BESREMi

BESREMi is an FDA-registered drug product whose active ingredient is ROPEGINTERFERON ALFA-2B. It is labelled by PharmaEssentia USA taken by subcutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 73536-500, application BLA761166, label effective 20260825. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ROPEGINTERFERON ALFA-2B are most often described in connection with: treatment adults, essential thrombocythemia, polycythemia vera, besremi indicated, interferon alfa-. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia vera.

2 DOSAGE AND ADMINISTRATION Essential thrombocythemia: • The recommended dose of BESREMi is: a starting dose of 250 mcg by subcutaneous injection, at 2 weeks, increase the dose to 350 mcg by subcutaneous injection, at 4 weeks, increase to the maintenance dosage of 500 mcg by subcutaneous injection every 2 weeks. Maintain an every 2‑week schedule throughout treatment unless dose modification is required for safety or tolerability. Consider dose re-escalation in case of prior dose reduction, recovery, and lack of hematologic response. ( 2.2 , 2.3 , 5 ) Polycythemia vera: • The recommended dose of BESREMi is: a starting dosage of 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 ( 2.1 ). Interrupt or discontinue dosing if certain adverse reactions occur. Dose re-increase to be considered in case of prior dose reduction, recovery, and lack of hematologic response. ( 2.2 , 2.3 , 5 ) 2.1 Pre-Treatment Testing Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with BESREMi [see Use in Specific Populations ( 8.3 )] . 2.2 Recommended Dosage Essential Thrombocythemia : • The recommended dose of BESREMi is: • A starting dose of 250 mcg by subcutaneous injection. • At 2 weeks, increase the dose to 350 mcg by subcutaneous injection. • At 4 weeks, increase to the maintenance dosage of 500 mcg by subcutaneous injection every 2 weeks. • Maintain an every 2-week schedule throughout treatment unless dose modification is required for safety or tolerability. • Consider dose re-escalation in case of prior dose reduction, recovery, and lack of hematologic response (platelets less than 400 × 10 9 /L and leukocytes less than 10 × 10 9 /L). • Monitor complete blood counts every 2 weeks during titration and every 3 to 6 months during maintenance. Polycythemia Vera: Patients Not Already on Hydroxyurea • The recommended BESREMi starting dosage for patients not on hydroxyurea is 100 mcg by subcutaneous injection every two weeks. • Increase the dose by 50 mcg every two weeks (up to a maximum of 500 mcg), until the hematological parameters are stabilized (hematologic response: hematocrit less than 45%, platelets less than 400 × 10 9 /L, and leukocytes less than 10 × 10 9 /L). • Consider dose re-escalation in case of prior dose reduction, recovery, and lack of hematologic response. Patients Transitioning from Hydroxyurea • When transitioning to BESREMi from hydroxyurea, start BESREMi at 50 mcg by subcutaneous injection every two weeks in combination with hydroxyurea. • Gradually taper off the hydroxyurea by reducing the total biweekly dose by 20-40% every two weeks during Weeks 3-12. • Increase the dose of BESREMi by 50 mcg every two weeks (up to a maximum of 500 mcg), until the hematological parameters are stabilized (hematocrit less than 45%, platelets less than 400 × 10 9 /L, and leukocytes less than 10 × 10 9 /L). • Discontinue hydroxyurea by Week 13. Maintain the two-week dosing interval of BESREMi at which hematological stability is achieved for at least 1 year. After achievement of hematological stability for at least 1 year on a stable dose of BESREMi, the dosing interval may be expanded to every 4 weeks. Monitor patients closely especially during the titration phase. Perform complete blood counts (CBC) regularly, every 2 weeks during the titration phase and every 3-6 months during the maintenance phase (after the patient’s optimal dose is established). Monitor CBC more frequently if clinically indicated. Phlebotomy as rescue treatment to normalize blood hyperviscosity may be necessary during the titration phase [see Clinical Pharmacology ( 12.2 )] . 