Warnings:

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.

Warnings:

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.

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Uses

Ropeginterferon alfa-2b is used to treat a certain type of cancer (polycythemia vera). This medication is the same as a protein that your body naturally produces (interferon). In the body, it is thought to work by affecting cell function/growth and the body's natural defenses (immune system) in many ways.

How to use Ropeginterferon Alfa-2B-Njft 500 Mcg/Ml Subcutaneous Syringe

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. To increase comfort, remove this medication from the refrigerator and let it warm to room temperature for 15 to 30 minutes. Do not warm up this medication in any other way such as heating in the microwave or placing in hot water. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Inject this medication under the skin in your abdomen or thigh as directed by your doctor, usually once every 2 weeks. Do not inject near the belly button or at the waistline. Do not inject into skin that is irritated, red, bruised, infected, or scarred. Change the injection site each time to lessen injury under the skin.

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). Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to use the medication.

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

Side Effects

See also Warning section.

Most people have flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches, but these usually decrease after the first few weeks of treatment. 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. Nausea, vomiting, diarrhea, dry mouth, dry eyes, loss of appetite, dizziness, drowsiness, trouble sleeping, or redness/swelling at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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, cough).

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/medwatch.

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

Precautions

See also Warning section.

Before using ropeginterferon alfa-2b, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol (PEG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: mental/mood disorders (such as depression, psychosis, suicidal thoughts), autoimmune disorders (such as rheumatoid arthritis, lupus, psoriasis), bleeding/blood problems, diabetes, heart problems, high blood pressure, intestinal problems (such as colitis), kidney problems, liver problems (such as hepatitis), lung problems (such as chronic obstructive pulmonary disease-COPD), pancreatitis, high triglyceride levels, thyroid problems, substance use disorder (such as overuse of or addiction to drugs/alcohol).

This medication can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using ropeginterferon alfa-2b before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication. You should not become pregnant while using ropeginterferon alfa-2b. Ropeginterferon alfa-2b may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for at least 8 weeks after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least 8 weeks after the last dose is not recommended. Consult your doctor before breast-feeding.

Interactions

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.

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Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

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.

Missed Dose

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.

Storage

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.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.