Plegridy Pen peginterferon beta-1a 125 ug/.5mL Injection, Solution, 2 syringes — NDC 64406-011-01 (Billing 64406-0011-01)

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 )

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… [Excerpted — this section continues on DailyMed.]

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

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… [Excerpted — this section continues on DailyMed.]

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… [Excerpted — this section continues on DailyMed.]

Instructions for Use PLEGRIDY ® (PLEGG-rih-dee) (peginterferon beta-1a) injection, for Subcutaneous Use Single-Dose Prefilled Pen Starter Pack Important: Do not remove the Plegridy Pen cap until you are ready to inject. How to Inject your Plegridy Pen Read this Instructions for Use before you start using Plegridy and each time you get a refill of your prescription. 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. Note: Before you use your Plegridy Pen for the first time, your healthcare provider should show you or your caregiver how to prepare and inject your Plegridy Pen the right way. If you experience difficulty or have questions, call 1-800-456-2255.

Plegridy Pen is for use under the skin only (subcutaneous). Each Plegridy Pen can be used 1 time only. Do not share your Plegridy Pen with anyone else.

By sharing the Pen, you may give an infection to them or get an infection from them. Take your Plegridy Pen out of the refrigerator and let it come to room temperature for at least 30 minutes before your injection. Do not use more than 1 Plegridy Pen every 14 days.

Do not use your Plegridy Pen if it has been dropped or is visibly damaged. 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 up to 30 days in total. Keep Plegridy in the original carton to protect it from light. Do not freeze Plegridy.

Keep Plegridy Pens, needles, and all medicines out of the reach of children. Supplies needed for your Starter Pack for Plegridy Pen injection (See Figure A ): 1 Starter Pack for Plegridy Pen which contains: 1 Plegridy 63 mcg Pen (orange pen) 1 Plegridy 94 mcg Pen (blue pen) Additional supplies which are not included in the pack (See Figure B ): alcohol wipe gauze pad adhesive bandage 1 sharps container for throwing away used needles and Plegridy Pens. See “ Disposing of your used Plegridy Pens ” at the end of these instructions. a well-lit area and a clean, flat surface to work on, like a table Dose Schedule Choose the right Plegridy Pen for your dose.

The Starter Pack for Plegridy Pen contains your first 2 injections to slowly adjust your dose. When Which Dose Choose Day 1 (63 mcg) First Dose: 63 mcg Orange Pen (See Figure C ) When Which Dose Choose Day 15 (94 mcg) Second Dose: 94 mcg Blue Pen (See Figure D ) Make sure you use the 63 mcg orange pen for your first dose (on day 1). Make sure you use the 94 mcg blue pen for your second dose (on day 15).

Ask your healthcare provider which Plegridy Pen you should use for your correct dose if you are not sure. Before Use – Parts of your Plegridy Pen before use (See Figure E ): Important: Do not remove the Plegridy Pen cap until you are ready to inject. If you remove the cap before you are ready to inject, do not re-cap the pen.

Re-capping could cause the pen to lock. Preparing for your injection: Step 1: Take your Plegridy Pen out of the refrigerator and let it come to room temperature for at least 30 minutes. Do not use external heat sources such as hot water to warm your Plegridy Pen.

Step 2: Collect your supplies and wash your hands Find a well-lit area and a clean, flat surface like a table and collect all the supplies you will need to give yourself or to receive an injection. Wash your hands with soap and water. Step 3: Check your Plegridy Pen (see Figure F ) Check the injection status window on your Plegridy Pen.

Before you give your injection, you should see green stripes in the injection status window. Do not use Plegridy Pen if you do not see the green stripes in the injection status window. Check the expiration date printed on your Plegridy Pen.

Do not use Plegridy Pen past the expiration date. Check the medicine window on your Plegridy Pen and make sure the Plegridy medicine is clear and colorless. Do not use Plegridy Pen if… [Excerpted — this section continues on DailyMed.]