If a second initiation dose is missed1

  • Less than 4 weeks since first injection

Administer the second initiation dose of 156 mg in the deltoid muscle as soon as possible

  1. Administer a third injection of 117 mg in either the deltoid or gluteal muscle 5 weeks after the first injection (regardless of timing of the second injection)
  2. Resume regular monthly dosing in either the deltoid or gluteal muscle
  • 4 to 7 weeks since first injection

Resume dosing with 2 injections of 156 mg:

  1. Deltoid injection as soon as possible
  2. Deltoid injection 1 week later
  3. Regular monthly dosing in either the deltoid or gluteal muscle
  • More than 7 weeks since first injection

Restart dosing with normal initiation plan:

  1. 234-mg deltoid injection at day 1
  2. 156-mg deltoid injection 1 week later
  3. Resume regular monthly dosing in either the deltoid or gluteal muscle

Second initiation dose may be given within a ± 4-day flexible dosing window1

If a monthly dose is missed1

  • 4 to 6 weeks since last injection

Resume regular dosing as soon as possible at patient’s previously stabilized dose, followed by injections at monthly intervals

  • More than 6 weeks to 6 months since last injection

Continue dosing at patient’s previously stabilized dose* by giving:

  1. Deltoid injection as soon as possible
  2. Second deltoid injection 1 week later at same dose
  3. Resume monthly deltoid or gluteal injections at patient’s previously stabilized dose 1 month after second dose

*If the patient was stabilized on 234 mg, the first 2 doses should be 156 mg.

  • More than 6 months since last injection

Restart dosing with normal initiation plan:

  1. 234-mg deltoid injection at day 1
  2. 156-mg deltoid injection 1 week later
  3. Resume regular monthly dosing in either the deltoid or gluteal muscle

To help avoid a missed monthly maintenance dose, patients may be given their monthly maintenance dose within a ± 7-day flexible dosing window1

Missing doses should be avoided1

Dose adjustments and special populations1

  • INVEGA SUSTENNA® has not been systematically studied in patients with renal impairment1
  • The dose of INVEGA SUSTENNA® should be reduced in patients with mild renal impairment (creatinine clearance ≥50 mL/min to <80 mL/min*)1
    • Recommended initiation dose of INVEGA SUSTENNA® is 156 mg on day 1 and 117 mg 1 week later, both administered in the deltoid muscle
    • Follow with monthly injections of 78 mg in either the deltoid or gluteal muscle
  • INVEGA SUSTENNA® is not recommended in patients with moderate or severe renal impairment (creatinine clearance <50 mL/min*)1

*Cockcroft-Gault formula.

Coadministration with strong inducers of both CYP3A4 and P-glycoprotein1

  • Avoid using a strong inducer of CYP3A4 and/or P-gp (eg, 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 patient using paliperidone extended-release tablets1
  • Adequate and well-controlled studies with INVEGA SUSTENNA® have not been conducted in pregnant women. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery1
  • INVEGA SUSTENNA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus1

Reference: 1. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2018.