Elelyso
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.
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.
Drug facts
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%)
Less Common Side Effects
- Stomach pain
- Itching
- Flushing
- Vomiting
- Hives
Elelyso (taliglucerase alfa) 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
The following Elelyso (taliglucerase alfa) 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
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
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 of Elelyso (taliglucerase alfa)
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
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 for Elelyso (taliglucerase alfa)
- 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.
Common questions about Elelyso (taliglucerase alfa)
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.
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.
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.
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.
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).
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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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.
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.
Elelyso (taliglucerase alfa) dosage
Typical dosage 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.
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If you haven't been treated before (treatment naive): In general, the typical starting dose is 60 units/kg once every other week.
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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 between Elelyso (taliglucerase alfa) and other drugs
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.
