Rebif


Also found in: Acronyms.

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.

Rebif®

Recombinant interferon beta-1a, see there.
References in periodicals archive ?
In addition to updating the indication section, the CHMP recommendation includes an update of the posology section adding the approved posology of Rebif in the first demyelinating event indication, and an update of the pharmacodynamic properties section summarising the design of the REFLEX trial together with its main results.
an estimated 87 percent of alemtuzumab-treated patients were free of sustained accumulation of disability compared to 62 percent of patients taking Rebif (previously reported).
Rebif was initially not to be available in the United States until mid-2003, unless clinical superiority of Rebif over Avonex could be demonstrated.
Genzyme's CAMMS223 Phase 2 trial, first reported in the New England Journal of Medicine in 2008, compared alemtuzumab to Rebif in early, active, RRMS patients who had received no prior therapy.
The subject of the public contract is the supply of drugs - Avonex - L03AB07, Esbriet - L04AX05, Herceptin 150 mg - L01XC03, Rebif - L03AB07, Sutent - L01XE04, Tarceva - L01XE03.
Avonex, Betaferon/Extavia, Rebif and Copaxone are all used in first-line therapy for RRMS.
25mg / 1 ml, interferon beta-1a - Rebif 44, a solution for injection 88MCG / ml 12 amp-shoot.
The CAMMS223 Phase II trial, first reported in the New England Journal of Medicine in 2008, compared alemtuzumab to the approved MS therapy Rebif (high dose interferon beta-1a) in early, active, relapsing-remitting multiple sclerosis (RRMS) patients who had received no prior therapy.
This study involves the enrollment of the first patient in a global Phase IIIb, randomized, rater-blinded, active-controlled study designed to evaluate switching to TYSABRI from Copaxone or Rebif and determine whether early use of TYSABRI in the treatment algorithm ultimately leads to better outcomes.
Two trials led to FDA approval of Rebif this past March.
Alemtuzumab-treated patients demonstrated consistently lower annualized relapse rates over the entire observation period compared to those treated with Rebif.
25 March 2010 - US-based biotechnology company Biogen Idec (NASDAQ: BIIB) and Ireland-based neuroscience-based biotechnology company Elan Corporation plc (ISE:3072950) announced yesterday enrollment of the first patient in a global study designed to evaluate switching to TYSABRI (natalizumab) from Copaxone (glatiramer acetate) or Rebif (interferon beta-1a) in patients with relapsing remitting multiple sclerosis (RRMS).