Drug: Avonex

AVONEX is a 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of AVONEX is identical to that of natural human interferon beta. Using the World Health Organization (WHO) International Standard for Interferon, AVONEX has a specific activity of approximately 200 million international units of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using lung carcinoma cells (A549) and Encephalomyocarditis virus (ECM). AVONEX 30 micrograms contains approximately 6 million international units of antiviral activity using this method. The activity against other standards is not known. Comparison of the activity of AVONEX with other interferon betas is not appropriate, because of differences in the reference standards and assays used to measure activity. AVONEX Lyophilized Powder Vial A vial of AVONEX is a sterile, white to off-white lyophilized powder for intramuscular injection after reconstitution with supplied diluent (Sterile Water for Injection, USP). Each vial of reconstituted AVONEX contains 30 micrograms of interferon beta-1a; 15 mg Albumin (Human), USP; 5.8 mg Sodium Chloride, USP; 5.7 mg Dibasic Sodium Phosphate, USP; and 1.2 mg Monobasic Sodium Phosphate, USP, in 1.0 mL at a pH of approximately 7.3. AVONEX Single-Use Prefilled Syringe A prefilled syringe of AVONEX is a sterile liquid for intramuscular injection. Each 0.5 Ml (30 microgram dose) of AVONEX in a prefilled glass syringe contains 30 micrograms of interferon beta-1a, 0.79 mg Sodium Acetate Trihydrate, USP; 0.25 mg Glacial Acetic Acid, USP; 15.8 mg Arginine Hydrochloride, USP; and 0.025 mg Polysorbate 20 in Water for Injection, USP at a pH of approximately 4.8. AVONEX PEN Single-Use Prefilled Autoinjector AVONEX PEN is a sterile liquid for intramuscular injection in a prefilled glass syringe surrounded by an autoinjector. Each 0.5 mL (30 microgram dose) in the AVONEX PEN contains 30 micrograms of interferon beta-1a, 0.79 mg Sodium Acetate Trihydrate, USP; 0.25 mg Glacial Acetic Acid, USP; 15.8 mg Arginine Hydrochloride, USP; and 0.025 mg Polysorbate 20 in Water for Injection, USP at a pH of approximately 4.8.

