Drugplain

Erzofri extended-release 156 mg/mL

paliperidone palmitate · INJECTION · Shandong Luye Pharmaceutical Co., Ltd.

No Recall History
Plain English

Erzofri extended-release is a injection containing paliperidone palmitate at 156 mg/mL, taken intramuscular. Manufactured by Shandong Luye Pharmaceutical Co., Ltd..

Key Facts

Brand Name
Erzofri extended-release
Generic Name
paliperidone palmitate
NDC Code (Product)
72526-108
Manufacturer
Shandong Luye Pharmaceutical Co., Ltd.
Strength
156 mg/mL
Dosage Form
INJECTION
Route
INTRAMUSCULAR
Marketing Status
Application #
NDA216352
Marketing Start
12/10/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

hospitalisation406 reports
drug ineffective318 reports
schizophrenia263 reports
death242 reports
off label use241 reports
suicide attempt241 reports
dyskinesia228 reports
sedation218 reports
sexual dysfunction205 reports
dystonia197 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ERZOFRI is indicated for the treatment of: Schizophrenia in adults . Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants . ERZOFRI 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 patients naïve to oral or injectable paliperidone, or oral or injectable risperidone, establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with ERZOFRI. ( 2.1 ) Each injection must be administered by a healthcare professional. ( 2.1 ) Initiate ERZOFRI by intramuscular injection in the deltoid muscle. Following the initial dose, monthly doses can be administered in either the gluteal or deltoid muscle. Do not administer by any other route. ( 2.1 ) Dosage recommendations: Indication Initial Dose (deltoid) Day 1 Monthly Dosage Administered 4 weeks after the first injection. (deltoid or gluteal) Maximum Monthly Dosage Schizophrenia ( 2.1 ) 351 mg 39 mg to 234 mg Recommended monthly dosage for treatment of schizophrenia is 117 mg. Some patients may benefit from lower or higher monthly doses within the additional available strengths (39 mg, 78 mg, 156 mg, and 234 mg). 234 mg Schizoaffective disorder ( 2.1 ) 351 mg 78 mg to 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 Missed dose: Refer …

Contraindications

4 CONTRAINDICATIONS ERZOFRI is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the ERZOFRI formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone [see Adverse Reactions (6.1 , 6.2) ] . Known hypersensitivity to paliperidone, risperidone, or to any excipients in ERZOFRI. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Drugs that may cause orthostatic hypotension: An additive effect may occur when co-administered with ERZOFRI. ( 7.1 ) Strong CYP3A4 and P-glycoprotein (P-gp) inducers : Avoid using a strong inducer of CYP3A4 and/or P-gp during a dosing interval for ERZOFRI. If concomitant use is necessary, consider using paliperidone extended-release tablets. ( 2.5 , 7.1 , 12.3 ) 7.1 Drugs Having Clinically Important Interactions with ERZOFRI 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 12 presents clinically significant drug interactions with ERZOFRI. Table 12: Clinically Important Drug Interactions with ERZOFRI 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 ERZOFRI. Clinical Recommendation: ERZOFRI should be used with caution in combination with other centrally acting drugs and alcohol [see Adverse Reactions (6.1 , 6.2) ] . Drugs with Potential for Induci…

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 Erzofri extended-release used for?

Erzofri extended-release contains paliperidone palmitate. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is Erzofri extended-release a controlled substance?

Erzofri extended-release is not classified as a controlled substance by the DEA.

What is the generic name for Erzofri extended-release?

The generic name for Erzofri extended-release is paliperidone palmitate. There are 9 other brand versions of paliperidone palmitate.

What is the NDC code for Erzofri extended-release 156 mg/mL?

The NDC (National Drug Code) for Erzofri extended-release 156 mg/mL is 72526-108, listed by Shandong Luye Pharmaceutical Co., Ltd..

Product NDC

72526-108

Package NDC

72526-108-11

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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