-Release tablets can attain similar paliperidone steady-state exposure during maintenance treatment with INVEGA SUSTENNA monthly doses as depicted in Table 7. (See Table 7.)

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Switching from Long-Acting Injectable 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.
When switching patients currently at steady-state on a long-acting injectable antipsychotic, initiate INVEGA SUSTENNA therapy in place of the next scheduled injection. INVEGA SUSTENNA should then be continued at monthly intervals. The one-week initiation dosing regimen as described in Schizophrenia and Schizoaffective Disorder as previously mentioned is not required. See Table 4 as previously shown for recommended monthly maintenance dosing. Based on previous clinical history of tolerability and/or efficacy, some patients may benefit from lower or higher maintenance doses within the available strengths (25 mg, 50 mg, 75 mg, 100 mg, and 150 mg). The 25 mg strength was not studied in the long-term schizoaffective disorder study. Monthly maintenance doses can be administered in either the deltoid or gluteal muscle (see Schizophrenia and Schizoaffective Disorder as previously mentioned).
If INVEGA SUSTENNA is discontinued, its prolonged-release characteristics must be considered. As recommended with other antipsychotic medications, the need for continuing existing extrapyramidal symptoms (EPS) medication should be re-evaluated periodically.