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 aged 18 to 65 years.

peginterferon beta-1a will not cure MS; it will only reduce how often relapse symptoms happen.

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

Follow all the instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. 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 use the medication by yourself.

Ask your doctor or pharmacist if you do not 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 according to 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 spot two times in a row.

About 2 hours after your injection, check for skin redness, swelling, or pain where you injected. 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 suggest taking a pain reliever or fever reducer like aspirin, acetaminophen (Tylenol), or ibuprofen (Advil, Motrin) on the days you receive your injections.

You will need regular medical tests.

Store peginterferon beta-1a in the original container in the refrigerator, away 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 in 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 the refrigerator for longer than a total of 30 days, including all times it has been taken out and put back into the refrigerator.

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

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

Peginterferon beta-1a can damage your liver. Contact your doctor if you experience symptoms like nausea, loss of appetite, tiredness, confusion, easy bruising or bleeding, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Some individuals may have suicidal thoughts while using peginterferon beta-1a. Be aware of any changes in your mood or symptoms. Inform your doctor about any new or worsening symptoms.

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.

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

Peginterferon beta-1a can lead to serious blood clots in the small blood vessels inside your organs, like your brain or kidneys. Seek medical help immediately if you experience symptoms of this condition, such as fever, tiredness, decreased urination, bruising, or nosebleeds.

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

• ongoing pain, swelling, or changes in the skin where the injection was given;
• feeling light-headed, as if you might faint;
• unusual changes in mood or behavior (feeling hopeless, anxious, nervous, irritable, or depressed);
• thoughts of suicide or self-harm;
• a seizure;
• heart issues—swelling, rapid weight gain, shortness of breath, fast heartbeats, chest pain that spreads 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 issues—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 issues—mood swings, trouble sleeping, tiredness, hunger, diarrhea, fast heartbeats, muscle weakness, sweating, dry skin, thinning hair, changes in menstrual cycle, 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 at the injection site; or
• flu-like 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.

Usual Adult Dose for Multiple Sclerosis:

Day 1: 63 mcg subcutaneouslyDay 15: 94 mcg subcutaneouslyDay 29 and every 14 days thereafter: 125 mcg subcutaneouslyComments: -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)

Call your doctor for guidance if you miss a dose.

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

Do not inject peginterferon beta-1a into skin that is red, bruised, irritated, scarred, or infected.

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

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