Plegridy Starter Pack

Peginterferon beta-1a is made from human proteins. Interferons stimulate the body's immune responses to infection or disease.

Peginterferon beta-1a is used to treat relapsing multiple sclerosis (MS). 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.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use peginterferon beta-1a if you are allergic to peginterferon or other interferons (Alferon, Avonex, Betaseron, Extavia, Intron, Rebetron, Rebif, and others).

To make sure peginterferon beta-1a is safe for you, tell your doctor if you have:

• liver disease;
• kidney disease;
• heart disease;
• a history of depression, mental illness, or suicidal thoughts or actions;
• a bleeding or blood clotting disorder;
• a thyroid disorder;
• epilepsy or other seizure disorder; or
• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis.

FDA pregnancy category C. It is not known whether peginterferon beta-1a will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether peginterferon beta-1a passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

In the U.S.

• Plegridy
• Plegridy Pen
• Plegridy Pen Starter Pack
• Plegridy Starter Pack

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interferon, Beta (class)

Peginterferon beta-1a injection is used to treat the relapsing forms of multiple sclerosis (MS). 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 that are 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of peginterferon beta-1a injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of peginterferon beta-1a injection in the geriatric population. Safety and efficacy have not been established.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell 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 used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

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

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain peginterferon beta-1a. It may not be specific to Plegridy Starter Pack. Please read with care.

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 abdomen, back of the upper arm, or 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 an area of the body where the skin is 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 a sheet called Instructions for Use. Read this information 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.

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:
  • For multiple sclerosis:
    • Adults—63 micrograms (mcg) injected under the skin 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 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.

Keep this medicine in the refrigerator if you store it at home. Do not freeze. If refrigeration is not available, it may be kept for up to 30 days at room temperature, away from heat and direct light. You may allow the prefilled pens and prefilled syringes to warm to room temperature for 30 minutes before injection. Do not heat in a microwave oven or in hot water.

• Tell all of your health care providers that you take Plegridy Starter Pack. This includes your doctors, nurses, pharmacists, and dentists.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol.
• A lot of times, reactions happen where the shot was given. Sometimes, very bad reactions may happen. Check with your doctor if you have any reaction that bothers you or does not go away. Call your doctor right away if you have any break in the skin, color changes (blue or black), swelling, or drainage of fluid where the shot was given.
• Very bad health problems like thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) have happened with drugs like this one. Sometimes, this has been deadly. This has happened several weeks to years after starting treatment. Call your doctor right away if you feel very tired or weak or have any bruising or bleeding, change in balance, change in eyesight, change in how much urine is passed, dark urine, fever, pale skin, trouble speaking or thinking, weakness on 1 side of the body, or yellow skin or eyes.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use Plegridy Starter Pack as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to give closely if you or a family member is giving the shot at home.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Wash your hands before and after use.
• Before giving the shot, let it come to room temperature. Do not heat this medicine.
• Move the site where you give the shot with each shot.
• Throw syringe away after use. Do not use the same syringe more than one time.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it and go back to your normal time.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of thyroid problems like a change in weight without trying, feeling nervous and excitable, feeling restless, feeling very weak, hair thinning, low mood (depression), neck swelling, not able to focus, not able to handle heat or cold, period (menstrual) changes, shakiness, or sweating.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Seizures.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• Very bad and sometimes deadly liver problems have happened with Plegridy Starter Pack. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Plegridy Starter Pack or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Plegridy Starter Pack. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017