Source: http://www.rxlist.com

The following serious adverse reactions are discussed in more detail in other sections of labeling:
  • Depression, Suicide, and Psychotic Disorders [see WARNINGS AND PRECAUTIONS]
  • Hepatic Injury [see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis and Other Allergic-Reactions [see WARNINGS AND PRECAUTIONS]
  • Congestive Heart Failure [see WARNINGS AND PRECAUTIONS]
  • Decreased Peripheral Blood Counts [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Autoimmune Disorders [see WARNINGS AND PRECAUTIONS]
  • Laboratory Tests [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of AVONEX cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice. Among 351 patients with relapsing forms of MS treated with AVONEX 30 micrograms (including 319 patients treated for 6 months and 288 patients treated for greater than one year) the most commonly reported adverse reactions (at least 5% more frequent on AVONEX than on placebo) were flu-like symptoms. Symptoms can include chills, fever, myalgia and asthenia occurring within hours to days following an injection. Most people who take AVONEX have flu-like symptoms early during the course of therapy. Usually, these symptoms last for a day after the injection. For many people, these symptoms lessen or go away over time. The most frequently reported adverse reactions resulting in clinical intervention (for example, discontinuation of AVONEX or the need for concomitant medication to treat an adverse reaction symptom) were flu-like symptoms and depression. Table 2 enumerates adverse reactions that occurred with AVONEX-treated patients at an incidence of at least 2% more than that observed in the placebo-treated patients in the pooled placebo-controlled studies in patients with relapsing forms of MS [see Clinical Studies]. Table 2: Adverse Reactions in the Placebo-Controlled Studies
Adverse Reaction Placebo
(N = 333) AVONEX
(N = 351) Body as a Whole   Headache 55% 58%   Flu-like symptoms (otherwise unspecified) 29% 49%   Pain 21% 23%   Asthenia 18% 24%   Fever 9% 20%   Chills 5% 19%   Abdominal pain 6% 8%   Injection site pain 6% 8%   Infection 4% 7%   Injection site inflammation 2% 6%   Chest pain 2% 5%   Injection site reaction 1% 3%   Toothache 1% 3% Nervous System   Depression 1 4% 1 8%   Dizziness 1 2% 1 4% Respiratory System   Upper respiratory tract infection 12% 14%   Sinusitis 1 2% 1 4%   Bronchitis 5% 8% Digestive System   Nausea 1 9% 23% Musculoskeletal System   Myalgia 22% 29%   Arthralgia 6% 9% Urogenital   Urinary tract infection 15% 17%   Urine constituents abnormal 0% 3% Skin and Appendages   Alopecia 2% 4% Special Senses   Eye disorder 2% 4% Hemic and Lymphatic System   Injection site ecchymosis 4% 6%   Anemia 1% 4% Cardiovascular System   Migraine 3% 5%   Vasodilation 0% 2% Immunogenicity Anaphylaxis and other allergic reactions have occurred in AVONEX-treated patients [see WARNINGS AND PRECAUTIONS]. As with all therapeutic proteins, there is a potential for immunogenicity. In studies assessing immunogenicity in multiple sclerosis patients administered AVONEX for at least 1 year, 5% (21 of 390 patients) showed the presence of neutralizing antibodies at one or more times. These data reflect the percentage of patients whose test results were considered positive for antibodies to AVONEX using a two-tiered assay (ELISA binding assay followed by an antiviral cytopathic effect assay), and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of neutralizing activity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to AVONEX with the incidence of antibodies to other products may be misleading. Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of AVONEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Menorrhagia and metrorrhagia
  • Rash (including vesicular rash)
  • Rare cases of injection site abscess or cellulitis requiring surgical intervention
Read the Avonex (interferon beta-1a) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Dosing Information AVONEX is administered intramuscularly. The recommended dose is 30 micrograms once a week. To reduce the incidence and severity of flu-like symptoms that may occur when initiating AVONEX therapy at a dose of 30 micrograms, AVONEX may be started at a dose of 7.5 micrograms and the dose may be increased by 7.5 micrograms each week for the next three weeks until the recommended dose of 30 micrograms is achieved (see Table 1). An AVOSTARTGRIP™ kit containing 3 titration devices can be used for titration and is to be used only with AVONEX Prefilled Syringes. Table 1: Schedule for Dose Titration
  AVONEX Dose1 Recommended Dose Week 1 7.5 micrograms 1/4 dose Week 2 15 micrograms ½ dose Week 3 22.5 micrograms 3/4 dose Week 4+ 30 micrograms full dose 1 Dosed once a week, intramuscularly Important Administration Instructions (All Dosage Forms) All AVONEX dosage forms are single-use (injection of reconstituted solution, prefilled syringe, and prefilled autoinjector). See Patient's Instructions for Use for complete administration instructions. The first AVONEX injection should be performed under the supervision of an appropriately qualified health care professional. If patients or caregivers are to administer AVONEX, train them in the proper intramuscular injection technique and assess their ability to inject intramuscularly to ensure the proper administration of AVONEX. Advise patients and caregivers to
  • rotate sites for intramuscular injections with each injection to minimize the likelihood of injection site reactions
  • NOT inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way
  • Check the injection site after 2 hours for redness, swelling, or tenderness
  • Contact their doctor or nurse if they have a skin reaction and it does not clear up in a few days
A 25 gauge, 1” needle for intramuscular injection with AVONEX prefilled syringe or injection of reconstituted solution may be substituted for the 23 gauge, 1 ¼” needle by the healthcare provider, if deemed appropriate. A 25 gauge, 5/8” needle specific to the prefilled autoinjector is supplied with the AVONEX PEN Administration Dose Pack. DO NOT use any other needle with the autoinjector. Use safe disposal procedures for needles and syringes. Do not re-use needles, syringes, prefilled syringes, or autoinjectors. Following the administration of each titrated dose, discard any remaining product. Premedication for Flu-like Symptoms Concurrent use of analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with AVONEX use.

Source: http://www.rxlist.com

No information provided. Last reviewed on RxList: 3/27/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

AVONEX (interferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

Source: http://www.rxlist.com

AVONEX is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation [see WARNINGS AND PRECAUTIONS]. The lyophilized vial formulation of AVONEX is contraindicated in patients with a history of hypersensitivity to albumin (human). Last reviewed on RxList: 3/27/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided.

