Besremi Pen

This medication may rarely cause or worsen some serious medical conditions, including mental/mood problems (such as depression), autoimmune conditions (such as lupus, rheumatoid arthritis), blood vessel problems (such as heart disease), or infections. Careful monitoring by your doctor may decrease your risk. Tell your doctor right away if you develop any serious symptoms or side effects (see Side Effects section). Some side effects may go away or lessen after stopping treatment with this medication.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using ropeginterferon alfa-2b and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Inject this medication under the skin as directed by your doctor, usually once every 2 weeks. The injection is given in the abdomen or thigh. Do not inject near the belly button or at the waistline. The dosage and schedule are based on your medical condition, lab tests, and response to treatment. If you are stable on this medication for at least a year, your doctor may change your dosing schedule to a longer time interval (such as every 4 weeks).

For a more comfortable injection, take the medication out of the refrigerator at least 15 to 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is irritated, red, bruised, infected, or scarred. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Drink plenty of fluids while using this medication unless your doctor directs you otherwise.

See also Warning section.

Redness or swelling at the injection site may occur. Nausea, vomiting, diarrhea, dry mouth, dry eyes, loss of appetite, dizziness, drowsiness, or trouble sleeping may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Flu-like symptoms (such as headache, tiredness, fever, chills, muscle aches) may also occur, especially when you first start this medication. You can lessen these side effects by injecting this medicine at bedtime and using fever reducers/pain relievers such as acetaminophen before each dose. Ask your doctor or pharmacist for more information.

Tooth and gum problems may sometimes occur during treatment. Having a dry mouth can worsen this side effect. Prevent dry mouth by drinking plenty of water or using a saliva substitute. Brush your teeth well at least twice a day and have regular dental exams. If you vomit, rinse your mouth afterward to lessen the chance of tooth and gum problems.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, feeling too hot or cold (more than others around you), gradual change in weight (without a change in diet or exercise), unusually slow/fast/pounding heartbeat, increased thirst/urination, black/tarry stools, signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), numbness/tingling of arms/legs, menstrual changes (such as absent/delayed/irregular periods).

Get medical help right away if you have any very serious side effects, including: chest pain, seizures, symptoms of a stroke (such as weakness on one side of the body, trouble speaking, confusion), vision changes (such as blurred vision, partial loss of vision).

This drug may cause serious mental/mood changes that may get worse during treatment or after your last dose. Tell your doctor right away if you have symptoms such as confusion, depression, hallucinations, thoughts of suicide or hurting others, unusual irritability, or aggressive behavior.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood counts, thyroid tests, kidney/liver function, triglyceride levels, dental and eye exams) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

It is important to use each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store in the refrigerator away from light and moisture. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.