Pegasys Proclick (Subcutaneous)

Peginterferon alfa-2a injection is used by itself or with other medicines (such as ribavirin [Copegus®, Rebetol®], boceprevir [Victrelis®], and telaprevir [Incivek®]) to treat chronic hepatitis C infection. It is also used to treat chronic hepatitis B infection. Peginterferon alfa-2a is a man-made version of a substance that your body normally produces. It helps your immune system fight hepatitis infections.

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

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine along with ribavirin during pregnancy can harm your unborn baby. These medicines may also cause birth defects if the father is using them when his partner becomes pregnant. If you become pregnant while using these medicines, tell your doctor right away.

Women of childbearing age need a negative pregnancy test before starting treatment with this medicine and ribavirin. Both male and female patients must use effective birth control during treatment and for 6 months after the last dose. Female patients will need to have monthly pregnancy tests during treatment and for 6 months after the last dose.

This medicine may cause some people to feel agitated, irritable, or show other unusual behaviors. It may also lead to suicidal thoughts and tendencies or increased depression in some people. If you, your child, or your caregiver notice any of these side effects, tell your doctor immediately.

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

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

This medicine will not prevent you from spreading hepatitis B or hepatitis C to others.

This medicine combined with ribavirin can temporarily reduce the number of white blood cells in your blood, increasing the risk of infections. It can also lower the number of platelets, which are needed for proper blood clotting. If this happens, there are specific precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people who have infections. Contact your doctor immediately if you think you have an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising, black or 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 doctor, dentist, or nurse may suggest 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 cautious when using sharp objects like a safety razor or fingernail or toenail cutters to avoid cuts.
• Avoid contact sports or other activities where bruising or injury could happen.

Contact your doctor right away if you or your child have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be signs of a blood disorder called hemolytic anemia.

Contact your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness. These could be symptoms of pancreatitis.

Contact your doctor immediately if you experience vision changes, such as blurred vision, difficulty reading, or eye pain during or after treatment. This could indicate a serious eye problem. Your doctor may want an eye doctor (ophthalmologist) to examine your eyes.

Peginterferon alfa-2a used with ribavirin may affect your child's growth. Your doctor may need to monitor your child's height and weight during and after treatment with these medicines.

This medicine may cause some people to feel drowsy, dizzy, or less alert than usual. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless you have discussed them with your doctor. 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 must consider the risks of the medicine compared to the benefits it will provide. Here are some important points to think about:

Allergies

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

Pediatric

Studies have not been done to determine how peginterferon alfa-2a injection affects children younger than 5 years old for treating chronic hepatitis C infection or children younger than 3 years old for treating chronic hepatitis B infection. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of peginterferon alfa-2a injection. However, older patients may experience more unwanted effects (such as heart and blood vessel problems, flu-like symptoms) or age-related kidney issues, which might require caution and dose adjustments for those receiving peginterferon alfa-2a.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the possible 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 situations, your doctor may need to change the dose, or other precautions might be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions are significant and are not a complete list.

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

• Fezolinetant
• Telbivudine

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 adjust the dose or frequency of use for one or both of the medicines.

• Bendamustine
• Clozapine
• Levoketoconazole
• Methotrexate
• Theophylline
• Triclabendazole

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment option for you. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both of the medicines.

• Methadone

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may impact the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Anemia or
• Bleeding problems, history of or
• Chest pain or
• Colitis (inflammation of the bowels) or
• Depression, history of or
• Diabetes or
• Diabetic retinopathy (eye problem caused by diabetes) or
• Eye or vision problems (such as optic neuritis, retinopathy) or
• Heart or blood vessel disease or
• Heart rhythm problems (such as arrhythmia), history of or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Hypoglycemia (low blood sugar) or
• Severe kidney disease or
• Lung disease (such as pneumonia, sarcoidosis) or
• History of manic episodes (bipolar depression) or
• Neutropenia (low white blood cells) or
• Psoriasis (skin disease) or
• History of psychiatric problems or
• Rheumatoid arthritis or
• History of stroke or
• Systemic lupus erythematosus (immune system disorder) or
• Thrombocytopenia (low blood platelet count) or
• Thyroid disease—Use with caution. May worsen these conditions.

• Autoimmune hepatitis (serious liver disease) or
• Severe liver disease (such as cirrhosis)—Should not be used in patients with these conditions.

• Infection (such as bacteria, virus, or fungus)—May reduce your body's ability to fight an infection.

