interferon beta 1b (Rx)

Brand and Other Names:Betaseron, Extavia
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for injection

  • 0.3mg/vial supplied with diluent for reconstitution

Relapsing/Remitting Multiple Sclerosis, Exacerbations

0.0625 mg SC every other day initially

Gradually increase over 6 wk to 0.25 mg (8 million U; 1 mL) SC every other day: may increase by 0.0625 mg q2wk

Betaconnect injectable devise

  • No cost autoinjector for use only with Betaseron syringes
  • Autoinjector offers customizable injection speed and depth settings
  • Patients should speak to a healthcare provider or nurse before making any changes to injection depth or speed settings
  • Automatic needle insertion and retraction Betaconnect has an optional backup reminder function to alert patient for next injection
  • Device lets patients know when the injection is complete with a visual and audio end-of-dose indication

Non-A/Non-B Hepatitis (Orphan)

Treatment of acute non-A, non-B hepatitis

Orphan indication sponsor

  • Biogen, Inc; 14 Cambridge Center; Cambridge, MA 02142

Dosing Considerations

Monitor Hgb, WBC, Plts, LFTs

Premedication for Flu-like Symptoms

  • Concurrent use of analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with drug

Missed dose

  • Take as soon as patient remembers or able to take it; do not take dose on two consecutive days; next dose should be taken 48 hr after last dose; see healthcare professional if dose taken on two consecutive days

Dosage Forms & Strengths

lyophilized powder for injection

  • 0.3mg/vial supplied with diluent for reconstitution

Multiple Sclerosis (Off-label)

Safety and efficacy not established

Limited data suggests to titrate as in adults; children 10 years or older typically tolerate full adult doses, although decreased tolerance may occur in younger children

0.0625 mg SC every other day initially

Gradually increase over 6 wk to 0.25 mg (8 million U; 1 mL) SC every other day: may increase by 0.0625 mg q2wk

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Interactions

Interaction Checker

and interferon beta 1b

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • deferiprone

                deferiprone, interferon beta 1b. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • pexidartinib

                interferon beta 1b and pexidartinib both increase inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

              • pretomanid

                interferon beta 1b, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

              Monitor Closely (7)

              • acalabrutinib

                acalabrutinib, interferon beta 1b. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • ifosfamide

                ifosfamide, interferon beta 1b. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Ifosfamide may enhance the toxicities of myelosuppressive agents. Monitor for increased risk of myelosuppression.

              • lomustine

                lomustine, interferon beta 1b. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • ofatumumab SC

                ofatumumab SC, interferon beta 1b. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • ozanimod

                ozanimod, interferon beta 1b. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

              • siponimod

                siponimod and interferon beta 1b both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immune effects during such therapy and in the weeks following administration. Siponimod can generally be started immediately after discontinuation of beta interferon.

              • zidovudine

                interferon beta 1b increases levels of zidovudine by decreasing renal clearance. Use Caution/Monitor. Interferons may enhance potential for adverse effects. Patients should be monitored for signs and symptoms of increased myelosuppression and liver decompensation.

              Minor (0)

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                Adverse Effects

                >10%

                Injection site reaction (85%)

                Flu-like syndrome (60%)

                Headache (57%)

                Myasthenia (46%)

                Fever (36%)

                Nausea (27%)

                Chills (25%)

                Constipation (20%)

                Abd pain (19%)

                Leukopenia (18%)

                Chest pain (11%)

                1-10%

                Malaise (8%)

                Inj site necrosis (5%)

                Hypersensitivity (3%)

                Lymphopenia (>5%)

                Myalgia (>5%)

                Neutropenia (>5%)

                Increased liver enzymes (>5%)

                Hypertonia (>5%)

                Pain (>5%)

                Rash (>5%)

                Insomnia (>5%)

                Abdominal pain (>5%)

                Asthenia (>5%)

                <1%

                Aggravation of seizure disorders

                Abortifacient potential

                Postmarketing Reports

                Blood and lymphatic system disorders: Anemia, thrombocytopenia, hemolytic anemia

                Endocrine disorders: Hypothyroidism, hyperthyroidism, thyroid dysfunction

                Metabolism and nutrition disorders: Triglyceride increased, anorexia, weight decrease, weight increase

                Psychiatric disorders: Anxiety, confusion, emotional lability

                Nervous system disorders: Convulsion, dizziness, psychotic symptoms

                Cardiac disorders: Cardiomyopathy, palpitations, tachycardia

                Vascular disorders: Vasodilatation

                Respiratory, thoracic and mediastinal disorders: Bronchospasm

                Gastrointestinal disorders: Diarrhea, nausea, pancreatitis, vomiting

                Hepatobiliary disorders: Hepatitis, increased GGT

                Skin and subcutaneous tissue disorders: Alopecia, pruritus, skin discoloration, urticaria

