Taliglucerase Alfa

DAE Class; Rx

Common Brand Names; Elelyso

• Enzymes, Metabolic

Metabolic enzyme replacement.
Used in the treatment of patients with Gaucher’s disease.
First plant-made recombinant pharmaceutical.

None

>10%

Treatment-naïve adults

• Headache (19%)
• Arthralgia (13%)

Treatment naïve children and adolescents

• Vomiting (≥10%)

Switch from imiglucerase adults and children

• Arthralgia (13%)
• Headache (13%)

1-10%

Treatment-naïve adults

• Fatigue (9%)
• Nausea (9%)
• Dizziness (9%)
• Abdominal pain (6%)
• Pruritus (6%)
• Flushing (6%)
• Vomiting (6%)
• Urticaria (6%)

Switch from imiglucerase adults and children

• Pain in extremity (10%)

Postmarketing Reports

Gastrointestinal disorders: Vomiting, diarrhea

General disorders and administration site conditions: Fatigue

Immune system disorders: Anaphylaxis, Type III immune-mediated fixed drug eruption

Musculoskeletal and connective tissue disorders: Back pain

Anaphylaxis reported; if anaphylaxis occurs, discontinue infusion immediately and initiate appropriate treatment

Allergic and infusion reactions are common and include headache, chest pain or discomfort, asthenia, fatigue, urticaria, erythema, increased blood pressure, back pain, arthralgia, and flushing; if allergic or infusion reactions occur, decrease the infusion rate or temporarily stop the infusion; antihistamines and/or antipyretics may be administered; medical support should be readily available when taliglucerase alfa administered; observe patients closely for an appropriate period of time after administration; reactions have occurred up to 3 hr after the start of infusion

Consider risks and benefits of re-administering taliglucerase alfa in patients who have experienced severe reaction associated with taliglucerase alfa; use caution upon rechallenge; appropriate medical support should be readily available

As with all therapeutic proteins, development of IgG anti-drug antibodies (ADA) has been reported (53%); unknown if presence of ADA is associated with higher risk of infusion reactions or immunogenicity

Monitor patients that have had an immune response to other enzyme replacement therapies or who are switching to taliglucerase alfa; unknown if these patients are at higher risk of infusion reactions

Dizziness and fatigue reported; caution patients against performing dangerous tasks that require mental alertness, including driving heavy machinery

Pregnancy

Insufficient data available on use in pregnant females to inform a drug-associated risk

Lactation

There are no data on taliglucerase alfa in human milk, effects on breast fed infants, or effects on milk production

Adults

60 units/kg/dose IV every 2 weeks.

Geriatric

60 units/kg/dose IV every 2 weeks.

Adolescents

60 units/kg/dose IV every 2 weeks.

Children

4 to 12 years: 60 units/kg/dose IV every 2 weeks.
1 to 3 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Taliglucerase Alfa