Peginterferon alfa-2b (Subcutaneous)

Peginterferon alfa-2b injection is a man-made version of natural substances in the body that help fight infections. Peginterferon alfa-2b injection is used alone or with ribavirin and another drug called a hepatitis C virus (HCV) NS3/4A protease inhibitor (like boceprevir or telaprevir) to treat chronic hepatitis C infection. It is meant 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 3 years of age and older who have symptoms of liver damage.

Peginterferon alfa-2b injection is also used to 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 at regular visits to ensure that this medicine is working properly. 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 an effective form of birth control during treatment and for 6 months after the last dose. Female partners of male patients should also use an effective form of 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 in 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 an effective form of birth control during treatment with this medicine and for at least 10 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

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, have 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 right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble with 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 immediately 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 blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Peginterferon alfa-2b injection combined with ribavirin can temporarily lower the number of white blood cells in your blood, increasing the risk of getting an infection. It can also lower the number of platelets in the blood, which are necessary for proper blood clotting. If this occurs, there are specific 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 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 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.

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 yellow eyes or skin. These could be symptoms of a serious liver problem.

Peginterferon alfa-2b injection when used with ribavirin may cause teeth and gum problems. These medicines may cause dryness of the mouth, and a dry mouth may damage your teeth and gums if you take these medicines for a long time. To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist. For temporary relief of mouth dryness, 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 lead to pancreatitis (swelling of the pancreas). This includes sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Children who use peginterferon alfa-2b and ribavirin combination 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 having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet.

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

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your healthcare 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

No appropriate studies have been conducted on the effects of Pegintron® in children younger than 3 years. Safety and effectiveness have not been established.

No appropriate studies have been conducted on the effects of Sylatron™ in children. Safety and effectiveness have not been established.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these cases, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• 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 together, your doctor may change the dose or frequency of 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 used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Other medical conditions 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. This medicine 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 should not be used together with ribavirin in patients with these conditions.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may require medical attention.

Check with your doctor right away if any of the following side effects happen:

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 happen 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, 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)

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.