Peginterferon Beta-1a

Peginterferon Beta-1a
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Peginterferon Beta-1a is an immunological agent that is FDA approved for the treatment of patients with relapsing forms of multiple sclerosis. Common adverse reactions include injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• PLEGRIDY (peginterferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Peginterferon Beta-1a in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Peginterferon Beta-1a in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Peginterferon Beta-1a in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Peginterferon Beta-1a in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Peginterferon Beta-1a in pediatric patients.

Contraindications

There is limited information regarding Peginterferon Beta-1a Contraindications in the drug label.

Warnings

Hepatic Injury

• Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure, have been reported with interferon beta. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge with interferon beta.

• Elevations in hepatic enzymes and hepatic injury have been observed with the use of PLEGRIDY in clinical studies. The incidence of increases in hepatic transaminases was greater in patients taking PLEGRIDY than in those taking placebo. The incidence of elevations of alanine aminotransferase above 5 times the upper limit of normal was 1% in placebo-treated patients and 2% in PLEGRIDY-treated patients. The incidence of elevations of aspartate aminotransferase above 5 times the upper limit of normal was less than 1% in placebo-treated patients and less than 1% in PLEGRIDY-treated patients. Elevations of serum hepatic transaminases combined with elevated bilirubin occurred in 2 patients. Both cases resolved following discontinuation of PLEGRIDY.

• Monitor patients for signs and symptoms of hepatic injury.

Depression and Suicide

• Depression, suicidal ideation, and suicide occur more frequently in patients receiving interferon beta than in patients receiving placebo.

• In clinical studies, the overall incidence of adverse events related to depression and suicidal ideation in multiple sclerosis patients was 8% in both the PLEGRIDY and placebo groups. The incidence of serious events related to depression and suicidal ideation was similar and less than 1% in both groups.

• Advise patients to report immediately any symptom of depression or suicidal ideation to their healthcare provider. If a patient develops depression or other severe psychiatric symptoms, consider stopping treatment with PLEGRIDY.

Seizures

• Seizures are associated with the use of interferon beta.

• The incidence of seizures in multiple sclerosis clinical studies was less than 1% in patients receiving PLEGRIDY and placebo.

• Exercise caution when administering PLEGRIDY to patients with a seizure disorder.

Anaphylaxis and Other Allergic Reactions

• Anaphylaxis and other serious allergic reactions are rare complications of treatment with interferon beta.

• Less than 1% of PLEGRIDY-treated patients experienced a serious allergic reaction such as angioedema or urticaria. Those who did have serious allergic reactions recovered promptly after treatment with antihistamines or corticosteroids.

• Discontinue PLEGRIDY if a serious allergic reaction occurs.

Injection Site Reactions

• Injection site reactions, including injection site necrosis, can occur with the use of subcutaneous interferon beta.

• In clinical studies, the incidence of injection site reactions (e.g., injection site erythema, pain, pruritus, or edema) was 66% in the PLEGRIDY group and 11% in the placebo group; the incidence of severe injection site reactions was 3% in the PLEGRIDY group and 0% in the placebo group. One patient out of 1468 patients who received PLEGRIDY in clinical studies experienced injection site necrosis. The injury resolved with standard medical treatment.

• Decisions to discontinue therapy following necrosis at a single injection site should be based on the extent of the necrosis. For patients who continue therapy with PLEGRIDY after injection site necrosis has occurred, avoid administration of PLEGRIDY near the affected area until it is fully healed. If multiple lesions occur, discontinue PLEGRIDY until healing occurs.

Congestive Heart Failure

• Congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure occur in patients receiving interferon beta.

• In clinical studies, the incidence of cardiovascular events was 7% in both PLEGRIDY and placebo treatment groups. No serious cardiovascular events were reported in the PLEGRIDY group.

• Monitor patients with significant cardiac disease for worsening of their cardiac condition during initiation and continuation of treatment with PLEGRIDY.

Decreased Peripheral Blood Counts

• Interferon beta can cause decreased peripheral blood counts in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia.

• In clinical studies, decreases in white blood cell counts below 3.0 x 109/L occurred in 7% of patients receiving PLEGRIDY and in 1% receiving placebo. There is no apparent association between decreases in white blood cell counts and an increased risk of infections or serious infections. The incidence of clinically significant decreases in lymphocyte counts (below 0.5 x 109/L), neutrophil counts (below 1.0 x 109/L), and platelet counts (below 100 x 109/L) were all less than 1% and similar in both placebo and PLEGRIDY groups. Two serious cases were reported in patients treated with PLEGRIDY: one patient (less than 1%) experienced severe thrombocytopenia (defined as a platelet count less than or equal to 10 x 109/L), and another patient (less than 1%) experienced severe neutropenia (defined as a neutrophil count less than or equal to 0.5 x 109/L). In both patients, cell counts recovered after discontinuation of PLEGRIDY. Compared to placebo, there were no significant differences in red blood cell counts in patients treated with PLEGRIDY.

