Biogen Inc.
Plegridy pen
BrandGeneric: Peginterferon beta-1a
ID: 64406001101
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TL;DR — Quick Summary
Key facts from the full medication guide below
🩺What it's for
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.
💊How to take it
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…
ℹ️Common side effects
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…
⚠️Serious risks
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…
📦Storage & missed dose
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.
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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)
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)
PLEGRIDY may only be administered subcutaneously (SC) or intramuscularly (IM).
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 prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment [see Dosage and Administration ( 2.3 ) and Adverse Reactions ( 6.1 )]. 43643-09 Manufactured by:Biogen Inc.Cambridge, MA 02142U.S. License # 16971-800-456-2255PLEGRIDY is a registered trademark of Biogen. 2013-2023 Biogen
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 injection site reactions, including necrosis or localized infection [see Warnings and Precautions (5.4)]. Once removed from the refrigerator, PLEGRIDY should be allowed to warm to room temperature (about 30 minutes) prior to injection. Do not use external heat sources such as hot water to warm PLEGRIDY. Each PLEGRIDY pen and syringe for subcutaneous injection is provided with the needle pre-attached. PLEGRIDY prefilled syringe for intramuscular injection is supplied as a prefilled syringe with a separate needle. Both intramuscular and subcutaneous prefilled syringes and subcutaneously administered prefilled pens are for one-time use in one patient only and should be discarded after use.
Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during treatment with PLEGRIDY.
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)
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)
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)
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.
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.
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 natural rubber latex which may cause allergic reactions and should not be handled by latex-sensitive individuals. The safe use of PLEGRIDY prefilled syringe in latex-sensitive individuals has not been studied.
Injection site reactions, including injection site necrosis, can occur with the use of interferon beta, including PLEGRIDY. In clinical studies of subcutaneous PLEGRIDY, 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. In Study 3, which compared single doses of intramuscular and subcutaneous PLEGRIDY [see Adverse Reactions (6.1)], the incidence of injection site reactions (e.g., injection site erythema, pain, pruritus, or edema) was 14% in the intramuscular PLEGRIDY group and 32% in the subcutaneous PLEGRIDY group. Injection site abscesses and cellulitis have been reported in the postmarketing setting with use of interferon beta. Some cases required treatment with hospitalization for surgical drainage and intravenous antibiotics. Periodically evaluate patient understanding and use of aseptic self-injection techniques and procedures, particularly if injection site necrosis has occurred. 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, change injection site or discontinue PLEGRIDY until healing occurs.
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.
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.
Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with interferon beta products. Cases have been reported several weeks to years after starting interferon beta products. Discontinue PLEGRIDY if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.
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.
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.
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.
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.
As with all therapeutic proteins, there is a potential for immunogenicity. 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 in the studies described below with the incidence of antibodies in other studies or to other interferon beta-1a products may be misleading. In Study 1, fewer than 1% of patients treated with PLEGRIDY SC every 14 days for 1 year developed neutralizing antibodies. Approximately 7% of PLEGRIDY SC-treated patients developed antibodies to the polyethylene glycol moiety. No formal studies have been conducted with regards to immunogenicity of the intramuscular route of administration of PLEGRIDY.
The following adverse reactions have been identified during post-approval use of PLEGRIDY. 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.
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)
Safety and effectiveness in pediatric patients have not been established.
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.
Monitor for adverse reactions due to increased drug exposure in patients with severe renal impairment [see Clinical Pharmacology ( 12.3 )].
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.
The mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown.
There is no biochemical or physiologic effect known to relate directly to the clinical effect of PLEGRIDY.
After single-dose or multiple-dose subcutaneous administration of PLEGRIDY to healthy subjects, serum PLEGRIDY peak concentration (Cmax) 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 Cmax 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, Cmax, and half-life was high (41% to 68%, 74% to 89%, and 45% to 93%, respectively).
