Results from the registration Phase 3 study
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SELECT IMPORTANT SAFETY INFORMATION

WARNING: DEPRESSION AND OTHER NEUROPSYCHIATRIC DISORDERS
The risk of serious depression, with suicidal ideation and completed suicides, and other serious neuropsychiatric disorders are increased with alpha interferons, including SYLATRON. Permanently discontinue SYLATRON in patients with persistently severe or worsening signs or symptoms of depression, psychosis, or encephalopathy. These disorders may not resolve after stopping SYLATRON.

View additional SELECT IMPORTANT SAFETY INFORMATION for SYLATRON  

In the Registration Phase 3 Study

  • Once-weekly dose of SYLATRON was adjusted to maintain an ECOG Performance Status of 0 or 1.
  • Patients achieved a significant improvement in relapse-free survival:
    • Based on 696 RFS events, determined by the Independent Review Committee.
    • Median RFS was 34.8 months (95% CI, 26.1–47.4) and 25.5 months (95% CI, 19.6–30.8) in the group treated with SYLATRON and the observation group, respectively.
    • The estimated hazard ratio for RFS was 0.82 (95% CI, 0.71–0.96; unstratified log-rank P=0.011) in favor of SYLATRON.

SELECT IMPORTANT SAFETY INFORMATION

SYLATRON is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, in patients with autoimmune hepatitis, and in patients with hepatic decompensation (Child-Pugh score >6 [Class B and C]).

Peginterferon alfa-2b can cause life-threatening or fatal neuropsychiatric reactions. These include suicide, suicidal and homicidal ideation, depression, and an increased risk of relapse of recovering drug addicts. Depression occurred in 59% of patients treated with SYLATRON and 24% of patients in the observation group. Depression was severe or life threatening in 7% of patients treated with SYLATRON compared with <1% of patients in the observation arm. Monitor and evaluate patients for signs and symptoms of depression and other psychiatric symptoms every 3 weeks during the first 8 weeks of treatment and every 6 months thereafter. Monitor patients during treatment and for at least 6 months after the last dose of SYLATRON. Permanently discontinue SYLATRON for persistent severe or worsening psychiatric symptoms or behaviors and refer for psychiatric evaluation.

Cardiac adverse reactions, including myocardial infarction, bundle-branch block, ventricular tachycardia, and supraventricular arrhythmia, occurred in 4% of patients treated with SYLATRON compared with 2% of patients in the observation group. Hypotension, cardiomyopathy, and angina pectoris have occurred in patients treated with peginterferon alfa-2b. Permanently discontinue SYLATRON for new onset of ventricular arrhythmia or cardiovascular decompensation.

Peginterferon alfa-2b can cause decrease in visual acuity or blindness due to retinopathy. Retinal and ocular changes including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema, and serous retinal detachment may be induced or aggravated by treatment with peginterferon alfa-2b or other alpha interferons. The overall incidence of serious retinal disorders, visual disturbances, blurred vision, and reduction in visual acuity was <1% in both patients treated with SYLATRON and those in the observation group. Perform an eye examination that includes assessment of visual acuity and indirect ophthalmoscopy or fundus photography at baseline in patients with preexisting retinopathy and at any time during treatment with SYLATRON in patients who experience changes in vision. Permanently discontinue SYLATRON in patients who develop new or worsening retinopathy.

Peginterferon alfa-2b increases the risk of hepatic decompensation and death in patients with cirrhosis. Monitor hepatic function with serum bilirubin, ALT, AST, alkaline phosphatase, and LDH at 2 and 8 weeks, and 2 and 3 months, following initiation of SYLATRON, then every 6 months while receiving SYLATRON. Permanently discontinue SYLATRON for evidence of severe (Grade 3) hepatic injury or hepatic decompensation (Child-Pugh score >6 [Class B and C]).

Peginterferon alfa-2b can cause new onset or worsening of hypothyroidism, hyperthyroidism, and diabetes mellitus. Hypothyroidism developed in 1% of patients treated with SYLATRON. The overall incidence of endocrine disorders was 2% in patients treated with SYLATRON compared to <1% for patients in the observation group. Obtain TSH levels within 4 weeks prior to initiation of SYLATRON, at 3 and 6 months following initiation, then every 6 months thereafter while receiving SYLATRON. Permanently discontinue SYLATRON in patients who develop hypothyroidism, hyperthyroidism, or diabetes mellitus that cannot be effectively managed.

The most common adverse reactions in patients treated with SYLATRON vs observation were fatigue (94% vs 41%), increased ALT (77% vs 26%), increased AST (77% vs 26%), pyrexia (75% vs 9%), headache (70% vs 19%), anorexia (69% vs 13%), myalgia (68% vs 23%), nausea (64% vs 11%), chills (63% vs 6%), and injection site reaction (62% vs 0%).

The most common serious adverse reactions in patients treated with SYLATRON vs observation were fatigue (7% vs <1%), increased ALT (3% vs <1%), increased AST (3% vs <1%), and pyrexia (3% vs <1%).

Thirty-three percent of patients receiving SYLATRON discontinued treatment due to adverse reactions.

When administering SYLATRON with medications metabolized by CYP2C9 or CYP2D6, the therapeutic effect of these drugs may be altered.

There are no adequate and well-controlled studies of SYLATRON in pregnant women. Use SYLATRON during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether the components of SYLATRON are excreted in human milk. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with SYLATRON.

Safety and effectiveness in patients below the age of 18 years have not been established.

Increase frequency of monitoring for toxicity with SYLATRON in patients with moderate and severe renal impairment.

Before prescribing SYLATRON, please read the Prescribing Information, including the Boxed Warning about depression and other neuropsychiatric disorders. The Medication Guide and Instructions for Use also are available.

ECOG=Eastern Cooperative Oncology Group; RFS=relapse-free survival; CI=confidence interval.

SYLATRON™  (peginterferon alfa-2b)