Peg Intron RP (Subcutaneous)

Peginterferon alfa-2b injection is a man-made version of substances that your body normally produces to fight infections. Peginterferon alfa-2b injection is used on its own or along with ribavirin and another medication called a hepatitis C virus (HCV) NS3/4A protease inhibitor (for example, boceprevir or telaprevir) to treat chronic hepatitis C infection. It is intended for patients who have never been treated with alpha interferons. The combination of peginterferon alfa-2b and ribavirin is used to treat adults and children aged 3 years and older who show signs of liver damage.

Peginterferon alfa-2b injection is also used to help prevent malignant melanoma (a type of skin cancer) from returning after it has been surgically removed. This medicine should be started within 84 days of surgery to remove lymph nodes that contain cancer.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your or your child's progress during regular visits to ensure that this medicine is working correctly. Blood and urine tests may be needed to check for side effects.

Using PegIntron® alone or with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using them when his partner becomes pregnant. Women should use effective birth control during treatment and for 6 months after the last dose. Female partners of male patients should also use effective birth control during treatment and for 6 months after the last dose. If you become pregnant while using these medicines, tell your doctor immediately.

A negative pregnancy test is required for women of childbearing age before starting treatment with this medicine and ribavirin. Female patients must also have regular pregnancy tests during treatment with this medicine and ribavirin and for 6 months after stopping treatment.

Using Sylatron™ while you are pregnant can harm your unborn baby. Use effective birth control during treatment with this medicine and for at least 10 days after the last dose. If you think you may be pregnant while using this medicine, tell your doctor immediately.

This medicine can increase thoughts of suicide in people with or without a history of mental illness. This medicine may also cause relapse in people with a history of substance abuse. Tell your doctor right away if you start to feel more depressed or show aggressive behavior. Also tell your doctor immediately if you have thoughts of hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or worsen quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, experience a significant increase in energy, or start to act recklessly. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects during treatment and for up to 6 months after treatment, tell your doctor or your child's doctor immediately.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing or swallowing, or any swelling of the hands, face, or mouth while you or your child are using this medicine.

Serious allergic reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, fever or chills, hives or welts, red skin lesions, severe acne or skin rash, or sores or ulcers on the skin while you or your child are using this medicine.

Check with your doctor right away if you experience blurred vision, difficulty reading, eye pain, or any other changes in vision during or after treatment. Your doctor may want you to see an ophthalmologist (eye doctor).

Peginterferon alfa-2b injection combined with ribavirin can temporarily lower your blood white blood cell count, increasing the chance of infection. It can also lower the number of platelets in your blood, which are necessary for proper blood clotting. If this happens, there are certain precautions you or your child can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have 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 urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your 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 using sharp objects like a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

Peginterferon alfa-2b injection when used with ribavirin may cause teeth and gum problems. These medicines may cause a dry mouth, which can damage your teeth and gums if you take them for a long time. To help prevent this condition, brush your teeth carefully at least twice a day and visit your dentist regularly. For temporary relief of dry mouth, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.

Check with your doctor right away if you or your child have symptoms that could indicate pancreatitis (swelling of the pancreas). This includes sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Children using peginterferon alfa-2b and ribavirin may experience weight loss and slowed growth. Most children have a growth spurt and gain weight after treatment ends. If you have questions about this, talk to your doctor.

Peripheral neuropathy may occur if you use this medicine with telbivudine (Tyzeka®). Check with your doctor right away if you or your child are experiencing burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will need to consider the risks of the medicine against the benefits it may provide. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how Pegintron® affects children younger than 3 years old. Safety and effectiveness have not been established.

There have not been appropriate studies on how Sylatron™ affects children. Safety and effectiveness have not been established.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the usefulness of peginterferon alfa-2b injection in older adults. However, elderly patients may be more sensitive to the effects of this medicine and may have age-related kidney issues, which could require caution and a dose adjustment.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with precautions. Your doctor may need to adjust the dose or take other precautions if you are taking any of the medicines listed below. The following interactions are significant, but not all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medicine or change some of your other medications.

• Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of use for one or both medicines.

• Aminophylline
• Amitriptyline
• Anagrelide
• Caffeine Citrate
• Clomipramine
• Desipramine
• Donepezil
• Doxepin
• Doxorubicin
• Flecainide
• Imipramine
• Methadone
• Nortriptyline
• Perphenazine
• Pirfenidone
• Rasagiline
• Ropivacaine
• Theophylline
• Tizanidine
• Tramadol
• Trimipramine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant, but not all-inclusive.

Other Medical Problems

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

• Allergic reactions (e.g., anaphylaxis, bronchoconstriction, Stevens-Johnson syndrome) or
• Autoimmune hepatitis (liver inflammation) or
• Decompensated liver disease—Should not be used in patients with these conditions.

• Angina (severe chest pain) or
• History of heart attack or
• Heart or blood vessel disease or
• History of heart rhythm problems (e.g., arrhythmia, tachycardia) or
• Hypotension (low blood pressure)—Use with caution. Patients with these conditions should be closely monitored while using this medicine.

• Bone marrow problems (e.g., aplastic anemia) or
• Brain disease (e.g., encephalopathy) or
• Breathing problems or other lung diseases (e.g., COPD, pneumonia, pulmonary infiltrates, sarcoidosis), or history of or
• History of depression or mental illness or
• Diabetes mellitus or
• Diabetic retinopathy (eye problem caused by diabetes) or
• Eye or vision problems (e.g., retinopathy, optic neuritis) or
• Hyperglycemia (high blood sugar level) or
• Hypertensive retinopathy (eye problem caused by high blood pressure) or
• Hypertriglyceridemia (high triglyceride levels or fats in the blood) or
• Kidney disease or
• Severe liver disease (including cirrhosis) or
• Psoriasis or
• History of psychiatric problems or
• Rheumatoid arthritis or
• Systemic lupus erythematosus or
• Thyroid disease or
• Type 1 diabetes—Use with caution. May worsen these conditions.

