Krystexxa
Krystexxa (pegloticase) is an infusion given into your veins (IV) every 2 weeks to treat chronic gout that's difficult to treat. This medication is only used when you've tried other anti-gout medications and they haven't worked well for you. Krystexxa (pegloticase) is given by a healthcare provider, typically at an outpatient infusion center or your doctor's office. Because it can put you at risk for serious allergic reactions, your provider will ask you to stay for some time after each infusion to monitor you for symptoms such as difficulty breathing and hives.
What is Krystexxa (pegloticase)?
What is Krystexxa (pegloticase) used for?
- Chronic gout in adults who've tried other anti-gout medications that didn't work well
How Krystexxa (pegloticase) works
Krystexxa (pegloticase) is an enzyme (protein) that targets uric acid. When there's too much uric acid in your body, it can form into sharp crystals that cause painful gout attacks. Krystexxa (pegloticase) helps lower uric acid levels in your body by changing it into a substance called allantoin that's removed through your urine. When you have lower uric acid levels, you'll have fewer gout attacks.
Drug facts
Side effects of Krystexxa (pegloticase)
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
- Gout flare (77%)
- Infusion reaction (26%)
- Nausea (12%)
- Bruising (11%)
- Runny nose, sore throat, and other symptoms of the common cold (7%)
- Constipation (6%)
- Chest pain (6%)
- Vomiting (5%)
Less Common Side Effects
- Swelling in arms or legs
- Feeling unwell
- Low energy
Krystexxa (pegloticase) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Anaphylaxis (closing of the throat): fainting, lightheadedness, trouble breathing, rash, nausea, vomiting swelling of the lips, tongue, throat, or face
- Infusion reaction: chest pain, skin redness, itching, hives, flushing, difficulty breathing
The following Krystexxa (pegloticase) 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 pain or discomfort
difficult or labored breathing
difficulty with swallowing
dizziness
facial swelling
fast heartbeat
fever or chills
flushing or redness of the skin
gout flare
headache
hives or welts, itching, or skin rash
nausea or vomiting
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of the skin
tightness in the chest
unusual tiredness or weakness
unusually warm skin
Rare
Decreased urine output
dilated neck veins
extreme fatigue
irregular breathing
irregular heartbeat
swelling of the face, fingers, feet, or lower legs
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
Bruise
contusion
difficulty having a bowel movement (stool)
large, flat, blue, or purplish patches in the skin
muscle aches
stuffy or runny nose
Less common
Vomiting
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 Krystexxa (pegloticase)
Pros
- Only need to get it once every 2 weeks
- Can greatly lower your uric acid level in just 24 hours after one treatment
- Dissolves most gout buildup in about 6 months (compared to 2 or more years with oral gout medications)
Cons
- Only controls chronic gout, not acute (sudden) gout flares
- High chance of getting a gout flare when first starting Krystexxa (pegloticase), especially during the first 3 months
- Brand name medication only, so can be expensive
Pharmacist tips for Krystexxa (pegloticase)
- Keep your infusion and lab appointments marked on a calendar so that you don't miss any treatment sessions or important labs. Your provider will likely check your uric acid level a day or two before your first infusion and every infusion afterwards. This will help your treatment team follow your progress on Krystexxa (pegloticase).
- Your provider will give you medications (e.g., antihistamines or corticosteroids) before your Krystexxa (pegloticase) infusions to lower the risk of an allergic reaction or infusion-related reaction.
- Each Krystexxa (pegloticase) infusion session will take at least 2 hours. Your provider might monitor you for little while after the infusion to make sure you don't have an allergic reaction. Most allergic reactions happen within 2 hours of the infusion, but some can appear later. Call 911 if you experience symptoms like trouble breathing, hives, and your throat
- Don't take other uric acid-lowering medications, like allopurinol (Zyloprim) or febuxostat (Uloric), while getting Krystexxa (pegloticase) infusions. These medications might cause the lab results for your uric acid level to not be accurate.
- Make sure to tell your provider or pharmacist about all the medications or infusions you're receiving to make sure that they're safe to take with Krystexxa (pegloticase) and won't affect how well the infusion works.
- There's co-pay assistance available for Krystexxa (pegloticase) that might allow you to pay as little as $0 per dose. Connect with a Patient Access Liaison (PAL) to see what cost-saving options are available for you.
Common questions about Krystexxa (pegloticase)
No, Krystexxa (pegloticase) is only approved for adults who've tried other oral (by mouth) anti-gout medications, but those didn't work well for them. Oral gout medications, like allopurinol (Zyloprim) and febuxostat (Uloric), should be used as first-choice treatment options for gout because they have less serious side effects than Krystexxa (pegloticase). Speak with your provider about the best treatment option for you.
