Peginterferon Beta-1a (Subcutaneous route)
- Plegridy Pen
- Plegridy Pen Starter Pack
- Plegridy Starter Pack
Interferon, Beta (class)
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
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.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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.
Proper Use of This Medicine:
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.
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.
- For multiple sclerosis:
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.
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.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause some people to be anxious, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may cause redness, pain, or swelling at the injection site. Some patients have developed a permanent depression (necrosis) under the skin at the injection site. Contact your doctor right away if you notice depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin.
This medicine commonly causes a flu-like reaction, with aching muscles, chills, fever, headaches, joint pain, and nausea. Using your shot at bedtime may allow you to sleep through the symptoms. Your doctor may want you to take a medicine to help control the pain or fever (eg, acetaminophen or ibuprofen). Carefully follow your doctor's instructions about how to prevent or treat these symptoms.
If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.
This medicine may lower the number of white blood cells in the blood. This will increase your chance of getting an infection. It can also lower the number of platelets in the blood. Platelets are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
Side Effects of This Medicine:
- More common
- Blue-green to black skin discoloration
- cough or sore throat
- extremely high fever or body temperature
- fast, shallow breathing
- fast, weak heartbeat
- general feeling of discomfort or illness
- joint pain
- muscle aches and pains
- muscle cramps
- pale, clammy skin
- runny nose
- trouble sleeping
- unusual tiredness or weakness
- Less common
- Dark urine
- decreased appetite
- general feeling of tiredness or weakness
- itching skin
- light-colored stools
- stomach or abdominal pain
- yellow eyes or skin
- Difficulty with swallowing
- hives or welts
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- skin rash
- tightness in the chest
- More common
- Difficulty with moving
- itching, rash, redness, soreness, swelling, or warmth at the injection site
- lack or loss of strength
- muscle stiffness
- pain, redness, or sloughing of skin at the injection site
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/15/2016