Version May 2024
Note: Safety: In high-risk populations or in countries with high tuberculosis burden, screen for latent infections (eg, hepatitis, tuberculosis) prior to initiating therapy. For patients who screen positive for latent infections, consult infectious disease or other appropriate specialists (eg, liver specialists) regarding treatment options before initiating therapy (Ref). Premedication: Analgesics and/or antipyretics may help decrease flu-like symptoms on treatment days.
Multiple sclerosis, relapsing: SubQ: Initial: 0.0625 mg (2 million units [0.25 mL]) every other day; gradually increase dose by 0.0625 mg every 2 weeks to a target dose of 0.25 mg (8 million units [1 mL]) every other day.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Pulmonary arterial hypertension: Discontinue treatment with confirmed diagnosis.
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: Peripheral edema (12%)
Dermatologic: Skin rash (21%)
Gastrointestinal: Abdominal pain (16%)
Genitourinary: Urinary urgency (11%)
Hematologic & oncologic: Decrease in absolute neutrophil count (13%), leukopenia (18%; decreased white blood cell count <3,000/mm3: 13%), lymphocytopenia (86%)
Hepatic: Increased serum alanine aminotransferase (>5 × baseline: 12%)
Immunologic: Antibody development (neutralizing: 17% to 45%)
Local: Inflammation at injection site (42%), injection-site reaction (78%), pain at injection site (16%)
Nervous system: Asthenia (53%), ataxia (17%), chills (21%), headache (50%), hypertonia (40%), insomnia (21%), pain (42%)
Neuromuscular & skeletal: Myalgia (23%)
Respiratory: Flu-like symptoms (57%)
Miscellaneous: Fever (31%)
1% to 10%:
Cardiovascular: Chest pain (9%), hypertension (6%)
Dermatologic: Dermatologic disorder (10%)
Genitourinary: Impotence (8%), uterine hemorrhage (9%)
Hematologic & oncologic: Lymphadenopathy (6%)
Hepatic: Increased serum aspartate aminotransferase (>5 × baseline: 4%)
Local: Hypersensitivity reaction at injection site (4%), residual mass at injection site (2%), swelling at injection site (2%), tissue necrosis at injection site (4%)
Nervous system: Malaise (6%)
Respiratory: Dyspnea (6%)
<1%: Nervous system: Suicidal ideation
Frequency not defined:
Cardiovascular: Palpitations, peripheral vascular disease, tachycardia, vasodilation
Dermatologic: Alopecia
Endocrine & metabolic: Heavy menstrual bleeding, weight gain
Gastrointestinal: Constipation, diarrhea, dyspepsia, nausea
Genitourinary: Dysmenorrhea, prostatic disease, urinary frequency
Nervous system: Anxiety, dizziness, myasthenia, nervousness
Neuromuscular & skeletal: Arthralgia, lower limb cramp
Postmarketing:
Cardiovascular: Capillary leak syndrome, cardiomyopathy, heart failure
Dermatologic: Pruritus, skin discoloration, urticaria
Endocrine & metabolic: Increased serum triglycerides, thyroid dysfunction (including hyperthyroidism and hypothyroidism), weight loss
Gastrointestinal: Anorexia, pancreatitis, vomiting
Hematologic & oncologic: Anemia, hemolytic anemia, hemolytic-uremic syndrome, thrombocytopenia, thrombotic microangiopathy, thrombotic thrombocytopenic purpura
Hepatic: Autoimmune hepatitis, hepatic failure, hepatic injury, hepatitis, hepatotoxicity (idiosyncratic) (Chalasani 2021), increased gamma-glutamyl transferase
Hypersensitivity: Anaphylaxis, tongue edema
Local: Abscess at injection site, cellulitis at injection site
Nervous system: Confusion, depression, emotional lability, psychotic symptoms, seizure
Neuromuscular & skeletal: Lupus erythematosus
Respiratory: Bronchospasm, pulmonary hypertension (including pulmonary arterial hypertension) (McGovern 2015; Health Canada Nov 2, 2016)
History of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any component of the formulation.
Canadian labeling: Additional contraindication (not in US labeling): Decompensated liver disease (Betaseron, Extavia); current severe depression and/or suicidal ideation (Extavia)
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Allergic reactions (eg, bronchospasm, dyspnea, skin rash, tongue edema, urticaria), including anaphylaxis (rare), have been reported with use; discontinue use if anaphylaxis occurs.
