- For US Healthcare Professionals Only
What to do if your patient misses an INVEGA SUSTENNA® dose1
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
- 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)
- 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:
- Deltoid injection as soon as possible
- Deltoid injection 1 week later
- Regular monthly dosing in either the deltoid or gluteal muscle
- More than 7 weeks since first injection
Restart dosing with normal initiation plan:
- 234 mg deltoid injection at day 1
- 156 mg deltoid injection 1 week later
- 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:
- Deltoid injection as soon as possible
- Second deltoid injection 1 week later at same dose
- 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:
- 234 mg deltoid injection at day 1
- 156 mg deltoid injection 1 week later
- 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 window.1 The utilization of this practice should be considered the exception rather than the rule.
Missing doses should be avoided1
Dose adjustments and special populations1
Renal impairment
- INVEGA SUSTENNA® has not been systematically studied in patients with renal impairment1
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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.
CYP3A4/P-gp
Coadministration with strong inducers of both CYP3A4 and P-glycoprotein (P-gp)1
- 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
Pregnancy and nursing
- 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.; January 2019.