Label Changes for:

Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension for intramuscular use

September 2011

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

 

September 2011

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

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.

 

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