Source: http://www.rxlist.com

Dosage Forms And Strengths For injection: 30 micrograms lyophilized powder in a single-use vial
  • Injection: 30 micrograms per 0.5 mL solution in a single-use prefilled syringe
  • Injection: 30 micrograms per 0.5 mL solution in a single-use prefilled autoinjector
Storage And Handling AVONEX Lyophilized Powder Vial A vial of AVONEX is supplied as a lyophilized powder in a single-use vial containing 33 micrograms (6.6 million international units) of interferon beta-1a; 16.5 mg Albumin (Human), USP; 6.4 mg Sodium Chloride, USP; 6.3 mg Dibasic Sodium Phosphate, USP; and 1.3 mg Monobasic Sodium Phosphate, USP, and is preservative-free. Diluent is supplied in a singleuse vial (Sterile Water for Injection, USP). AVONEX lyophilized vials are available in the following package configuration (NDC 59627-001- 03): A package containing four Administration Dose Packs (each containing one vial of AVONEX, one 10 mL diluent vial, two alcohol wipes, one gauze pad, one 3 mL syringe, one MICRO PIN®* vial access pin, one 23 gauge, 1¼ inch needle, and one adhesive bandage). Vials of AVONEX should be stored in a 2°C to 8°C (36°F to 46°F) refrigerator. Should refrigeration be unavailable, vials of AVONEX can be stored at 25°C (77°F) for a period of up to 30 days. DO NOT EXPOSE TO HIGH TEMPERATURES. DO NOT FREEZE. Protect from light. Do not use beyond the expiration date stamped on the vial. Following reconstitution, it is recommended the product be used as soon as possible within 6 hours stored at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE RECONSTITUTED AVONEX. AVONEX Single-Use Prefilled Syringe A prefilled syringe of AVONEX is supplied as a sterile liquid albumin-free formulation containing 30 micrograms of interferon beta-1a, 0.79 mg Sodium Acetate Trihydrate, USP; 0.25 mg Glacial Acetic Acid, USP; 15.8 mg Arginine Hydrochloride, USP; and 0.025 mg Polysorbate 20 in Water for Injection, USP. Each prefilled glass syringe contains 0.5 mL for Intramuscular injection. AVONEX prefilled syringes are available in the following package configuration (NDC 59627- 002-05): A package containing four Administration Dose Packs (each containing one single-use syringe of AVONEX and one 23 gauge, 1¼ inch needle), and a recloseable accessory pouch containing 4 alcohol wipes, 4 gauze pads, and 4 adhesive bandages. AVONEX in prefilled syringes should be stored in a 2°C to 8°C (36°F to 46°F) refrigerator. Once removed from the refrigerator, AVONEX in a prefilled syringe should be allowed to warm to room temperature (about 30 minutes). Do not use external heat sources such as hot water to warm AVONEX in a prefilled syringe. Should refrigeration be unavailable, AVONEX in a prefilled syringe can be stored at ≤ 25°C (77°F) for a period up to 7 days. Once the product is removed from the refrigerator, it must not be stored above 25°C (77°F). If the product has been exposed to conditions other than those recommended, DISCARD THE PRODUCT and DO NOT USE. DO NOT EXPOSE TO HIGH TEMPERATURES. DO NOT FREEZE. Protect from light. Do not use beyond the expiration date stamped on the syringe. AVONEX PEN Single-Use Prefilled Autoinjector AVONEX PEN is supplied as a sterile liquid albumin-free formulation containing 30 micrograms of interferon beta-1a, 0.79 mg Sodium Acetate Trihydrate, USP; 0.25 mg Glacial Acetic Acid, USP; 15.8 mg Arginine Hydrochloride, USP; and 0.025 mg Polysorbate 20 in Water for Injection, USP. Each single-use prefilled autoinjector contains 0.5 mL for intramuscular injection. AVONEX PEN single-use prefilled autoinjectors are available in the following package configuration (NDC 59627-003-04): A package containing four AVONEX PEN Administration Dose Packs (each containing one AVONEX PEN autoinjector, one 25 gauge, 5/8 inch needle and an AVONEX PEN cover), and a recloseable accessory pouch containing 4 alcohol wipes, 4 gauze pads, and 4 adhesive bandages. AVONEX PEN should be stored in a 2°C to 8°C (36°F to 46°F) refrigerator. Once removed from the refrigerator, AVONEX PEN should be allowed to warm to room temperature (about 30 minutes). Do not use external heat sources such as hot water to warm AVONEX. Should refrigeration be unavailable, AVONEX PEN can be stored at ≤ 25°C (77°F) for a period up to 7 days. Once the product is removed from the refrigerator, it must not be stored above 25°C (77°F). If the product has been exposed to conditions other than those recommended, DISCARD THE PRODUCT and DO NOT USE. DO NOT EXPOSE TO HIGH TEMPERATURES. DO NOT FREEZE. Protect from light. Do not use beyond the expiration date stamped on the prefilled autoinjector. Manufactured by: BIOGEN IDEC INC., 14 Cambridge Center, Cambridge, MA 02142 USA. Revised: 03/2013 Last reviewed on RxList: 3/27/2013
This monograph has been modified to include the generic and brand name in many instances.

