Plegridy Starter Pack

The starting dose of peginterferon beta-1a is 63 µg injected subcutaneously (under the skin), followed by 94 µg injected subcutaneously 2 weeks later, and then 125 µg injected subcutaneously 2 weeks after the second dose. The regular dose of peginterferon beta-1a is 125 µg injected subcutaneously every 2 weeks thereafter. Peginterferon beta-1a is available as an injection only. It comes in single-use prefilled syringes or injection pens.

There are special directions enclosed in the package with the injection. Read these directions carefully before using the medication. Follow the instructions closely to avoid accidentally contaminating the medication or needle and giving yourself an infection, or from damaging the equipment or losing the medication.

Peginterferon beta-1a is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject Plegridy Starter Pack (Peginterferon-beta-1a) on your own until you completely understand how to inject a dose.

Rotate the injection sites (arms, thighs, upper buttocks, or stomach) to minimize injection site skin irritation.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, and it is more than 7 days until your next dose, inject it as soon as possible and continue with your regular schedule. If it is less than 7 days until your next dose, inject the missed dose and wait 2 weeks before administering any future doses. Do not inject 2 doses of Plegridy Starter Pack (Peginterferon-beta-1a) within 7 days of each other. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Before using a syringe, check it carefully to ensure that there are no particles in it. Do not use the syringe if the pen or syringe is broken or the solution is not clear and colourless. Store Plegridy Starter Pack (Peginterferon-beta-1a) in the refrigerator and protect it from freezing. Store the medication in its original packaging to protect it from light and keep it out of the reach of children. Peginterferon beta-1a may be stored at room temperature for up to 30 days.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Prefilled syringe

63 µg
Each prefilled syringe containing 0.5 mL of sterile, clear liquid for subcutaneous injection contains 63 µg of peginterferon beta-1a.

94 µg
Each prefilled syringe containing 0.5 mL of sterile, clear liquid for subcutaneous injection contains 94 µg of peginterferon beta-1a.

125 µg
Each prefilled syringe containing 0.5 mL of sterile, clear liquid for subcutaneous injection contains 125 µg of peginterferon beta-1a.

Prefilled pen
Each single prefilled syringe containing 0.5 mL of 63 µg, 94 µg, or 125 µg peginterferon beta-1a is contained within a single-use, disposable, injection device (prefilled pen).

Do not take Plegridy Starter Pack (Peginterferon-beta-1a) if you:

• are allergic to peginterferon or any ingredients of the medication
• are allergic to interferon beta
• are pregnant
• have severe Depression or thoughts of suicide

There may be an interaction between peginterferon beta-1a and any of the following:

• Cladribine
• zidovudine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Plegridy Starter Pack (Peginterferon-beta-1a). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Plegridy Starter Pack (Peginterferon-beta-1a).

Blood counts: Plegridy Starter Pack (Peginterferon-beta-1a) can decrease the number of neutrophils (a type of white blood cell that helps fight infection) and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, contact your doctor immediately.

Depression and suicidal behaviour: If you have or have had depression or bipolar disorder, you may be at an increased risk of feeling agitated (restless, anxious, aggressive, emotional, and feeling not like yourself), or wanting to hurt yourself or others. If you develop severe depression or experience other mood or behaviour changes, stop using this medication and contact your doctor immediately. If you have thoughts or feelings about harming yourself, get immediate medical attention.

Fever and flu-like symptoms: Plegridy Starter Pack (Peginterferon-beta-1a) can cause fever and other flu-like symptoms such as chills and headache. Gradually increasing the dose of Plegridy Starter Pack (Peginterferon-beta-1a) when you start using it should also help reduce these symptoms. Your doctor may suggest that you take Acetaminophen if you develop these symptoms.

If you have a persistent fever while using Plegridy Starter Pack (Peginterferon-beta-1a), contact your doctor.

Heart problems: Plegridy Starter Pack (Peginterferon-beta-1a) may worsen symptoms of heart disease. If you have heart disease such as Angina, Congestive Heart Failure, or arrhythmia, discuss with your doctor how Plegridy Starter Pack (Peginterferon-beta-1a) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Plegridy Starter Pack (Peginterferon-beta-1a), and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Liver function: Peginterferon beta-1a may cause decreased liver function and occasionally, liver failure. If you have liver problems, discuss with your doctor how Plegridy Starter Pack (Peginterferon-beta-1a) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may recommend regular liver tests while you are using Plegridy Starter Pack (Peginterferon-beta-1a). If you have severe changes in liver function, your doctor may recommend that you take a lower dose of Plegridy Starter Pack (Peginterferon-beta-1a) or stop taking it altogether.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Seizures: There have been occasional reports of seizures occurring with interferons. Seizures are more likely to occur when higher doses of Plegridy Starter Pack (Peginterferon-beta-1a) are taken. If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Plegridy Starter Pack (Peginterferon-beta-1a) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Plegridy Starter Pack (Peginterferon-beta-1a), and whether any special monitoring is needed.

Thyroid problems: Some people taking Plegridy Starter Pack (Peginterferon-beta-1a) develop changes in the function of their thyroid. Symptoms of these changes include increased sweating, rapid heartbeat, weight loss without a change in your diet or amount of exercise you get, or feeling emotional or anxious. Contact your doctor if you experience these symptoms.

Pregnancy: Plegridy Starter Pack (Peginterferon-beta-1a) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Plegridy Starter Pack (Peginterferon-beta-1a), contact your doctor immediately. It is important to use effective birth control while taking Plegridy Starter Pack (Peginterferon-beta-1a).

Breast-feeding: It is not known if peginterferon beta-1a passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.