• Drug-induced lupus erythematosus: Cases of drug-induced lupus erythematosus have been reported with some interferon beta products; signs and symptoms include nephritis, polyarthritis, rash, Raynaud phenomenon, and serositis. Positive serologic testing, including positive anti-nuclear and/or anti-double-stranded DNA antibody testing, may occur; discontinue treatment if signs and symptoms of drug-induced lupus erythematosus develop.
• Flu-like symptoms: Associated with a high incidence of flu-like adverse effects; use of analgesics and/or antipyretics on treatment days may be helpful. Improvement in symptoms occurs over time.
• Hepatotoxicity: Has been reported with beta interferons, including rare reports of hepatitis (autoimmune) and hepatic failure requiring transplant; use with caution in patients with concurrent exposure to other hepatotoxic drugs. Monitor liver function tests as clinically necessary. Consider discontinuation if serum transaminase levels increase significantly or are associated with clinical symptoms (eg, jaundice).
• Infections: In high-risk populations or in countries with high tuberculosis burden, screen for latent infections (eg, hepatitis, tuberculosis) prior to initiating therapy. For patients who screen positive for latent infections, consult infectious disease or other specialists (eg, liver specialists) regarding treatment options before initiating therapy (AAN [Farez 2019]).
• Injection site reactions: Severe injection site reactions may occur, including abscess, cellulitis, edema, hypersensitivity, inflammation, mass, necrosis, and pain. Necrosis may or may not heal with continued therapy; reactions generally arise within the first 4 months of therapy but have occurred ≥1 year after initiation. Incidence of reactions tend to improve over time but may require antibiotics or surgical intervention. Patient and/or caregiver competency in injection technique should be confirmed and periodically re-evaluated. Do not inject into affected area until completely healed; if multiple lesions occur, discontinue use until they are fully healed.
• Leukopenia: Leukopenia has been observed; routine monitoring of complete blood counts with differentials is recommended. Dose reduction may be required.
• Neuropsychiatric disorders: Interferons have been associated with severe psychiatric adverse events (psychosis, mania, depression, suicidal behavior/ideation) in patients with and without previous psychiatric symptoms. Avoid use in severe psychiatric disorders and use caution in patients with a history of depression; patients exhibiting symptoms of depression should be closely monitored and discontinuation of therapy should be considered.
• Pulmonary effects: Pulmonary arterial hypertension (sometimes requiring hospitalization and one patient requiring a lung transplant) has occurred in patients without other risk factors taking interferon beta products; onset varies and may occur several years after initiation of treatment. Patients with unexplained symptoms (eg, dyspnea, new or worsening fatigue) should be evaluated for pulmonary arterial hypertension.
• Thrombotic microangiopathy: Cases of thrombotic microangiopathy manifesting as thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS) (some fatal) have been reported with interferon beta products. Some cases may occur after several years of therapy. Monitor for new onset hypertension, thrombocytopenia, or impaired renal function; discontinue therapy and administer prompt treatment if TTP/HUS are confirmed or suspected to be due to interferon beta-1b therapy.
Disease-related concerns:
• Bone marrow suppression: Use with caution in patients with bone marrow suppression; may require increased monitoring.
• Cardiovascular disease: Use with caution in patients with preexisting cardiovascular disease. Rare cases of new-onset cardiomyopathy and/or HF have been reported. If HF worsens in the absence of another etiology, consider discontinuation of therapy. In a scientific statement from the American Heart Association, interferon has been determined to be an agent that may either cause reversible direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: moderate/major) (AHA [Page 2016]).
• Hepatic impairment: Use with caution in patients with hepatic impairment or in combination with alcohol.
• Seizure disorder: Use with caution in patients with a history of seizure disorder.
• Thyroid dysfunction: Thyroid abnormalities may develop with use; may worsen pre-existing thyroid conditions. Monitor thyroid function tests every 6 months or as clinically necessary.
Dosage form specific issues:
• Albumin: Contains albumin, which may carry a remote risk of transmitting Creutzfeldt-Jakob or other viral diseases.
• Latex: Some dosage forms may contain natural rubber latex.
Other warnings/precautions:
• Immunizations: Avoid live-attenuated vaccines in patients who currently receive or have recently discontinued interferon beta-1b; consider using live-attenuated vaccines only if risk of infection is high and killed vaccines are unavailable (AAN [Farez 2019]).
