peginterferon beta-1a

What is the most important information I should know about peginterferon beta-1a?

Some people have thoughts about suicide while using peginterferon beta-1a. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

What is peginterferon beta-1a?

Peginterferon beta-1a is used to treat relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease) in adults who are 18 to 65 years old.

This medicine will not cure MS, it will only decrease the frequency of relapse symptoms.

Peginterferon beta-1a may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using peginterferon beta-1a?

Tell your doctor if you have ever had:

• depression, mental illness, or suicidal thoughts or actions;
• liver disease;
• bleeding problems;
• an allergy to latex (if you use the prefilled syringe);
• low blood cell counts;
• heart disease;
• a thyroid disorder;
• a seizure; or
• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis.

Some people have thoughts about suicide while using peginterferon beta-1a. Stay alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of peginterferon beta-1a on the baby.

Peginterferon beta-1a is not approved for use by anyone younger than 18 or older than 65 years old.

How is peginterferon beta-1a given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Peginterferon beta-1a is injected under the skin or into a muscle, usually given once every 2 weeks. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject peginterferon beta-1a. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Peginterferon beta-1a can cause flu-like symptoms. Your doctor may recommend taking a pain reliever or fever reducer such as aspirin, acetaminophen (Tylenol), or ibuprofen (Advil, Motrin) on the days you receive your injections.

You will need frequent medical tests.

About 30 minutes before your injection, take the syringe or pen out of the refrigerator and allow it to reach room temperature. Do not warm the medicine under hot water.

Do not freeze peginterferon beta-1a, and throw away the medicine if it has become frozen.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using peginterferon beta-1a?

Avoid injecting this medicine into skin that is red, bruised, irritated, scarred, or infected.

What are the possible side effects of peginterferon beta-1a?

• ongoing pain, swelling, or skin changes where the injection was given;
• a light-headed feeling, like you might pass out;
• unusual changes in mood or behavior (feeling hopeless, anxious, nervous, irritable, or depressed);
• thoughts about suicide or hurting yourself;
• a seizure;
• heart problems --swelling, rapid weight gain, feeling short of breath, rapid heartbeats, chest pain spreading to your jaw or shoulder, nausea, sweating;
• low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• liver problems --nausea, loss of appetite, tiredness, confusion, easy bruising or bleeding, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes); or
• thyroid problems --mood swings, trouble sleeping, tiredness, hunger, diarrhea, pounding heartbeats, muscle weakness, sweating, dry skin, thinning hair, menstrual changes, weight changes, puffiness in your face, feeling more sensitive to hot or cold temperatures.

Common side effects may include:

• pain, redness, itching, or swelling where the injection was given; or
• flu symptoms --headache, fever, chills, tiredness, body aches.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect peginterferon beta-1a?

Other drugs may affect peginterferon beta-1a, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about peginterferon beta-1a.