The efficacy of PLEGRIDY was demonstrated in the randomized, double-blind, and placebo-controlled phase (year 1) of Study 1. The trial compared clinical and MRI outcomes at 48 weeks in patients who received PLEGRIDY 125 micrograms (n=512) or placebo (n=500) by the subcutaneous route, once every 14 days. Study 1 enrolled patients who had a baseline Expanded Disability Status Scale (EDSS) score from 0 to 5, who had experienced at least 2 relapses within the previous three years, and had experienced at least 1 relapse in the previous year. The trial excluded patients with progressive forms of multiple sclerosis. The mean age of the study population was 37 years, the mean disease duration was 3.6 years, and the mean EDSS score at baseline was 2.46. The majority of the patients were women (71%). The trial scheduled neurological evaluations at baseline, every 12 weeks, and at the time of a suspected relapse. Brain MRI evaluations were scheduled at baseline, week 24, and week 48. The primary outcome was the annualized relapse rate 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. Table 4 and Figure 1 show the results of Study 1. Table 4: Clinical and MRI Results of Study 1 Endpoint PLEGRIDY 125 micrograms every 14 days Placebo p-value Clinical outcomes at 48 weeks N=512 N=500 Annualized relapse rate 0.26 0.40 0.0007 Relative reduction 36% Proportion of patients with relapses 0.19 0.29 0.0003 Relative risk reduction 39% Proportion of patients with disability progression 0.07 0.11 0.0383 Relative risk reduction 38% MRI outcomes at 48 weeks N=457 N=476 Mean number of new or newly enlarging T2 hyperintense lesions 3.6 10.9 <0.0001 Relative reduction 67% Mean number of Gd enhancing lesions 0.2 1.4 <0.0001 Relative reduction 86% Figure 1: Time to first relapse
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.
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.
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
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 injection into the muscle (intramuscular injection): you should use a PLEGRIDY Titration Kit to slowly adjust your dose when you begin treatment. inject PLEGRIDY into your thigh 1 time every 14 days. If your healthcare provider changes where you are injecting PLEGRIDY (under the skin or into the muscle), you do not need to slowly increase your dose again. Change (rotate) the site you choose with each injection to help decrease the chance that you will have an injection site reaction. Do not inject into an area of the body where the skin is irritated, reddened, bruised, infected, or scarred in any way. After 2 hours check your injection site for redness, pain, itching, swelling, tenderness, a break in your skin that becomes blue and black, or drains fluid. If you have a skin reaction and it does not clear up in a few days, contact your healthcare provider. Always use a new, PLEGRIDY prefilled pen or new, unopened single dose prefilled syringe for each injection. What are the possible side effects of PLEGRIDY? See What is the most important information I should know about PLEGRIDY? PLEGRIDY may cause serious side effects, including: serious allergic reactions. Serious allergic reactions can happen if you take PLEGRIDY. Symptoms may include: itching, swelling of the face, eyes, lips, tongue, or throat, trouble breathing, feeling faint, anxiousness, skin rash, hives, skin bumps. Get emergency help right away if you have any of these symptoms. Talk to your healthcare provider before taking another dose of PLEGRIDY. injection site reactions. PLEGRIDY may commonly cause redness, pain, itching, or swelling at the place where your injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider. heart problems, including congestive heart failure. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using PLEGRIDY. Some people using PLEGRIDY may have other heart problems, including low blood pressure, fast or abnormal heart beat, chest pain, heart attack, or a heart muscle problem (cardiomyopathy). blood problems and changes in your blood tests. PLEGRIDY can decrease your white blood cells or platelets, which can cause an increased risk of infection, bleeding, or anemia and can cause changes in your liver function tests. Your healthcare provider will do tests to monitor for side effects while you use PLEGRIDY. thrombotic microangiopathy (TMA). TMA is a condition that involves injury to the smallest blood vessels in your body. TMA can also cause injury to your red cells (the cells that carry oxygen to your organs and tissues) and your platelets (cells that help your blood clot) and can sometimes lead to death. Your healthcare provider may tell you to stop taking PLEGRIDY if you develop TMA. pulmonary arterial hypertension. Pulmonary arterial hypertension can occur with interferon beta products, including PLEGRIDY. Symptoms may include new or increasing fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms. autoimmune diseases. Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use interferon beta. seizures. Some people have had seizures while taking PLEGRIDY, including people who have never had seizures before. The most common side effects of PLEGRIDY include: flu-like symptoms. Many people who use PLEGRIDY have flu-like symptoms, especially early in the course of therapy. These symptoms are not really the flu. You cannot pass it on to anyone else. You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers and drinking plenty of water. Flu-like symptoms or other common side effects of PLEGRIDY may include: headache, muscle and joint aches, fever, chills, or tiredness.These are not all the possible side effects of PLEGRIDY.