The Extavia diluent syringe cap may contain latex.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Subcutaneous:
Betaseron: 0.3 mg [contains albumin human]
Kit, Subcutaneous [preservative free]:
Extavia: 0.3 mg [contains albumin human]
No
Kit (Betaseron Subcutaneous)
0.3 mg (per each): $835.96
Kit (Extavia Subcutaneous)
0.3 mg (per each): $635.42
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Subcutaneous:
Betaseron: 0.3 mg (1 ea)
Extavia: 0.3 mg ([DSC]) [contains albumin human]
For SubQ administration. The first injection should be administered under the supervision of a health care professional. Withdraw dose of reconstituted solution from the vial into a sterile syringe fitted with needle provided in manufacturer packaging (refer to manufacturer labeling for appropriate size) and inject the solution subcutaneously. Autoinjectors may be used with their corresponding prepared syringes after health care provider selects proper depth setting and injection technique (see autoinjector instructions for more details). Sites for self-injection include outer surface of the arms, abdomen (except 2-inch area around the navel), buttocks, and thighs. If patient is very thin, only use the thigh or outer surface of arms. Rotate SubQ injection site. Do not inject into area where skin is bruised, infected, or broken. Patient should be well hydrated. If a dose is missed, administer as soon as remembered; do not administer on 2 consecutive days. Time subsequent doses every 48 hours.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Betaseron: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103471s5202lbl.pdf#page=19
Extavia: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125290s074lbl.pdf#page=16
Multiple sclerosis, relapsing: Treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
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.
Cladribine: May enhance the adverse/toxic effect of Interferons (Beta). Specifically, the risk for lymphopenia may be increased. Risk X: Avoid combination
Zidovudine: Interferons may enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Risk C: Monitor therapy
In general, disease-modifying therapies for multiple sclerosis (MS) are stopped prior to a planned pregnancy, except in females at high risk of MS activity (AAN [Rae-Grant 2018]). When disease-modifying therapy is needed in females planning a pregnancy (eg, high risk of disease reactivation), interferon beta-1b may be considered until pregnancy is confirmed, and in select cases (eg, women with active disease), use may be continued during pregnancy. Delaying pregnancy is recommended for females with persistent high disease activity (ECTRIMS/EAN [Montalban 2018]).
Data from available pregnancy registries have not observed an increased risk or pattern of major birth defects, preterm birth, or decreased birth weight following maternal use of interferon beta-1b (Coyle 2014; Romero 2015; Thiel 2016). In most cases, therapy was stopped during the first trimester after pregnancy was detected (Thiel 2016).
In general, disease-modifying therapies for multiple sclerosis (MS) are not initiated during pregnancy, except in females at high risk of MS activity (AAN [Rae-Grant 2018]). When disease-modifying therapy is needed in females planning a pregnancy (eg, high risk of disease reactivation), interferon beta-1b may be considered until pregnancy is confirmed, and in select cases (eg, women with active disease), use may be continued during pregnancy (ECTRIMS/EAN [Montalban 2018]).
It is not known if interferon beta-1b is present in breast milk.
Studies conducted with interferon beta-1a show only small amounts are present in breast milk. In addition, interferon beta does not have a systemic biologic effect if given orally (Almas 2016; Fragoso 2018). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. However, based on its chemical properties, others consider interferon beta compatible with breastfeeding (Almas 2016; Dobson 2019; Fragoso 2018).
Latent infection screening (eg, hepatitis, tuberculosis) in high-risk populations or in countries with high tuberculosis burden (baseline); complete metabolic panel, CBC with differential, liver function tests (1, 3, and 6 months following initiation of therapy; periodically thereafter); thyroid function tests (every 6 months in patients with history of thyroid dysfunction or as clinically necessary); assess patients who develop unexplained symptoms (eg, dyspnea, new or worsening fatigue) for pulmonary arterial hypertension; symptoms of flu, allergic or anaphylactic reactions, injection-site reactions, worsening of cardiac symptoms (in heart failure patients); sign/symptoms of depression.
Interferon beta-1b differs from naturally occurring human protein by a single amino acid substitution and the lack of carbohydrate side chains; mechanism in the treatment of MS is unknown; however, immunomodulatory effects attributed to interferon beta-1b include enhancement of suppressor T cell activity, reduction of proinflammatory cytokines, down-regulation of antigen presentation, and reduced trafficking of lymphocytes into the central nervous system. Improves MRI lesions, decreases relapse rate, and disease severity in patients with secondary progressive MS.
Limited data due to small doses used
Half-life elimination: 8 minutes to 4.3 hours
Time to peak, serum: 1-8 hours
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