Ropeginterferon alfa-2b-njft (Besremi®)

How to Take Ropeginterferon alfa-2b-njft (Besremi®)

Ropeginterferon alfa-2b is given as a deep subcutaneous injection (SQ, "sub q", under the skin), usually every 2 weeks. Your dose may increase with each dose, depending on how you tolerate the medication. Your blood levels will be checked often during treatment.

Ropeginterferon alfa-2b comes as a single-dose, prefilled syringe. If able, you or a caregiver can give this medication at home. If not, you will need to have a healthcare provider administer it.  Your provider or pharmacist will review how to store, prepare, administer, and discard the syringe for this medication.

Tell your provider if you have a history of any psychiatric illnesses, including depression and/or suicidal thoughts. This medication can cause increased central nervous system (CNS) effects, such as depression and suicidal thoughts. Tell your provider if you are taking narcotic pain medication, hypnotics, or sedating medications, as these can make CNS effects worse while taking ropeginterferon alfa-2b.

Tell your provider if you are taking medication that affects your bone marrow, sometimes called myelosuppressive medications, or if you have had a transplant of any kind.

Tell your provider if you have a history of an autoimmune disease that affects your endocrine system, such as Type 1 Diabetes or problems with your thyroid.

This medication can cause neurological (brain) side effects, including dizziness, sleepiness, and hallucinations. You should not drive or operate heavy machinery while taking this medication until you know how it affects you.

Possible Side Effects of Ropeginterferon alfa-2b

There are a number of things you can do to manage the side effects of ropeginterferon alfa-2b. Talk to your provider about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Risk of Serious Disorders

This type of medication has caused worsening of certain disorders, such as:

• CNS/neuropsychiatric: Life-threatening and fatal mental and emotional reactions have happened in patients with and without a history of psychiatric illness.
• Autoimmune: This medication can worsen autoimmune disorders, especially those that affect your endocrine system (Type 1 Diabetes, hyper- or hypothyroidism, thyroiditis).
• Ischemic (lack of blood supply): This medication can cause ischemia of the heart, including cardiomyopathy, heart attack, atrial fibrillation (afib), and coronary artery ischemia. Tell your provider if you have a history of heart disease, heart attack, or stroke.
• Infectious: Risk for infection may be higher while on this medication, with or without leukopenia (decreased white blood cells). Your blood counts will be monitored closely during and after treatment.

Flu-Like Symptoms

You may have flu-like symptoms, including muscle and body aches, headache, fever, and chills. Acetaminophen may help relieve these symptoms. However, fever can be a sign of an infection and should be reported to your provider.

Infection Risk and Low White Blood Cell Count (Leukopenia or Neutropenia)

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. This medication can suppress your immune system, putting you at higher risk of getting an infection whether or not your WBC count is low.

You should let your provider know right away if you have a fever (temperature greater than 38°C or 100.4°F), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal. Infections are a common side effect of treatment with ropeginterferon alfa-2b. Some of the most common infections include upper respiratory tract infection and nasopharyngitis (common cold).

Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your provider before scheduling dental appointments or procedures.
• Ask your provider before you or someone you live with has any vaccinations.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and save energy for more important activities. Exercise can help with fatigue. A simple daily walk with a friend can help. Talk to your provider for helpful tips on dealing with this side effect.

Pruritis/Itching

Itching can be a side effect of ropeginterferon alfa-2b. You may be given skin care instructions to lessen the itch. Skincare can also prevent infection due to scratching. Medications may be prescribed to help with the itchiness.

Muscle/Abdominal Pain or Headache

This medication can cause muscle aches and pains and headache, which may be treated with medications. Talk with your provider about which pain relievers you can safely take. Non-medical therapies, such as acupuncture, yoga, gentle stretching, and exercise may also help with these side effects.

Diarrhea

Your provider can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole-grain breads, cereals, and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, uncaffeinated fluid a day to prevent dehydration.

Nausea and/or Vomiting

Talk to your provider so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your provider if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Injection Site Reactions

Some people may have redness, swelling, or itching at the site of injection. Sites where you inject should be your lower abdominal (belly) area, at least 2 inches away from your belly button, or the top of one of your thighs. Rotate (change) the injection site for each injection. Do not inject into skin that is irritated, red, bruised, infected, or scarred.

Liver Toxicity

This medication can cause liver toxicity, which your provider may monitor for using blood tests called liver function tests (LFTs). Call your healthcare provider if you notice yellowing of the skin or eyes, if your urine is dark or brown, or if you have pain in your abdomen (belly), as these can be signs of liver toxicity.

Hyperhidrosis (Excess Sweating)

Ropeginterferon alfa-2b can cause you to sweat more than you normally would. Talk with your provider if the sweating affects your daily life.

Important but Less Common Side Effects

• Allergic Reactions: If you have any signs of an allergic reaction after administering this medication, call your provider or 911 right away. Signs and symptoms of an allergic reaction may be:
  • Hives.
  • Face or lip swelling.
  • Having a hard time breathing.
  • Chest tightness.
  • Wheezing.
  • Nausea/vomiting.
• Pancreatitis: Symptoms may be:
  • Nausea/vomiting.
  • Upper abdominal (belly) pain.
  • Bloating.
  • Fever.
• Colitis: Ulcerative or hemorrhagic/ischemic colitis has happened as early as 12 weeks after starting treatment. Symptoms may be:
  • Abdominal pain.
  • Bloody diarrhea.
  • Fever.
• Lung Toxicity: Call your provider if you have:
  • Shortness of breath.
  • Swelling in your ankles, legs, or belly.
  • Fatigue.
  • Chest pain or pressure.
• Ocular Toxicity: Tell your provider about any new or worsening vision or eye symptoms, such as blurry vision, redness, eye pain, excess tears or discharge from your eye, sensitivity to light, or a feeling that something is in your eye.
• High Lipids: This medication can cause hyperlipidemia, including high triglycerides. Your blood levels will be monitored during and after treatment.
• Kidney Problems: This medication can cause an increased creatinine level and elevated uric acid levels, which your oncology provider may monitor for using blood tests. Call your provider if you notice you are peeing less, have blood in the urine, swelling in the ankles, or loss of appetite.
• Dental and Periodontal Problems: You may have dental and periodontal problems while taking this medication, including dry mouth and loss of teeth. You will need regular dental appointments during and after treatment.
• Skin Problems: You may have a new rash, itching, loss of hair (alopecia), redness, psoriasis, dry skin, thickening of the skin, excessive sweating, or acne-like bumps.

Sexual & Reproductive Concerns

This medication may affect your reproductive system, resulting in the menstrual cycle or sperm production becoming irregular or stopping permanently. Women may experience menopausal effects, including hot flashes and vaginal dryness. In addition, the desire for sex may decrease during treatment. Talk with your provider about possible egg freezing before starting treatment.

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant while on this medication. Effective birth control is necessary for women during treatment and for at least 8 weeks after treatment, even if your menstrual cycle stops. Male patients with female partners of reproductive potential should talk with their provider about birth control needs. You should not breastfeed while taking this medication and for 8 weeks after the last dose.