Starting BESREMi and staying on track
BESREMi Pen™ is a single-dose, ready-to-use pen that you administer once every 2 weeks to treat essential thrombocythemia (ET).
Your doctor will prescribe BESREMi through a specialty pharmacy, and your first prescription will be shipped directly to you.
- Your doctor will increase your BESREMi dose step by step over the first month of treatment
- Most people then stay on a consistent dosing schedule of once every 2 weeks
This is the typical BESREMi dosing schedule. Your doctor will work with you to determine the dosing approach that’s right for you.
Storing BESREMi Pen
Store the BESREMi carton containing the pen in a refrigerator at 36 °F to 46 °F (2 °C to 8 °C).
How to use BESREMi Pen: Prep. Click. Push.
BESREMi Pen makes it easy to handle, set your dose, and self-administer. Check out the resources below to feel prepared and confident using BESREMi Pen.
- A PharmaEssentia SOURCE Case Manager
- A specialty pharmacy nurse
- Your doctor’s office
Knowing what to expect can help you feel prepared
When will I start to see results with BESREMi?
BESREMi is different from other treatments you may have tried. BESREMi is not chemotherapy, it is an innovative immunotherapy that targets the source of ET in your bone marrow. It’s important to stay on treatment, as it could take several months to see results with BESREMi.
Managing side effects at home
Because BESREMi works with your body’s immune system, you may experience some side effects as you start treatment. Not everyone experiences the same side effects, and your doctor will monitor you closely as treatment gets underway. In the clinical study, side effects decreased over time with continued BESREMi treatment.
Here are some practical tips to help manage some of the side effects people experience with BESREMi:
- Talk with your doctor about taking acetaminophen to help reduce fever symptoms or ibuprofen to help reduce aches and pains
- Stay hydrated
- Start injections on a day and time that is convenient for your schedule
- Alternate periods of rest and activity
- Avoid hot showers
- Use unscented body products
- Ask your doctor about taking an antihistamine
- Apply ice to the injection site
- Rotate your injection site
Tips for traveling with BESREMi Pen
It’s important to stick with your treatment schedule while you’re away. A little planning can help you protect BESREMi Pen and ensure a smoother experience on your trip.
- Tell your doctor about your travel plans and ask them to sign the Letter of Medical Necessity for Travel to show airport security staff
- Confirm that a refrigerator will be available at your destination for storing BESREMi Pen
- Pack enough medicine and supplies for your trip, including a sharps disposal container
- Pack BESREMi Pen in your carry-on bag rather than checked luggage
- Tell the Transportation Security Administration officer that you are carrying liquid medication and injection supplies
- Ask for a visual inspection of BESREMi Pen. Do not put BESREMi Pen through X-ray screening
- Keep BESREMi Pen in your carry-on bag. It does not need to be placed in a separate clear plastic bag
- Always keep BESREMi Pen cold in a cooler pack until you need it
- Transport any pens and needles used during your trip in an FDA-cleared sharps disposal container. You can put the container in either your checked bag or carry-on bag
FAQs about taking BESREMi
How is BESREMi administered, and how often is it used?
How is the BESREMi dose adjusted and monitored?
What are the most common side effects of BESREMi?
How are side effects managed while taking BESREMi?
How should BESREMi Pen be stored and transported?
Read this Important Safety Information carefully. It explains the serious risks of BESREMi and how to take it safely. Talk to your healthcare provider if you have any questions.
What is the most important information I should know about BESREMi?
BESREMi can cause serious side effects, including conditions that may cause death or may worsen certain serious diseases you may already have. 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 mood or behavior problems that can get worse during treatment or after your last dose, including:
- Irritability (getting upset easily)
- Restlessness and agitation
- Confusion
- Depression (feeling low, hopeless, or bad about yourself)
- Unusually grand ideas
- Acting aggressive or impulsively
- Thoughts of hurting yourself or others, or thoughts of suicide
If you develop any of these symptoms, call your healthcare provider immediately.
New or worsening autoimmune problems
BESREMi may cause your immune system to attack healthy cells, leading to conditions such as thyroid disease, increased blood sugar (hyperglycemia), or type 1 diabetes. Call your healthcare provider if you experience:
- Extreme tiredness
- Frequent urination
- Excessive thirst
Heart problems
BESREMi may cause heart problems, including:
- Cardiomyopathy (heart muscle disease)
- Heart attack
- Irregular heartbeat (atrial fibrillation)
- Decreased blood flow to the heart
You should not take BESREMi if you have:
- Uncontrolled high blood pressure
- 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
Who should not take BESREMi?
Do not take BESREMi if you:
- Have or had severe mental health problems, especially depression, suicidal thoughts, or attempted suicide
- Have or had a serious or untreated autoimmune disease
- Are allergic to interferon or any ingredient in BESREMi (symptoms may include itching, swelling, trouble breathing, dizziness, or chest pain)
- Have certain types of liver disease
- Have had a transplant and take immune-suppressing medication
Before using BESREMi, tell your healthcare provider about all of your medical conditions, including if you have any of the following:
- A mental illness
- Type 1 diabetes
- Heart or bleeding problems
- Problems with your immune system
- Hepatitis B or HIV infection
- Kidney or liver problems
- Are pregnant or planning to become pregnant
- –BESREMi may harm your unborn baby. Use effective birth control during treatment and for at least 8 weeks after your last dose
- –BESREMi may affect your menstrual cycle and could stop your periods
- –Do not breastfeed while taking BESREMi
What are the possible side effects of BESREMi?
Serious side effects include:
- Low blood cell counts: Taking BESREMi can lead to infections, anemia, or bleeding problems. Call your healthcare provider right away if you develop weakness and tiredness, bruising easily, nose bleeds often, fever, chills, burning and painful urination, urinating often, or coughing up yellow or pink mucus (phlegm)
- Serious allergic reactions: Get medical help right away if you get any of the following symptoms: skin rash or hives; itching; swelling of the face, eyes, lips, tongue, or throat; trouble breathing; chest pain; or 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 with BESREMi if you have diabetes or high blood pressure and also have retinal problems
- 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, swelling in your ankles, blood in your urine, or loss of appetite
- Tooth and gum problems: BESREMi can cause tooth loss and/or dry mouth. It is important for you to brush your teeth well, two times each day and have regular dental examinations during treatment with BESREMi
- Skin reactions: BESREMi may cause reaction such as rash, itching, and hair loss
- Increased triglycerides: You may require blood tests to monitor levels
The most common side effects of BESREMi include increased liver function tests, low red blood cell counts (anemia), fever, increased protein in the urine, bacterial infection, itching, and weight loss.
These are not all of the possible side effects of BESREMi.
Call your doctor for medical advice about side effects. You may report side effects to PharmaEssentia at 1-800-999-2449 or FDA at 1-800-FDA-1088.
What is BESREMi used for?
BESREMi is for the treatment of adults with essential thrombocythemia.
Please see full Prescribing Information, including Boxed Warning and Medication Guide.
Read this Important Safety Information carefully. It explains the serious risks of BESREMi and how to take it safely.
Talk to your healthcare provider if you have any questions.
What is the most important information I should know about BESREMi?
BESREMi can cause serious side effects, including conditions that may cause death or may worsen certain serious diseases you may already have. 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.