Plegridy Pen peginterferon beta-1a Kit
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Interferon beta class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Peginterferon beta-1a injection is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including the following: clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Peginterferon beta-1a...
Read the full MedlinePlus article ↗- Plegridy is an interferon beta, which is a type of protein your immune system naturally makes. In MS, the immune system mistakenly attacks the protective coating around nerve fiber...
- What exactly is Plegridy doing for my MS?
- Starting at a lower dose is a way to help your body get used to the medication. Flu-like symptoms — fever, chills, muscle aches — are very common when people first start an interfe...
- Why do I have to start on a lower dose and work my way up?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Peginterferon Beta-1a — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Plegridy Penthis 64406-0012-01 | Biogen | 1 kit | — | — | FDA listed | — |
| Plegridy 64406-0016-01 | Biogen | 1 kit | — | — | FDA listed | — |
| Plegridy Pen 125 ug/.5mL 64406-0011-01 | Biogen | 2 syringes | — | — | FDA listed | — |
| Plegridy 125 ug/.5mL 64406-0015-01 | Biogen | 2 syringes | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Aug 15, 2026 |
Is there a biosimilar for PLEGRIDY PEN INJ STARTER PACK?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64406-0012-01 You're viewing this | 1 CARTON in 1 KIT (64406-012-01) / 1 KIT in 1 CARTON * .5 mL in 1 SYRINGE (64406-010-02) * .5 mL in 1 SYRINGE (64406-009-02) | 2014-08-15 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
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Do I need a prescription for this product?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE PLEGRIDY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. PLEGRIDY is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For subcutaneous or intramuscular use only ( 2.1 ) Recommended dose: 125 micrograms every 14 days ( 2.1 ) PLEGRIDY dose should be titrated, starting with 63 micrograms on day 1, 94 micrograms on day 15, and 125 micrograms (full dose) on day 29 ( 2.1 ) A healthcare professional 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 ( 2.2 ) Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms ( 2.3 )
2.1Dosing Information PLEGRIDY may only be administered subcutaneously (SC) or intramuscularly (IM). Recommended Maintenance Dosage After initial titration (see Table 1 and Table 2 ), the recommended dosage of PLEGRIDY is 125 micrograms injected every 14 days. For subcutaneous injection: Patients may rotate injection sites between the abdomen, back of the upper arm, or thigh.
For intramuscular injection: Patients may rotate injection sites between the left and right thighs. Treatment Initiation Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons. Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during treatment with PLEGRIDY.
Switching between the subcutaneous and intramuscular routes of administration and vice versa has not been studied. It is not expected that dose titration should be repeated to ameliorate flu-like symptoms if switching between subcutaneous and intramuscular routes of administration, or vice versa based upon bioequivalence demonstrated between the two routes of administration. Subcutaneous Administration of PLEGRIDY Patients using PLEGRIDY for the first time should start treatment with 63 micrograms on day 1.
On day 15 (14 days later), the dose is increased to 94 micrograms, reaching the full dose of 125 micrograms on day 29 (after another 14 days). Patients continue with the full dose (125 micrograms) every 14 days thereafter (see Table 1 ). A PLEGRIDY Starter Pack is available containing two prefilled pens or syringes: 63 micrograms (dose 1) and 94 micrograms (dose 2).
Table 1: Schedule for Subcutaneous Dose Titration Dose Time a Amount (micrograms) Color of Pen or Syringe Label a Dosed every 14 days Dose 1 On day 1 63 Orange Dose 2 On day 15 94 Blue Dose 3 On day 29 and every 14 days thereafter 125 (full dose) Grey Intramuscular Administration of PLEGRIDY For patients using PLEGRIDY injected intramuscularly for the first time, PLEGRIDY should be titrated using the PLEGRIDY Titration Kit designed for use with the prefilled syringe. The PLEGRIDY Titration Kit is supplied separately and contains two titration devices to be used only with PLEGRIDY prefilled syringes for intramuscular use.
Patients should start treatment with 63 micrograms (yellow clip) on day 1. On day 15 (14 days later), the dose is increased to 94 micrograms (purple clip), reaching the full dose of 125 micrograms on day 29 (after another 14 days). Patients continue with the full dose (125 micrograms) every 14 days thereafter (see Table 2 ).
