Elelyso (taliglucerase alfa)

Generic drug: taliglucerase alfa

Brand name: Elelyso

Elelyso (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of type 1 Gaucher disease.

Common side effects of Elelyso include:

• infusion reactions,
• cold symptoms (sore throat, runny or stuffy nose, sinus pain),
• throat infection,
• headache,
• joint pain,
• flu,
• urinary tract infection (UTI),
• back pain,
• pain in the extremities,
• fever,
• dizziness,
• tired feeling,
• fatigue,
• nausea,
• stomach or abdominal pain,
• joint pain,
• itching,
• flushing (warmth, redness, or tingly feeling), or
• rash.

Some people receiving an Elelyso injection have had a reaction to the infusion (when the medicine is injected into the vein).

Tell your doctor if you feel

• dizzy,
• nauseated,
• anxious,
• lightheaded,
• weak,
• tired, or
• have a sudden headache, red skin rash, fast or uneven heartbeats,
• chest pain or tightness, or
• buzzing in your ears during the injection of Elelyso.

These side effects of Elelyso could occur up to 24 hours after your injection.

Recommended Dosage In Patients 4 Years And Older

Treatment-Naïve Patients

• The recommended dosage of Elelyso for long-term treatment is 60 units/kg of body weight administered every other week as a 60 to 120 minute intravenous infusion.

Patients Switching From Imiglucerase

• Patients currently being treated with imiglucerase for Type 1 Gaucher disease can be switched to Elelyso.
• Patients previously treated on a stable dosage of imiglucerase are recommended to begin treatment with Elelyso at that same units/kg dosage when they switch from imiglucerase to Elelyso.
• Administer Elelyso for long-term treatment every other week as a 60 to 120 minute intravenous infusion.
• Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.

• The limited available data on Elelyso use in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations. See prescribing information for more information.
• There are no data on the presence of taliglucerase alfa in human milk, the effects on the breast fed infant or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Elelyso and any potential adverse effects on the breastfed child from Elelyso or from the underlying maternal condition.