Ropeginterferon alfa-2b

Ropeginterferon alfa-2b (brand name Besremi) is used to treat adults with essential thrombocythemia or polycythemia vera.

It is not known if ropeginterferon alfa-2b is safe and effective in children.

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

• Use ropeginterferon alfa-2b exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you how much to inject and when to inject it. Do not inject more than your prescribed dose.
• Do not inject more than 1 dose of ropeginterferon alfa-2b every 2 weeks without talking to your healthcare provider.
• Ropeginterferon alfa-2b comes in a single-dose prefilled syringe and in a single-dose prefilled pen injector.
• Ropeginterferon alfa-2b is given as an injection under your skin (subcutaneous injection).
• Ropeginterferon alfa-2b can be given by yourself, a caregiver, or healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections at home, you should receive training on the right way to prepare and inject it. Do not try to inject ropeginterferon alfa-2b yourself until your healthcare provider has shown you how to give it the right way.
• Read the Instructions for Use that comes with ropeginterferon alfa-2b for detailed instructions on how to prepare and inject a dose.
• Do not reuse the single-dose prefilled syringe or the single-dose prefilled pen injector. They are for one-time use only. Place used needles and syringes in a puncture-proof sharps container and dispose of it following state or local laws. Keep out of the reach of children and pets.
• Your healthcare provider will do blood tests before you start ropeginterferon alfa-2b, and regularly during treatment to monitor your essential thrombocythemia or polycythemia vera, and to check you for side effects.
• Brush and floss your teeth well and get regular dental examinations during treatment.
• Store ropeginterferon alfa-2b in the refrigerator between 36°F to 46°F (2°C to 8°C). Keep it in the original carton to protect it from light. Do not freeze.

Ropeginterferon alfa-2b can cause serious side effects that may cause death, be life-threatening, or worsen certain serious conditions that you may already have. Interferon alfa products may cause or worsen serious nervous system, autoimmune, ischemic, and infectious disorders.

Tell your healthcare provider right away if you get any new or worsening mood or behavior problems, such as depression, feeling very agitated or restless, acting aggressively, angry, or violent, new or worse irritability, or an extreme increase in activity or talking (mania). If you have thoughts of hurting yourself or thoughts of suicide, stop using ropeginterferon alfa-2b right away. You, your caregiver, or family member should tell your healthcare provider or get medical help right away.

Tell your healthcare provider right away if you develop signs of heart or blood vessel problems, such as a fast heart rate or abnormal heartbeat, trouble breathing or chest pain, pain, swelling, or redness in the arms, legs, ankles, or feet, tiredness, sudden confusion, numbness or weakness, loss of coordination, trouble speaking clearly, or sudden vision changes.

Tell your healthcare provider right away if you develop signs of new or worsening autoimmune problems, such as tiredness, urinating more often than normal, very thirsty, an increase in appetite, problems concentrating, sensitivity to heat or cold temperature, weight changes, or skin changes.

You should not use ropeginterferon alfa-2b if you:

• have or had severe mental health problems, especially severe depression, thoughts of suicide, or attempted suicide
• are allergic to another interferon product, including interferon alfa-2b, or to any of the ingredients in ropeginterferon alfa-2b
• have certain types of liver problems
• have or had a serious or untreated autoimmune disease
• have received an organ or stem cell transplant and take immunosuppressive medicines

You should also not use ropeginterferon alfa-2b if you have any of the following heart or blood vessel problems:

• high blood pressure that is not controlled
• congestive heart failure
• a serious abnormal heart rhythm
• narrowing of the arteries to your heart
• certain types of chest pain (angina)
• a recent stroke or heart attack

Tell your healthcare provider about all of your medical conditions, including if you:

• are being treated for a mental illness or had treatment in the past for any mental illness, including depression, and have had thoughts of hurting yourself or others
• have thyroid problems
• have diabetes
• have a condition that suppresses your immune system, such as cancer
• have or ever had any problems with your heart, including a heart attack or high blood pressure
• have or ever had bleeding problems or a blood clot
• have liver problems
• have kidney problems

Ropeginterferon alfa-2b can harm your unborn baby and can cause loss of your pregnancy (miscarriage). Your healthcare provider should do a pregnancy test before you start treatment. Use effective birth control during treatment and for at least 8 weeks after your final dose. Ropeginterferon alfa-2b can affect your menstrual cycles and may cause your menstrual periods to stop. Tell your healthcare provider if you become pregnant during treatment.

