Version May 2024
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 Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions.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.
Note: Phlebotomy (as rescue treatment) may be necessary during the titration phase of ropeginterferon alfa-2b therapy to normalize blood hyperviscosity. Do not use ropeginterferon alfa-2b in patients with active serious or untreated endocrine disorders associated with autoimmune disease.
Polycythemia vera:
In patients not already on hydroxyurea:
SUBQ: Initial: 100 mcg once every 2 weeks. Increase the dose by 50 mcg every 2 weeks (maximum: 500 mcg), until hematological parameters are stabilized (hematocrit <45%, platelets <400,000/mm3, and leukocytes <10,000/mm3).
In patients transitioning from hydroxyurea:
SUBQ: Initial: 50 mcg once every 2 weeks (in combination with hydroxyurea). Increase the dose by 50 mcg every 2 weeks (maximum: 500 mcg), until hematological parameters are stabilized (hematocrit <45%, platelets <400,000/mm3, and leukocytes <10,000/mm3). Gradually taper the hydroxyurea off by reducing the total biweekly hydroxyurea dose by 20% to 40% every 2 weeks during weeks 3 to 12; discontinue hydroxyurea by week 13.
Duration of therapy:
Maintain the 2-week ropeginterferon alfa-2b dosing interval (at the dose at which hematological stability is achieved) for at least 1 year. After 1 year of hematologic stability on a stable ropeginterferon alfa-2b dose, the dosing interval may be increased to once every 4 weeks.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Renal impairment prior to treatment initiation:
eGFR ≥30 mL/minute: No dosage adjustment is necessary.
eGFR <30 mL/minute: Avoid use.
Renal toxicity during treatment:
Discontinue ropeginterferon alfa-2b if severe renal impairment occurs during treatment.
Hepatic impairment prior to treatment initiation:
Mild (Child-Pugh class A) impairment: There are no dosage adjustments provided in the manufacturer's labeling.
Moderate or severe (Child-Pugh class B or C) impairment: Use is contraindicated.
Hepatotoxicity during treatment:
Any ALT/AST/GGT increase over baseline with concomitant bilirubin increase over baseline, or other evidence of hepatic decompensation: Interrupt ropeginterferon alfa-2b treatment until recovery, then restart at a dose 50 mcg lower than the previous dose. If the dose at the time of therapy interruption was 50 mcg, hold ropeginterferon alfa-2b until recovery. Consider permanent discontinuation if hepatotoxicity persists after 4 dose modifications.
ALT/AST/GGT >5 to ≤20 times ULN: Decrease ropeginterferon alfa-2b dose by 50 mcg. If improvement does not occur, continue decreasing the dose at biweekly intervals until ALT and AST are <3 times ULN (if baseline was normal) or <3 times baseline (if baseline was abnormal), and GGT is <2.5 times ULN (if baseline was normal) or <2.5 times baseline (if baseline was abnormal). If the dose at the time of therapy interruption was 50 mcg, hold ropeginterferon alfa-2b until recovery.
ALT/AST/GGT >20 times ULN: Interrupt ropeginterferon alfa-2b treatment until ALT and AST are <3 times ULN (if baseline was normal) or <1.5 times baseline (if baseline was abnormal), and GGT is <2.5 times ULN (if baseline was normal) or <2 times baseline (if baseline was abnormal). Reduce the dose to the next lower level upon recovery. Consider permanent discontinuation if hepatotoxicity persists after 4 dose modifications.
Note: If drug-related adverse reactions occur, reduce the dose or interrupt therapy as clinically necessary. If efficacy is compromised following dose reduction for adverse reactions, after recovery to grade 1 toxicity, consider increasing the dose, based on clinical response and tolerance.
