Ropeginterferon Alfa-2b-njft (ro-peg-in-ter-FEER-on AL-fa-too-bee - njft)

Treats polycythemia vera.

Brand Name(s):

BESREMi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the upper thighs or stomach.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into an area of the body where the skin is irritated, red, bruised, infected, or scarred.
• Check the medicine in the prefilled syringe. It should be clear and colorless to slightly yellow. Do not use the medicine if it is cloudy, discolored, or has particles in it. Do not use the prefilled syringe if it is damaged or broken.
• Allow the medicine to warm to room temperature for 15 to 30 minutes before you use it. Do not warm it in any other way.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Do not use this medicine if it has been frozen or left in direct sunlight.
• Each prefilled syringe or needle should be used only one time. Do not reuse your prefilled syringe or needle. Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have received a transplant and take medicines that weaken your immune system.
• Some medicines can affect how ropeginterferon alfa-2b-njft works. Tell your doctor if you are using hydroxyurea.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 8 weeks after the last dose.
• Do not breastfeed during treatment and for at least 8 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease (including heart failure, heart rhythm problems), high blood pressure, bleeding problems, diabetes, eye problems, thyroid problems, immune system problems (including autoimmune disease, weakened immune system), any type of infection, or a history of heart attack, stroke, or mental health problems (including depression, thoughts of suicide).
• This medicine may cause the following problems:
  • Depression or suicidal thoughts
  • Heart problems
  • Pancreatitis (swelling of the pancreas)
  • Lung or breathing problems
  • Eye or vision problems
  • High cholesterol in the blood
  • Liver problems
  • Kidney problems
  • Serious skin reactions
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• This medicine may cause tooth and gum problems, which can lead to tooth loss. It may also cause dry mouth, which may cause teeth or mouth problems, if you take this medicine for a lone time. Brush your teeth well (2 times a day) and have regular visits to your dentist during treatment with this medicine.
• This medicine may cause dizziness, drowsiness, or seeing, hearing, or feeling things that are not there. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may affect your menstrual cycles. Talk with your doctor if you have any concerns about this.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody diarrhea, stomach cramps or tenderness
• Bloody or cloudy urine, change in how much or how often you urinate, lower back or side pain
• Blurred vision, severe headache, slow, fast, or uneven heartbeat, lightheadedness, dizziness
• Chest pain, tiredness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Depression, thoughts of hurting yourself or others
• Dry mouth, tooth loss
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Muscle, joint, or bone pain
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088