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General Information about the safe and effective use of PLEGRIDY. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PLEGRIDY for a condition for which it was not prescribed. Do not give PLEGRIDY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about PLEGRIDY that is written for health professionals. What are the ingredients in PLEGRIDY? Active ingredient: peginterferon beta-1a. Inactive ingredients: Single-dose Prefilled Pen (subcutaneous injection only): L-arginine hydrochloride, glacial acetic acid, polysorbate 20, and sodium acetate trihydrate in sterile water for injection. Single-dose Prefilled Syringe (subcutaneous and intramuscular injection): L-arginine hydrochloride, glacial acetic acid, polysorbate 20, and sodium acetate trihydrate in sterile water for injection. For more information, go to www.plegridy.com or call 1-800-456-2255.Manufactured by: Biogen Inc., Cambridge, MA 02142, U.S. License # 1697PLEGRIDY is a registered trademark of Biogen. 2013-2023 Biogen
Instructions for Use PLEGRIDY (PLEGG-rih-dee) (peginterferon beta-1a) injection for intramuscular use Titration Kit for use with the PLEGRIDY intramuscular Single-Dose Prefilled Syringe Only Read this Instructions for Use 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 to your healthcare provider about your medical condition or your treatment. Important information: The tip of the cap of the Plegridy prefilled syringe is made of natural rubber latex. Tell your healthcare provider if you are allergic to rubber or latex. Note: Before you use your Plegridy prefilled syringe for the first time, your healthcare provider should show you or your caregiver how to prepare and inject your Plegridy prefilled syringe the right way. Each Plegridy prefilled syringe can be used 1 time only. Do not share your Plegridy prefilled syringe with anyone else. By sharing the needle, you may give an infection to them or get an infection from them. Do not use more than 1 Plegridy prefilled syringe every 14 days. How should I store Plegridy? Store Plegridy in the refrigerator between 36 F to 46 F (2 C to 8 C). If a refrigerator is not available, Plegridy may be stored at room temperature up to 77 F (25 C) for a total of 30 days. You can store your Plegridy prefilled syringes at room temperature and then put it back in the refrigerator. Do not freeze Plegridy. Do not use Plegridy that has been frozen. Store Plegridy in the original carton to protect it from light. Keep the Plegridy Titration Kit, the Plegridy prefilled syringe, and all medicines out of the reach of children. Supplies you will need for the Plegridy injection: 1 Plegridy Titration Kit that contains: 1 yellow clip 1 purple clip 1 Plegridy Administration Dose Pack that contains: 1 Plegridy prefilled syringe 23 gauge, 1 inch long sterile needle Additional supplies not included in your Plegridy Titration Kit and Plegridy Administration Dose Pack: 1 alcohol wipe 1 gauze pad 1 adhesive bandage a sharps disposal container for throwing away used syringes and needles. See After the Plegridy injection at the end of these instructions. Preparing the Plegridy Prefilled Syringe: Find a well-lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or receive an injection. Take 1 Plegridy Administration Dose Pack out of the refrigerator and let it come to room temperature for about 30 minutes. Do not use external heat sources such as hot water to warm the Plegridy prefilled syringe. Check the expiration date printed on the Plegridy prefilled syringe, Plegridy prefilled syringe Administration Dose Package carton, and the outer carton. Do not use the Plegridy prefilled syringe past the expiration date. Wash your hands with soap and water. Identifying parts of the Plegridy prefilled syringe (See Figure A). Preparing the Plegridy injection: Step 1: Check the Plegridy prefilled syringe (Figure A): The syringe should not have any cracks or damage. Check that the cap is intact and has not been removed. Plegridy should look slightly clear, colorless to slightly yellow, and should not have any particles in it. Do not use the Plegridy prefilled syringe if: the syringe is cracked or damaged. the solution is cloudy, colored other than slightly yellow, or has lumps or particles in it. the cap has been removed or is not tightly attached. If you cannot use that syringe, you will need to get a newsyringe. Contact Biogen at 1-800-456-2255. Step 2: With 1 hand, hold the Plegridy prefilled syringe right under the cap and with the cap pointing up (See Figure B). Make sure you are holding the Plegridy prefilled syringe by the ridged part, directly under the cap. Step 3: With the other hand, grasp the cap and bend it at a 90 angle until the cap snaps off (See Figure C and Figure D). Step 4: Open the sterile needle package and take out the covered needle. Hold the Plegridy prefilled syringe with the glass syringe tip pointing up. Press the needle on the Plegridy prefilled