|
Adverse reaction |
Possible symptoms/severity |
Dosage modification |
|---|---|---|
|
Hematologic toxicity | ||
|
Anemia |
Hemoglobin <8 g/dL |
Decrease ropeginterferon alfa-2b dose by 50 mcg. If anemia does not improve, continue decreasing the dose at biweekly intervals until improvement to hemoglobin >10 g/dL. If the dose at the time of therapy interruption was 50 mcg, hold ropeginterferon alfa-2b until recovery. |
|
Life-threatening anemia or urgent intervention required |
Interrupt ropeginterferon alfa-2b treatment until improvement to hemoglobin >10 g/dL. Reduce the dose to the next lower level upon recovery. Consider permanent discontinuation if anemia persists after 4 dose modifications. | |
|
Leukopenia |
WBC ≥1,000/mm3 to <2,000/mm3 |
Decrease ropeginterferon alfa-2b dose by 50 mcg. If leukopenia does not improve, continue decreasing the dose at biweekly intervals until improvement to WBC >3,000/mm3. If the dose at the time of therapy interruption was 50 mcg, hold ropeginterferon alfa-2b until recovery. |
|
WBC <1,000/mm3 |
Interrupt ropeginterferon alfa-2b treatment until improvement to WBC >3,000/mm3. Reduce the dose to the next lower level upon recovery. Consider permanent discontinuation if leukopenia persists after 4 dose modifications. | |
|
Thrombocytopenia |
Platelets ≥25,000/mm3 to <50,000/mm3 |
Decrease ropeginterferon alfa-2b dose by 50 mcg. If thrombocytopenia does not improve, continue decreasing the dose at biweekly intervals until improvement to platelets >75,000/mm3. If the dose at the time of therapy interruption was 50 mcg, hold ropeginterferon alfa-2b until recovery. |
|
Platelets <25,000/mm3 |
Interrupt ropeginterferon alfa-2b treatment until improvement to platelets >75,000/mm3. Reduce the dose to the next lower level upon recovery. Consider permanent discontinuation if thrombocytopenia persists after 4 dose modifications. | |
|
Nonhematologic toxicities | ||
|
Cardiovascular toxicity |
Severe or unstable cardiovascular disease (eg, uncontrolled hypertension, heart failure [≥ NYHA class 2], serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina) or recent stroke or myocardial infarction |
Avoid ropeginterferon alfa-2b use. |
|
Colitis |
Abdominal pain, bloody diarrhea, and fever |
Discontinue ropeginterferon alfa-2b. |
|
Depression |
Mild, without suicidal ideation |
Consider psychiatric consultation if persisting >8 weeks. |
|
Moderate, without suicidal ideation |
Consider dose reduction and psychiatric consultation. | |
|
Severe, or any severity with suicidal ideation |
Discontinue ropeginterferon alfa-2b; psychiatric consultation is recommended. | |
|
Dermatologic toxicity |
Skin rash, pruritus, alopecia, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhidrosis |
Consider ropeginterferon alfa-2b discontinuation for clinically significant dermatologic toxicity. Transient rash may not require treatment interruption. |
|
Endocrine toxicity |
Examples may include worsening hypothyroidism, hyperthyroidism, autoimmune thyroiditis, and hyperglycemia (including new onset type 1 diabetes) |
Evaluate as clinically necessary. Discontinue ropeginterferon alfa-2b for endocrine disorders that cannot be adequately managed during treatment. |
|
Hypersensitivity |
Urticaria, angioedema, bronchoconstriction, anaphylaxis |
Discontinue ropeginterferon alfa-2b and immediately initiate appropriate medical therapy. |
|
Hypertriglyceridemia |
Consider ropeginterferon alfa-2b discontinuation for persistently, markedly elevated triglycerides. | |
|
Ocular toxicity |
Retinopathy, retinal hemorrhage, retinal exudates, retinal detachment, retinal artery or vein occlusion |
Evaluate eye symptoms promptly; discontinue ropeginterferon alfa-2b if new or worsening eye disorders develop. |
|
Pancreatitis |
Nausea, vomiting, upper abdominal pain, bloating, fever; increased amylase, lipase, WBC; altered renal/hepatic function |
Interrupt ropeginterferon alfa-2b therapy for possible pancreatitis; evaluate promptly. Consider discontinuation of ropeginterferon alfa-2b for confirmed pancreatitis. |
|
Pulmonary toxicity |
Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, sarcoidosis |
Discontinue ropeginterferon alfa-2b if pulmonary infiltrates develop or for pulmonary function impairment. |
