Besremi

Generic name: Ropeginterferon Alfa-2b-njft
Dosage form: injection, for subcutaneous use
Drug class: Antineoplastic interferons

Usage of Besremi

Besremi is a prescription medicine that is used to treat adults with polycythemia vera.

It is not known if this medicine is safe and effective in children.

Besremi side effects

Besremi can cause serious side effects including:

See Important information.

Decreased blood cell counts. Decreased blood cell counts are common with Besremi and can sometimes also be severe, especially decreased platelets or white blood cells. Your red blood cells may also be decreased. Your healthcare provider should check your blood cell counts before you start and during treatment. If your blood cell counts are low you can develop anemia, infections or have problems with bleeding or bruising.

Call your healthcare provider right away if you develop any of the following symptoms:

weakness and tiredness

bruising easily

you have nose bleeds often

chills

burning and painful urination

urinating often

fever

coughing up yellow or pink mucus (phlegm)

Serious allergic reactions and skin reactions. Besremi can cause serious, sudden allergic reactions. Get medical help right away if you get any of the following symptoms:

skin rash or hives

itching swelling of your face, eyes, lips

tongue, or throat

trouble breathing

chest pain

feeling faint

Eye problems. Besremi can cause severe eye problems with your retinas that can lead to vision loss or blindness. You should have an eye exam before and during treatment if you have diabetes or high blood pressure and also have retinal problems. Your healthcare provider may stop Besremi if you develop new or worse eye problems during treatment.

Liver problems. Besremi can cause increases in liver enzymes and liver damage. Your healthcare provider should do blood tests to monitor your liver enzymes and liver function before you start and during treatment.

Kidney problems. Your healthcare provider will do blood tests to check your kidney function before starting and during treatment. Tell your healthcare provider right away if you develop any symptoms of a kidney problem, including:

changes in the amount or color of your urine

blood in your urine

swelling in your ankles

loss of appetite

Your healthcare provider may stop Besremi if you develop severe kidney problems.

Tooth and gum (periodontal) problems. Besremi can cause tooth and gum problems which can lead to tooth loss. Besremi can also cause problems with dry mouth that can damage your teeth and the lining of the mouth during long-term treatment with Besremi. It is important for you to brush your teeth well, two times each day and have regular dental examinations during treatment.

Skin problems. Besremi can cause skin problems. Signs and symptoms of a skin problem with Besremi include:

itching

hair loss

rash

redness

psoriasis

acne

thickening of the skin

excessive sweating

Call your healthcare provider if you develop a rash that is bothersome or covers a large skin area.

The most common side effects include:

flu like symptoms including: tiredness, weakness, fever, chills, muscle aches, and joint pain

itching

sore throat.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Besremi

Do not use Besremi if you:

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

have or had a serious or untreated autoimmune disease

have had a serious allergic reaction to another interferon product or to any of the ingredients. Symptoms of a serious allergic reaction to alpha-interferon may include itching, swelling of your face, tongue, throat, trouble breathing, feeling dizzy or faint, and chest pain. See the end of this Medication Guide for a complete list of ingredients. Ask your healthcare provider if you are not sure.

have certain types of liver problems

have received a transplant and take immunosuppressive medicines

Relate drugs

How to use Besremi

Usual Adult Dose for Polycythemia Vera

- Recommended starting dose: 100 mcg by suBCutaneous injection every 2 weeks (50 mcg if receiving hydroxyurea). Increase the dose by 50 mcg every 2 weeks (up to a maximum of 500 mcg) until hematological parameters are stabilized.

- Use: treatment of adults with polycythemia vera

Warnings

Besremi can cause serious side effects that:

may cause death, or

may worsen certain serious diseases that you may already have

Tell your healthcare provider right away if you have any of the symptoms listed below during treatment. If symptoms get worse, or become severe and continue, your healthcare provider may tell you to stop taking Besremi permanently. These symptoms may go away in some people after they stop treatment. Mental health problems, including suicide. Besremi may cause you to develop mood or behavior problems that may get worse during treatment, or after your last dose, including:

irritability (getting upset easily)

restlessness and agitation

confusion

depression (feeling low, feeling bad about yourself or feeling hopeless)

unusually grand ideas

acting aggressive

acting impulsively

thoughts of hurting yourself or others, or thoughts of suicide

If you develop any of these symptoms, stop using Besremi right away. You, your caregiver, or family member should call your healthcare provider right away. Your healthcare provider should carefully monitor you during treatment with Besremi. New or worsening autoimmune problems. Besremi may cause autoimmune problems (a condition where the body’s immune cells attack other cells or organs in the body), including thyroid problems, increased blood sugar (hyperglycemia), and type I diabetes. In some people who already have an autoimmune problem, it may get worse during your treatment. Tell your healthcare provider if you have any of the following symptoms: tiredness, urinating often, or if you are very thirsty. Heart problems. Besremi may cause heart problems, including problems with your heart muscle (cardiomyopathy), heart attack, abnormal heart rhythm (atrial fibrillation), and decreased blood flow to your heart. You should not use Besremi if you: have 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), or a recent stroke or heart attack. If you have a heart problem before you start using Besremi, your healthcare provider should monitor you closely during treatment. Call your healthcare provider right away if you get any of the symptoms listed above during treatment. Before and during treatment, you will need to see your healthcare provider regularly and have blood tests to monitor your polycythemia vera, and to check for side effects. Besremi can cause serious side effects. Some of these side effects may cause death. Tell your healthcare provider right away if you have any of the symptoms listed above during treatment. For more information about side effects, see Besremi side effects.

What other drugs will affect Besremi

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Especially tell your healthcare provider if you are taking:

drugs that are metabolized a certain way (known as CYP450 substrates) including amiodarone, cyclosporine, tacrolimus, or warfarin

myelosuppressive drugs

narcotics, hypnotics or sedatives

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.