BESREMi contains the active ingredient ropeginterferon alfa-2b-njft, which is a form of interferon alfa-2b. It is an injection intended for subcutaneous use, supplied in a prefilled syringe with a dosage of 500 mcg per mL. Key inactive ingredients include benzyl alcohol, glacial acetic acid, polysorbate 80, sodium acetate, sodium chloride, and Water for Injection, USP.

How should I use this medication?

This medication is injected under the skin. It is usually given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

If you give yourself this medication at home: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team with questions.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in the refrigerator. Do not freeze. Keep it in the original carton until you are ready to take it. Remove the dose from the carton about 30 minutes before it is time for you to take it. Avoid exposure to extreme heat. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Eye pain, change in vision, vision loss
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Lung injury—shortness of breath or trouble breathing, cough, spitting up blood, chest pain, fever
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting
• Thoughts of suicide or self-harm, worsening mood, feelings of depression
• Tooth decay—change in tooth color, bad breath, sensitive gums or teeth
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dry mouth
• Fatigue
• Hair loss
• Joint pain
• Muscle pain
• Sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Autoimmune disease
• Bleeding disorder
• Blood clots
• Diabetes
• Heart attack
• Heart disease
• High blood pressure
• HIV or AIDS
• Immune system problems
• Kidney disease
• Liver disease
• Low blood cell levels, such as low white cells, red cells, platelets
• Mental health conditions
• Organ transplant
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to ropeginterferon, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Certain medications for anxiety
• Medications that cause low blood cell levels (white cells, red cells, and platelets)
• Medications that help you fall asleep
• Medications that lower your chance of fighting infection
• Opioids

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication. You may need blood work while taking this medication.

This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

If you have hepatitis B, talk to your care team if you plan to stop this medication. The symptoms of hepatitis B may get worse if you stop this medication.

Your vision may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight.

This medication can cause tooth and gum problems. Tenderness, swelling, or minor bleeding of the gums may occur. Brushing and flossing your teeth regularly may reduce the risk of side effects. Visit your dentist on a regular basis. Tell your dentist about any medications you are taking.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 8 weeks after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 8 weeks after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for 8 weeks after the last dose.

What are the most serious risks of this medication?

This medicine can increase the risk of having a heart attack or stroke.

This medicine can lower your body’s ability to fight infections. You may get more infections while taking this medicine. Any infection you get could become serious and even deadly.

This medicine can cause immune system disorders or make them worse. Examples are rheumatoid arthritis, lupus, sarcoidosis, thyroid disease, and psoriasis. Tell your healthcare provider if you have any kind of immune disease.

This medicine can cause changes in behavior or mental health. There is a higher risk in those with, or with a history of, mental health problems. Patients of all ages and their families should watch out for changes in behavior during treatment. Call your health care provider right away if you have any of these symptoms: anxiety; feel paranoid; hallucinations; depression; restlessness; unusual behavior; confusion; or suicidal thoughts or actions.