syringe glass tip (See Figure E). Step 5: Gently turn the needle to the right (clockwise) until it is tight and firmly attached (See Figure F). If the needle is not firmly attached, it may leak and you may not get your full dose of Plegridy. Do not remove the protective cover from the needle. Using the Plegridy prefilled syringe with the Plegridy Titration Kit: You must prepare the Plegridy prefilled syringe and needle before you put it into the Plegridy titration clip. Follow Step 1 to Step 5 above to prepare the Plegridy prefilled syringe. Your Plegridy dose may be titrated over 2 doses by using the Plegridy prefilled syringe with the Plegridy Titration Kit. Dose 1 (Day 1): dose (yellow clip) Dose 2 (Day 15): dose (purple clip) Dose 3 (Day 29): a full dose (no clip needed) The 2 Plegridy titration clips are for single-use only with the Plegridy prefilled syringe. Do not re-use the Plegridy prefilled syringe or Plegridy titration clips. Identifying the parts of Plegridy Titration Kit (See Figure G): The Plegridy titration clip has a collar on top that will stop the syringe from injecting a full dose (See Figure H). The collar is to make sure that you receive the correct dose. Attaching the Plegridy titration clip: Step 6: Choose the right titration clip for your dose. Dose 1 (Day 1): Choose the yellow clip to give dose (See Figure I). Dose 2 (Day 15): Choose the purple clip to give dose (See Figure J). Step 7: Put the correct titration clip on a flat surface with the door open (See Figure K). Step 8: Line up the Plegridy prefilled syringe over the titration clip with the plunger pointing to the left and the needle pointing to the right (See Figure L). Step 9: Push the Plegridy prefilled syringe down into the titration clip until both ends snap into place (See Figure M). Step 10: Using 2 fingers, push the door down until it closes over the Plegridy prefilled syringe (See Figure N). You will hear a snap when the door is closed the right way. Do not open door after it is closed. Step 11: Check to make sure that the Plegridy prefilled syringe is in the titration clip the right way and that the door is tightly closed. Giving the Plegridy injection: Your healthcare provider should show you or a caregiver how to prepare and inject the dose of Plegridy before the Plegridy prefilled syringe is used for the first time. Your healthcare provider should watch you inject the dose of Plegridy the first time the Plegridy prefilled syringe is used. Inject your Plegridy exactly as your healthcare provider has shown you. Plegridy is injected into the muscle (intramuscularly). Plegridy should be injected into the thigh (See Figure P). Change (rotate) your injection sites for each dose. Do not use the same injection site for each injection. Do not inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way. Step 12: Choose your left or right thigh and wipe the skin with an alcohol wipe (See Figure P). Let the injection site dry before injecting the dose. Do not touch this area again before giving the injection. Step 13: Pull the protective cover straight off the needle (See Figure Q). Do not twist the cover off. Step 14: With 1 hand, stretch the skin out around the injection site. With the other hand, hold the syringe like a pencil. Use a quick dart-like motion and insert the needle at a 90 angle, through the skin and into the muscle (See Figure R). After the needle is in, let go of the skin. Step 15: Slowly push the plunger all the way down until it touches the collar (See Figure S). Step 16: Pull the needle out of the skin (See Figure T). Press down on the injection site with the gauze pad for a few seconds or rub gently in a circular motion. If you see blood after you press the injection site for a few seconds, wipe it off with the gauze pad and apply an adhesive bandage. After the Plegridy injection: Do not recap the needle. Recapping the needle can lead to a needle stick injury. Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: made of heavy-duty plastic, can be closed with a tight-fitting puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Check the injection site: After 2 hours, check the injection site for redness, pain, itching, swelling, tenderness, a break in your skin that becomes blue and black, or drains fluid. If you have a skin reaction and it does not clear up in a few days, contact your healthcare provider. General information about the safe and effective use of Plegridy Always use a new Plegridy prefilled syringe, titration clip, and needle. Do not re-use your Plegridy prefilled syringe, titration clip, or needle. Do not share your Plegridy prefilled syringe, titration clip, or needle. You can use the table below to keep track of your injections. Day Dose Use Titration Clip Date/Time Day 1 1/2 Dose Yellow Day 15 3/4 Dose Purple Day 29 Full Dose None Manufactured for:Biogen Inc.Cambridge, MA 02142 USA 2021 Biogen Inc. All rights reserved. 1-800-456-2255This Instructions for Use has been approved by the U.S. Food and Drug Administration.Revised: 1/2021 54930-01
Principal Display Panel Carton Label NDC 64406-017-01 Plegridy (peginterferon beta-1a)Injection 125 mcg/0.5 mL For intramuscular use only Every 14 Days Contents: 2 Single-Dose Prefilled Syringes and2 Needles for Injection Every 14 Days Dispense with enclosedMedication Guide Rx only