2.3 Dose Modifications Essential Thrombocythemia: If dose interruption occurs, resume dosing at previously attained levels. If drug-related toxicities arise, reduce the dose to the next lower level or interrupt in accordance with the tables below ( Table 1 and Table 2 ). Table 1 Dose Modifications for BESREMi Adverse Reactions in Patients with Essential Thrombocythemia 1 National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. 2 If toxicity or neutropenia occurs at the lowest recommended dose (100 mcg), withhold treatment until resolution to baseline or Grade ≤1, then resume at the same dose level at the discretion of the treating healthcare provider. Severity 1 Recommended Dosage Modification 2 Grade 3 or 4 toxicity (except neutropenia) Interrupt treatment until recovery to Grade ≤1. Re-escalate the dose to the previous dose level if recovered to Grade ≤1, and if patient is a non-responder (hematological parameters). Grade 3 or 4 neutropenia (ANC <0.5 × 10⁹/L) Interrupt treatment until ANC >0.5 × 10⁹/L. Re-escalate the dose to the previous dose level if recovered to Grade ≤1, and if patient is a non-responder (hematological parameters). Grade 2 toxicity (except neutropenia) Reduce to the next lower dose level (see Table 2 ). Treatment interruption may be considered until recovery to Grade ≤1. Re-escalate the dose to the previous dose level if recovered to Grade ≤1, and if patient is a non-responder (hematological parameters). Grade 2 neutropenia (ANC <0.75 × 10⁹/L but ≥0.5 × 10⁹/L) Reduce to the next lower dose level (see Table 2 ). Treatment interruption is not required. Continued monitoring of the patient is advised; re-escalation to the previous dose level may be considered. Re-escalate the dose to the previous dose level if recovered to Grade ≤1, and if patient is a non-responder (hematological parameters). Table 2 Dose Reduction Sequence for BESREMi Adverse Reactions in Patients with Essential Thrombocythemia Dose Level Dosage Maintenance dose 500 mcg every 2 weeks First dose reduction 350 mcg every 2 weeks Second dose reduction 250 mcg every 2 weeks Third dose reduction 200 mcg every 2 weeks Fourth dose reduction 150 mcg every 2 weeks Fifth dose reduction 100 mcg every 2 weeks Polycythemia Vera: Monitor CBC every 2 weeks during the titration phase and dose modification phase. Phlebotomy as rescue treatment to normalize blood hyperviscosity may be necessary [see Clinical Pharmacology ( 12.2 )] . If dose interruption occurs, resume dosing at previously attained levels. If drug-related toxicities arise, reduce the dose to the next lower level or interrupt in accordance with the table below ( Table 3 ). If there is insufficient efficacy at the decreased dose following dose modification, a dose increase attempt to the next higher dose level should be considered after recovery to grade 1 toxicity. Table 3 Dose Modifications for BESREMi Adverse Reactions in Patients with Polycythemia Vera a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 Adverse Reaction a Severity Dosage Modification Liver enzyme elevation with concomitant bilirubin elevation, or other evidence of hepatic decompensation Any increase above baseline Interrupt treatment until recovery, restart at dose 50 mcg lower than the interrupted dose. If the interrupted dose is 50 mcg, refrain from treatment until recovery. Consider permanent discontinuation if toxicity persists after four dose reductions. Liver enzyme elevation >5 × the upper limit of normal (ULN) but ≤20 × ULN Decrease dose by 50 mcg; if toxicity does not improve, continue decreasing by 50 mcg at biweekly intervals until alanine aminotransferase (ALT) and aspartate aminotransferase (AST) recover <3 × ULN if baseline was normal; 3 × baseline if baseline was abnormal, and gamma-glutamyltransferase (GGT) recovers to <2.5 × ULN if baseline was normal; 2.5 × baseline if baseline was abnormal. If the interrupted dose is 50 mcg, refrain from treatment until recovery. >20 × ULN Interrupt treatment until ALT and AST recover to <3 × ULN if baseline was normal; 1.5 × baseline if baseline was abnormal, and gamma-glutamyltransferase (GGT) recovers to <2.5 × ULN if baseline was normal; 2 × baseline if baseline was abnormal. Continued monitoring of the patient is advised; re-escalation to the previous dose level may be considered. Re-escalate the dose to the previous dose level if recovered to Grade ≤1, and if patient is a non-responder (hematological parameters). Consider permanent discontinuation if toxicity persists after four dose