Peginterferon Beta-1A, Injection

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KEY POINTS

• This medicine is given by injection to treat relapsing forms of multiple sclerosis. Use it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious liver problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: biological response modulator; immune system booster

Generic and brand names: peginterferon beta-1a, injection; Plegridy

What is this medicine used for?

This medicine is given by injection to treat relapsing forms of multiple sclerosis.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to human albumin
• An autoimmune disease such as lupus, psoriasis, or rheumatoid arthritis
• Bleeding problems or blood disorders such as anemia
• Depression, anxiety, or other mental health problem
• Heart disease
• Kidney or liver disease
• Problems with alcohol abuse
• Seizures
• Thyroid problems

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Often you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know how and when to have them and how much medicine to use. Change your injection site each time you inject the medicine, following your healthcare provider's instructions. Carefully read and follow the directions that come in the package of medicine for preparing and giving the shots. If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is given by subcutaneous injection (shot just under the skin). It is usually given once every 2 weeks. The medicine comes in a pen or prefilled syringe with needles already attached to it. Always use a new prefilled pen or syringe. Do NOT inject into an area of the body where the skin is irritated, reddened, bruised, infected, or scarred.

Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

What if I miss a dose?

If you miss a dose, take it as soon as possible. If it is almost time to take your next dose, skip the missed dose. Do not take double or extra doses. If you accidentally take more than the prescribed dose, call your healthcare provider right away.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If you have any unusual mood changes or behavior, or feel depressed or have thoughts of suicide, contact your healthcare provider right away.

This medicine may cause serious liver problems. If you develop nausea, vomiting, a fever, stomach pain, yellowing of your eyes or skin, or severe fatigue, contact your healthcare provider right away. These may be signs of liver damage. Alcohol may increase the risk of liver problems. Do not drink alcohol while taking this medicine unless your healthcare provider approves.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

You may have mild fever, chills, and muscle aches when you first start taking this medicine. These side effects usually get better with time. Talk with your healthcare provider if the side effects are bothersome.

This medicine may cause redness, pain, or swelling at the injection site. If these symptoms don’t go away or get worse, contact your healthcare provider.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

You may need lab tests regularly to see how this medicine is affecting you. Keep all appointments.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Depression or thoughts of suicide; mood changes; confusion or unusual thoughts or behavior; seizures; unusual bruising or bleeding; yellowing of the skin or eyes; dark yellow or brown urine; light-colored bowel movements; severe nausea, vomiting, or stomach pain; swelling of the fingers, ankles, or feet; sudden shortness of breath; fast or irregular heartbeat; chest pain; unusual tiredness or weakness; unexplained fever, sore throat, or cough; trouble urinating; vision changes; unexplained weight changes; unexplained sweating, shaking, or tremors; severe dizziness or fainting; trouble with balance or walking; trouble with speech.

Other: Headache, mild fever, chills, mild tiredness, muscle or joint pain, mild nausea or vomiting, mild dizziness, irritation at the spot where the shot is given.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cancer medicines such as abiraterone (Zytiga), axitinib (Inlyta), bortezomib (Velcade), bosutinib (Bosulif), crizotinib (Xalkori), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), sorafenib (Nexavar), sunitinib (Sutent), vandetanib (Caprelsa), vemurafenib (Zelboraf), and vincristine (Marqibo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)

Do not have any vaccinations with live virus vaccines unless your healthcare provider approves. Do not drink alcohol while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Keep this medicine refrigerated. Protect it from heat, high humidity, and bright light. Do not let it freeze. Allow the medicine to come to room temperature (about 30 minutes) before injection.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.