Ropeginterferon alfa-2b is used in adults to treat polycythemia vera, which is a disorder that affects your body's ability to produce blood cells.

Ropeginterferon alfa-2b may also be used for purposes not listed in this medication guide.

Ropeginterferon alfa-2b may cause serious or fatal side effects.

Tell your doctor right away about any new or worsening mood symptoms, such as feeling irritable, hostile, aggressive, depressed, or having thoughts about suicide or hurting yourself.

Call your doctor right away if you have symptoms such as tiredness, increased thirst or urination, chest pain, or fast heartbeats.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ropeginterferon alfa-2b is usually given once every 2 weeks.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Ropeginterferon alfa-2b is injected under the skin. A healthcare provider will give you this injection and may teach you how to properly use the medication by yourself.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Pay special attention to your dental hygiene and have regular dental exams while using ropeginterferon alfa-2b.

You will need frequent blood tests before and during treatment with ropeginterferon alfa-2b.

Store in the refrigerator away from heat and light. Do not freeze.

Usual Adult Dose for Polycythemia Vera:

For Patients NOT Receiving Hydroxyurea:
Initial dose: 100 mcg subcutaneously every 2 weeks
-Increase the dose in increments of 50 mcg every 2 weeks until the hematologic parameters stabilize
Maximum dose: 500 mcg subcutaneously every 2 weeks

For Patients TRANSITIONING from Hydroxyurea:
Initial dose: 50 mcg subcutaneously every 2 weeks in combination with hydroxyurea
-Gradually taper off hydroxyurea in weeks 3 through 12 by reducing total biweekly dose by 20% to 40% every 2 weeks while increasing this drug in increments of 50 mcg every 2 weeks until the hematologic parameters stabilize; discontinue hydroxyurea by week 13
Maximum dose: 500 mcg subcutaneously every 2 weeks

Stabilized Hematologic Parameters:
--Hematocrit less than 45%
--Platelets less than 400 x 10(9)/L
--Leukocytes less than 10 x 10(9)/L

Maintenance dose:
-Maintain 2-week dosing interval with hematological stability for at least 1 year
-After 1 year of hematological stability on a stable dose, the dosing interval may be expanded to every 4 weeks

Comments:
-Patients should be monitored closely; complete blood counts (CBC) should be obtained every 2 weeks during titration and every 3 to 6 months during maintenance phase, and as clinically indicated.
-Phlebotomy may be necessary as rescue treatment to normalize blood hyperviscosity,

Use: For the treatment of polycythemia vera.

You should not use ropeginterferon alfa-2b if you are allergic to it, or if you:

• have liver disease;

• have or had severe mental health problems, especially severe depression, thoughts of suicide;

• have or had a serious autoimmune disease; or

• have received a transplant and take medications that weaken the immune system.

Tell your doctor if you:

• are being treated for a mental illness or had treatment in the past for any mental illness;

• have diabetes;

• have or ever had any heart problems or high blood pressure;

• have or ever had bleeding problems or a blood clot;

• have or ever had low blood cells;

• have a condition that suppresses your immune system;

• have hepatitis B or HIV; or

• kidney or liver problems.

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using ropeginterferon alfa-2b and for at least 8 weeks after your last dose. ropeginterferon alfa-2b may affect your menstrual cycle. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 8 weeks after your last dose.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how ropeginterferon alfa-2b will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives, or a rash that spreads and causes blistering and peeling; chest pain, anxiety, difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have unusual changes in mood or behavior, such as: depression, irritability, feeling hostile or aggressive, hallucinations, or thoughts about hurting yourself.

Ropeginterferon alfa-2b may cause serious side effects. Call your doctor at once if you have:

• pain and burning when you urinate, increased urination;

• new or worsening cough, cough with mucus, trouble breathing;

• vision changes;

• liver problems--diarrhea, loss of appetite, pain or swelling in your stomach, swelling in your legs, easy bleeding, drowsiness, confusion, or jaundice (yellowing of the skin or eyes);

• kidney problems--swelling, urinating less, feeling tired or short of breath; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of ropeginterferon alfa-2b may include:

• flu-like symptoms (tiredness, weakness, fever, chills, muscle aches, and joint pain);

• itching; or

• sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some drugs should not be used at the same time with ropeginterferon alfa-2b. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.