- ON THIS PAGE:
- Missed Doses
- Dose Adjustments and Special Populations
Missed doses
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.
- 1Administer 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) - 2Resume 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:
- 1Deltoid injection as soon as possible
- 2Deltoid injection 1 week later
- 3Regular monthly dosing in either the deltoid or gluteal muscle
MORE THAN 7 WEEKS SINCE FIRST INJECTION
Restart dosing with normal initiation plan:
- 1234 mg deltoid injection on Day 1
- 2156 mg deltoid injection 1 week later*
- 3Resume regular monthly dosing in either the deltoid or gluteal muscle
*Second initiation dose may be given within a ±4-day flexible dosing window.1
If a monthly maintenance 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:
- 1Deltoid injection as soon as possible
- 2Second deltoid injection 1 week later at same dose
- 3Resume 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:
- 1234 mg deltoid injection on Day 1
- 2156 mg deltoid injection 1 week later
- 3Resume 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 avoided.1
Dose adjustments and special populations1
Patients with renal impairment
- 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
- Adjust monthly maintenance dose based on tolerability and/or efficacy within the strengths of 39 mg, 78 mg, 117 mg, or 156 mg
- The maximum monthly dose is 156 mg for patients with mild renal impairment
- 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-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
Patients who are pregnant or 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
- If you become pregnant while taking INVEGA SUSTENNA®, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
CYP3A4=cytochrome P450 3A4.
Reference: 1. INVEGA SUSTENNA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.