Table 2: Schedule for Intramuscular Dose Titration Dose Time a Amount (micrograms) Titration Clip a Dosed every 14 days Dose 1 On day 1 63 Yellow Dose 2 On day 15 94 Purple Dose 3 On day 29 and every 14 days thereafter 125 (full dose) No Clips Needed
2.2Important Administration Instructions (All Dosage Forms) Healthcare 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Advise patients and caregivers to rotate injection sites with each administration to minimize the likelihood of severe…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS PLEGRIDY is a clear to slightly opalescent and colorless to slightly yellow solution. Subcutaneous Administration: Injection: 125 mcg/0.5 mL in a single-dose prefilled pen or single-dose prefilled syringe ( 3 ) Injection: 63 mcg/0.5 mL in a single-dose prefilled pen or single-dose prefilled syringe ( 3 ) Injection: 94 mcg/0.5 mL in a single-dose prefilled pen or single-dose prefilled syringe ( 3 ) Intramuscular Administration: Injection: 125 mcg/0.5 mL solution in a single-dose prefilled syringe ( 3 ) Subcutaneous Administration: Injection: 125 mcg/0.5 mL in a single-dose prefilled pen or single-dose prefilled syringe Injection: 63 mcg/0.5 mL in a single-dose prefilled pen or a single-dose prefilled syringe Injection: 94 mcg/0.5 mL in a single-dose prefilled pen or a single-dose prefilled syringe Intramuscular Administration: Injection: 125 mcg/0.5 mL in a single-dose prefilled syringe
⛔ Contraindications ▾
4 CONTRAINDICATIONS PLEGRIDY is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY [see Warnings and Precautions ( 5.3 )] . History of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hepatic injury: monitor liver function tests; monitor patients for signs and symptoms of hepatic injury; consider discontinuation of PLEGRIDY if hepatic injury occurs ( 5.1 ) Depression and suicide: advise patients to report immediately any symptom of depression or suicidal ideation to their healthcare provider; consider discontinuation of PLEGRIDY if depression occurs ( 5.2 ) Anaphylaxis and other allergic reactions: Discontinue PLEGRIDY if a serious allergic reaction occurs ( 5.3 ) Injection site reactions: Do not administer PLEGRIDY into affected area until fully healed; if multiple lesions occur, change injection site or discontinue PLEGRIDY until healing of skin lesions ( 5.4 ) Congestive heart failure: monitor patients with pre-existing significant cardiac disease for worsening of cardiac symptoms ( 5.5 ) Decreased peripheral blood counts: monitor complete blood counts ( 5.6 ) Thrombotic Microangiopathy: Cases of thrombotic microangiopathy have been reported with interferon beta products.
Discontinue PLEGRIDY if clinical symptoms and laboratory findings consistent with TMA occur ( 5.7 ) Pulmonary Arterial Hypertension: Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including PLEGRIDY. Discontinue PLEGRIDY if PAH is diagnosed ( 5.8 ) Autoimmune disorders: consider discontinuation of PLEGRIDY if a new autoimmune disorder occurs ( 5.9 )
5.1Hepatic 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. Cases of noninfectious hepatitis have been reported in the postmarketing setting with use of PLEGRIDY.
Monitor patients for signs and symptoms of hepatic injury.
5.2Depression 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.
