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U.S. Department of Health and Human Services

Safety

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Invega Sustenna (paliperidone palmitate) extended-release injectable suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

April 2014

Summary View

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • added ..... ileus
  • added ..... Very rarely, cases of anaphylactic reaction after injection with INVEGA SUSTENNA have been reported during postmarketing experience in patients who have previously tolerated oral risperidone or oral paliperidone

7 DRUG INTERACTIONS

7.2 Potential for Other Drugs to Affect INVEGA
  • Co-administration of INVEGA 6 mg once daily with carbamazepine, a strong inducer of both CYP3A4 and P-glycoprotein (P-gp), at 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone. This decrease ..... 

 

September 2011

Summary View

WARNINGS and PRECAUTIONS

Metabolic Changes
  • Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.

 

June 2011

Summary View 

 

DRUG INTERACTION

Potential for Invega to Affect Other Drugs
  • Pharmacokinetic interaction between Invega Sustenna and lithium is unlikely. In a drug interaction study, co-administration of oral paliperidone extended-release tablets (12 mg once daily for 5 days) with divalproex sodium extended-release tablets (500 mg to 2000 mg once daily) did not affect the steady-state pharmacokinetics (AUC24h and Cmax,ss) of valproate in 13 patients stabilized on valproate. In a clinical study, subjects on stable doses of valproate had comparable valproate average plasma concentrations when oral paliperidone extended-release tablets 3-15 mg/day was added to their existing valproate treatment.
Potential for Other Drugs to Affect Invega Sustenna
  • Pharmacokinetic interaction between lithium and Invega Sustenna is unlikely.

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • In a study in which juvenile rats were treated with oral paliperidone from days 24 to 73 of age, a reversible impairment of performance in a test of learning and memory was seen, in females only, with a no-effect dose of 0.63 mg/kg/day, which produced plasma levels (AUC) of…
  • The long-term effects of paliperidone on growth and sexual maturation have not been fully evaluated in children and adolescents.

 

May 2010

Summary View

ADVERSE REACTIONS

Commonly-Observed Adverse Events in Double-Blind, Placebo-Controlled Clinical Trials
  • (updated) Table 2. Incidence if Treatment Emergent Adverse Events in ≥2% of Invega Sustenna-Treated Subjects with Schizophrenia in Four Fixed- Dose, Double-Blind, Placebo-Controlled Trials 
Adverse Reactions Observed During the Clinical Trial Evaluation of Invega Sustenna and Not Listed in Table 2 
  • section updated
Adverse Reactions Reported in Clinical Trials with Oral Paliperidone
  • Cardiac disorders: bundle branch block left
  • Gastrointestinal disorders: flatulence, small intestinal obstruction
  • General disorders and administration site conditions: edema peripheral
  • Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, torticollis, trismus
  • Nervous system disorders: cogwheel rigidity, grand mal convulsion, parkinsonian gait, transient ischemic attack
  • Psychiatric disorders: sleep disorder
  • Reproductive system and breast disorders: breast engorgement, breast tenderness/breast pain, retrograde ejaculation
  • Respiratory, thoracic and mediastinal disorders: nasal congestion, pharyngolaryngeal pain, pneumonia aspiration
  • Skin and subcutaneous tissue disorders: rash papular
  • Vascular disorders: hypotension
Postmarketing Experience
  • The following adverse reactions have been identified during postapproval use of paliperidone; because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency: angioedema, priapism, swollen tongue, urinary incontinence, urinary retention.