Ropeginterferon Alfa-2b Prefilled Syringe (ROPEGINTERFERON ALFA-2B - INJECTION)

Instructions

This medicine is injected into the skin. Ask your doctor, nurse, or pharmacist where on your body this medicine can be injected and how to inject it.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The liquid should be clear or light yellow.

Check the medicine before each use. If the liquid medicine has any particles in it, appears discolored, or if the vial appears damaged, do not use it.

Keep medicine in refrigerator. Do not freeze. Protect from light.

Keep the medicine in its original container.

Take the medicine out of the refrigerator about 15 to 30 minutes before use to warm to room temperature.

Never use any medicine that has expired.

Discard any remaining medicine after your dose is given.

Wash your hands before and after handling this medicine.

Clean the injection site with alcohol before applying the injector.

Do not inject into skin that is bruised, tender, red, hard or has scars or stretch marks.

Do not inject near the navel or at the waistline.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

Do not rub or massage the area where the injection was given.

To relieve dry mouth, chew gum, suck on hard candy/ice chips, drink extra water, or use a saliva substitute.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Pain or fever reducers may relieve some side effects. Please speak with your healthcare provider or pharmacist.

Visit your dentist regularly. Proper care of your teeth is very important while taking this medicine. Brush your teeth and floss regularly.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Do not drink beverages with alcohol while on this medicine.

After being on this medication, speak with your doctor about any new, unusual or strong thoughts or feelings.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 8 weeks after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

To prevent pregnancy, women must use reliable forms of birth control while taking this medicine and for 8 weeks after stopping it.

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• decreased appetite
• diarrhea
• dizziness or drowsiness
• lack of energy and tiredness
• flu-like symptoms
• hair loss
• headaches
• pain, redness, swelling near injection
• nausea and vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• agitated feeling or trouble sleeping
• bleeding or bruising
• chest pain
• coughing
• depression or feeling sad
• fever or chills
• numbness or tingling in hands and feet
• severe or persistent headache
• fast, irregular, or slow heartbeat
• irritability
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• menstruation changes (missed or fewer periods)
• seizures
• dark, tarry stool
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• suicidal thoughts
• difficulty adjusting to changes in temperature
• persistent or unusual thirst
• increased urinary frequency
• blurring or changes of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.