• Monitor patients for infections, bleeding, and symptoms of anemia. Monitor complete blood cell counts, differential white blood cell counts, and platelet counts during treatment with PLEGRIDY. Patients with myelosuppression may require more intensive monitoring of blood cell counts.

Autoimmune Disorders

• Autoimmune disorders of multiple target organs including idiopathic thrombocytopenia, hyper- and hypothyroidism, and autoimmune hepatitis have been reported with interferon beta.

• In clinical studies, the incidence of autoimmune disorders was less than 1% in both PLEGRIDY and placebo treatment groups.

• If patients develop a new autoimmune disorder, consider stopping PLEGRIDY.

Adverse Reactions

Clinical Trials Experience

• The following serious adverse reactions are discussed in more detail in other sections of labeling:

• Hepatic Injury
• Depression and Suicide
• Seizures
• Anaphylaxis and Other Allergic Reactions
• Injection Site Reactions
• Congestive Heart Failure
• Decreased Peripheral Blood Counts
• Autoimmune Disorders

Clinical Trials Experience

• Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of PLEGRIDY cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

• In clinical studies (Study 1 and Study 2), a total of 1468 patients with relapsing multiple sclerosis received PLEGRIDY for up to 177 weeks (41 months), with an overall exposure equivalent to 1932 person-years. A total of 1093 patients received at least 1 year, and 415 patients at least 2 years of treatment with PLEGRIDY. A total of 512 and 500 patients, respectively, received PLEGRIDY 125 micrograms every 14 days or every 28 days during the placebo-controlled phase of Study 1 (year 1). The experience in year 2 of Study 1 and in the 2-year safety extension study (Study 2) was consistent with the experience in the 1-year placebo-controlled phase of Study 1.

• In the placebo-controlled phase of Study 1, the most common adverse drug reactions for PLEGRIDY 125 micrograms subcutaneously every 14 days were erythema, influenza-like illness, pyrexia, headache, myalgia, chills, pain, asthenia, pruritus, and arthralgia (all had incidence more than 10% and at least 2% more than placebo). The most commonly reported adverse event leading to discontinuation in patients treated with PLEGRIDY 125 micrograms subcutaneously every 14 days was influenza-like illness (in less than 1% of patients).

• TABLE 2 summarizes adverse reactions reported over 48 weeks from patients treated in the placebo-controlled phase of Study 1 who received subcutaneous PLEGRIDY 125 micrograms (n=512), or placebo (n=500), every 14 days.

This image is provided by the National Library of Medicine.

Immunogenicity

• For therapeutic proteins, there is a potential for immunogenicity. In Study 1, fewer than 1% of patients treated with PLEGRIDY every 14 days for 1 year developed neutralizing antibodies. Approximately 7% of PLEGRIDY-treated patients developed antibodies to PEG.

• The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to PLEGRIDY with the incidence of antibodies to other products may be misleading.

Flu-Like Symptoms

• Influenza-like illness was experienced by 47% of patients receiving PLEGRIDY 125 micrograms every 14 days and 13% of patients receiving placebo. Fewer than 1% of PLEGRIDY-treated patients in Study 1 discontinued treatment due to flu-like symptoms.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Peginterferon Beta-1a in the drug label.

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Peginterferon Beta-1a in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Peginterferon Beta-1a during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Peginterferon Beta-1a with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Peginterferon Beta-1a with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Peginterferon Beta-1a with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Peginterferon Beta-1a with respect to specific gender populations.

Race

There is no FDA guidance on the use of Peginterferon Beta-1a with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Peginterferon Beta-1a in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Peginterferon Beta-1a in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Peginterferon Beta-1a in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Peginterferon Beta-1a in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Peginterferon Beta-1a in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Peginterferon Beta-1a in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Peginterferon Beta-1a in the drug label.

Pharmacology

There is limited information regarding Peginterferon Beta-1a Pharmacology in the drug label.

Mechanism of Action

Structure

File:Peginterferon Beta-1a01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Peginterferon Beta-1a in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Peginterferon Beta-1a in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Peginterferon Beta-1a in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Peginterferon Beta-1a in the drug label.

How Supplied

Storage

There is limited information regarding Peginterferon Beta-1a Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Peginterferon Beta-1a |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Peginterferon Beta-1a |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Peginterferon Beta-1a in the drug label.

Precautions with Alcohol

• Alcohol-Peginterferon Beta-1a interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• PLEGRIDY®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Page Name=Peginterferon Beta-1a
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Peginterferon Beta-1a
 |Label Name=Peginterferon Beta-1a11.png

}}

{{#subobject:

 |Label Page=Peginterferon Beta-1a
 |Label Name=Peginterferon Beta-1a11.png

}}