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Depression, Suicide, and Psychotic Disorders Patients treated with AVONEX and their caregivers should be advised to report immediately any symptoms of depression, suicidal ideation, and/or psychosis to their prescribing physicians. If a patient develops depression or other severe psychiatric symptoms, cessation of AVONEX therapy should be considered. Depression and suicide have been reported to occur with increased frequency in patients receiving AVONEX. In Study 1, the incidence of depression was similar in placebo-treated and in AVONEX-treated patients, but suicidal tendency was seen more frequently in AVONEXtreated patients (4% in AVONEX group vs. 1% in placebo group). In Study 2, there was a greater incidence of depression in AVONEX-treated patients than in placebo-treated patients (20% in AVONEX group vs. 13% in placebo group) [see Clinical Studies]. Additionally, there have been post-marketing reports of depression, suicidal ideation, and/or development of new or worsening of other pre-existing psychiatric disorders, including psychosis. For some of these patients, symptoms of depression improved upon cessation of AVONEX. Hepatic Injury Severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking AVONEX. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge with AVONEX. In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury. The potential risk of AVONEX used in combination with known hepatotoxic drugs or other products (e.g., alcohol) should be considered prior to starting AVONEX, or before starting hepatotoxic drugs. Patients should be monitored for signs of hepatic injury. Anaphylaxis and Other Allergic-Reactions Anaphylaxis has been reported as a rare complication of AVONEX use. Other allergic reactions have included dyspnea, orolingual edema, skin rash and urticaria. Discontinue AVONEX if anaphylaxis or other allergic reactions occur. Congestive Heart Failure Patients with pre-existing congestive heart failure should be monitored for worsening of their cardiac condition during initiation of and continued treatment with AVONEX. While beta interferons do not have any known direct cardiac toxicity, during the post-marketing period cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition to these events, and without other etiologies being established. In some cases, these events have been temporally related to the administration of AVONEX. In some of these instances recurrence upon rechallenge was observed. Decreased Peripheral Blood Counts Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia, have been reported from postmarketing experience in AVONEX-treated patients [see ADVERSE REACTIONS]. In some cases, platelet counts were below 10,000/microliter. Some cases recurred with rechallenge [see ADVERSE REACTIONS]. Patients should be monitored for symptoms or signs of decreased blood counts. Seizures Seizures have been temporally associated with the use of beta interferons in clinical trials and postmarketing safety surveillance. In the two placebo-controlled studies in multiple sclerosis (Studies 1 and 2), 4 patients receiving AVONEX experienced seizures, while no seizures occurred in the placebo group [see Clinical Studies]. Three of these 4 patients had no prior history of seizure [see ADVERSE REACTIONS]. It is not known whether these events were related to the effects of multiple sclerosis alone, to AVONEX, or to a combination of both. Autoimmune Disorders Post-marketing reports of autoimmune disorders of multiple target organs in AVONEX-treated patients included idiopathic thrombocytopenia, hyper- and hypothyroidism, and rare cases of autoimmune hepatitis. If AVONEX-treated patients develop a new autoimmune disorder, consider stopping the therapy. Laboratory Tests In addition to those 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 during AVONEX therapy. