Remleas Adverse Reactions

The following adverse reactions are discussed in more detail in other sections of the labelling: Hypersensitivity [see Contraindications]; Somnolence [see Precautions]; QT Prolongation [see Precautions]; Parkinsonism [see Precautions].
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Variable and Fixed Dose Placebo-Controlled Trial Experience: In 3 randomized, placebo-controlled studies REMLEAS was administered once daily for up to 6 weeks at doses ranging from 25 mg to 100 mg (N=254) compared to placebo (N=178). In the controlled trial setting, the REMLEAS study population was approximately 59% male, 59% White and 37% Black or African American, and the mean age was 56 years at study entry. The study population was diagnosed with schizophrenia or schizoaffective disorder (72%) or mood disorder (28%). At study initiation, 83% of patients were taking concomitant antipsychotic medication; 64% of patients specified concomitant atypical antipsychotic use and 19% of patients specified concomitant use of typical or both typical and atypical antipsychotics.
Common Adverse Reactions (incidence ≥5% and at least twice the rate of placebo): somnolence.
Adverse Reactions Leading to Discontinuation of Treatment: During the 6-week placebo-controlled studies, 4% (10/254) of REMLEAS-treated patients (doses ranging from 25 mg to 100 mg) and 5% (8/178) of placebo treated patients discontinued because of adverse reactions.
No single adverse reaction leading to discontinuation occurred at a rate of ≥2% and at least twice the rate of placebo in REMLEAS-treated patients.
Adverse reactions of interest that occurred in the 3 placebo-controlled studies are presented in Table 2. (See Table 2.)

Click on icon to see table/diagram/image

Other Adverse Reactions Observed During the Premarketing Evaluation of REMLEAS: Other adverse reactions of ≥1% incidence and greater than placebo are shown as follows.
The following list does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.
General Disorders: weight increased.
Infectious Disorders: respiratory infections.
Neurologic Disorders: drooling, dyskinesia, extrapyramidal symptoms (non-akathisia) including dystonia, extrapyramidal disorder, muscle rigidity, tremor, muscle spasms, and cogwheel rigidity.
Psychiatric Disorders: anxiety, insomnia.
During controlled trials, there was a dose-related increase in prolactin.
Postmarketing Experience: The following adverse reactions have been identified during post-approval use of REMLEAS that are not included in other sections of labeling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: hypersensitivity reactions (including allergic dermatitis, angioedema, pruritis, and urticaria).
Skin and Subcutaneous Tissue Disorders: rash.