• Organ transplant (such as liver)—The use of peginterferon alfa-2a 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. Not all of these side effects will occur, but if they do, they may require medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools
• chills
• cough
• discouragement
• feeling sad or empty
• fever
• irritability
• lack of appetite
• loss of interest or pleasure
• lower back or side pain
• painful or difficult urination
• pale skin
• sore throat
• tiredness
• trouble sleeping
• trouble concentrating
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Bone pain
• chest pain or discomfort
• confusion
• constipation
• depressed mood
• dizziness
• dry skin and hair
• fainting
• fast heartbeat
• feeling cold
• hair loss
• headache
• heart murmur
• hives
• hoarseness or husky voice
• lightheadedness
• muscle cramps and stiffness
• pale skin
• rapid, shallow breathing
• slowed heartbeat
• sneezing
• stomach pain
• tightness in the chest
• troubled breathing with exertion
• weight gain

Incidence not known

• Accumulation of pus in the arms or legs
• blistering, peeling, loosening of the skin
• decreased urination
• diarrhea
• dry mouth
• increase in heart rate
• itching
• joint or muscle pain
• red, irritated eyes
• red skin lesions, often with a purple center
• seizures
• sunken eyes
• swollen, red, tender area of infection in the arms or legs
• thirst
• wrinkled skin

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. Your health care professional may also provide 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

• Back pain
• cracked, dry, scaly skin
• crusting, irritation, itching, or reddening of the skin
• fear
• feeling unusually cold, shivering
• hair loss or thinning of the hair
• muscle or joint pain
• nervousness
• numbness
• pain
• rash
• redness
• scarring
• soreness
• stinging
• swelling
• tenderness
• tingling
• ulceration
• vomiting
• warmth

Less common

• Belching
• blurred vision
• heartburn
• indigestion
• memory problems
• stomach discomfort or upset

Incidence not known

• Change of hearing
• loss of hearing

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.

• Pegasys
• Pegasys Proclick

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Interferon, Alfa (class)

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional may give you this medicine. It is given as a shot under your skin, usually in the stomach or thighs. You may 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.

Each package of peginterferon alfa-2a contains a Medication Guide. Read the instructions carefully and make sure you understand:

• How to prepare the injection.
• How to properly use disposable syringes.
• How to give the injection.
• How long the injection is stable.

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

This medicine is available in 3 dosage forms: a vial (glass container), a prefilled syringe, or a disposable autoinjector. If you switch from using the vial to using the prefilled syringe or autoinjector, double-check that you are giving yourself the correct amount of medicine.

Use each vial, syringe, or autoinjector only one time. You might not use all of the medicine. Do not save an open vial, syringe, or autoinjector. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Drink extra fluids while you are using this medicine. This will keep you well hydrated, especially during the early part of your treatment.

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 (solution): For hepatitis B: Adults—Dose is based on body weight and must be determined by your doctor. It is usually 180 micrograms (mcg) injected under the skin once a week for 48 weeks. The medicine should be used on the same day each week and at about the same time. Children 3 years of age and older—Dose is based on body weight or body size and must be determined by your doctor. It is usually not more than 180 mcg injected under the skin once a week (same time and day each week) for 48 weeks. The length of time will be determined by your doctor. Children younger than 3 years of age—Use and dose must be determined by your doctor. For hepatitis C: Adults—Dose is based on body weight and must be determined by your doctor. It is usually 180 micrograms (mcg) injected under the skin once a week for 48 weeks. The medicine should be used on the same day each week and at about the same time. Children—Use and dose must be determined by your doctor. For hepatitis C infection, in combination with ribavirin: Adults—Dose is based on body weight and must be determined by your doctor. It is usually 180 micrograms (mcg) injected under the skin once a week (same time and day each week) together with oral ribavirin twice daily for 24 to 48 weeks. The length of time will be determined by your doctor. Children 5 years of age and older—Dose is based on body weight or body size and must be determined by your doctor. It is usually 180 mcg injected under the skin once a week (same time and day each week) together with oral ribavirin twice daily for 24 to 48 weeks. The length of time will be determined by your doctor. Children younger than 5 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use your medicine and you are 1 or 2 days late, use it as soon as you can. If it has been more than 2 days since you were supposed to use the medicine, call your doctor 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.

Store in the refrigerator. Do not freeze.

Do not leave this medicine out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect it from light.

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