Avonex

interferon beta-1a

Avonex, Rebif

interferon beta-1b

Betaferon (UK), Betaseron, Extavia

Pharmacologic class: Biological response modifier

Therapeutic class: Antiviral, immunoregulator

Pregnancy risk category C

Action

Binds and competes with specific receptors on cell surface, inducing various interferon-induced gene products. Also inhibits proliferation of T cells.

Availability

Lyophilized powder for injection (beta-1a): 22 mcg (6 million international units; Rebif), 33 mcg (6.6 million international units; Avonex), 44 mcg (12 million international units; Rebif)

Lyophilized powder for injection (beta-1b): 0.3 mg in glass, single-use, 3-ml vial

Powder for injection (beta-1b): 0.3 mg (9.6 million international units; Betaseron)

Prefilled syringes (beta-1a): 30 mcg/0.5 ml (Avonex)

Indications and dosages

To reduce frequency of exacerbations in relapsing-remitting multiple sclerosis

Adults ages 18 and older: 8.8 mcg Rebif subcutaneously three times weekly, increased over a 4-week period to 44 mcg three times weekly. Or 30 mcg Avonex I.M. once a week. Or 8 million international units (0.25 mg) Betaseron subcutaneously every other day. Or initially, 0.0625 mg (0.25 ml) (Extavia) subcutaneously every other day, increased over 6 weeks to 0.25 mg (1 ml) every other day.

Contraindications

• Hypersensitivity to drug, its components, or albumin

Precautions

Use cautiously in:

• cardiac disease, seizure disorders, mental disorders, depression, suicidal tendencies

• women of childbearing age

• pregnant or breastfeeding patients

• children ages 18 and younger.

Administration

• Reconstitute Avonex (I.M. injection) and Rebif (subcutaneous injection) using diluent provided, according to instructions provided.

• Reconstitute Betaseron (subcutaneous injection) using 1.2 ml of diluent supplied by manufacturer, to yield a concentration of 0.25 mg/ml. Swirl gently to mix; don't shake. Use reconstituted drug within 3 hours; discard unused portion.

• Reconstitute Extavia (subcutaneous injection) by attaching prefilled, single-use syringe containing 1.2 ml of diluent supplied by manufacturer to vial using vial adapter. Slowly inject 1.2 ml of diluent into vial to yield a concentration of 0.25 mg/ml. Swirl gently to mix; don't shake. Use reconstituted drug within 3 hours; discard unused portion.

Adverse reactions

CNS: dizziness, confusion, rigors, paresthesia, lethargy, depression, difficulty thinking or concentrating, insomnia, anxiety, fatigue, amnesia, nervousness, drowsiness, asthenia, malaise, suicidal ideation

CV: chest pain, hypertension, palpitations, arrhythmias

EENT: visual disturbances, stye, hearing disorders, nasal congestion, sinusitis, rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, eructation, stomatitis, dry mouth, intestinal obstruction

GU: gynecomastia, breast pain, early or delayed menses, menstrual bleeding or spotting, shortened duration of menstrual flow, menorrhagia

Hematologic: anemia, neutropenia, leukopenia, thrombocytopenia

Metabolic: hypocalcemia

Musculoskeletal: joint pain, back pain, myalgia, myasthenia

Respiratory: cough, dyspnea

Skin: rash, dry skin, pruritus, flushing, alopecia, dermatitis, diaphoresis

Other: gingivitis, flulike symptoms, weight loss, edema, candidiasis, lymphadenopathy, inflammation, pain

Interactions

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, glucose, lactate dehydrogenase, neutralizing antibodies, phosphorus, uric acid: increased values

Hemoglobin, neutrophils, white blood cells: decreased values

Patient monitoring

Before therapy and monthly during therapy, assess CBC with white cell differential, glucose and electrolyte levels, and liver and kidney function tests.

• Assess fluid intake and output. Keep patient well hydrated.

• Watch for GI upset. Provide small, frequent meals to minimize nausea and vomiting.

Monitor for mental status changes, depression, and suicidal ideation.

• Evaluate for bleeding and bruising.

• Institute infection-control measures. Monitor for infection symptoms.

Patient teaching

• Teach patient or caregiver how to administer drug subcutaneously or I.M., rotate injection sites, and track dosing schedule and injection sites on calendar.

• Advise patient to avoid sources of potential infection, such as crowds and people with known infections.

• Tell patient to eat small, frequent meals to combat nausea, vomiting, and appetite loss.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, and vision.

Tell patient to contact prescriber immediately if depression or suicidal ideation occurs.