reductions. Cytopenia Anemia: Hemoglobin (Hgb) <8 g/dL Thrombocytopenia: platelet count <50,000/mm 3 but ≥25,000/mm 3 Leukopenia: white blood cell count (WBC) <2,000/mm 3 but ≥1,000/mm 3 Decrease dose by 50 mcg; if toxicity does not improve, continue decreasing by 50 mcg at bi-weekly intervals until recovery of Hgb >10.0 g/dL, platelets >75,000/mm 3 , and WBC >3,000/mm 3 . If the interrupted dose is 50 mcg, refrain from treatment until recovery. Continued monitoring of the patient is advised; re-escalation to the previous dose level may be considered. Re-escalate the dose to the previous dose level if recovered to Grade ≤1, and if patient is a non-responder (hematological parameters). Anemia: Hemoglobin levels are life threatening, or urgent intervention needed Thrombocytopenia: platelet count <25,000/mm 3 Leukopenia: WBC <1,000/mm 3 Interrupt treatment until recovery of Hgb >10.0 g/dL, platelets >75,000/mm 3 , and WBC >3,000/mm 3 . Re-escalate the dose to the previous dose level if recovered to Grade ≤1, and if patient is a non-responder (hematological parameters). Consider permanent discontinuation if toxicity persists after four dose reductions. Depression Mild, without suicidal ideation Consider psychiatric consultation if persistent (>8 weeks). Moderate, without suicidal ideation Consider dose reduction to 50 mcg and psychiatric consultation is recommended. Severe, or any severity with suicidal ideation Discontinue therapy, recommend psychiatric consultation. 2.4 Preparation and Administration Read the INSTRUCTIONS FOR USE before administering the single-dose BESREMi prefilled syringe or prefilled pen injector. BESREMi is for subcutaneous injection only and may be administered by either a healthcare professional, a patient or a caregiver. Before a decision is made to allow BESREMi to be administered by a patient or caregiver, ensure that the patient is an appropriate candidate for self-administration or administration by a caregiver. Proper training on storage, preparation and administration technique should be provided. If a patient or caregiver is not an appropriate candidate for any reason, then BESREMi should be administered by a healthcare professional. Before each injection, remove the carton that contains the BESREMi prefilled syringe or prefilled pen injector from the refrigerator. Keep the prefilled syringe or prefilled pen injector in the carton and lay it flat on a clean work surface for 15-30 minutes to allow the prefilled syringe or prefilled pen injector to reach room temperature [59˚F to 77˚F (15˚C to 25˚C)]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (do not use if the solution in the syringe or pen injector is cloudy, discolored, contains particulate matter or if the syringe or pen injector shows any sign of damage). Prefilled Syringe Preparation • Remove the prefilled syringe cap by unscrewing it counterclockwise. • Attach the covered needle to the prefilled syringe by firmly pushing it onto the collar of the syringe and then screwing (turn clockwise) it on until it feels securely attached. • Choose one of the following injection sites: Lower stomach (abdomen) area, at least 2 inches away from the belly button, or top of thighs. Rotate (change) the injection site for each injection. Do not inject into skin that is irritated, red, bruised, infected, or scarred; clean the chosen injection site with an alcohol swab and let air dry. • Uncap needle and move air bubbles to top. Pull the pink needle shield back and hold the syringe from the syringe body. Remove the clear needle cap by pulling it straight off. Throw away the needle cap into the trash. Hold the prefilled syringe with the needle pointing up. Tap on the body of the prefilled syringe to move any air bubbles to the top. Set Injection Dose • The dose markings on the prefilled syringe are in 50 mcg increments. • Depending on the prescribed dose, the amount of dose in the syringe may need to be adjusted by discarding some of the medication. • Hold the prefilled syringe at eye level with the needle pointing straight up over a paper towel, sink, or trash can. Check that you can see the dose lines and number markings on the prefilled syringe. • Pinch the end of the plunger and slowly push up to remove liquid medicine until the top edge of the gray stopper lines up with the marking