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Cardiovascular: Edema (16%), hypertension (16%, including hypertensive crisis)
Dermatologic: Alopecia (16%), hyperhidrosis (29%), pruritus (45%), skin rash (16%)
Gastrointestinal: Abdominal pain (20%), decreased appetite (18%), diarrhea (33%), nausea (28%)
Genitourinary: Urinary tract infection (16%; serious urinary tract infection: 8%)
Hematologic & oncologic: Leukopenia (18% to 20%; grades ≥3: 2%), neutropenia (16%), thrombocytopenia (12% to 19%; grades ≥3: 2%)
Hepatic: Increased serum transaminases (16% to 20%, including increased gamma-glutamyl transferase, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum bilirubin)
Infection: Infection (48%; serious infection: 8%)
Local: Injection site reaction (26%)
Nervous system: Depression (≤20%; severe depression: 4%), dizziness (22%), fatigue (12% to 47%), headache (39%), sleep disorder (20%), vertigo (12%)
Neuromuscular & skeletal: Arthralgia (13% to 47%), muscle spasm (16%), musculoskeletal pain (41%), myalgia (11%)
Ophthalmic: Eye disease (23%)
Respiratory: Flu-like symptoms (11% to 59%), nasopharyngitis (43%), upper respiratory tract infection (27%)
1% to 10%:
Cardiovascular: Atrial fibrillation (<10%), transient ischemic attacks (6%)
Endocrine & metabolic: Dyslipidemia (≤3%), hyperlipidemia (≤3%), hyperthyroidism (5%), hypertriglyceridemia (≤3%), hypothyroidism (4%), thyroiditis (autoimmune: 3%)
Gastrointestinal: Pancreatitis (2%)
Hematologic & oncologic: Anemia (grades ≥3: 1%)
Immunologic: Antibody development (1%)
Nervous system: Depressed mood (≤10%), lethargy (≤10%), psychiatric disturbance (3%)
Ophthalmic: Cataract (6%), xerophthalmia (5%)
<1%:
Genitourinary: Toxic nephrosis
Renal: Renal insufficiency
Frequency not defined:
Cardiovascular: Cardiovascular toxicity, ischemic changes
Dermatologic: Skin toxicity (including acneiform eruption, erythema of skin, hyperkeratosis, psoriasis, xeroderma)
Hepatic: Hepatotoxicity
Hypersensitivity: Hypersensitivity reaction
Immunologic: Autoimmune disease
Ophthalmic: Ocular toxicity
Respiratory: Pulmonary toxicity
Miscellaneous: Physical health deterioration
Hypersensitivity to interferons, including interferon alfa-2b, or any component of the formulation; existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt; moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment; history or presence of active serious or untreated autoimmune disease; immunosuppressed transplant recipients.
Concerns related to adverse effects:
• Bone marrow suppression: Decreased peripheral blood cell counts, such as thrombocytopenia and leukopenia (which may increase bleeding or infection risk, respectively), and anemia have occurred with use of interferon alfa products, including ropeginterferon alfa-2b; ≥ grade 3 thrombocytopenia, leukopenia (including serious infection), and anemia have been reported in patients receiving ropeginterferon alfa-2b.
• Cardiovascular toxicity: Cardiovascular toxicity has occurred in patients receiving interferon alfa products, including ropeginterferon alfa-2b; toxicities may include cardiomyopathy, myocardial infarction (MI), atrial fibrillation, and coronary artery ischemia. Avoid use in patients with severe or unstable cardiovascular disease such as uncontrolled hypertension, heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina, or recent stroke or MI.
• CNS effects: Ropeginterferon alfa-2b therapy may impair the ability to drive and use machinery; patients should not drive or operate heavy machinery until they know how ropeginterferon alfa-2b affects them. If dizziness, somnolence, or hallucinations occur, patients should avoid driving or using heavy machinery.
• Colitis: Serious or fatal ulcerative or hemorrhagic/ischemic colitis (some cases occurring as early as 12 weeks after therapy initiation) has been reported in patients receiving interferon alfa products. Symptoms may include abdominal pain, bloody diarrhea, and fever; colitis may resolve within 1 to 3 weeks after treatment discontinuation.
• Dental/Periodontal disorders: Dental and periodontal toxicities may occur in patients receiving interferon alfa products, including ropeginterferon alfa-2b. Dental and periodontal disorders may result in tooth loss. Dry mouth may damage teeth and oral mucous membranes during long-term ropeginterferon alfa-2b therapy.