• Inform female patient that drug is linked to fetal abnormalities. Advise her not to get pregnant during therapy, and to use barrier contraception. Tell her to consult prescriber before breastfeeding.

Instruct patient to immediately report signs or symptoms of infection (such as fever, chills, sore throat, achiness), unusual bleeding or bruising, mental status changes, dizziness, palpitations, or chest pain.

• Tell patient he'll need regular follow-up examinations and blood tests to monitor drug effects.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

interferon beta-1a

(in-ter-feer-on bay-ta won-aye) ,

Avonex

(trade name),

Rebif

(trade name)

Classification

Therapeutic: anti multiple sclerosis agents
Pharmacologic: interferons
Pregnancy Category: C

Indications

Relapsing forms of multiple sclerosis.

Action

Antiviral and immunoregulatory properties produced by interacting with specific receptor sites on cell surfaces may explain beneficial effects.
Produced by recombinant DNA technology.

Therapeutic effects

Reduce incidence of relapse (neurologic dysfunction) and slow physical disability.

Pharmacokinetics

Absorption: 50% absorbed following subcut administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 69 hr (subcutaneous), 10 hr (IM).

Time/action profile (serum concentrations)

ROUTEONSETPEAKDURATION
IMunknown3–15 hrunknown
SCunknown16 hrunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to natural or recombinant interferon beta or human albumin.
Use Cautiously in: Patients with a history of suicide attempt or depression; History of seizures; Cardiovascular disease; Liver disease; History of alcohol abuse; Patients with childbearing potential; Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • depression (most frequent)
  • dizziness (most frequent)
  • fatigue (most frequent)
  • headache (most frequent)
  • drowsiness
  • incoordination
  • rigors
  • suicidal ideation

Ear, Eye, Nose, Throat

  • sinusitis (most frequent)
  • vision abnormalities

Respiratory

  • upper respiratory tract infection

Cardiovascular

  • chest pain
  • heart failure

Gastrointestinal

  • abdominal pain (most frequent)
  • nausea (most frequent)
  • autoimmune hepatitis
  • dry mouth
  • elevated liver function studies

Genitourinary

  • urinary tract infection (most frequent)
  • urinary incontinence
  • polyuria

Dermatologic

  • alopecia
  • rash

Endocrinologic

  • hyperthyroidism
  • hypothyroidism
  • spontaneous abortion

Hematologic

  • neutropenia (most frequent)
  • anemia
  • thrombocytopenia

Local

  • injection-site reactions (most frequent)
  • injection site necrosis

Musculoskeletal

  • myalgia (most frequent)
  • arthralgia
  • back pain
  • muscle spasm

Miscellaneous

  • allergic reactions including anaphylaxis
  • chills (most frequent)
  • fever (most frequent)
  • flu-like symptoms (most frequent)
  • pain (most frequent)

Interactions

Drug-Drug interaction

↑ myelosuppression may occur with other myelosuppressives including antineoplastics.Concurrent use of hepatotoxic agents may ↑ the risk of hepatotoxicity (↑ liver enzymes). Avoid concommitant use with immmunomodulating natural products such as astragalus, echinacea, and melatonin.

Route/Dosage

Avonex
Intramuscular (Adults) 30 mcg once weekly.
Rebif
Subcutaneous (Adults) Target dose of 22 mcg 3 times/wk–Start with 4.4 mcg 3 times/wk for 2 wk, then increase to 11 mcg 3 times/wk for 2 wk, then increase to maintenance dose of 22 mcg 3 times/wk;Target dose of 44 mcg 3 times/wk–Start with 8.8 mcg 3 times/wk for 2 wk, then increase to 22 mcg 3 times/wk for 2 wk, then increase to maintenance dose of 44 mcg 3 times/wk.

Availability

Avonex
Powder for injection: 30 mcg/vial
Prefilled syringes: 30 mcg/0.5 mL
Prefilled pens: 30 mcg/0.5 mL
Rebif
Pre-filled syringes: 22 mcg/0.5 mL, 44 mcg/0.5 mL, titration pack of 6 syringes prefilled with 8.8 mcg/0.2 mL and 6 syringes prefilled with 22 mcg/0.5 mL

