taliglucerase alfa

(redirected from Elelyso)

taliglucerase alfa

(tali-gloo-ser-ase al-fa) ,


(trade name)


Therapeutic: orphan drugs
Pharmacologic: enzymes
Pregnancy Category: B


Long-term replacement therapy in adults with confirmed Type 1 Gaucher disease.


Prevents the accumulation of glucocerebrosides in cells. Replaces glucocerebrosidases that are deficient in type 1 Gaucher’s disease.

Therapeutic effects

Improvement in symptoms of Gaucher disease (anemia, thrombocytopenia, bone disease, splenomegaly, and hepatomegaly)


Absorption: IV administration results in complete bioavailability
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 18.9–28.7 min

Time/action profile

IVunknownend of infusion2 wk


Contraindicated in: None noted.
Use Cautiously in: Obstetric: Use during pregnancy only if clearly needed Lactation: Use cautiously in nursing women Pediatric: Safe and effective use in children has not been established

Adverse Reactions/Side Effects


  • allergic reactions including anaphylaxis
  • infusion reactions


Drug-Drug interaction

None noted.


Intravenous (Adults) 60 Units/kg every other week (range 11–73 Units/kg)


Lyophilized powder for IV injection (requires reconstitution): 200 Units/vial

Nursing implications

Nursing assessment

  • Monitor for an improvement in symptoms including hepatomegaly, splenomegaly, anemia, thrombocytopenia, bone demineralization, and increased appetite and energy level periodically throughout therapy. Assess liver and spleen size every 6 mo to determine effectiveness of therapy.
  • Assess for signs and symptoms of anaphylaxis (angioedema, dyspnea, wheezing, coughing, cyanosis, hypotension). Stop infusion immediately and treat symptomatically.
  • Monitor for signs and symptoms of infusion reactions (headache, chest pain, asthenia, fatigue, urticaria, erythema, increased BP, back pain, flushing). Treat by slowing infusion or with antihistamines or antipyretics. Pretreatment with antihistamines and/or corticosteroids may be used.

Potential Nursing Diagnoses

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


  • Patients treated with imiglucerase can be switched to taliglucerase at the same dose.
  • Remove required vials from refrigerator; do not leave at room temperature for longer than 24 hr. Reconstitute each vial with 5.1 mL of Sterile Water for Injection for a volume of 5.3 mL. Mix gently; do not shake. Solution is clear and colorless; do not administer solutions that are discolored or contain particulate matter. Vials are for single use; discard solution.Diluent: Withdraw 5 mL from each vial and dilute with 100–200 mL 0.9% NaCl.Mix gently; do not shake.
  • Rate: Initial infusion rate should be 1.3 mL/min; if tolerated, may increase to 2.3 mL/min. Infuse over 60–120 min; total infusion should be administered over at least 1 hr.

Patient/Family Teaching

  • Inform patient of the purpose of this medication and the importance of treatment every 2wk. taliglucerase helps control the symptoms but does not cure Gaucher’s disease. Lifelong therapy may be required.
  • Instruct patient to notify health care professional if signs and symptoms of anaphylaxis or infusion reactions occur.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
  • Emphasize the importance of follow-up examinations and lab tests.

Evaluation/Desired Outcomes

  • Increasing hemoglobin and platelet counts and decreasing acid phosphatase levels, hepatomegaly, and splenomegaly. In pediatric patients, cachexia and wasting should diminish.
References in periodicals archive ?
Clinical review report: taliglucerase alfa (Elelyso) (30 to 60 U/kg intravenous infusion) for long-term enzyme replacement therapy for adults and children (2 to 17 years old) with a confirmed diagnosis of type 1 Gaucher disease and for hematological manifestations in pediatric patients with a confirmed diagnosis of type 3 Gaucher disease [Internet].
M2 EQUITYBITES-June 2, 2014-Protalix wins approval to market ELELYSO (taliglucerase alfa) in Canada for the treatment of Gaucher Disease
M2 PHARMA-June 2, 2014-Protalix wins approval to market ELELYSO (taliglucerase alfa) in Canada for the treatment of Gaucher Disease
The three endocrine/metabolic agents are ivacaftor (Kalydeco; cystic fibrosis), taliglucerase alfa (Elelyso; Gaucher disease), and pasireotide (Signifor; Cushing's disease).
That promises more competition in some established areas, with Pfizer, for example, launching its new Gaucher disease drug Elelyso at a 25% discount to Genzyme's Cerezyme.
The first plant-based recombinant therapeutic protein, Elelyso, was approved in 2012.
The company stated Oral GCD is an orally available form of the plant cell-expressed enzyme, glucocerebrosidase or GCD, which is the same active substance as the Company's approved enzyme replacement therapy, ELELYSO. Oral GCD is an active form of human glucocerebrosidase which is naturally encapsulated within the carrot cells in which it is produced.
(PFE) as per which Protalix will continue to manage, administer and sponsor existing, ongoing clinical trials in relation with Elelyso (taliglucerase alfa).
The partnership said that UPLYSO, which is called ELELYSO (taliglucerase alfa) outside of Latin America, was approved by the US Food and Drug Administration in May 2012, Israel's Ministry of Health in September 2012 and the Ministry of Public Health in Uruguay in November 2012.
In May 2012, the company was cleared to market Elelyso (who names these things?) for treatment of Gaucher disease.
under the companies' global commercial agreement for ELELYSO (taliglucerase alfa).