• Dermatologic toxicity: Dermatologic toxicity has been observed with interferon alfa products, including ropeginterferon alfa-2b. Toxicities may include skin rash, pruritus, alopecia, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, and hyperhidrosis.
• Endocrine toxicity: Endocrine toxicity has been reported with use of interferon alfa products, including ropeginterferon alfa-2b; toxicities may include worsening hypothyroidism and hyperthyroidism. In addition, autoimmune thyroiditis and hyperglycemia (including new onset type 1 diabetes) have been observed in patients receiving interferon alfa-2b products.
• Hepatotoxicity: Hepatotoxicity has been observed in patients receiving interferon alfa products, including ropeginterferon alfa-2b, and may include serum ALT, AST, GGT, and bilirubin elevations. Increases in serum ALT ≥3 times ULN, AST ≥3 times ULN, GGT ≥3 times ULN, and bilirubin >2 times ULN have been observed with ropeginterferon alfa-2b therapy. Elevations in liver enzymes have also been reported after long-term ropeginterferon alfa-2b therapy.
• Hypersensitivity: Hypersensitivity reactions have occurred in patients receiving interferon alfa products, including ropeginterferon alfa-2b; reactions may include serious, acute hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, and anaphylaxis.
• Hyperlipidemia: Hyperlipidemia has been observed in patients receiving interferon alfa products, including ropeginterferon alfa-2b. Hyperlipidemia, hypertriglyceridemia, or dyslipidemia were reported in a small number of patients receiving ropeginterferon alfa-2b. Elevated triglycerides may result in pancreatitis.
• Neuropsychiatric effects: Life-threatening or fatal neuropsychiatric reactions have occurred in patients receiving interferon alfa products, including ropeginterferon alfa-2b; reactions may occur with or without a history of previous psychiatric conditions. Depression, depressive symptoms, depressed mood, and listlessness have been reported. CNS effects reported with other interferon products include suicidal ideation, attempted suicide, aggression, bipolar disorder, mania, and confusion.
• Ocular toxicity: Ophthalmologic toxicity has occurred in patients receiving interferon alfa products, including ropeginterferon alfa-2b; toxicities may include severe eye disorders such as retinopathy, retinal hemorrhage, retinal exudates, retinal detachment, and retinal artery or vein occlusion, which may result in blindness. Almost one-quarter of patients receiving ropeginterferon alfa-2b experienced an eye disorder, which included cataract and dry eye.
• Pancreatitis: Pancreatitis has been reported with use of interferon alfa products, including ropeginterferon alfa-2b. Pancreatitis symptoms may include nausea, vomiting, upper abdominal pain, bloating, and/or fever. Elevated amylase, lipase, or WBC or altered renal or hepatic function may also occur.
• Pulmonary toxicity: Pulmonary toxicity has been reported in patients receiving interferon alfa products, including ropeginterferon alfa-2b; toxicity may present as dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and/or sarcoidosis. Some pulmonary toxicity events have resulted in respiratory failure or death.
• Renal toxicity: Renal toxicity has occurred with use of interferon alfa products, including ropeginterferon alfa-2b. A small percentage of patients developed renal impairment and toxic nephropathy during ropeginterferon alfa-2b treatment.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Besremi: Ropeginterferon alfa-2b-njft 500 mcg/mL (1 mL) [contains benzyl alcohol, polysorbate 80]
No
Solution Prefilled Syringe (Besremi Subcutaneous)
500 mcg/mL (per mL): $9,908.40
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Besremi is available through a limited specialty pharmacy network. Information regarding distribution is available from the manufacturer at 1-800-700-5053 or at https://www.pharmaessentiasource.com/hcp/forms-resources/.
SUBQ: Administer SUBQ in the lower stomach/abdomen area (at least 2 inches away from the navel) or top of the thighs. Rotate injection site for each dose; do not inject into skin that is irritated, red, bruised, infected, or scarred. While pinching the skin of the injection site, insert needle at a 45- to 90-degree angle, then release the skin and inject slowly.
Allow the carton containing the syringe to come to room temperature for 15 to 30 minutes prior to injection. Refer to product labeling for syringe preparation for prescribed dose, needle attachment, and for further details/information.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Besremi: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761166s000lbl.pdf#page=18
Polycythemia vera: Treatment of polycythemia vera in adults.
