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Invega Sustenna

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Invega Sustenna

Indications
Dosage
How Supplied

INDICATIONS

INVEGA® SUSTENNA® (paliperidone palmitate) is indicated for the treatment of schizophrenia. Efficacy was established in four short-term studies and one longer-term study in adults [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Administration Instructions

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 intravascularly or subcutaneously. Avoid inadvertent injection into a blood vessel. Each injection must be administered only by a health care professional. 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 those ≥ 90 kg, the 1½-inch, 22 gauge needle is recommended. For those < 90 kg, the 1-inch, 23 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. Administer into the upper-outer quadrant of the gluteal muscle. Gluteal injections should be alternated between the two gluteal muscles.

Recommended Dosing

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® .

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. The recommended monthly maintenance dose is 117 mg; however, based on previous clinical history of tolerability and/or efficacy, some patients may benefit from lower or higher maintenance doses within the additional available strengths (39 mg, 78 mg, 156 mg, and 234 mg). Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.

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], 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.

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.

Missed second initiation dose ( < 4 weeks from first injection)

If less than 4 weeks have elapsed since the first injection, then the patient should be administered the second injection of 156 mg in the deltoid muscle as soon as possible. A third INVEGA® SUSTENNA® injection of 117 mg is recommended in either the deltoid or gluteal muscle administered 5 weeks after the first injection (regardless of the timing of the second injection). The normal monthly cycle of injections in either the deltoid or gluteal muscle of 39 mg to 234 mg based on individual patient tolerability and/or efficacy should be followed thereafter.

Missed second initiation dose (4-7 weeks from first injection)

If 4 to 7 weeks have elapsed since the first injection of INVEGA® SUSTENNA® , resume dosing with two injections of 156 mg in the following manner: a deltoid injection as soon as possible followed by another deltoid injection one week later, then resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 39 mg to 234 mg based on individual patient tolerability and/or efficacy.

Missed second initiation dose ( > 7 weeks from first injection)

If more than 7 weeks have elapsed since the first injection of INVEGA® SUSTENNA® , initiate dosing as described in Section 2.2 above.

Missed Maintenance Dose (1 Month to 6 Weeks)

After initiation, the recommended injection cycle of INVEGA® SUSTENNA® is monthly. If less than 6 weeks have elapsed since the last injection, then the previously stabilized dose should be administered as soon as possible, followed by injections at monthly intervals.

Missed Maintenance Dose ( > 6 Weeks to 6 Months)

If more than 6 weeks have elapsed since the last injection of INVEGA® SUSTENNA® , resume the same dose the patient was previously stabilized on (unless the patient was stabilized on a dose of 234 mg, then the first two injections should each be 156 mg) in the following manner: 1) a deltoid injection as soon as practically possible, followed by 2) another deltoid injection (same dose) one week later, and 3) resumption of either deltoid or gluteal dosing at monthly intervals.

Missed Maintenance Dose ( > 6 Months)

If more than 6 months have elapsed since the last injection of INVEGA® SUSTENNA® , initiate dosing as described in Section 2.1 above.

Use with Oral Paliperidone or with Risperidone

Concomitant use of INVEGA® SUSTENNA® with oral paliperidone or oral or injectable risperidone has not been studied. Since paliperidone is the major active metabolite of risperidone, consideration should be given to the additive paliperidone exposure if any of these medications are coadministered with INVEGA® SUSTENNA® .

Dosage Adjustments

Renal Impairment

INVEGA® SUSTENNA® has not been systematically studied in patients with renal impairment [see CLINICAL PHARMACOLOGY]. 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 and CLINICAL PHARMACOLOGY].

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

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 and CLINICAL PHARMACOLOGY].

Maintenance Therapy

INVEGA® SUSTENNA® has been shown to be effective in delaying time to relapse of symptoms of schizophrenia in long-term use. It is recommended that responding patients be continued on treatment at the lowest dose needed. Patients should be periodically reassessed to determine the need for continued treatment.

Switching from Other Antipsychotics

There are no systematically collected data to specifically address switching patients with schizophrenia 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 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. 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 1.

Table 1: 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
12 234
Dose (mg) 6 117
3 39-78

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. The recommended monthly maintenance dose is 117 mg; however, based on previous clinical history of tolerability and/or efficacy, some patients may benefit from lower or higher maintenance doses within the additional available strengths (39 mg, 78 mg, 156 mg, and 234 mg). Monthly maintenance doses can be administered in either the deltoid or gluteal muscle.

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.

Instructions For Use

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.

Contents of the kit -

INVEGA® SUSTENNA® is for single use only.

a. Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension.

Shake the syringe vigorously - Illustration

b. Select the appropriate needle.

For DELTOID injection, if the patient weighs < 200 lb ( < 90 kg), use the 1-inch 23 gauge needle (needle with blue colored hub); if the patient weighs ≥ 200 lb ( ≥ 90 kg), 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).

c. While holding the syringe upright, remove the rubber tip cap with an easy clockwise twisting motion.

Remove the rubber tip cap - Illustration

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.

Peel the safety needle pouch half way open - Illustration

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.

Pull the needle sheath away - Illustration

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.

De-aerate the syringe - Illustration

g. Inject the entire contents intramuscularly into the selected deltoid or gluteal muscle of the patient. Do not administer intravascularly or subcutaneously.

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

Activate the needle protection system - Illustration

h2

Activate the needle protection system - Illustration

h3

Activate the needle protection system - Illustration

HOW SUPPLIED

Dosage Forms And Strengths

INVEGA® SUSTENNA® is available as a white to off-white aqueous extended-release injectable suspension for intramuscular injection in dose strengths of 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg paliperidone palmitate.

INVEGA® SUSTENNA® is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in dose strengths of 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg paliperidone palmitate. The kit contains a prefilled syringe and 2 safety needles (a 1 ½- inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).

39 mg paliperidone palmitate kit (NDC 50458-560-01)
78 mg paliperidone palmitate kit (NDC 50458-561-01)
117 mg paliperidone palmitate kit (NDC 50458-562-01)
156 mg paliperidone palmitate kit (NDC 50458-563-01)
234 mg paliperidone palmitate kit (NDC 50458-564-01)

Storage And Handling

Store at room temperature (25°C, 77°F); excursions between 15°C and 30°C (between 59°F and 86°F) are permitted.

Keep out of reach of children.

Manufactured by: Janssen Pharmaceutica N.V. Beerse, Belgium Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560

Last reviewed on RxList: 5/19/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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