Invega Sustenna

Invega Sustenna Manufacturers

• Janssen Pharmaceuticals, Inc.
  

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  Invega Sustenna | Janssen Pharmaceuticals, Inc.

  

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  2.1 Administration Instructions

  Each injection must be administered only by a health care 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 muscle.

  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.

  2.2 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 1. The recommended initiation of INVEGA SUSTENNA® is with a dose of 234 mg on treatment day 1 and 156 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.

  Table 1. Recommended Dosing of INVEGA SUSTENNA® for Adults with Schizophrenia or Schizoaffective Disorder Indication Initiation Dosing
  (deltoid) Monthly
  Maintenance Dose*
  (deltoid or gluteal) Maximum Monthly Dose Day 1 Day 8 * Administered 5 weeks after the first injection. † The recommended maintenance dose 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). ‡ Adjust dose based on tolerability and/or efficacy using available strengths. The 39 mg strength was not studied in the long-term schizoaffective disorder study. Schizophrenia 234 mg 156 mg 39–234 mg† 234 mg Schizoaffective disorder 234 mg 156 mg 78–234 mg‡ 234 mg

  Adjustment of the maintenance dose may be made monthly. When making dose adjustments, the prolonged-release characteristics of INVEGA SUSTENNA® should be considered [see Clinical Pharmacology (12.3)], as the full effect of the dose adjustment may not be evident for several months.

  2.3 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 2.

  Table 2. Management of a Missed Second Initiation Dose TIMING OF MISSED SECOND INITIATION DOSE DOSING Less than 4 weeks since first injection Administer the second initiation dose of 156 mg in the deltoid muscle as soon as possible. It is recommended to administer a third injection of 117 mg in either the deltoid or gluteal muscle 5 weeks after the first injection (regardless of the timing of the second injection). Thereafter, resume regular monthly dosing in either the deltoid or gluteal muscle. 4 to 7 weeks since first injection Resume dosing with two injections of 156 mg in the following manner: Administer a deltoid injection as soon as possible. Administer a second deltoid injection 1 week later. Thereafter, resume regular monthly dosing in either the deltoid or gluteal muscle. More than 7 weeks since first injection Restart dosing with recommended initiation (see Section 2.2, Table 1): Administer a 234 mg deltoid injection on Day 1. Administer a 156 mg deltoid injection 1 week later. Thereafter, resume regular monthly dosing in either the deltoid or gluteal muscle.

  Management of a Missed Maintenance Dose

  In case of a missed maintenance dose follow the dosing instructions provided in Table 3.

  Table 3. Management of a Missed Maintenance Dose TIMING OF MISSED MAINTENANCE DOSE DOSING 4 to 6 weeks since last injection Resume regular monthly dosing as soon as possible at the patient's previously stabilized dose, followed by injections at monthly intervals. More than 6 weeks to 6 months since last injection Resume the same dose the patient was previously stabilized on (unless the patient was stabilized on a dose of 234 mg, then the first 2 injections should each be 156 mg) in the following manner: Administer a deltoid injection as soon as possible. Administer a second deltoid injection 1 week later at the same dose. Thereafter, resume administering the previously stabilized dose in the deltoid or gluteal muscle 1 month after the second injection. More than 6 months since last injection Restart dosing with recommended initiation (see Section 2.2, Table 1): Administer a 234 mg deltoid injection on Day 1. Administer a 156 mg deltoid injection 1 week later. Thereafter, resume administering the previously stabilized dose in the deltoid or gluteal muscle 1 month after the second injection. 2.4 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.

  2.5 Dosage Adjustments

  Renal Impairment

  INVEGA SUSTENNA® has not been systematically studied in patients with renal impairment [see Clinical Pharmacology (12.3)]. 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 156 mg on treatment day 1 and 117 mg one week later. Administer both doses in the deltoid muscle. Thereafter, follow with monthly injections of 78 mg in either the deltoid or gluteal muscle [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  INVEGA SUSTENNA® is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  Coadministration with Strong CYP3A4/P-glycoprotein (P-gp) Inducers

  It may be necessary to increase the dose of INVEGA SUSTENNA® when a strong inducer of both CYP3A4 and P-gp (e.g., carbamazepine, rifampin, St John's wort) is co-administered. Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of INVEGA SUSTENNA® [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

  2.6 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.

  2.6.1 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 234 mg on treatment day 1 and 156 mg one week later, both administered in the deltoid muscle [see Dosage and Administration (2.2)]. 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 4.

  Table 4. Doses of INVEGA® and INVEGA SUSTENNA® needed to attain similar steady-state paliperidone exposure during maintenance treatment Formulation INVEGA® Extended-Release Tablet INVEGA SUSTENNA® Injection Dosing Frequency Once Daily Once every 4 weeks Dose (mg) 12
  6
  3 234
  117
  39–78

  2.6.2 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 Section 2.2 is not required. See Table 1 above 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 (39 mg, 78 mg, 117 mg, 156 mg, and 234 mg). The 39 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 Dosage and Administration (2.2)].

  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.

  2.7 Instructions for Use

  Each injection must be administered only by a health care professional.

  The kit contains a prefilled syringe and 2 safety needles (a 1 ½-inch 22 gauge needle and a 1-inch 23 gauge needle) for intramuscular injection.

  INVEGA SUSTENNA® is for single use only.

  a. Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension. b. Select the appropriate needle.

  For DELTOID injection:

  If the patient weighs less than 90 kg, use the 1-inch 23 gauge needle (needle with blue colored hub). If the patient weighs 90 kg or more, use the 1 ½-inch 22 gauge needle (needle with gray colored hub).

  For GLUTEAL injection:

  Use the 1 ½-inch 22 gauge needle (needle with gray colored hub) regardless of patient's weight.

  c. While holding the syringe upright, remove the rubber tip cap with an easy clockwise twisting motion. d. Peel the safety needle pouch half way open. Grasp the needle sheath using the plastic peel pouch. Attach the safety needle to the luer connection of the syringe with an easy clockwise twisting motion. e. Pull the needle sheath away from the needle with a straight pull. Do not twist the sheath as the needle may be loosened from the syringe. f. Bring the syringe with the attached needle in upright position to de-aerate. De-aerate the syringe by moving the plunger rod carefully forward. g. Inject the entire contents intramuscularly slowly, deep into the selected deltoid or gluteal muscle of the patient. Do not administer by any other route. h. After the injection is complete, use either thumb or finger of one hand (h1, h2) or a flat surface (h3) to activate the needle protection system. The needle protection system is fully activated when a 'click' is heard. Discard the syringe with needle appropriately. h1 h2 h3

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