• Colitis (inflammation of the bowel) or
• Pancreatitis (inflammation of the pancreas)—Peginterferon alfa-2b should be stopped in patients with these conditions.

• Severe and unstable heart disease, or history of or
• Severe kidney disease or
• Sickle cell anemia (red blood cell disorder) or
• Thalassemia major (genetic blood disorder)—Peginterferon alfa-2b with ribavirin should not be used in patients with these conditions.

• Organ transplant (e.g., liver)—Use of peginterferon alfa-2b alone or with ribavirin has not been studied in patients with this condition.

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:

More common

• Anxiety
• black, tarry stools
• blood in the urine or stools
• bloody diarrhea
• chills
• cloudy urine
• cough
• depression
• difficult or labored breathing
• fever
• hoarseness
• irritability
• lower back or side pain
• mood swings
• nausea
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• stomach pain
• tightness in the chest
• trouble sleeping
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Changes in menstrual cycle
• constipation
• drowsiness
• dry hair and skin
• sensitivity to cold
• weight gain

Rare

• Aching, pain, or stiffness in the joints
• aggressive behavior
• attempts to kill yourself
• backache
• chest pain (severe)
• cool, pale skin
• decrease in vision
• diarrhea
• difficulty with speaking
• dizziness
• drug addiction or overdose
• eye pain
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of constant movement of self or surroundings
• headache
• loss of appetite
• muscle weakness
• nervousness
• numbness or loss of feeling in one or both limbs on the same side of the body
• paralysis
• possible decrease in the amount of urine
• rash, hives, or itching
• restlessness
• sensation of spinning
• sensitivity to heat
• sensitivity to sunlight
• sweating (excessive)
• thick, scaly skin
• thoughts of killing someone or yourself
• warm, smooth, or moist skin
• weight loss

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:

More common

• Aching, fullness, or tension in the sinuses
• bruising, irritation, or itching at the injection site
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• difficulty with moving
• feeling of warmth
• hair loss
• indigestion
• loss of taste
• muscle pain or stiffness
• pain in the bones or muscles
• redness of the face, neck, arms and occasionally, upper chest
• runny nose
• sneezing
• sore throat
• thinning of the hair

Less common

• Muscle rigidity or stiffness

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.

In the U.S.

• PEG-Intron
• Peg Intron RP
• Sylatron

Pharmacologic Class: Interferon, Alfa (class)

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional may give you or your child this medicine. It is given as a shot under your skin, usually in the stomach, thigh, or upper arm. If you are very thin, it should only be given as a shot under the skin of your thigh or outer surface of your arm. You may also be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

If you use this medicine at home, 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. This will help prevent skin problems from the injections. Do not inject into skin areas that are red, bruised, irritated, or infected, or have scars, stretch marks, or lumps.

Each package of peginterferon alfa-2b injection contains a Medication Guide and a patient instruction sheet. Read this sheet carefully and make sure you understand:

• How to prepare the injection.
• How to give the injection.
• How long the injection is stable for.

If you have any questions about any of this, check with your doctor.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Check the medicine in the pen or vial. It should look like a white to off-white tablet that is whole, or in pieces, or powdered. Gently swirl the pen or vial after adding water in it. Do not use the medicine if it is cloudy, discolored, or has particles in it. Do not shake.

Use the pen or vial only one time. Throw away any leftover medicine.

If you are using this medicine at home, your doctor may tell you to inject the medicine at bedtime and to take a fever medicine (eg, acetaminophen, Tylenol®) 30 minutes before the injection. This helps prevent common "flu-like" symptoms such as fever, chills, headaches, muscle or joint pain, or tiredness. Also, drinking extra fluids may help if you experience these unwanted effects.

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 hepatitis C virus infection: Adults—Dose is based on body weight and must be determined by your doctor. It is usually between 40 and 150 micrograms (mcg) injected under the skin once a week (same time and day each week). Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. Children younger than 3 years of age—Use and dose must be determined by your doctor. For hepatitis C virus infection, in combination with ribavirin: Adults—Dose is based on body weight and must be determined by your doctor. It is usually between 50 and 150 micrograms (mcg) injected under the skin once a week (same time and day each week) and should be taken together with ribavirin capsules or solution 2 times a day. Children 3 years of age and older—Dose is based on body surface area and must be determined by your doctor. The dose is usually 60 micrograms per square meter (mcg/m[2]) of body surface area injected under the skin once a week (same time and day each week) and should be taken together with ribavirin capsules or solution 2 times a day. Children younger than 3 years of age—Use and dose must be determined by your doctor. For treatment of melanoma: Adults—Dose is based on body weight and must be determined by your doctor. It is usually 6 micrograms (mcg) per kilogram (kg) of body weight injected under the skin once a week for 8 doses. This should be followed by a dose of 3 mcg/kg of body weight injected under the skin once a week for up to 5 years. 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.

For patients with hepatitis C: Use a dose as soon as you remember if it is the same day or the next day. Then go back to your regular dosing schedule. If it has been several days since you have missed your dose, call your doctor or pharmacist for instructions. Do not use more than one injection in a week.

Storage

Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.

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.

Store the PegIntron® Redipen® prefilled pen in the refrigerator. After mixing the medicine, use it right away. If you are unable to do this, the mixture may be stored in the refrigerator for 24 hours. Throw away any mixed medicine that has not been used within this time. Do not freeze the solution.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.