5.3Anaphylaxis and Other Allergic Reactions Serious allergic reactions are rare complications of treatment with interferon beta; anaphylaxis has been reported with use of PLEGRIDY in the postmarketing setting. 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. The protective rubber cover of the PLEGRIDY prefilled syringe for intramuscular administration contains nat…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of labeling: Hepatic Injury [see Warnings and Precautions ( 5.1 )] Depression and Suicide [see Warnings and Precautions ( 5.2 )] Anaphylaxis and Other Allergic Reactions [see Warnings and Precautions ( 5.3 )] Injection Site Reactions Including Necrosis [see Warnings and Precautions ( 5.4 )] Congestive Heart Failure [see Warnings and Precautions (Section 5.5 )] Decreased Peripheral Blood Counts [see Warnings and Precautions ( 5.6 )] Thrombotic Microangiopathy [see Warnings and Precautions ( 5.7 )] Pulmonary Arterial Hypertension [see Warnings and Precautions ( 5.8 )] Autoimmune Disorders [see Warnings and Precautions ( 5.9 )] Seizures [see Warnings and Precautions ( 5.10 )] The most common adverse reactions in clinical trials of subcutaneous PLEGRIDY (incidence ≥10% and at least 2% more frequent on PLEGRIDY than on placebo) were injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-800-456-2255 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
6.1Clinical 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. PLEGRIDY Via Subcutaneous Administration In clinical studies (Study 1 and Study 2), a total of 1468 patients with relapsing multiple sclerosis received PLEGRIDY by subcutaneous injection 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 injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site 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 3 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. Table 3: Adverse Reactions in the 48-Week Placebo-Controlled Phase of Study 1 with an Incidence 2% Higher for PLEGRIDY Than for Placebo PLEGRIDY (N=512) % Placebo (N=500) % Nervous System Disorders Headache 44 33 Gastrointestinal Disorders Nausea 9 6 Vomiting 5 2 Musculoskeletal and Connective Tissue Disorders Myalgia 19 6 Arthralgia 11 7 General Disorders and Administration Site Conditions Injection site erythema 62 7 Influenza like illness 47 13 Pyrexia 45 15 Chills 17 5 Injection site pain 15 3 Asthenia 13 8 Injection site pruritus 13 1 Hyperthermia 4 1 Pain 5 3 Injection site edema 3 0 Injection site warmth 3 0 Injection site hematoma 3 1 Injection site rash 2 0 Investigations Body temperature increased 6 3 Alanine aminotransferase increased 6 3 Aspartate aminotransferase increased 4 2 Gamma-glutamyl-transferase increased 3 1 Skin and Subcutaneous Tissue Disorder Pruritus 4 1 Flu-Like Symptoms Influenza-like illness was exper…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Epidemiological data do not suggest a clear relationship between interferon beta use and major congenital malformations, but interferon beta may cause fetal harm based on animal data ( 8.1 ) Severe Renal Impairment: monitor for adverse reactions ( 8.6 )
8.1Pregnancy Risk Summary Data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see Data ). In a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion ( see Data ).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data The majority of observational studies reporting on pregnancies exposed to interferon beta products did not identify an association between the use of interferon beta products during early pregnancy and an increased risk of major birth defects.
In a population-based cohort study conducted in Finland and Sweden, data were collected from 1996--2014 in Finland and 2005--2014 in Sweden on 2,831 pregnancy outcomes from women with MS. 797 pregnancies were in women exposed to interferon beta only. No evidence was found of an increased risk of major birth defects among women with MS exposed to interferon beta products compared to women with MS that were unexposed to any non-steroid therapy for MS (n=1,647) within the study.
No increased risks were observed for miscarriages and ectopic pregnancies, though there were limitations in obtaining complete data capture for these outcomes, making the interpretation of the findings more difficult. Two small cohort studies that examined pregnancies exposed to interferon beta products (without differentiating between subtypes of interferon beta products) suggested that a decrease in mean birth weight may be associated with interferon beta exposure during pregnancy, but this finding was not confirmed in larger observational studies.
Two small studies observed an increased prevalence of miscarriage, although the finding was only statistically significant in one study. Most studies enrolled patients later in pregnancy, which made it difficult to ascertain the true percentage of miscarriages. In one small cohort study, a significantly increased risk of preterm birth following interferon beta exposure during pregnancy was observed.
Animal Data PLEGRIDY has not been tested for developmental toxicity in pregnant animals. In monkeys given interferon beta by subcutaneous injection every other day during early pregnancy, no adverse effects on embryofetal development were observed. Abortifacient activity was evident following 3 to 5 doses.
8.2Lactation Risk Summary Limited published literature has described the presence of interferon beta-1a products in human milk at low levels. There are no data on the effects of interferon beta-1a on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PLEGRIDY and any potential adverse effects on the breastfed infant from PLEGRIDY or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Clinical studies of PLEGRIDY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patie…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see Data ). In a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion ( see Data ).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data The majority of observational studies reporting on pregnancies exposed to interferon beta products did not identify an association between the use of interferon beta products during early pregnancy and an increased risk of major birth defects.