To prevent gout flares, your provider will prescribe you medications like colchicine (Colcrys) or a non-steroidal anti-inflammatory drug (NSAID). You should start this about a week before you begin Krystexxa (pegloticase) and to continue for at least half a year after your last dose.
You don't need to stop getting Krystexxa (pegloticase) infusions if you have a gout flare in the time between your infusions.
No, Krystexxa (pegloticase) must be given by a trained healthcare professional. Krystexxa (pegloticase) can put you at high risk for serious allergic reactions after starting the infusion, so you'll need to be monitored by a provider who can recognize and give you medical care if you have a reaction. This medication is typically given in a clinic or a hospital. But if you want to have treatment at home, you can ask your provider about the possibility of setting up home infusions by a trained professional.
Krystexxa (pegloticase) is PEGylated, which means that it's a medication with special molecules attached to it. The special attachments can affect things like how long the medication lasts in your body or how easily absorbed the medication is by your body.
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Risks and warnings for Krystexxa (pegloticase)
Krystexxa (pegloticase) 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.
Severe allergic and infusion-related reactions
- Risk factors: Antibodies to Krystexxa (pegloticase) | High uric acid levels | Stopping treatment for longer than 4 weeks
Krystexxa (pegloticase) can cause serious, and sometimes life-threatening, allergic reactions and infusion-related reactions. These reactions typically happen within 2 hours after the start of the infusion. The risk might be higher in people who have high uric acid levels. Sometimes, your body makes antibodies against Krystexxa (pegloticase), which can also raise your risk for these serious reactions. That's why your provider might order labs from time to time to check if you have antibodies. Before your infusion, your provider will give you medications to help prevent these reactions. If you experience symptoms of an allergic reaction, including hives, dizziness, fever, rash, shaking, itching, nausea, flushing, low blood pressure, shortness of breath, chest pain, get medical attention right away.
If you've missed or stopped treatment for longer than a month, let your provider know. You might be at higher risk for a serious allergic reaction if you restart Krystexxa (pegloticase) infusions after you've missed that many weeks. For this reason, keep your infusion appointments marked on a calendar so that you don't miss them. If you do happen to miss more than a month of appointemnts, your provider will monitor you closely for any allergic or infusion-related reactions once you resume your treatments.
Blood problem (methemoglobinemia)
- Risk factors: G6PD deficiency | History of methemoglobinemia | Other methemoglobin-inducing agents
Krystexxa (pegloticase) might cause a rare condition called methemoglobinemia, a serious blood problem where your red blood cells cannot bring enough oxygen to your body. This condition is more likely if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency. Your provider will screen you for this condition before you get treatment with Krystexxa (pegloticase). Earliest signs of this blood problem include headache, tiredness, and your skin turning blue. Get medical help right away to avoid more serious and life-threatening side effects like seizures, loss of consciousness, and heart rhythm problems (fast heart beat, dizziness, shortness of breath).
Gout flares
- Risk factors: First 3 months after starting Krystexxa (pegloticase)
When you first start a uric-acid lowering medication, such as Krystexxa (pegloticase), your risk for gout flares typically goes up in the first few months. This is because the medication causes the uric acid that was previously stored in your tissues to move into your bloodstream in the process of getting rid of uric acid. To help lessen this risk, your provider will ask you to take a pill to prevent gout flares at least 1 week before starting Krystexxa (pegloticase) and for at least 6 months afterwards. If you do happen to have a gout flare in between your Krystexxa (pegloticase) infusions, talk with your provider about treatment options like non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine (Colcrys).
Heart failure
- Risk factors: History of congestive heart failure
Krystexxa (pegloticase) might cause people with congestive heart failure (CHF) to experience worsening heart failure symptoms. Make sure to tell your provider about your full medical history before receiving Krystexxa (pegloticase) because you might need to be monitored closely if you have CHF. If you have CHF, let your provider know right away if you experience difficulty catching your breath, swelling in your legs and feet, sudden weight gain, tiredness, and dizziness.
Krystexxa (pegloticase) dosage
Typical dosage for Krystexxa (pegloticase)
Krystexxa (pegloticase) is only available as an IV infusion that's given by a healthcare provider. The typical dose is 8 mg infused into the veins (IV) every 2 weeks.
Interactions between Krystexxa (pegloticase) 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Allopurinol
- Oxypurinol
- Probenecid
- Sulfinpyrazone
Krystexxa (pegloticase) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Krystexxa (pegloticase) will not be safe for you to take.
- People with G6PD deficiency
What are alternatives to Krystexxa (pegloticase)?
