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.

peginterferon beta-1a 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.

Peginterferon beta-1a can harm your liver. Call your doctor if you have symptoms such as nausea, loss of appetite, tiredness, confusion, easy bruising or bleeding, dark urine, clay-colored stools, or yellowing of your skin or eyes.

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

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 once every 2 weeks. A healthcare provider may teach you how to properly use the medication by yourself.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine has changed colors or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Your healthcare provider will show you where to inject peginterferon beta-1a. Do not inject into the same place two times in a row.

About 2 hours after your injection, check for skin redness, swelling, or pain where you gave the injection. Call your doctor if you have a skin reaction that does not go away within a few days.

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.

Store peginterferon beta-1a in the original container in the refrigerator, protected from light.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using. Do not warm the medicine under hot water.

You can also store peginterferon beta-1a for a short time at cool room temperature protected from light. Do not leave the medicine out of a refrigerator for longer than a total of 30 days, including all times it has been taken out of and put back into a refrigerator.

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

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

Usual Adult Dose for Multiple Sclerosis:

Day 1: 63 mcg subcutaneously
Day 15: 94 mcg subcutaneously
Day 29 and every 14 days thereafter: 125 mcg subcutaneously

Comments:
-Patient should be advised to rotate injection sites (abdomen, back of the upper arm, and thigh).
-Prefilled pens and syringes are for single dose only and should be discarded after use.
-Prophylactic and concurrent use of analgesics and/or antipyretics and dose titration may prevent or reduce influenza-like symptoms sometimes experienced.

Use: For the treatment of patients with relapsing forms of multiple sclerosis (MS)

You should not use peginterferon beta-1a if you are allergic to it.

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 taking peginterferon beta-1a. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be 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.

Not approved for use by anyone younger than 18 or older than 65 years old.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid injecting peginterferon beta-1a into skin that is red, bruised, irritated, scarred, or infected.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, bumps on your skin; feeling anxious or light-headed; difficult breathing; swelling of your face, lips, tongue, or throat.

Peginterferon beta-1a can cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Peginterferon beta-1a may cause serious side effects. Call your doctor at once if you have:

• 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 of peginterferon beta-1a 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.

Other drugs may affect peginterferon beta-1a, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.