In a population-based cohort study conducted in Finland and Sweden, data were collected from 1996--2014 in Finland and 2005--2014 in Sweden on 2,831 pregnancy outcomes from women with MS. 797 pregnancies were in women exposed to interferon beta only. No evidence was found of an increased risk of major birth defects among women with MS exposed to interferon beta products compared to women with MS that were unexposed to any non-steroid therapy for MS (n=1,647) within the study.
No increased risks were observed for miscarriages and ectopic pregnancies, though there were limitations in obtaining complete data capture for these outcomes, making the interpretation of the findings more difficult. Two small cohort studies that examined pregnancies exposed to interferon beta products (without differentiating between subtypes of interferon beta products) suggested that a decrease in mean birth weight may be associated with interferon beta exposure during pregnancy, but this finding was not confirmed in larger observational studies.
Two small studies observed an increased prevalence of miscarriage, although the finding was only statistically significant in one study. Most studies enrolled patients later in pregnancy, which made it difficult to ascertain the true percentage of miscarriages. In one small cohort study, a significantly increased risk of preterm birth following interferon beta exposure during pregnancy was observed.
Animal Data PLEGRIDY has not been tested for developmental toxicity in pregnant animals. In monkeys given interferon beta by subcutaneous injection every other day during early pregnancy, no adverse effects on embryofetal development were observed. Abortifacient activity was evident following 3 to 5 doses.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of PLEGRIDY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown.
12.2Pharmacodynamics There is no biochemical or physiologic effect known to relate directly to the clinical effect of PLEGRIDY.
12.3Pharmacokinetics After single-dose or multiple-dose subcutaneous administration of PLEGRIDY to healthy subjects, serum PLEGRIDY peak concentration (C max ) and total exposure over time (area under the curve, or AUC) increased in proportion to doses from 63 to 188 micrograms. PLEGRIDY did not accumulate in the serum after multiple doses of 125 micrograms every 14 days. Pharmacokinetic parameters for PLEGRIDY, including C max and AUC, did not differ significantly between healthy volunteers and multiple sclerosis patients or between single-dose and multiple-dose administrations.
However, the coefficient of variation between individual patients for AUC, C max , and half-life was high (41% to 68%, 74% to 89%, and 45% to 93%, respectively). Absorption After 125 microgram subcutaneous doses of PLEGRIDY in multiple sclerosis patients, the maximum concentration occurred between 1 and 1.5 days, the mean C max 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 and Elimination Clearance mechanisms for PLEGRIDY include catabolism and excretion. The major pathway of elimination is renal. The half-life is approximately 78 hours in multiple sclerosis patients.
The mean steady state clearance of PLEGRIDY is approximately
4.1L/hr. PLEGRIDY is not extensively metabolized in the liver. The pharmacokinetics of 125 μg single dose of PLEGRIDY administered subcutaneously and intramuscularly were similar.
Specific Populations Body weight, gender, and age do not require dosage adjustment. Renal impairment can increase the C max and AUC for PLEGRIDY. Results of a pharmacokinetic study in patients with mild, moderate, and severe renal impairment (creatinine clearance 50 to 80, 30 to 50, and less than 30 mL/minute, respectively) showed increases above normal for C max of 27%, 26%, and 42%, and for AUC, increases of 30%, 40%, and 53%.
The half-life was 53, 49, and 82 hours in patients with mild, moderate, and severe renal impairment, respectively, compared to 54 hours in normal subjects. In the same study, subjects with end stage renal disease requiring hemodialysis two or three times weekly had AUC and C max of PLEGRIDY values that were similar to those of normal controls. Each hemodialysis session removed approximately 24% of circulating PLEGRIDY from the systemic circulation [see Use in Specific Populations ( 8.6 )] .
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How 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 (NDC 64406-011-01).
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 (NDC 64406-012-01). Carton containing two-125 mcg/0.5 mL single-dose prefilled syringes of PLEGRIDY (NDC 64406-015-01). 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 (NDC 64406-016-01).
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 (NDC 64406-017-01). 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.
16.2Storage and Handling 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. Dispose in a sharps-bin container or other hard plastic or metal sealable container. Always follow local regulations for disposal.
