BESREMi Safety

What are the possible side effects of BESREMi?

BESREMi can cause side effects. You can read about them in the Medication Guide or see the Important Safety Information below.

What is the most important information I should know about BESREMi?

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 with BESREMi. 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 taking BESREMi.

Mental health problems, including suicide.

BESREMi may cause you to develop mood or behavior problems that may get worse during treatment with BESREMi 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 with BESREMi. 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 with BESREMi.

Call your healthcare provider right away if you get any of the symptoms listed above during treatment with BESREMi. Before and during treatment with BESREMi 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 with BESREMi. For more information about side effects, see “What are the possible side effects of BESREMi?”

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 with BESREMi. If your blood cell counts are low you can develop anemia, infections or have problems with bleeding or bruising.

Weakness and tiredness.

Bruising easily

You have nose bleeds often

Fever

Chills

Burning and painful urination

Urinating often

Coughing up yellow or pink mucus (phlegm)

Allergic reactions

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

• Skin rash or hives
• Itching or swelling of your face, eyes, lips, tongue, or throat
• Trouble breathing
• Chest pain
• Feeling faint

Other side effects that may occur

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 with BESREMi 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 with BESREMi.

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 with BESREMi.

Kidney problems. Your healthcare provider will do blood tests to check your kidney function before starting and during treatment with BESREMi. 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, 2 times each day and have regular dental examinations during treatment with BESREMi.

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.

Most common side effects

• Flu like symptoms including: tiredness, weakness, fever, chills, muscle aches, and joint pain
• Itching
• Sore throat