Nursing implications

Nursing assessment

  • Assess frequency of exacerbations of symptoms of multiple sclerosis periodically during therapy.
  • Monitor patient for signs of depression during therapy. If depression occurs, notify.health care professional immediately.
  • Lab Test Considerations: Monitor hemoglobin, WBC, platelets, and blood chemistries including liver function tests prior to and 1, 3, and 6 mo after initiation of therapy. Therapy may be temporarily discontinued if the absolute neutrophil count is < 750/mm3, if AST or ALT exceeds 10 times the upper limit of normal, or if serum bilirubin exceeds 5 times the upper limit of normal. Once the absolute neutrophil count is > 750/mm3 or the hepatic enzymes have returned to normal, therapy can be restarted at 50% of the original dose. Thyroid function tests should also be monitored every 6 mo, especially in those patients with a history of thyroid abnormalities.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Do not confuse products. Interferon beta-1a and interferon beta-1b are not interchangeable.
  • Avonex:Reconstitute with 1.1 mL of diluent and swirl gently to dissolve. Do not shake the vial. Inject into the thigh or upper arm. Keep reconstituted solution in refrigerator; inject within 6 hr of reconstitution.
    • Rebif:Administer subcutaneously via pre-filled, single-use syringe at the same time (preferably the late afternoon or evening) on the same days (Monday, Wednesday, Friday) at least 48 hr apart each wk. Rotate sites with each injection to minimize risk of injection site reactions. Discard unused portions. Store in refrigerator.

Patient/Family Teaching

  • Home Care Issues: Instruct patient in correct technique for injection and care and disposal of equipment. Caution patient not to reuse needles or syringes and provide patient with a puncture-resistant container for disposal.
    • Instruct patient to take medication as directed; do not change dose or schedule without consulting health care professional. Patients should receive a medication guide with each product.
    • Inform patient that flu-like symptoms (fever, chills, myalgia, sweating, malaise) may occur during therapy. Acetaminophen may be used for relief of fever and myalgias.
    • Obstetric: Advise patient to notify health care professional if pregnancy is planned or suspected. May cause spontaneous abortion.

Evaluation/Desired Outcomes

  • Decrease in the frequency of relapse (neurologic dysfunction) in patients with relapsing-remitting multiple sclerosis.

Avonex

A brand name for INTERFERON BETA-1a.
References in periodicals archive ?
Celgene Corporation announced the results of a post-hoc analysis of data from the Phase 3 RADIANCE Part B trial showing that ozanimod reduced cortical grey matter volume loss versus first-line treatment, Avonex, in adults with relapsing multiple sclerosis across all age groups, including patients ages 18 to 25.
SUNBEAM is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI respectively) against weekly intramuscular interferon beta-1a (Avonex) for at least a 12-month treatment period.
announced that the companies have commenced co-promotion of Biogen Japan's multiple sclerosis treatments TECFIDERA (dimethyl fumarate), TYSABRI (natalizumab, genetic recombinant) and AVONEX (interferon beta 1a, genetic recombinant) in Japan as of today.
Meanwhile, the pair will also co-promote Biogen's multiple sclerosis treatments, Avonex (interferon beta-1a), Tysabri (natalizumab) and Tecfidera (dimethyl fumarate), in Japan to certain accounts.
Celgene's Phase III SUNBEAM trial, evaluating the efficacy and safety of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) [beta]-1a (Avonex).
In DECIDE and SELECT, ZINBRYTA significantly reduced the annualized relapse rate (ARR), the primary endpoint of the studies, by 45 percent compared to AVONEX up to 144 weeks and by 54 percent compared to placebo at 52 weeks (both p<0.0001), respectively.
Disease-modifying drugs, such as Copaxone and Avonex, can change the lives of people with relapsing-remitting MS - but there is currently no treatment that affects the course of the more serious primary progressive MS.
The dominance of first-line injectable DMTs, including the interferon beta (IFNB) agents: Bayer's Betaseron/Betaferon (IFNB-1b), Biogen's Avonex (IFNB-1a) and Merck's Rebif (IFNB-1a), and Teva's Copaxone (glatiramer acetate), has been a salient feature of the MS therapeutics market.
[ClickPress, Wed May 01 2013] GlobalData has released its new PharmaPoint Drug Evaluation report, "Avonex (Multiple Sclerosis) - Forecast and Market Analysis to 2022".
Stacey Max remembers well the first time she couldn't face giving herself her weekly injection of Avonex, the disease-modifying therapy (DMT) that she takes to manage her multiple sclerosis.
On quality of life measures, monotherapy and combination therapy proved largely equal--and equally well tolerated--in the "CombiRx" study, in which half of the patients got the combination and a quarter got either glatiramer acetate (Copaxone) or interferon beta-la (Avonex) alone plus a placebo.
On quality of life measures, monotherapy and combination therapy proved largely equal--and equally well tolerated--in the "'CombiRx" study, in which half of the patients got the combination and a quarter got either glatiramer acetate (Copaxone) or interferon beta-1a (Avonex) alone plus a placebo.