Avonex

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 trademark for an antiviral and immune system regulator (interferon beta-1a) useful for treating multiple sclerosis.

Avonex

A brand name for INTERFERON BETA-1a.
References in periodicals archive ?
NASDAQ: CELG) has released detailed results from the phase III SUNBEAM trial evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, versus a first-line treatment, Avonex (interferon beta-1a; IFN), in patients with relapsing multiple sclerosis (RMS), the company said.
5 mg treatment arms demonstrated statistically significant and clinically meaningful improvements compared to Avonex for the primary endpoint of ARR and the measured secondary endpoints of the number of gadolinium-enhancing MRI lesions and the number of new or enlarging T2 MRI lesions at month 12.
The subject of the public contract is the supply of drugs Avonex - L03AB07, Herceptin 150 mg - L01XC03, Rebif - L03AB07, Tarceva - L01XE03, Votrient - L01XE11, Zaltrap - L01XX44.
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.
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.
Results from a second pivotal study, known as Bravo and comparing laquinimod to existing treatment Avonex by Biogen Idec Inc (NASDAQ: BIIB), are expected in the third quarter of 2011.
The company said it received positive opinion for Avonex Pen against multiple sclerosis from the European Medicines Agency's Committee for Medicinal Products for Human Use.
33 in those on Avonex (a comparative reduction of 52%).
Cambridge MA) reported better-than-expected earnings, helped by higher sales of its multiple sclerosis drug Avonex, but sales of its MS drug Tysabri were lower than expected.
Growth is expected to be driven by Avonex, a multiple sclerosis drug, and Rituxan, a cancer treatment.
The disease-modifiers approved for treatment of MS are Avonex (interferon beta-1a), Betaseron (interferon beta-1b), Copaxone (glatiramer acetate), and Rebif (interferon beta-1a).
People with relapsing-remitting MS are now being enrolled in a multicenter clinical trial designed to test the safety and effectiveness of combining Avonex (interferon beta-1a) with other immune-suppressing drugs.