It is not known if ropeginterferon alfa-2b passes into your breast milk. Do not breastfeed during treatment and for 8 weeks after your final dose.

Stop using ropeginterferon alfa-2b and get medical help right away if you get any of the following symptoms of a serious, sudden allergic reaction: skin rash or hives; itching or swelling of your face, eyes, lips, tongue, or throat; trouble breathing; chest pain; or feeling dizzy or faint.

Tell your healthcare provider 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:

• decreased blood cell counts and bleeding problems--weakness and tiredness, bruising easily, frequent nose bleeds, fever, gum or tongue bleeding, chills, burning and painful urination, urinating often, coughing up yellow or pink mucus (phlegm), bleeding in the eye;
• inflammation of the pancreas (pancreatitis)--nausea, vomiting, upper stomach area (abdomen) pain, bloating, fever;
• inflammation of the intestine (colitis)--stomach area (abdomen) pain, bloody diarrhea or blood in your stool, fever;
• lung problems--shortness of breath, cough, difficulty breathing;
• eye problems--blurred vision, dry eyes, seeing floaters or flashes of light, sudden loss of vision, eye pain or redness. You should have an eye exam before and during treatment if you have diabetes or high blood pressure;
• high cholesterol and triglycerides (fats in the blood), which may lead to inflammation of the pancreas;
• liver problems--yellowing of your skin or the white part of your eyes, swelling of your stomach area (abdomen), stomach area pain or discomfort, confusion, sleepiness, nausea, loss of appetite, tiredness, diarrhea, bleeding more easily than normal;
• kidney problems--changes in the amount or color of your urine, blood in your urine, swelling in your ankles, loss of appetite;
• tooth and gum (periodontal) problems, which can lead to tooth loss, and dry mouth that can damage your teeth and the lining of your mouth; or
• skin problems--itching, hair loss, rash, redness, dry skin, a skin condition causing red, scaly patches (psoriasis), acne, thickening of the skin, excessive sweating.

The most common side effects in adults with essential thrombocythemia include:

• increased liver function tests
• low red blood cell counts (anemia)
• fever
• increased protein in the urine
• bacterial infection
• itching
• weight loss

The most common side effects in adults with polycythemia vera include:

• flu-like symptoms
• joint pain
• tiredness
• itching
• runny or stuffy nose, cough, or sore throat
• muscle and bone pain

Your healthcare provider may reduce your dose, temporarily stop, or permanently stop your treatment if you develop side effects.

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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Essential Thrombocythemia:

Starting dose: 250 mcg subcutaneously-At 2 weeks, increase the dose to 350 mcg subcutaneously-At 4 weeks, increase to the maintenance dose of 500 mcg subcutaneously every 2 weeksMaintain an every 2-week schedule throughout treatment unless dose modification is required for safety or tolerability.

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 stabilizeMaximum 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 the 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 13Maximum 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:-Obtain a pregnancy test in females of reproductive potential prior to starting treatment.-Patients should be monitored closely; complete blood counts (CBC) should be obtained every 2 weeks during titration and every 3 to 6 months during the maintenance phase, and as clinically indicated.-In polycythemia vera, phlebotomy may be necessary as rescue treatment to normalize blood hyperviscosity.

Uses: For the treatment of essential thrombocythemia and polycythemia vera.

Call your doctor for instructions if you miss a dose.

If you inject too much ropeginterferon alfa-2b, call the Poison Help line at 1-800-222-1222 or your healthcare provider right away.

Ropeginterferon alfa-2b may cause neurologic symptoms, including dizziness, sleepiness, and hallucinations. Avoid driving or using heavy machinery if you develop any of these neurologic symptoms during treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ropeginterferon alfa-2b and certain other medicines may affect each other and cause side effects.

Tell your doctor in particular if you take:

• medicines that lower your blood cell counts, which can add to the effect of ropeginterferon alfa-2b on your blood counts;
• narcotics, sleeping medicines, or sedatives, which can add to nervous system side effects; or
• medicines that need careful dose control, because ropeginterferon alfa-2b can change the levels of some of these medicines in your body.

Not all possible interactions are listed here. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Active ingredient: ropeginterferon alfa-2b-njft

Inactive ingredients (Besremi): benzyl alcohol, glacial acetic acid, polysorbate 80, sodium acetate, sodium chloride, and Water for Injection.