                Musculoskeletal and connective tissue disorders: Arthralgia, lupus erythematosus

                Reproductive system and breast disorder: Menorrhagia

                General disorders and administration site conditions: Fatal capillary leak syndrome

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                Warnings

                Contraindications

                Hypersensitivity to beta interferons, human albumin or other ingredients

                Cautions

                Do not administer into affected area until fully healed; if multiple lesions occur, discontinue therapy until skin lesions heal

                Abortifacient potential

                Increased risk of infection

                Betaseron & Extavia, although dosed similarly, not considered therapeutically equivalent

                Leukopenia may occur; monitor complete blood count

                Anaphylaxis reported as a rare complication of interferon beta-1b use; other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash, and urticaria; discontinue therapy if anaphylaxis occurs; the removable rubber cap of the diluent (0.54% sodium chloride solution, USP) pre-filled syringe contains natural rubber latex, which may cause allergic reactions and should not be handled by latex-sensitive individuals; the safe use of pre-filled syringe in latex-sensitive individuals has not been studied

                Depression and suicide reported with increased frequency in patients receiving interferon beta products, including interferon beta-1b; advise patients to report symptoms of depression and/or suicidal ideation to healthcare provider; if patient develops depression, consider discontinuation of therapy

                In addition to laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts and blood chemistries, including liver function tests, are recommended at regular intervals (one, three, and six months) following introduction of interferon 1b therapy, and periodically thereafter in absence of clinical symptoms

                Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, reported; some cases have been reported several weeks to years after starting interferon beta products; discontinue therapy if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated

                Consider analgesics and/or antipyretics on injection days if flu-like symptoms occur

                Cases of drug-induced lupus erythematosus have reported;. signs and symptoms of drug-induced lupus reported in treated patients have included rash, serositis, polyarthritis, nephritis, and Raynaud’s phenomenon; discontinue therapy if patients develop new characteristic signs and symptoms

                Monitoring of complete blood and differential white blood cell counts recommended; patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts

                Monitor patients with preexisting congestive heart failure (CHF) for worsening of cardiac condition during initiation of and continued treatment with drug; while beta interferons do not have any known direct-acting cardiac toxicity, cases of CHF, cardiomyopathy, and cardiomyopathy with CHF have occurred in patients without known predisposition to these events, and without other known etiologies being established; in some cases, these events have been temporally related to administration of interferon beta-1b; recurrence upon rechallenge was observed in some patients; consider discontinuation of therapy if worsening of CHF occurs with no other etiology

                Injection site necrosis

                • Injection site necrosis (ISN) reported; typically occurs within first four months of therapy, although postmarketing reports have been received of ISN occurring over one year after initiation of therapy
                • The necrotic lesions are typically 3 cm or less in diameter, but larger areas reported; generally, necrosis has extended only to subcutaneous fat, but has extended to fascia overlying muscle; in some lesions where biopsy results are available, vasculitis has been reported
                • Some lesions have required debridement, and/or skin grafting; in most cases, healing was associated with scarring; whether to discontinue therapy following a single site of necrosis is dependent on extent of necrosis
                • For patients who continue therapy after injection site necrosis has occurred, avoid administration into the affected area until fully healed; if multiple lesions occur, discontinue therapy until healing occurs
                • Periodically evaluate patient understanding and use of aseptic self-injection techniques and procedures, particularly if injection site necrosis has occurred

                Hepatic injury

                • Severe hepatic injury, including cases of hepatic failure, some of which have been due to autoimmune hepatitis, rarely reported; in some cases, these events have occurred in presence of other drugs or comorbid medical conditions associated with hepatic injury
                • Consider potential risk of drug used in combination with known hepatotoxic drugs or other products (eg, alcohol) prior to administration, or when adding new agents to regimen of patients receiving the medication
                • Monitor patients for signs and symptoms of hepatic injury; consider discontinuing therapy if serum transaminase levels significantly increase, or if they are associated with clinical symptoms, such as jaundice
                • Asymptomatic elevation of serum transaminases is common in patients receiving therapy; monitor liver function tests
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                Pregnancy & Lactation

                Pregnancy

                Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects during pregnancy

                The majority of observational studies reporting on pregnancies did not identify an association between use during pregnancy and increased risk of major birth defects

                Animal data

                • Administration to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose

                Lactation

                There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production

                The developmental and health benefits of breastfeeding should be considered along with mother's clinical need for drug and any potential adverse effects on breastfed child from therapy or from the underlying maternal condition

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Recombinant interferon; antiviral, antiproliferative, immunoregulatory protein; alters response to surface antigen and may inhance immune cell activities

