Taliglucerase Alfa

Taliglucerase Alfa is a prescription medication used for the treatment of Type 1 Gaucher disease in patients 4 years and above with a confirmed diagnosis. 

• Taliglucerase Alfa is available under the following different brand names: Elelyso.

Common side effects of Taliglucerase Alfa include:

• Headache,
• Rash,
• Itching,
• Warmth or tingly feeling,
• Dizziness,
• Tiredness,
• Nausea,
• Stomach pain,
• Vomiting,
• Joint pain,
• Back pain, and
• Pain in your arms or legs

Serious side effects of Taliglucerase Alfa include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Dizziness,
• Lightheadedness,
• Chest tightness,
• Wheezing,
• Cough,
• Throat irritation,
• Flushing (warmth, redness, or tingly feeling),
• Nausea,
• Vomiting,
• Skin rash,
• Itching, and
• Redness

Rare side effects of Taliglucerase Alfa include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, lyophilized powder for reconstitution

• 200 units/vial

Gaucher Disease

Adult dosage

• Treatment-naïve
  • 60 units/kg intravenous every other week
• Switching from imiglucerase
  • Currently on stable imiglucerase dose: Begin Taliglucerase Alfa at the same units/kg dosage of imiglucerase when switching from imiglucerase to Taliglucerase Alfa.
  • Administer long-term treatment as an intravenous infusion every other week.
  • Adjust dosage based on achievement and maintenance of each patient’s therapeutic goals.

Pediatric dosage

• Children below 4 years: Safety and efficacy not established.
• Children 4 years and above: 60 units/kg intravenous every other week
• Switching from imiglucerase
  • Currently on stable imiglucerase dose: Begin Taliglucerase Alfa at the same units/kg dosage of imiglucerase when switching from imiglucerase to Taliglucerase Alfa.
  • Administer long-term treatment as an intravenous infusion every other week.
  • Adjust dosage based on achievement and maintenance of each patient’s therapeutic goals.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Taliglucerase Alfa has no noted severe interactions with any other drugs.
• Taliglucerase Alfa has no noted serious interactions with any other drugs.
• Taliglucerase Alfa has no noted moderate interactions with any other drugs.
• Taliglucerase Alfa has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Taliglucerase Alfa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Taliglucerase Alfa?”

Cautions

• 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 after administration; reactions have occurred up to 3 hours after the start of infusion
• Consider risks and benefits of re-administering Taliglucerase Alfa in patients who have experienced severe reactions associated with Taliglucerase Alfa; use caution upon rechallenge; appropriate medical support should be readily available.
• As with all therapeutic proteins, the development of IgG anti-drug antibodies (ADA) has been reported (53%); unknown if the presence of ADA is associated with a 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 were reported; caution patients against performing dangerous tasks that require mental alertness, including driving heavy machinery.

Pregnancy and Lactation

• Insufficient data available on use in pregnant females to inform a drug-associated risk.
• Clinical considerations
  • Women with Type 1 Gaucher disease have an increased risk of a spontaneous abortion if disease symptoms are not treated and controlled preconception and during pregnancy.
  • Pregnancy may exacerbate existing Type 1 Gaucher disease symptoms or result in new disease manifestations.
  • Type 1 Gaucher disease manifestations may lead to adverse pregnancy outcomes, including hepatosplenomegaly which can interfere with the normal growth of a fetus, and thrombocytopenia which can lead to increased bleeding and possible postpartum hemorrhage requiring transfusion.

Lactation

• There are no data on Taliglucerase Alfa in human milk, effects on breastfed infants, or effects on milk production.