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Elelyso

taliglucerase alfa
Used for Inherited Metabolic Diseases, Lysosomal Storage Disease
Used for Inherited Metabolic Diseases, Lysosomal Storage Disease

Elelyso (taliglucerase alfa) is a form of enzyme replacement therapy (ERT) used to treat Type 1 Gaucher disease in people 4 years of age or older. It's given as an intravenous (IV) infusion by a healthcare provider. Overall, Elelyso (taliglucerase alfa) is well tolerated, but it can cause allergic reactions such as hives or trouble breathing.

Last reviewed on April 3, 2022
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What is Elelyso (taliglucerase alfa)?

What is Elelyso (taliglucerase alfa) used for?

  • Type 1 Gaucher disease in adults and children 4 years of age or older

How Elelyso (taliglucerase alfa) works

Elelyso (taliglucerase alfa) is a plant-based, modified (lab-made) version of the enzyme glucocerebrosidase that is normally found in the body. People with Gaucher disease don't have enough of this enzyme, which breaks down a fatty substance called glucocerebroside. As a result, there are higher levels of glucocerebroside in the body, and it can build up in the spleen, liver, and bones. Elelyso (taliglucerase alfa) works as an enzyme replacement for glucocerebrosidase and helps your body break down glucocerebroside.

Are you looking for information on Cerezyme (imiglucerase), Vpriv (velaglucerase alfa) instead?

Drug Facts

Common BrandsElelyso
Drug ClassHydrolytic lysosomal glucocerebrosidase-specific enzyme
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Elelyso (taliglucerase alfa)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Headache (13-19%)
  • Joint pain (13%)
  • Arm or leg pain (10%)
  • Fatigue (9%)
  • Nausea (9%)
  • Dizziness (9%)

Other Side Effects

  • Stomach pain
  • Itching
  • Flushing
  • Vomiting
  • Hives

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
Serious allergic reactions: throat tightness or irritation, trouble breathing, cough, wheezing, itching or hives, flushing, swelling, chest pain or tightness, dizziness, fainting, nausea, vomiting

Source: DailyMed

The following side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Chest tightness

dizziness

feeling of warmth

hives or welts, itching, or skin rash

irritation in the throat

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

nausea or vomiting

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

Less common

Blurred vision

confusion

cough

difficulty with swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast heartbeat

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sweating

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain

difficulty with moving

feeling of warmth

headache

muscle pain or stiffness

pain in the joints

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

pros-and-cons

Pros and cons of Elelyso (taliglucerase alfa)

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Pros

Can be used in people switching from Cerezyme (imiglucerase)

Can be used in children as young as 4 years of age

Fewer side effects compared to oral medications for Gaucher disease type 1

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Cons

Might require frequent trips to the infusion center to receive treatment

Potential for allergic reactions

Requires IV access, so it's not as convenient as taking a pill

pharmacist-tips

Pharmacist tips for Elelyso (taliglucerase alfa)

pharmacist
  • It takes 1 to 2 hours to give the full dose of Elelyso (taliglucerase alfa). Most commonly, you'll receive this medication at an infusion center or provider's office. In some cases, it can be given at home by a home health nurse.

    • You might experience an allergic reaction during or shortly after your Elelyso (taliglucerase alfa) infusion, some of which can be life-threatening. Let your provider know or get help right away if you experience any trouble breathing, hives, flushing, chest pain, fast heartbeat, or dizziness.

      • Children can experience more vomiting during Elelyso (taliglucerase alfa) treatment compared to adults. This could be a sign of an allergic reaction, so let your child's provider know if it happens.

        • If you're switching from Cerezyme (imiglucerase), your dose of Elelyso (taliglucerase alfa) will likely be the same as the dose of Cerezyme (imiglucerase) you were previously on.