📦 Storage and Handling ▾
16.2Storage and Handling 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. Dispose in a sharps-bin container or other hard plastic or metal sealable container. Always follow local regulations for disposal.
📋 Description ▾
11 DESCRIPTION Peginterferon beta-1a is a covalent conjugate of recombinant interferon beta-1a (approximate molecular weight [MW] 20,000 daltons) with a single, linear methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde molecule (approximate MW 20,000 daltons). Interferon beta-1a is produced as a glycosylated protein using genetically-engineered Chinese hamster ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of recombinant interferon beta-1a is identical to that of the human interferon beta counterpart.
The molecular weight of peginterferon beta-1a is approximately 44,000 daltons, consistent with the mass of the protein, the carbohydrate moieties (approximately 2,500 daltons), and the attached poly(ethylene glycol). Peginterferon beta-1a 125 mcg contains 125 mcg of interferon beta-1a plus 125 mcg of poly(ethylene glycol). Using the World Health Organization International Standard for interferon beta, peginterferon beta-1a has a specific antiviral activity of approximately 100 million International Units (MIU) per mg of protein as determined using an in vitro cytopathic effect assay.
Peginterferon beta-1a 125 mcg contains approximately 12 MIU of antiviral activity. Subcutaneous Administration PLEGRIDY (peginterferon beta-1a) injection is a sterile, preservative-free solution in a single-dose prefilled pen or single-dose prefilled syringe with a 29-gauge, 0.5-inch needle for subcutaneous use. Each prefilled pen or prefilled syringe delivers 0.5 mL.
Each 0.5 mL contains 63 mcg, 94 mcg, or 125 mcg of peginterferon beta-1a, and L-arginine HCl (15.8 mg), glacial acetic acid (0.25 mg), polysorbate 20 (0.025 mg), and sodium acetate trihydrate (0.79 mg) in Water for Injection, USP. The pH is approximately 4.8. Intramuscular Administration PLEGRIDY (peginterferon beta-1a) injection is a sterile, preservative-free solution in a single-dose prefilled syringe with a 23-gauge, 1.25-inch needle for intramuscular use.
Each prefilled syringe delivers 0.5 mL. Each 0.5 mL contains 125 mcg of peginterferon beta-1a, and L-arginine HCl (15.8 mg), glacial acetic acid (0.25 mg), polysorbate 20 (0.025 mg), and sodium acetate trihydrate (0.79 mg) in Water for Injection, USP. The pH is approximately 4.8.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Instructions for Self-Injection Technique and Procedures Provide appropriate instruction for methods of self-injection, including careful review of the PLEGRIDY Medication Guide and Instructions for Use. Instruct patients in the use of aseptic technique when administering PLEGRIDY.
Inform patients that a healthcare provider should show them or their caregiver how to prepare to inject PLEGRIDY before administering the first dose. Tell patients not to re-use needles or syringes, and instruct patients on safe disposal procedures. Inform patients to dispose of used needles and syringes in a puncture-resistant container, and instruct patients regarding safe disposal of full containers.
Advise patients: to rotate areas of injection with each dose to minimize the likelihood of injection site reactions [see Warnings and Precautions ( 5.4 )] . For subcutaneous administration, the usual injection sites are the abdomen, back of the upper arm, and thigh. For intramuscular administration, alternate injections between the left and right thigh.
NOT to inject into an area of the body where the skin is irritated, reddened, bruised, infected, or scarred in any way to check the injection site after 2 hours for redness, swelling, and tenderness to contact their healthcare professional if they have a skin reaction and it does not clear up in a few days Pregnancy Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations ( 8.1 )]. Liver Disease Advise patients that severe hepatic injury, including rare cases of hepatic failure, has been reported during the use of interferon beta.
Advise patients of symptoms of hepatic dysfunction, and instruct patients to report them immediately to their physician [see Warnings and Precautions ( 5.1 )] . Depression and Suicide Advise patients that depression, suicidal ideation, and suicide have been reported with the use of interferon beta. Instruct patients to report symptoms of depression or thoughts of suicide to their physician immediately [see Warnings and Precautions ( 5.2 )] .
