Plegridy

— THERAPEUTIC CATEGORIES —
  • Multiple sclerosis
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Plegridy Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Peginterferon beta-1a 63mcg, 94mcg, 125mcg; per 0.5mL prefilled pen or syringe; soln for SC or IM inj; preservative-free.

    Pharmacological Class

    Immunomodulator.

    How Supplied

    For SC: single-dose prefilled pens (125mcg/0.5mL)—2; single-dose prefilled syringes (125mcg/0.5mL)—2; Starter Pack (pens and syringes)—2 (63mcg/0.5mL + 94mcg/0.5mL); For IM: single-dose prefilled syringes (125mcg/0.5mL)—2; Titration Kit (syringes)—2 (63mcg/0.5mL + 94mcg/0.5mL)

    How Supplied

    Plegridy (peginterferon beta-1a) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution supplied as a 0.5 mL single-dose prefilled pen or a 0.5 mL single-dose prefilled syringe.

    Subcutaneous Administration

    Plegridy (peginterferon beta-1a) injection for subcutaneous use is supplied as a single-dose prefilled pen or single-dose prefilled syringe with a rubber stopper and a 29-gauge, 0.5-inch staked needle with a rigid needle shield in the following packaging configurations:

    • Carton containing two-125 mcg/0.5 mL single-dose prefilled pens of Plegridy 

    • Starter Pack carton containing two single-dose prefilled pens; dose 1 provides 63 mcg/0.5 mL of Plegridy and dose 2 provides 94 mcg/0.5 mL of Plegridy 

    • Carton containing two-125 mcg/0.5 mL single-dose prefilled syringes of Plegridy 

    • Starter Pack carton containing two single-dose prefilled syringes; dose 1 provides 63 mcg/0.5 mL of Plegridy, and dose 2 provides 94 mcg/0.5 mL of Plegridy 

    Intramuscular Administration

    Plegridy (peginterferon beta-1a) injection for intramuscular use is supplied as a single-dose prefilled syringe with a rubber stopper and a 23-gauge, 1.25-inch staked needle provided separately with the syringe in the following packaging configurations:

    • Carton containing two-125 mcg/0.5 mL single-dose prefilled syringes of Plegridy 

    • The Plegridy Titration Kit must be prescribed and dispensed separately for treatment initiation. The Titration Kit contains two titration clips: The yellow clip (for dose 1) allows a delivered dose of 63 mcg of Plegridy, and the purple clip (for dose 2) allows a delivered dose of 94 mcg of Plegridy. 

    Storage

    • Store Plegridy prefilled pens and prefilled syringes in a refrigerator between 2°C to 8°C (36°F to 46°F) in the closed original carton to protect from light until ready for injection. Do not freeze. Discard if frozen. 
    • If refrigeration is unavailable, Plegridy may be stored at room temperature up to 25°C (77°F) for a period up to 30 days, protected from light. Plegridy can be removed from, and returned to, a refrigerator if necessary. The total combined time out of refrigeration should not exceed 30 days. Plegridy prefilled syringe for intramuscular administration contains natural rubber latex which may cause allergic reactions.

     

    Manufacturer

    Biogen

    Generic Availability

    NO

    Mechanism of Action

    The mechanism by which peginterferon beta-1a exerts its therapeutic effect in multiple sclerosis is unknown.

    Plegridy Indications

    Indications

    Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

    Plegridy Dosage and Administration

    Adult

    See full labeling. May give by SC inj in abdomen, back of the upper arm, or by SC or IM inj in thigh(s). Rotate inj sites. Initially 63mcg on Day 1, increase to 94mcg on Day 15, then 125mcg on Day 29 and every 14 days thereafter. May give analgesics and/or antipyretics for flu-like symptoms. Switching between SC and IM inj or vice versa has not been studied.

    Adult

    Recommended Maintenance Dosage

    • May only administer subcutaneously (SC) or intramuscularly (IM).

    • After initial titration, inject Plegridy 125 mcg every 14 days.

    • For SC injection: May rotate injection sites between abdomen, back of the upper arm, or thigh.

    • For IM injection: May rotate injection sites between left and right thighs.

    Treatment Initiation

    • Dose titration at initiation may help to ameliorate flu-like symptoms.

    • Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms.

    • Switching between SC and IM inj or vice versa has not been studied.

    Subcutaneous Administration of Plegridy

    • Titrate using the Plegridy Starter Pack.

    • Initially 63mcg on Day 1, increase to 94mcg on Day 15, then 125mcg on Day 29 and every 14 days thereafter. 

    Intramuscular Administration of Plegridy

    • Titrate using the Plegridy Titration Kit.

    • Initially 63mcg on Day 1, increase to 94mcg on Day 15, then 125mcg on Day 29 and every 14 days thereafter. 

    Children

    Not established.

    Administration

    • Health care professionals should train patients in the proper technique for self-administering subcutaneous injections using the prefilled pen or syringe or intramuscular injections using the prefilled syringe.

    • Advise patients and caregivers to rotate injection sites to minimize severe injection site reactions, including necrosis or localized infection.

    • Once removed from the refrigerator, advise to warm Plegridy to room temperature for about 30 minutes prior to injection. Do not use external heat sources such as hot water to warm.

    Plegridy Contraindications

    Not Applicable

    Plegridy Boxed Warnings

    Not Applicable

    Plegridy Warnings/Precautions

    Warnings/Precautions

    Depression. Suicidal ideation. Consider discontinuing if depression or other severe psychiatric symptoms occur. Seizure disorder. Discontinue if serious allergic reactions occur. Significant cardiac disease; monitor for worsening condition at initiation and during treatment. Risk of thrombotic microangiopathy; discontinue if occurs. Monitor for hepatic injury, infections, bleeding, anemia. Risk for pulmonary arterial hypertension (PAH); evaluate and discontinue if PAH is confirmed. Myelosuppression. Obtain CBCs with differential and platelets during treatment. Consider discontinuing if new autoimmune disorder develops. Latex allergy (IM syringe cover). Severe renal impairment: monitor. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Hepatic Injury

    • Severe hepatic injury has been rarely reported with Plegridy.

    • Asymptomatic elevation of serum transaminases is common with Betaseron; monitor liver function tests.

    • Monitor for signs/symptoms of hepatic injury.

    Depression and Suicide

    • Depression and suicide have been reported with interferon beta products.

    • Patients should report symptoms of depression or suicidal ideation.

    • Consider discontinuing Plegridy if depression or other severe psychiatric symptoms develops.

    Anaphylaxis and Other Allergic Reactions

    • Serious allergic reactions are rare complications with Plegridy.

    • Discontinue if serious allergic reaction occurs.

    Injection Site Reactions Including Necrosis

    • Injection site reactions, including injection site necrosis (ISN), have been reported with interferon beta products.

    • Injection site abscesses and cellulitis have been reported in the postmarketing setting; some cases required hospitalization for surgical drainage and IV antibiotics.

    • Periodically evaluate patient understanding and use of aseptic self-injection techniques and procedures, particularly if ISN has occurred.

    • For patients who continue therapy after ISN, avoid administration into the affected area until fully healed.

    • Change injection site or discontinue Plegridy if multiple lesions occur until healing occurs.

    Congestive Heart Failure

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

    • Cases of CHF and cardiomyopathy have been reported; some cases were temporally related to Betaseron.

    Decreased Peripheral Blood Counts

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

    • Monitor 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. 

    Thrombotic Microangiopathy (TMA)

    • Discontinue Plegridy if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.

    Pulmonary Arterial Hypertension (PAH)

    • Assess for PAH if unexplained symptoms develop.
    • Discontinue treatment and manage as clinically indicated if a diagnosis of PAH is confirmed.

    Autoimmune Disorders

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

    Seizures

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

    Pregnancy Considerations

    Available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy.

    Nursing Mother Considerations

    There are no data on the presence of Betaseron in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Consider the benefits to the mother vs the potential risks to the infant.

    Pediatric Considerations

    Safety and efficacy in pediatric patients have not been established.

    Geriatric Considerations

    Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

    Renal Impairment Considerations

    Monitor for adverse reactions due to increased drug exposure in patients with severe renal impairment.