Ropeginterferon alfa-2b may be confused with interferon alfa-2a, interferon alfa-2b, interferon alfa-n3, interferon beta-1a, interferon beta-1b, interferon gamma-1b, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon beta-1a.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Aldesleukin: Interferons (Alfa) may enhance the adverse/toxic effect of Aldesleukin. In particular, risks of myocardial and renal toxicity may be increased by this combination. Management: Consider using lower doses to minimize toxicity of this combination. Only coadminister aldesleukin and interferons (alfa) in patients in whom potential benefits outweigh the risk of severe toxicity. Monitor renal and cardiac function closely if combined. Risk D: Consider therapy modification
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
CNS Depressants: May enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modification
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Myelosuppressive Agents: May enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Pegloticase: May diminish the therapeutic effect of PEGylated Drug Products. Risk C: Monitor therapy
Pegvaliase: PEGylated Drug Products may enhance the adverse/toxic effect of Pegvaliase. Specifically, the risk of anaphylaxis or hypersensitivity reactions may be increased. Risk C: Monitor therapy
Ribavirin (Oral Inhalation): Interferons (Alfa) may enhance the adverse/toxic effect of Ribavirin (Oral Inhalation). Hemolytic anemia has been observed. Risk C: Monitor therapy
Ribavirin (Systemic): Interferons (Alfa) may enhance the adverse/toxic effect of Ribavirin (Systemic). Hemolytic anemia has been observed. Risk C: Monitor therapy
Telbivudine: Interferons (Alfa) may enhance the adverse/toxic effect of Telbivudine. Specifically, the risk of peripheral neuropathy may be increased. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Interferons (Alfa) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Pregnancy testing is recommended prior to treating patients who can become pregnant. Patients who may become pregnant should use effective contraception during therapy and for at least 8 weeks after the last ropeginterferon alfa-2b dose.
Based on the mechanism of action, ropeginterferon alfa-2b may disrupt the menstrual cycle.
Based on the mechanism of action, in utero exposure to ropeginterferon alfa-2b may cause fetal harm.
It is not known if ropeginterferon alfa-2b is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 8 weeks after the last ropeginterferon alfa-2b dose.
CBC at baseline, every 2 weeks during dose titration, and every 3 to 6 months during maintenance treatment (monitor more frequently if clinically indicated); LFTs (eg, AST, ALT, GGT, bilirubin) at baseline and during treatment; serum creatinine at baseline and during therapy; serum triglycerides prior to treatment and periodically throughout therapy. Assess amylase and lipase in patients with symptoms of pancreatitis. Evaluate pregnancy status prior to therapy initiation in patients who may become pregnant. Closely monitor for any symptoms of psychiatric disorders (consider psychiatric consultation and treatment if clinically indicated). Evaluate thyroid function if symptoms suggestive of thyroid disease occur. Perform an ophthalmologic examination before and during ropeginterferon alfa-2b therapy, specifically in patients with a retinopathy-associated disease (eg, diabetes mellitus or hypertension); evaluate eye symptoms promptly. Closely monitor for cardiovascular toxicity in patients with a history of cardiovascular disease. Perform dental examinations as clinically indicated. Assess patients for good oral hygiene practices. Monitor for signs/symptoms of infection or bleeding, hypersensitivity reactions, colitis, pancreatitis, pulmonary toxicity, dry mouth, dermatologic toxicity, and hepatic decompensation (eg, jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, variceal hemorrhage).
Ropeginterferon alfa-2b is a mono-pegylated interferon alfa-2b (Gisslinger 2015); specifically, it is an N-terminal mono-pegylated covalent conjugate of proline interferon alfa-2b (produced in Escherichia coli cells by recombinant DNA technology), with a methoxy polyethylene glycol moiety. In polycythemia vera, type I interferons (including interferon alfa) bind to a transmembrane receptor (interferon alfa receptor [IFNAR]), which initiates a downstream signaling cascade through the activation of Janus kinase 1 (JAK1), tyrosine kinase 2 (TYK2), and activator of transcription (STAT) proteins. Nuclear translocation of STAT proteins controls gene-expression and results in various cellular effects.
Distribution: Vd: 4.8 L.
Half-life elimination: ~7 days.
Excretion: Clearance: 1.7 to 2.5 L/hour (over a dose range of 100 to 500 mcg, respectively).
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