Planning for Success: Supporting Patients on BESREMi

Dr Beth Faiman discusses practical strategies for patient counseling, monitoring, and adverse event management to support long-term treatment persistence in polycythemia vera.

Hello, and welcome.

I'm Beth Faiman from Cleveland, Ohio, and I'm here to discuss polycythemia vera management.

Successful long-term polycythemia vera, or PV, management depends not only on selecting the appropriate therapy, but also on having a clear plan for monitoring, counseling, and managing adverse events that may arise.

In this video, we will discuss practical strategies that can help support patients with PV in maintaining long-term treatment persistence with BESREMi. These strategies will focus on educating patients about their treatment, implementing proactive monitoring, and addressing side effects promptly. 

Before starting treatment, it's essential for clinicians to have thorough discussions with patients about what to expect regarding treatment response and potential side effects. This is particularly important for interferon-based therapies, because adverse events may occur early in treatment before clinical benefits are realized.

Indication 

BESREMi is indicated for the treatment of adults with polycythemia vera. 

Boxed Warning 

WARNING: RISK OF SERIOUS DISORDERS

Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.

Ropeginterferon alfa-2b (BESREMi) is a single-site mono-pegylated interferon and a preferred first-line cytoreductive therapy option for the treatment of both low-risk symptomatic and high-risk PV in the NCCN Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms.

In the PEGINVERA study, a prospective, single-arm trial evaluating the dosing, tolerability, and efficacy of BESREMi in 51 adult patients with PV, the most common treatment-emergent adverse events reported over 7.5 years were influenza-like illness, arthralgia, fatigue, and pruritus.

Notably, nearly 40% of BESREMi-related adverse events occurred within the first 3 months and decreased over time.

This pattern is clinically useful because it helps us frame the early treatment period. Adverse events may be more noticeable during the first several months, but they often lessen over time.

To support tolerability, starting at a lower dose and titrating up to treatment dose is recommended.

The recommend starting dose of BESREMi is 100 𝜇g by subcutaneous injection every 2 weeks, or 50 mcg if receiving hydroxyurea. The dose can be increased by 50 mcg every 2 weeks, up to a maximum dose of 500 mcg, until the hematologic parameters are stabilized. Dosing can be interrupted or discontinued according to the full Prescribing Information if certain adverse reactions occur.

It is important to counsel patients that BESREMi therapy may take time to work and often requires continued treatment before benefits are seen. Among patients who achieved a complete hematologic response, the median time to response was 7.8 months.

This is an important discussion to have early, as premature discontinuation may limit the opportunity for long-term benefit. When patients understand that response can build over time, they may be better prepared for dose titration, supportive care, and close monitoring or early follow-ups. 

In practice, specific strategies may help improve tolerability during the early phase of treatment.

For fatigue, counseling can focus on sleep hygiene, including avoiding caffeine later in the day, reducing evening bright or blue light exposure, and balancing activity with rest periods to allow for recovery. Framing fatigue management in practical terms can make the discussion more useful for patients who are trying to fit treatment into daily life. 

For fever, myalgias, and arthralgias, acetaminophen can be useful when clinically appropriate. Proactive planning for supportive care can help patients feel more prepared for flu-like symptoms emerge early in treatment.

For pruritus, cooler showers, avoiding hot water, and using fragrance-free products formulated for sensitive skin are recommended. Clinicians may also consider first-generation antihistamines at bedtime when itching interferes with sleep. Small adjustments in skin care and symptom management can sometimes make a meaningful difference in day-to-day tolerability.

For sore throat symptoms, nonpharmacologic measures such as hot tea with honey, lozenges, or salt-water gargles can be helpful.

For injection site reactions, applying an ice pack after injection and rotating injection sites to avoid repeated injections in the same area is recommended. 

For timing of administration, clinicians can encourage patients to inject at a time that fits their schedule. Some patients may prefer dosing before a period of reduced activity—for example, Friday afternoon—to allow time to recover.

Planning earlier check-ins during the initial months of treatment is essential. These visits help reinforce expectations for response time, monitor laboratory trends, address side effects, and maintain patient engagement before manageable issues lead to therapy discontinuation. Proactive follow-up can be especially important in community practice. 