    Plegridy Pharmacokinetics

    Absorption

    After 125 microgram subcutaneous doses of Plegridy in multiple sclerosis patients, the maximum concentration occurred between 1 and 1.5 days, the mean Cmax was 280 pg/mL, and the AUC over the 14 day dosing interval was 34.8 ng.hr/mL. 

    Distribution

    In multiple sclerosis patients taking 125 microgram subcutaneous doses of Plegridy every 14 days, the estimated volume of distribution was 481 liters. 

    Metabolism

    Clearance mechanisms for Plegridy include catabolism and excretion. 

    Elimination

    Renal. Half-life: ~78 hours.

    Plegridy Interactions

    Not Applicable

    Plegridy Adverse Reactions

    Adverse Reactions

    Inj site reactions (erythema, pain, pruritus, necrosis, cellulitis, abscess), influenza-like illness, pyrexia, headache, myalgia, chills, asthenia, arthralgia; hepatic injury, seizures, CHF, hematologic or autoimmune disorders, rare: serious allergic reactions (discontinue if occurs).

    Plegridy Clinical Trials

    Clinical Trials

    • The approval was based on efficacy data from a randomized, double-blind, placebo-controlled phase (year 1) of Study 1. Patients were randomly assigned to receive Plegridy 125 mcg (n=512) or placebo (n=500) subcutaneously once every 14 days. 

    • The primary outcome was the annualized relapse rate (ARR) over 1 year. Secondary outcomes included the proportion of patients relapsing, number of new or newly enlarging T2 hyperintense lesions, and time to confirmed disability progression. Confirmed disability progression was defined as follows: if the baseline EDSS score was 0, a sustained 12-week increase in EDSS score of 1.5 points was required; if the baseline EDSS score was greater than 0, a sustained 12-week increase in EDSS score of 1 point was required.

    • At week 48, results showed the following clinical outcomes for Plegridy compared with placebo, respectively:

      • ARR: 0.26 vs 0.40 (relative reduction, 36%; P =.0007)

      • Proportion of patients with relapses: 0.19 vs 0.29 (relative risk reduction, 39%; P =.0003).

      • Proportion of patients with disability progression: 0.07 vs 0.11 (relative risk reduction, 38%; P =.0383).

    • At week 48, results showed the following MRI outcomes for Plegridy compared with placebo, respectively:

      • Mean number of new or newly enlarging T2 hyperintense lesions: 3.6 vs 10.9 (relative reduction, 67%; P <.0001).

      • Mean number of Gd enhancing lesions: 0.2 vs 1.4 (relative reduction, 86%; P <.0001).

    Plegridy Note

    Notes

    To enroll women exposed to Plegridy during pregnancy call (866) 810-1462 or visit https://www.plegridypregnancyregistry.com/.

    Plegridy Patient Counseling

    Patient Counseling

    Instructions for Self-Injection Technique and Procedures

    • Provide appropriate instruction for methods of self-injection.

    • Instruct patients in the use of aseptic technique when administering Plegridy.

    • Do not reuse needles or syringes.

    Advise patients

    • To rotate areas of injection to minimize injection site reactions.

    • For SC injection: inject into abdomen, back of the upper arm, and thigh.

    • For IM injection: alternate injections between the left and right thigh.

    • Do not inject into an area where the skin is irritated, reddened, bruised, infected, or scarred in any way.

    • Check injection site after 2 hours for redness, swelling, and tenderness.

    • Contact health care professional if skin reaction occurs and does not clear up in a few days.

    Pregnancy

    • Notify health care provider if patient becomes pregnancy during treatment or plan to become pregnant.

    Liver Disease

    • Instruct patients on the symptoms of hepatic dysfunction.

    Depression and Suicide

    • Instruct patients to report symptoms of suicidal ideation and suicide.

    Anaphylaxis and Other Allergic Reactions 

    • Inform latex-sensitive patients that Plegridy prefilled syringe for IM administration contains natural rubber latex.

    Injection Site Reactions Including Necrosis

    • Instruct patients to report any break in the skin associated with blue-black discoloration, swelling, or drainage of fluid from the injection site.

    Cardiac Disease

    • Advise patients of symptoms of worsening cardiac condition, and instruct patients to report them immediately to their physician.

    Seizure

    • Instruct patients to report seizures immediately to their physician.

    Flu-like Symptoms

    • Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with Betaseron use.

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