for the prescribed dose. Inject BESREMi • Pinch the chosen injection site. While pinching the skin, insert needle at a 45- to 90-degree angle into the pinched skin, then release the pinched skin. • Inject BESREMi by slowly pressing on the plunger all the way until it stops. After all the liquid medicine is injected, remove the needle from the skin. Dispose of Used Prefilled Syringe • Carefully push the pink needle shield over the needle until it snaps into place and covers the needle. Do not recap the needle using the needle cap; only use the pink needle shield to cover the needle. • Throw away the used prefilled syringe with the needle still attached, into an FDA-cleared sharps disposal container. Prefilled Pen Injector Preparation • The prefilled pen injector delivers BESREMi in 50 mcg increments. • Remove the prefilled pen injector cap by pulling it straight off. • Choose one of the following injection sites: Lower stomach (abdomen) area, at least 2 inches away from the belly button, or top of thighs. Rotate (change) the injection site for each injection. Do not inject into skin that is irritated, red, bruised, infected, or scarred; clean the chosen injection site with an alcohol swab and let air dry. • Clean the rubber stopper on the tip of the prefilled pen injector with an alcohol swab. Peel off the protective seal from the needle. Attach the capped needle by pushing it straight onto the prefilled pen injector until you feel or hear it snap into place. Turn or rotate the needle until it “clicks” into place. The needle is attached when it no longer turns or rotates freely. • Remove the needle cover by pulling off the needle cover and throw it away. Remove Air/Flow Check • Turn the dose selector knob until the drop symbol is centered in the dose window. Hold the prefilled pen injector with the needle pointing up and press the injection button all the way in until it stops and the dose window returns to “0”. Repeat these steps 3 more times for a total of 4 cycles. • Look for liquid medicine at the tip of the needle. If you do not see liquid at the tip of the needle, repeat these steps up to 3 more times for a total of 7 cycles or until you see liquid medicine at the tip of the needle. Inject BESREMi • Set your dose by turning the dose selector clockwise until the prescribed dose is centered in the dose window. Check the number in the dose window to make sure you have dialed the correct prescribed dose before giving the injection. • If you accidentally dial past the prescribed dose, dial the dose selector back to the correct dose. • Hold the prefilled pen injector straight (90 degrees) over the cleaned injection site. • Push the prefilled pen injector down to fully insert the needle without touching the injection button. • Press and hold the injection button all the way until it stops. The number in the dose window will go back to “0”. • Keep holding the injection button down after the dose window returns to “0” and count to 5 to make sure the full dose is delivered. • Note: There may still be liquid remaining in the prefilled pen injector after the injection. This is normal. • Remove the needle from the skin by lifting straight up. Dispose of Used Prefilled Pen Injector • Do not recap the needle or attempt to remove it. Throw away the used prefilled pen injector with the needle still attached into a sharps disposal container.

4 CONTRAINDICATIONS BESREMi is contraindicated in patients with: • Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt. • Hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of BESREMi. • Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. • History or presence of active serious or untreated autoimmune disease. • Immunosuppressed transplant recipients. BESREMi is contraindicated in patients with: • Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt ( 4 ) • Hypersensitivity to interferons or to any of the inactive ingredients in BESREMi ( 4 ) • Hepatic impairment (Child-Pugh B or C) ( 4 ) • History or presence of active serious or untreated autoimmune disease ( 4 ) • Immunosuppressed transplant recipients ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. • Depression and Suicide [see Warnings and Precautions ( 5.1 )] • Endocrine Toxicity [see Warnings and Precautions ( 5.2 )] • Cardiovascular Toxicity [see Warnings and Precautions ( 5.3 )] • Hematologic and Hemorrhagic Disorders [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] • Pancreatitis [see Warnings and Precautions ( 5.6 )] • Colitis [see Warnings and Precautions ( 5.7 )] • Pulmonary Toxicity [see Warnings and Precautions ( 5.8 )] • Ophthalmologic Toxicity [see Warnings and Precautions ( 5.9 )] • Hyperlipidemia [see Warnings and Precautions ( 5.10 )] • Hepatotoxicity [see Warnings and Precautions ( 5.11 )] • Renal Toxicity [see Warnings and Precautions ( 5.12 )] • Dental and Periodontal Toxicity [see Warnings and Precautions ( 5.13 )] • Dermatologic Toxicity [see Warnings and Precautions ( 5.14 )] • Driving and Operating Machinery [see Warnings and Precautions ( 5.15 )] • Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.16 )] • Essential thrombocythemia: The most common adverse reactions reported in >20% of patients were transaminase elevations, anemia, pyrexia, beta 2 microglobulin urine increased, bacterial infection, pruritus, and weight decreased. ( 6 ) • Polycythemia vera: The most common adverse reactions reported in >40% of patients were influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact PharmaEssentia at 1-800-999-2449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Essential Thrombocythemia The pooled safety population described in the Warnings and Precautions section reflects exposure to BESREMi as monotherapy for the treatment of essential thrombocythemia dosed every 2 weeks in 182 patients in an open-label trial [P1101 ET, SURPASS ET] and a single-arm trial [A22-301, EXCEED ET]. The mean age was 56 years (range: 21 to 84 years). There were 104 (57%) women, 78 (43%) men, and 93 (51%) Asian, 76 (42%) Caucasian, 5 (2.7%) Black or African American, 5 (2.7%) Other, and 3 (1.6%) Hispanic patients were included in the studies. Among 182 patients who received BESREMi, 70 (39%) patients were exposed for >56 weeks (>14 months). The mean (SD) dose of BESREMi was 394.9 (98.4) mcg during the treatment period. In this pooled safety population, the most common adverse reactions in ≥10% of BESREMi-treated patients were aspartate aminotransferase increased (44%), alanine aminotransferase increased (43%), fatigue (31%), anemia (24%), white blood cell count decreased (23%), neutrophil count decreased (22%), pruritus (17%), gamma-glutamyltransferase increased (16%), alopecia (16%), headache (15%), diarrhea (13%), nausea (13%), beta 2 microglobulin urine increased (12%), influenza like illness (11%), and myalgia (11%). The safety findings described below reflect exposure to BESREMi as monotherapy for the treatment of essential thrombocythemia in 91 patients in the SURPASS ET study [see Clinical Studies ( 14 )] . Among the 91 patients receiving BESREMi, 55% were exposed for 9 to 13 months and 36% were exposed for more than 13 months. Serious adverse reactions were reported in 2.2% of patients treated with BESREMi in the SURPASS ET study and included vascular headache and drug eruption. Adverse reactions requiring permanent discontinuation of patients treated with BESREMi occurred in 1.1% patient each and included aspartate aminotransferase increased, alanine aminotransferase increased, gamma-glutamyltransferase increased, pneumonitis, pulmonary hypertension, thyroiditis, dry eye, and erythema. The most common adverse reactions reported in ≥10% of patients in the SURPASS ET study are listed in Table 4 . Table 4 Adverse Reactions in ≥10% of Patients with Essential Thrombocythemia in the SURPASS ET Study Over 13 Months. * Adverse Reactions defined as all treatment-emergent adverse events 1 Transaminase elevations include: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatic function abnormal, and Liver function test increased 2 Grouped related terms 3 Rash includes: Rash, Rash maculo-papular, and Rash pruritic Term BESREMi N=91 Anagrelide N=80 All Grade n (%) Grade ≥3 n (%) All Grade n (%) Grade ≥3 n (%) Transaminase elevations 1 49 (54) 3 (3) 11 (14) 0 Anemia 25 (28) 0 24 (30) 3 (4) Pyrexia 24 (26) 0 7 (9) 0 Beta 2 microglobulin urine increased 23 (25) 0 3 (4) 0 Bacterial infection 2 22 (24) 5 (5) 18 (23) 2 (3) Pruritus 20 (22) 1 (1.1) 15 (19) 0 Weight decreased 19 (21) 1 (1) 5 (6) 0 Leukopenia 2 17 (19) 1 (1) 2 (3) 1 (1) Fatigue 16 (18) 0 10 (13) 0 Hemorrhage 2 15 (17) 0 30 (38) 3 (4) Alopecia 14 (15) 0 1 (1) 