Drugplain

INVEGA SUSTENNA 117 mg/.75mL

paliperidone palmitate · INJECTION · Janssen Pharmaceuticals, Inc.

1 Recall on Record
Plain English

INVEGA SUSTENNA is a injection containing paliperidone palmitate at 117 mg/.75mL, taken intramuscular. Manufactured by Janssen Pharmaceuticals, Inc..

Key Facts

Brand Name
INVEGA SUSTENNA
Generic Name
paliperidone palmitate
NDC Code (Product)
50458-562
Manufacturer
Janssen Pharmaceuticals, Inc.
Strength
117 mg/.75mL
Dosage Form
INJECTION
Route
INTRAMUSCULAR
Marketing Status
Application #
NDA022264
Marketing Start
07/31/2009

Recall History

1 Recall on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use2,694 reports
drug ineffective1,746 reports
hospitalisation1,612 reports
weight increased1,537 reports
drug dose omission1,339 reports
product dose omission issue1,075 reports
gynaecomastia1,065 reports
treatment noncompliance865 reports
schizophrenia859 reports
blood prolactin increased829 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia in adults [see Clinical Studies (14.1) ]. Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2) ]. INVEGA SUSTENNA is an atypical antipsychotic indicated for Treatment of schizophrenia in adults. ( 1 ) Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For intramuscular injection only. ( 2.1 ) Each injection must be administered only by a healthcare professional. ( 2.1 ) For deltoid injection, use 1-inch 23G needle for patients weighing less than 90 kg or 1½-inch 22G needle for patients weighing 90 kg or more. For gluteal injection, use 1½-inch 22G needle regardless of patient weight. ( 2.1 ) Indication Initiation Dosing (deltoid) Monthly Maintenance Dose Administered 5 weeks after the first injection. (deltoid or gluteal) Maximum Monthly Dose Day 1 Day 8 Schizophrenia ( 2.2 ) 234 mg 156 mg 39–234 mg 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). 234 mg Schizoaffective disorder ( 2.2 ) 234 mg 156 mg 78–234 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. 234 mg For patients naïve to oral paliperidone or oral or injectable risperidone, establish tolerability with oral paliperidone or oral risperidone prior to initiating tr…

Contraindications

4 CONTRAINDICATIONS INVEGA SUSTENNA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA SUSTENNA formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone. Known hypersensitivity to paliperidone, risperidone, or to any excipients in INVEGA SUSTENNA. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Drugs that may cause orthostatic hypotension: An additive effect may occur when co-administered with INVEGA SUSTENNA. ( 7.1 ) Strong CYP3A4/P-glycoprotein (P-gp) inducers : Avoid using a strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John's Wort) during a dosing interval for INVEGA SUSTENNA. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets. ( 2.5 , 7.1 , 12.3 ) 7.1 Drugs Having Clinically Important Interactions with INVEGA SUSTENNA Because paliperidone palmitate is hydrolyzed to paliperidone [see Clinical Pharmacology (12.3) ] , results from studies with oral paliperidone should be taken into consideration when assessing drug-drug interaction potential. Table 13. Clinically Important Drug Interactions with INVEGA SUSTENNA Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Centrally Acting Drugs and Alcohol Given the primary CNS effects of paliperidone, concomitant use of centrally acting drugs and alcohol may modulate the CNS effects of INVEGA SUSTENNA. INVEGA SUSTENNA should be used with caution in combination with other centrally acting…

Adverse Reactions

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] QT prolongation [see Warnings and Precautions (5.4) ] Tardive dyskinesia [see Warnings and Precautions (5.5) ] Metabolic changes [see Warnings and Precautions (5.6) ] Orthostatic hypotension and syncope [see Warnings and Precautions (5.7) ] Falls [see Warnings and Precautions (5.8) ] Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions (5.9) ] Hyperprolactinemia [see Warnings and Precautions (5.10) ] Potential for cognitive and motor impairment [see Warnings and Precautions (5.11) ] Seizures [see Warnings and Precautions (5.12) ] Dysphagia [see Warnings and Precautions (5.13) ] Priapism [see Warnings and Precautions (5.14) ] Disruption of body temperature regulation [see Warnings and Precautions (5.15) ] The most common adverse re…

Frequently Asked Questions

What is INVEGA SUSTENNA used for?

INVEGA SUSTENNA contains paliperidone palmitate. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is INVEGA SUSTENNA a controlled substance?

INVEGA SUSTENNA is not classified as a controlled substance by the DEA.

What is the generic name for INVEGA SUSTENNA?

The generic name for INVEGA SUSTENNA is paliperidone palmitate. There are 8 other brand versions of paliperidone palmitate.

What is the NDC code for INVEGA SUSTENNA 117 mg/.75mL?

The NDC (National Drug Code) for INVEGA SUSTENNA 117 mg/.75mL is 50458-562, listed by Janssen Pharmaceuticals, Inc..

Product NDC

50458-562

Package NDC

50458-562-01

Other Paliperidone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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