Plegridy Pen Starter Pack (Intramuscular, Subcutaneous)

Peginterferon beta-1a injection is used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease. Peginterferons are natural substances produced in the body to help fight infections. Peginterferon beta-1a is a synthetic (man-made) version of these substances.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress during regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Contact your doctor immediately if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be signs of a serious liver problem.

This medicine may cause some people to feel anxious, irritable, or show other unusual behaviors. It may also lead some people to have suicidal thoughts and tendencies or to feel more depressed. If you or your caregiver notice any of these side effects, inform your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor immediately if you experience a rash, itching, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth while using this medicine.

The tip cap of the prefilled syringe for intramuscular injection contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals who are sensitive to latex. Inform your doctor if you have a latex allergy before starting this medicine.

This medicine may cause redness, pain, or swelling at the injection site. Some patients have developed serious skin infections or damage (necrosis), including a permanent depression under the skin at the injection site. Contact your doctor right away if you notice depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or peeling of the skin.

This medicine commonly causes flu-like symptoms, including aching muscles, chills, fever, headaches, joint pain, and nausea. Taking your shot at bedtime may help you sleep through these symptoms. Your doctor may recommend medication to help control pain or fever (e.g., acetaminophen or ibuprofen). Carefully follow your doctor's instructions on how to prevent or treat these symptoms.

If you experience rapid weight gain, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, excessive swelling of the hands, wrists, ankles, or feet, or trouble breathing, contact your doctor immediately. These may be signs of heart problems or your body retaining too much water.

This medicine may lower the number of white blood cells in your blood, increasing your risk of infection. It can also reduce the number of platelets in your blood, which are necessary for proper blood clotting. If this happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Contact your doctor immediately if you think you are getting an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Inform your doctor immediately if you notice any unusual bleeding or bruising, black or tarry stools, blood in your urine or stools, or pinpoint red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may suggest other methods for cleaning your teeth and gums. Consult your medical doctor before undergoing any dental work.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and haven’t touched anything else since.
• Be careful not to cut yourself when using sharp objects, such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other activities where bruising or injury could happen.

This medicine may cause pulmonary arterial hypertension (high blood pressure in the lungs). Contact your doctor immediately if you experience trouble breathing or unusual tiredness or weakness.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how peginterferon beta-1a injection affects children. Safety and effectiveness have not been established for this age group.

Geriatric

While there have not been appropriate studies on how peginterferon beta-1a injection affects older adults, there are no expected geriatric-specific problems that would limit its usefulness in this population.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect your use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Anemia or
• Autoimmune disorders (e.g., autoimmune hepatitis, idiopathic thrombocytopenia) or
• Bleeding problems or
• Congestive heart failure or
• Depression or mental health problems, history of or
• Heart disease (e.g., cardiomyopathy) or
• Liver disease (including hepatitis) or
• Seizures, history of or
• Thyroid problems—Use with caution. May worsen these conditions.

• Infection—May reduce your body's ability to fight an infection.

• Severe kidney disease—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

Along with its needed effects, Plegridy Pen may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Blue-green to black skin discoloration
• chills
• cough
• diarrhea
• dizziness
• extremely high fever or body temperature
• fast, shallow breathing
• fast, weak heartbeat
• fever
• general feeling of discomfort or illness
• joint pain
• muscle aches, cramps, and pains
• pale, clammy skin
• runny nose
• seizures
• shivering
• sore throat
• sweating
• thirst
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Less common

• Dark urine
• decreased appetite
• itching skin
• light-colored stools
• stomach pain
• yellow eyes or skin

Rare

• Chest tightness
• difficulty with swallowing
• hives or welts, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Plegridy Pen. Your health care professional may also know ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty with moving
• itching, rash, redness, soreness, swelling, or warmth at the injection site
• lack or loss of strength
• muscle aches, cramps, pains, or stiffness
• pain, redness, or sloughing of the skin at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Plegridy Pen
• Plegridy Pen Starter Pack

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interferon, Beta (class)

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin (usually in the stomach, back of the upper arm, or thighs) or into your muscle (usually in the left and right thighs).

If you are injecting peginterferon beta-1a yourself, use it exactly as directed by your doctor. Do not change your dose or dosing schedule without checking first with your doctor. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk for side effects, while using too little may not improve your condition.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are irritated, reddened, bruised, infected, or scarred in any way.

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

Each package of the medicine contains a Medication Guide and patient instructions. Read the instructions carefully and make sure you understand:

• How to prepare the injection.
• How to use disposable syringes or pen.
• How to store the syringes or pen.

Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.

You might not use all of the medicine in each prefilled syringe or pen. Use each prefilled syringe and pen only one time. Do not save an open syringe or pen.

You may also receive other medicines (fever medicine, pain medicine) to help prevent or lessen flu-like symptoms (eg, fever, cough, chills, body aches) that may occur during treatment with this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):For multiple sclerosis: Adults—63 micrograms (mcg) injected under the skin or into a muscle on Day 1. Your doctor will increase your dose to 94 mcg after 14 days, reaching the full dose of 125 mcg on Day 29 (after another 14 days). Then, 125 mcg injected under your skin or into your muscle every 14 days. Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may also store this medicine at room temperature, away from heat and direct light, for up 30 days. Throw away any unused medicine after 30 days.

• What is Plegridy used for and is it an immunosuppressant?
• How do you use the Plegridy pen and where do you inject?