Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (11)
- axicabtagene ciloleucel
interferon beta 1b, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
interferon beta 1b, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
interferon beta 1b, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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.
- etrasimod
etrasimod, interferon beta 1b. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod.
- idecabtagene vicleucel
interferon beta 1b, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
interferon beta 1b, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, interferon beta 1b. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- tisagenlecleucel
interferon beta 1b, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (10)
- 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.
- isavuconazonium sulfate
interferon beta 1b and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- 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.
- ublituximab
ublituximab and interferon beta 1b both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- valoctocogene roxaparvovec
interferon beta 1b and valoctocogene roxaparvovec both increase Other (see comment). Use Caution/Monitor. Medications that may cause hepatotoxicity when combined with valoctogene roxaparvovec may potentiate the risk of elevated liver enzymes. Closely monitor these medications and consider alternative medications in case of potential drug interactions.
- 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)
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, pulmonary arterial hypertension
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
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 reactions
- Injection site reactions can occur with use of interferon beta products
- Injection site abscesses and cellulitis reported in postmarketing setting with use of interferon beta products; some cases required treatment with hospitalization for surgical drainage and intravenous antibiotics
- 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
- Patients should be advised of importance of rotating injection sites with each dose; whether to discontinue therapy following a single site of necrosis is dependent on extent of necrosis
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
Pulmonary arterial hypertension
- Cases of pulmonary arterial hypertension (PAH) reported; PAH has occurred in patients treated with interferon beta products in absence of other contributory factors; many of reported cases required hospitalization, including one case with interferon beta in which the patient underwent a lung transplant
- PAH has developed at various time points after initiating therapy with interferon beta products and may occur several years after starting treatment
- Patients who develop unexplained symptoms (eg, dyspnea, new or increasing fatigue) should be assessed for PAH; if alternative etiologies ruled out and diagnosis of PAH confirmed, discontinue treatment and manage as clinically indicated
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.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
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Betaseron subcutaneous - | 0.3 mg kit |  | |
| Extavia subcutaneous - | 0.3 mg kit |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 this medication has been prescribed because your doctor 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 make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using interferon before having any immunizations/vaccinations. 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 March 2023. Copyright(c) 2023 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.
Formulary
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.
