INVEGA HAFYERA 1092 mg/3.5mL

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

No Recall History

Plain English

INVEGA HAFYERA is a injection, suspension, extended release containing paliperidone palmitate at 1092 mg/3.5mL, taken intramuscular. Manufactured by Janssen Pharmaceuticals, Inc.

Key Facts

Brand Name: INVEGA HAFYERA
Generic Name: paliperidone palmitate
NDC Code (Product): 50458-611
Manufacturer: Janssen Pharmaceuticals, Inc
Strength: 1092 mg/3.5mL
Dosage Form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: INTRAMUSCULAR
Marketing Status
Application #: NDA207946
Marketing Start: 08/30/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

hospitalisation424 reports

drug ineffective396 reports

schizophrenia309 reports

off label use286 reports

condition aggravated247 reports

death243 reports

suicide attempt243 reports

dyskinesia231 reports

sedation220 reports

sexual dysfunction208 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE INVEGA HAFYERA, an every-six-month injection, is indicated for the treatment of schizophrenia in adults after they have been adequately treated with: A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA) for at least four months, or An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA TRINZA) for at least one three-month cycle. INVEGA HAFYERA, an every-six-month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in adults after they have been adequately treated with: A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA) for at least four months or An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA TRINZA) for at least one three-month cycle. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administer INVEGA HAFYERA by gluteal injection once every 6 months by a healthcare professional. Do not administer by any other route. ( 2.1 ) See Full Prescribing Information for complete dosing information. ( 2.2 ) Initiate INVEGA HAFYERA when the next once-a-month or every three-month paliperidone palmitate extended-release injectable suspension dose is scheduled. Dose is based on the previous once-a-month or every-three-month product. ( 2.2 ): INVEGA HAFYERA Doses for Adults Adequately Treated with Once-a-month paliperidone palmitate extended-release injectable suspension (PP1M) Switching from the PP1M 39 mg, 78 mg and 117 mg doses was not studied. If the Last Dose of PP1M is: Initiate INVEGA HAFYERA at the Following Dose: 156 mg 1,092 mg 234 mg 1,560 mg INVEGA HAFYERA Doses for Adults Adequately Treated with Every-three-month paliperidone palmitate injectable suspension (PP3M) Switching from the PP3M 273 mg and 410 mg doses was not studied. If the Last Dose of PP3M is: Initiate INVEGA HAFYERA at the Following Dose: 546 mg 1,092 mg 819 mg 1,560 mg Missed Doses: Refer to the Full Prescribing Information. ( 2.3 ) See Full Prescribing Information for im…

Contraindications

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

Drug Interactions

7 DRUG INTERACTIONS Strong CYP3A4/P-glycoprotein (P-gp) inducers : Avoid using strong CYP3A4 and/or P-gp inducers during a dosing interval for INVEGA HAFYERA. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets. ( 7.1 , 12.3 ) 7.1 Drugs Having Clinically Important Interactions with INVEGA HAFYERA Because paliperidone palmitate is hydrolyzed to paliperidone, results from studies with oral paliperidone should be taken into consideration when assessing drug-drug interaction potential. In addition, consider the 6-month dosing interval and the half-life of INVEGA HAFYERA [see Clinical Pharmacology (12.3) ] . Table 10 presents clinically significant drug interactions with INVEGA HAFYERA. Table 10. Clinically Important Drug Interactions with INVEGA HAFYERA Centrally acting Drugs and Alcohol Clinical Rationale Given the primary CNS effects of paliperidone, concomitant use of centrally acting drugs and alcohol may modulate the CNS effects of INVEGA HAFYERA. Clinical Recommendation INVEGA HAFYERA should be used with caution with other centrally acting drugs and alcohol. Drugs with Potential for Inducing Orthostatic Hypoten…

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 HAFYERA used for?

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

Is INVEGA HAFYERA a controlled substance?

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

What is the generic name for INVEGA HAFYERA?

The generic name for INVEGA HAFYERA is paliperidone palmitate. There are 11 other brand versions of paliperidone palmitate.

What is the NDC code for INVEGA HAFYERA 1092 mg/3.5mL?

The NDC (National Drug Code) for INVEGA HAFYERA 1092 mg/3.5mL is 50458-611, listed by Janssen Pharmaceuticals, Inc.

Product NDC

50458-611

Package NDC

50458-611-01

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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