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts. Thyroid function should be monitored periodically. If patients have or develop symptoms of thyroid dysfunction (hypo- or hyperthyroidism), thyroid function tests should be performed according to standard medical practice. Patient Counseling Information See FDA-approved patient labeling (Medication Guide and Patient's Instructions for Use). Instruct patients to carefully read the supplied AVONEX Medication Guide and caution patients not to change the AVONEX dose or schedule of administration without medical consultation. Instruction on Self-injection Technique and Procedures Provide appropriate instruction for reconstitution of AVONEX and methods of self-injection, including careful review of the AVONEX Medication Guide. Instruct patients in the use of aseptic technique when administering AVONEX. Inform patients that their healthcare provider should show them or their caregiver how to prepare and inject AVONEX before administering the first dose. Their healthcare provider should watch the first AVONEX injection given. Tell patients not to re-use needles or syringes and instruct patients on safe disposal procedures. Inform patients to dispose of used needles and syringes in a puncture-resistant container and instruct the patient regarding safe disposal of full containers. Advise patients:
  • of the importance of rotating areas of injection with each dose to minimize the likelihood of injection site reactions. [see Choose an Injection Site section of the Medication Guide].
  • NOT to inject area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way
  • to check the injection site after 2 hours for redness, swelling, or tenderness
  • contact their doctor or nurse if they have a skin reaction and it does not clear up in a few days
Pregnancy Advise patients that AVONEX should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Special Population]. Depression Advise patients of the symptoms of depression, suicidal ideation, or psychotic disorders as they have been reported with the use of AVONEX and instruct patients to report them immediately to their physician [see WARNINGS AND PRECAUTIONS]. Liver Disease Advise patients that severe hepatic injury, including hepatic failure, has been reported during the use of AVONEX. Advise patients of symptoms of hepatic dysfunction, and instruct patients to report them immediately to their physician [see WARNINGS AND PRECAUTIONS]. Allergic Reactions and Anaphylaxis Advise patients of the symptoms of allergic reactions and anaphylaxis, and instruct patients to seek immediate medical attention if these symptoms occur [see WARNINGS AND PRECAUTIONS]. Congestive Heart Failure Advise patients that worsening of pre-existing congestive heart failure has been reported in patients using AVONEX. Advise patients of symptoms of worsening cardiac condition, and instruct patients to report them immediately to their physician [see WARNINGS AND PRECAUTIONS]. Seizures Advise patients that seizures have been reported in patients using AVONEX. Instruct patients to report seizures immediately to their physician [see WARNINGS AND PRECAUTIONS]. Flu-like Symptoms Inform patients that flu-like symptoms are common following initiation of therapy with AVONEX [see DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS]. Advise patients that starting with a lower dose than 30 micrograms and increasing the dose over 3 weeks reduces the incidence and severity of flu-like symptoms. Nonclinical Toxicology Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis The carcinogenic potential of AVONEX has not been tested in animals. Mutagenesis Interferon beta was not mutagenic when tested in an in vitro bacterial reverse mutation (Ames) test or in an in vitro cytogenetic assay in human lymphocytes. Impairment of Fertility In monkeys administered interferon beta by subcutaneous injection (8 to 15 doses of 1.25 mcg/kg or 50 mcg/kg) over the course of one menstrual cycle, menstrual irregularities, anovulation, and decreased serum progesterone levels were observed at the higher dose. These effects were reversible after discontinuation of drug. The no-effect dose (1.25 mcg/kg) is approximately 2 times the recommended weekly dose in humans (30 mcg) on a mg/m² basis. Use In Specific Populations Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. AVONEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant monkeys given interferon beta at 100 times the recommended weekly human dose (based upon a body surface area [mg/m²] comparison), no teratogenic or other adverse effects on fetal development were observed. Abortifacient activity was evident following 3 to 5 doses at this level. No abortifacient effects were observed in monkeys treated at 2 times the recommended weekly human dose (based upon mg/m²). Nursing Mothers It is not known whether AVONEX is excreted in human milk. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of AVONEX did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. Last reviewed on RxList: 3/27/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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