0 Headache 14 (15) 0 25 (31) 0 Diarrhea 13 (14) 0 19 (24) 0 Gamma-glutamyl transferase increased 12 (13) 0 9 (11) 0 Nasopharyngitis 2 12 (13) 0 14 (18) 0 Abdominal pain 2 11 (12) 0 11 (14) 0 Neutrophil count decreased 11 (12) 1 (1) 0 0 Arthralgia 10 (11) 0 7 (9) 0 Cough 10 (11) 0 5 (6) 0 Rash 3 10 (11) 0 4 (5) 0 Dizziness 10 (11) 0 16 (20) 1 (1) Malaise 10 (11) 0 3 (4) 0 Myalgia 10 (11) 0 7 (9) 0 Back pain 2 10 (11) 0 5 (6) 0 Polycythemia Vera The pooled safety population described in the Warnings and Precautions section reflects exposure to BESREMi as monotherapy for the treatment of polycythemia vera dosed every two to four weeks in 178 patients in two open-label trials [PEGINVERA, PROUD-PV/CONTINUATION-PV]. The mean age at baseline was 58.6 years (range 30-85 years), 88 (49%) women, 90 (51%) men, 177 (99%) Caucasian and 1 (1%) Asian. Among 178 patients who received BESREMi, 80% were exposed for 12 months or longer. The mean dose of BESREMi was 334 mcg SD ± 121 during the treatment period. In this pooled safety population, the most common adverse reactions greater than 10%, were liver enzyme elevations (20%), leukopenia (20%), thrombocytopenia (19%), arthralgia (13%), fatigue (12%), myalgia (11%), and influenza-like illness (11%). The safety findings described below reflect exposure to BESREMi as monotherapy for the treatment of polycythemia vera in 51 patients in the PEGINVERA study [see Clinical Studies ( 14 )] . Among the 51 patients receiving BESREMi, 71% were exposed for 12 months or longer, 63% were exposed for three years or longer, and 53% were exposed for greater than five years. Serious adverse reactions were reported in 16% of patients in the PEGINVERA study. The most common serious adverse reactions observed during the study ( > 4%) included urinary tract infection (8%), transient ischemic attack (6%) and depression (4%). Adverse reactions requiring permanent discontinuation in >2% of patients who received BESREMi included depression (8%), arthralgia (4%), fatigue (4%), and general physical health deterioration (4%). In the PEGINVERA study, patients were not pre-screened for depression or anxiety disorders. The most common adverse reactions reported in ≥10% of patients in the PEGINVERA study are listed in Table 5 . Table 5 Adverse Reactions in >10% of Patients with Polycythemia Vera in the PEGINVERA Study Over 7.5 Years. *Adverse Reactions defined as all treatment emergent adverse events Grouped Term Definitions a Includes pyrexia, chills, and influenza-like illness. b Includes asthenia, malaise, and fatigue. c Includes pharyngitis and nasopharyngitis. d Includes musculoskeletal pain, back pain, pain in extremity, bone pain, flank pain, and spinal pain. e Includes headache, migraine, and head pain. f Includes night sweats and hyperhidrosis. g Includes upper respiratory tract infection, rhinitis, bronchitis, and respiratory tract infection. h Includes abdominal pain upper, abdominal pain lower, and abdominal pain. i Includes insomnia, sleep disorder, and abnormal dreams. j Includes peripheral edema and generalized edema. k Includes hypertension and hypertensive crisis. l Includes rash, maculopapular rash, and pruritic rash. m Includes transaminase increase, hepatic enzyme increase, GGT increase, AST increase, and ALT increase. Clinically relevant adverse reactions in <10% of patients include: Cardiovascular System: Atrial fibrillation Adverse Reactions* BESREMi N=51 % Influenza-like illness a 59 Arthralgia 47 Fatigue b 47 Pruritus 45 Nasopharyngitis c 43 Musculoskeletal pain d 41 Headache e 39 Diarrhea 33 Hyperhidrosis f 29 Nausea 28 Upper respiratory tract infection g 27 Local administration site reactions 26 Dizziness 22 Abdominal pain h 20 Depression 20 Sleep disorder i 20 Leukopenia 18 Decreased appetite 18 Alopecia 16 Edema j 16 Hypertension k 16 Muscle spasms 16 Neutropenia 16 Rash l 16 Transaminase elevations m 16 Urinary tract infection 16 Thrombocytopenia 12 Vertigo 12

What is BESREMi used for?
1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia …

Who makes BESREMi?
PharmaEssentia USA is the labeler of record for BESREMi.

What form does BESREMi come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is BESREMi prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has BESREMi been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.