Clinicians should acknowledge that side effects can differ across patients as immune stimulation begins. Clinicians should also educate patients that dose adjustments and supportive care are part of long-term management.

A successful start with BESREMi depends on more than the treatment choice itself. Clear counseling, realistic expectations around time to response, close monitoring, and practical management of early adverse events can support long-term persistence and durable disease control.

INDICATION 

BESREMi is indicated for the treatment of adults with polycythemia vera. 

IMPORTANT SAFETY INFORMATION 

WARNING: RISK OF SERIOUS DISORDERS 

Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.  

CONTRAINDICATIONS 

• Existence of or history of severe depression, suicidal ideation, or suicide attempt 

• Hypersensitivity to interferons or any inactive ingredients 

• Moderate or severe hepatic impairment 

• History or presence of active serious or untreated autoimmune disease 

• History of transplantation and receiving immunosuppressant agents 

WARNINGS AND PRECAUTIONS 

• Depression and Suicide: Closely monitor patients for any symptoms of psychiatric disorders and, if needed, consider psychiatric consultation and treatment or dosage modifications as listed in the full prescribing information. 

• Endocrine Toxicity: Do not use BESREMi in patients with active serious or untreated endocrine disorders associated with autoimmune disease. Evaluate thyroid function in patients who develop symptoms suggestive of thyroid disease during BESREMi therapy. Discontinue BESREMi in patients who develop endocrine disorders that cannot be adequately managed during treatment with BESREMi. 

• Cardiovascular Toxicity: Patients with a history of cardiovascular disorders should be closely monitored for cardiovascular toxicity during BESREMi therapy. Avoid use of BESREMi in patients with severe or unstable cardiovascular disease or recent stroke or myocardial infarction. 

• Decreased Peripheral Blood Counts: Monitor complete blood counts at baseline, during titration, and every 3-6 months during the maintenance phase. 

• Pancreatitis/Colitis/Pulmonary Toxicity: Interrupt BESREMi treatment in patients with possible pancreatitis, colitis, or pulmonary toxicity and evaluate promptly. Consider discontinuation of BESREMi in patients with confirmed pancreatitis or who show signs or symptoms of serious ulcerative or hemorrhagic colitis, or who develop pulmonary infiltrates or pulmonary function impairment. 

• Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Discontinue BESREMi in patients who develop new or worsening eye disorders. 

• Hyperlipidemia/Hepatotoxicity/Renal Toxicity: Monitor serum triglycerides, liver enzymes, hepatic function, and serum creatinine at baseline and during therapy. Avoid use of BESREMi in patients with eGFR <30 mL/min. Discontinue BESREMi in patients with persistently marked elevated triglycerides, evidence of hepatic decompensation, or if renal impairment develops during treatment. 

• Dental and Periodontal Toxicity: Patients should have good oral hygiene and regular dental examinations. 

• Dermatologic Toxicity: Consider discontinuation of BESREMi if clinically significant dermatologic toxicity occurs. 

• Driving and Operating Machinery: BESREMi may impact the ability to drive and use machinery. Patients should not drive or use heavy machinery until they know how BESREMi affects their abilities. Patients who experience dizziness, somnolence, or hallucination during BESREMi therapy should avoid driving or using machinery. 

• Embryo-Fetal Toxicity: Based on the mechanism of action, BESREMi can cause fetal harm when administered to a pregnant woman. Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with BESREMi. Advise females of reproductive potential to use an effective method of contraception during treatment with BESREMi and for at least 8 weeks after the final dose. Advise women not to breastfeed during treatment and for 8 weeks after the final dose. 

ADVERSE REACTIONS 

The most common adverse reactions reported in >40% of patients were influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain. 

DRUG INTERACTIONS 

Patients on BESREMi who are receiving concomitant drugs which are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification. Avoid use with myelosuppressive agents, narcotics, hypnotics, or sedatives, and monitor patients receiving the combination for effects of excessive CNS toxicity. 

To report SUSPECTED ADVERSE REACTIONS, contact PharmaEssentia at 1-800-999-2449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 

Please see full Prescribing Information, including Boxed Warning at besremihcp.com.