                Pharmacokinetics

                Peak plasma time: 1-8 hr

                Concentration: 40 IU/mL

                Half-Life: 8 min - 4.3 hr

                Onset: 6-12 hr

                Bioavailability: 50%

                Vd: 0.25-2.88 L/kg

                Clearance: 9.4-28.9 mL/min

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                Administration

                Reconstitution of the Lyophilized Powder

                Prior to reconstitution, verify that the vial containing lyophilized drug is not cracked or damaged; do not use cracked or damaged vials

                To reconstitute lyophilized drug for injection, attach pre-filled syringe containing diluent (0.54% sodium chloride solution, USP) to the vial using the vial adapter

                The removable rubber cap of the diluent (0.54% Sodium Chloride Solution, USP) pre-filled syringe contains natural rubber latex, which may cause allergic reactions and should not be handled by latex-sensitive individuals; slowly inject 1.2 mL of diluent into vial

                Gently swirl vial to dissolve lyophilized powder completely; do not shake; foaming may occur during reconstitution or if vial is swirled or shaken too vigorously; if foaming occurs, allow vial to sit undisturbed until foam settles; 1 mL of reconstituted solution contains 0.25 mg of interferon beta-1b

                After reconstitution, if not used immediately, refrigerate the reconstituted solution at 35°F to 46°F (2°C to 8°C) and use within three hours; do not freeze

                Administration Instructions

                Perform first injection under supervision of an appropriately qualified healthcare professional

                If patients or caregivers are to administer drug, train them in proper subcutaneous injection technique and assess their ability to inject subcutaneously to ensure proper administration of drug

                Visually inspect reconstituted solution before use; discard if it contains particulate matter or is discolored

                Keeping syringe and vial adapter in place, turn assembly over so that vial is on top

                Withdraw appropriate dose of solution; remove vial from vial adapter before injecting drug

                Use safe disposal procedures for needles and syringes.

                Do not re-use needles or syringes

                Advise patients and caregivers to rotate sites for subcutaneous injections to minimize the likelihood of severe injection site reactions, including necrosis or localized infection

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Betaseron subcutaneous
                -
                0.3 mg kit
                Extavia subcutaneous
                -
                0.3 mg kit

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                interferon beta-1b subcutaneous

                INTERFERON BETA-1B - INJECTION

                (IN-ter-FEER-on BAY-ta-wun-bee)

                COMMON BRAND NAME(S): Betaseron, Extavia

                USES: This medication is used to treat multiple sclerosis (MS). Interferon is not a cure for MS, but it may help to slow disease worsening and decrease flare-ups of symptoms (such as balance problems, numbness, or weakness).

                HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Inject this medication under the skin as directed by your doctor, usually every other day. It is best to use this medication near bedtime to reduce side effects.Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is red, sore, scarred, or infected. Inject this medication under the skin in the thigh, abdomen, buttock, or the back of the upper arm as directed by your doctor, usually every other day. Tell your doctor of any skin reactions that do not go away after a few days.The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time for each scheduled dose.Tell your doctor if your condition gets worse.

                SIDE EFFECTS: Injection site reactions (such as pain/swelling/redness), abdominal pain, constipation, diarrhea, upset stomach, and nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Most people have flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches when they first start this medication. These symptoms usually last about 1 day after the injection and improve or go away after a few months of continued use. You can lessen these side effects by injecting this medicine at bedtime and by using fever reducers/pain relievers such as acetaminophen or ibuprofen before each dose. Ask your doctor or pharmacist for more information.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as new or worsening depression, thoughts of suicide, psychosis), feeling too hot or cold (more than others around you), blue fingers/toes, easy bleeding/bruising, pus or change in skin color at the injection site, joint pain/swelling, signs of kidney problems (such as a change in the amount of urine), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), butterfly-shaped rash on the nose and cheeks, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).Get medical help right away if you have any very serious side effects, including: seizures.This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat that doesn't go away, fever, chills, cough).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using interferon, tell your doctor or pharmacist if you are allergic to it; or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood problems, heart problems (such as heart failure, angina, fast/irregular heartbeat), liver disease, mental/mood disorders (such as depression, psychosis, suicidal thoughts), seizure disorder, thyroid disease.Interferon can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, liver/thyroid function) should be done while you are using this medication. Keep all medical and lab appointments.

                MISSED DOSE: If you miss a dose, use it as soon as you remember, and ask your doctor or pharmacist right away for a new dosing schedule. Your next injection should be used about 48 hours (2 days) after you actually receive the missed dose. Do not use this medication 2 days in a row. Do not double the dose to catch up.

                STORAGE: Store the unmixed product at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.If the mixed solution is not used right after mixing, refrigerate and use within 3 hours. Do not freeze. Discard any unused portion after 3 hours.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised September 2020. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.