          • Elelyso (taliglucerase alfa) infusions can be shifted around travel or other plans, but it's best to stay on your regular schedule so you'll get the most benefit. If you miss an infusion, talk with your provider about rescheduling your appointment.

            faqs

            Frequently asked questions about Elelyso (taliglucerase alfa)

            What is Gaucher disease?
            Gaucher disease is a rare, genetic condition where your body has lower levels of an enzyme, a specific protein, that breaks down a type of fatty substance called glucocerebroside (also known as glucosylceramide). As a result, glucocerebroside can build up in certain organs, like your spleen, liver, and bones. A buildup in the liver or spleen can lead to these organs getting abnormally large and causing a swollen belly. While a buildup in the bones and bone marrow can cause serious bleeding, bruising, and bone pain or weakness. Elelyso (taliglucerase alfa) helps to replace this enzyme that you're missing so that your body can break down glucocerebroside.
            How is Elelyso (taliglucerase alfa) made?
            Elelyso (taliglucerase alfa) is plant-based and made using carrot cells and other supportive nutrients. This is different from other ERTs like Cerezyme (imiglucerase) and Vpriv (velaglucerase alfa) which are made using hamster cells and human cells, respectively.
            Can I receive Elelyso (taliglucerase alfa) again if I've had an allergic reaction before?
            Possibly, it depends on how severe your reaction was. Your provider should discuss with you the risks and benefits of treatment with Elelyso (taliglucerase alfa) again following an allergic reaction. People who experience such reactions to Elelyso (taliglucerase alfa) can be given antihistamines or corticosteroids before future infusions. The rate of infusion can also be slowed down to try and prevent reactions. Talk to your provider if you’re concerned about receiving this treatment.
            Can I receive Elelyso (taliglucerase alfa) if I've been treated with ERT before?
            Yes, you can receive Elelyso (taliglucerase alfa) if you have previously been treated with Cerezyme (imiglucerase). Your dose might be different from the typical starting dose in people who have never received ERT before (treatment-naïve). Your provider will determine your starting dose when switching treatments.
            Is Elelyso (taliglucerase alfa) safe in pregnancy?
            There's not enough information about how Elelyso (taliglucerase alfa) can affect your unborn baby. In animal studies, Elelyso (taliglucerase alfa) was not shown to cause birth defects. It's known that people with Gaucher disease have a higher risk of miscarriage, especially if symptoms aren't controlled before and during pregnancy. Pregnancy can also worsen symptoms. If you're pregnant or think you might become pregnant, talk to your provider before starting Elelyso (taliglucerase alfa).
            Is Elelyso (taliglucerase alfa) safe while breastfeeding?
            It's not known if Elelyso (taliglucerase alfa) is found in human breast milk or how it can affect your milk supply or breastfed baby. If you’re breastfeeding, discuss with your provider about the risks and benefits of taking Elelyso (taliglucerase alfa).
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            What are the risks and warnings for Elelyso (taliglucerase alfa)?

            Elelyso (taliglucerase alfa) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

            risk-warning

            Allergic reactions

            Elelyso (taliglucerase alfa) can cause allergic reactions, which can be serious. These reactions can happen during or a few hours after the start of infusion. This is due to your body developing antibodies to Elelyso (taliglucerase alfa), but it's unknown whether having antibodies leads to a higher risk for reactions. If you've had a reaction with other ERTs like Cerezyme (imiglucerase), your provider might occasionally monitor your antibody levels during treatment.

            Let your provider know right away if you experience any chest tightness, trouble breathing, throat irritation, cough, wheezing, flushing, hives, itching, redness, rash, nausea, vomiting, or dizziness.

            dosage

            Elelyso (taliglucerase alfa) dosage forms

            Typical dosing for Elelyso (taliglucerase alfa)

            Elelyso (taliglucerase alfa) is an intravenous (IV) infusion that is administered by a healthcare provider. The dose depends on your weight.

            • If you haven't been treated before (treatment naive): In general, the typical starting dose is 60 units/kg once every other week.

            • If you're switching from Cerezyme (imiglucerase): The usual starting dose of Elelyso (taliglucerase alfa) is the same dose of Cerezyme (imiglucerase) you were previously on.

            interactions

            Interactions between Elelyso (taliglucerase alfa) and other drugs

            Elelyso (taliglucerase alfa) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Elelyso (taliglucerase alfa). Please note that only the generic name of each medication is listed below.

            Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

            alternatives

            What are alternatives to Elelyso (taliglucerase alfa)?

            There are a number of medications that your doctor can prescribe in place of Elelyso (taliglucerase alfa). Compare a few possible alternatives below.
            Elelyso (taliglucerase alfa)
            Used for:
            • Type 1 Gaucher disease in adults and children 4 years of age or older

            Used for:
            • Type 1 Gaucher disease in adults and children 2 years of age or older

            Used for:
            • Type 1 Gaucher disease in adults and children 4 years of age or older

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