Drugplain

INVEGA TRINZA 819 mg/2.63mL

paliperidone palmitate · INJECTION, SUSPENSION, EXTENDED RELEASE · Janssen Pharmaceuticals, Inc

No Recall History
Plain English

INVEGA TRINZA is a injection, suspension, extended release containing paliperidone palmitate at 819 mg/2.63mL, taken intramuscular. Manufactured by Janssen Pharmaceuticals, Inc.

Key Facts

Brand Name
INVEGA TRINZA
Generic Name
paliperidone palmitate
NDC Code (Product)
50458-609
Manufacturer
Janssen Pharmaceuticals, Inc
Strength
819 mg/2.63mL
Dosage Form
INJECTION, SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
Marketing Status
Application #
NDA207946
Marketing Start
05/19/2015

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective744 reports
off label use726 reports
hospitalisation598 reports
schizophrenia492 reports
condition aggravated444 reports
product dose omission issue327 reports
death303 reports
therapeutic response decreased290 reports
psychotic disorder282 reports
weight increased280 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE INVEGA TRINZA (paliperidone palmitate), a 3-month injection, is indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) for at least four months [see Dosage and Administration (2.2) and Clinical Studies (14) ] . INVEGA TRINZA, a 3-month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) for at least four months. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Use INVEGA TRINZA only after the patient has been adequately treated with the 1-month paliperidone palmitate extended-release injectable suspension for at least four months. ( 2.2 ) INVEGA TRINZA should be administered once every 3 months. ( 2.1 ) For intramuscular injection only. ( 2.1 ) Each injection must be administered only by a healthcare professional. ( 2.1 ) For deltoid injection: For patients weighing less than 90 kg, use the 1-inch 22 gauge thin wall needle. For patients weighing 90 kg or more, use the 1½-inch 22 gauge thin wall needle. For gluteal injection: Regardless of patient weight, use the1½-inch 22 gauge thin wall needle. Prior to administration, shake the prefilled syringe vigorously for at least 15 seconds within 5 minutes prior to administration to ensure a homogeneous suspension. ( 2.1 ) Initiate INVEGA TRINZA when the next 1-month paliperidone palmitate dose is scheduled with an INVEGA TRINZA dose based on the previous 1-month injection dose as shown below. ( 2.2 ) INVEGA TRINZA Doses for Adult Patients Adequately Treated with INVEGA SUSTENNA If the Last Dose of INVEGA SUSTENNA is: Initiate INVEGA TRINZA at the Following Dose: 78 m…

Contraindications

4 CONTRAINDICATIONS INVEGA TRINZA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA TRINZA 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 TRINZA. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 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 TRINZA. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended release tablets. ( 7.2 , 12.3 ) 7.1 Drugs Having Clinically Important Interactions with INVEGA TRINZA 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. In addition, consider the 3-month dosing interval and long half-life of INVEGA TRINZA [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] . Table 11. Clinically Important Drug Interactions with INVEGA TRINZA 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 TRINZA. INVEGA TRINZA should be used with caution in combination with other…

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 TRINZA used for?

INVEGA TRINZA contains paliperidone palmitate. It is a injection, suspension, extended release taken intramuscular. Consult your doctor for specific uses.

Is INVEGA TRINZA a controlled substance?

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

What is the generic name for INVEGA TRINZA?

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

What is the NDC code for INVEGA TRINZA 819 mg/2.63mL?

The NDC (National Drug Code) for INVEGA TRINZA 819 mg/2.63mL is 50458-609, listed by Janssen Pharmaceuticals, Inc.

Product NDC

50458-609

Package NDC

50458-609-01

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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