Anaphylaxis and Other Allergic Reactions Advise patients of the symptoms of allergic reactions and anaphylaxis, and instruct patients to seek immediate medical attention if these symptoms occur. Inform latex-sensitive patients that the PLEGRIDY prefilled syringe for intramuscular administration contains natural rubber latex [see Warnings and Precautions ( 5.3 )] . Injection Site Reactions Including Necrosis Advise patients that injection site reactions can occur and that the reactions can include injection site necrosis.
Instruct patients to report promptly any break in the skin that is associated with blue-black discoloration, swelling, or drainage of fluid from the injection site [see Warnings and Precautions ( 5.4 )] . Cardiac Disease Advise patients that worsening of significant cardiac disease has been reported in patients using interferon beta. Advise patients of symptoms of worsening cardiac condition, and instruct patients to report them immediately to their physician [see Warnings and Precautions ( 5.5 )] .
Pulmonary Arterial Hypertension Inform patients that PAH has occurred in patients treated with interferon beta products, including PLEGRIDY. Instruct patients to promptly report any new symptoms such as new or increasing fatigue or shortness of breath to their healthcare provider [see Warnings and Precautions ( 5.8 )] . Seizure Advise patients that seizures have been reported in patients using PLEGRIDY.
Instruct patients to report seizures immediately to their physician [see Warnings and Precautions ( 5.10 )] . Flu-like Symptoms Inform patients that flu-like symptoms are common following initiation of therapy with PLEGRIDY. Prophylactic and concurrent use of analgesics and/or antipyretics may…
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 7/2023 Medication Guide PLEGRIDY ® (PLEGG-rih-dee) (peginterferon beta-1a) injection, for subcutaneous or intramuscular use Read this Medication Guide before you start using PLEGRIDY, and each time you get a refill.
There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about PLEGRIDY?
PLEGRIDY can cause serious side effects, including: Liver problems or worsening of liver problems, including liver failure and death. Symptoms may include: yellowing of your skin or the white part of your eye, nausea, loss of appetite, tiredness, bleeding more easily than normal, confusion, sleepiness, dark colored urine, and pale stools. During your treatment with PLEGRIDY you will need to see your healthcare provider and have regular blood tests to check for these possible side effects.
Depression or suicidal thoughts. Symptoms may include: new or worsening depression (feeling hopeless or bad about yourself), thoughts of hurting yourself or suicide, irritability (getting upset easily), nervousness, or new or worsening anxiety. Call your healthcare provider right away if you have any of the symptoms listed above.
What is PLEGRIDY? PLEGRIDY is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if PLEGRIDY is safe and effective in people under 18 or over 65 years of age.
Do not take PLEGRIDY if you: are allergic to interferon beta or peginterferon, or any of the other ingredients in PLEGRIDY. See the end of this Medication Guide for a complete list of ingredients in PLEGRIDY. Before using PLEGRIDY, tell your healthcare provider about all of your medical conditions, including if you: are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior. have or had liver problems. have or had low blood cell counts. have or had bleeding problems. have or had heart problems. have or had seizures (epilepsy). have or had thyroid problems. have or had any kind of autoimmune disease (where the body's immune system attacks the body's own cells). have or had an allergic reaction to rubber or latex.
The tip of the cap of the PLEGRIDY prefilled syringe for intramuscular use is made of natural rubber latex. are pregnant or plan to become pregnant. It is not known if PLEGRIDY can harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with PLEGRIDY. are breastfeeding or plan to breastfeed.
PLEGRIDY may pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you use PLEGRIDY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use PLEGRIDY? See the detailed Instructions for Use for instructions on how to prepare and inject your dose of PLEGRIDY. Use PLEGRIDY exactly as your healthcare provider tells you.
A healthcare provider should show you how to inject your PLEGRIDY before you use it for the first time. Your healthcare provider will tell you how much PLEGRIDY to inject and how often to inject PLEGRIDY. Do not inject more than your healthcare provider tells you to.
When you use PLEGRIDY for the first time, your healthcare provider may tell you to slowly increase your dose. If you are prescribed PLEGRIDY for injection under the skin (subcutaneous injection): you should use a PLEGRIDY Starter Pack to slowly adjust your dose when you begin treatment. inject PLEGRIDY under the skin of your stomach (abdomen), back of upper arm, or thigh 1 time every 14 days. If you are prescribed PLEGRIDY for…