Asparlas (calaspargase pegol-mknl) is a long-acting prescription injection medicine used for people with a certain type of blood cancer known as acute lymphoblastic leukemia (ALL). It is approved in children and young adults who are one month to 21 years of age.
Asparlas is given as an infusion into a vein (IV) by a health care provider in a hospital or clinic setting. It is given as part of a treatment regimen with other chemotherapy medicines.
How Does Asparlas Work?
Asparlas works by lowering levels of an amino acid called L-asparagine that cancer cells in ALL need to survive. Leukemia cells cannot make enough L-asparagine on their own and must get it from the blood.
Asparlas contains an enzyme called L-asparaginase. L-asparaginase breaks down L-asparagine in the blood. If L-asparagine in the blood is broken down, it cannot be used by leukemia cells to make proteins they need to survive. Healthy cells are less affected by the lack of L-asparagine, because they can make their own L-asparagine.
Asparlas is pegylated. This means that the medicine is attached to a compound called polyethylene glycol, or PEG. This helps the medicine stay in the body longer. For Asparlas, being pegylated allows the L-asparaginase enzyme to be given about once every 21 days.
How Will I Receive Asparlas?
You will receive Asparlas in a health care setting. Most people will receive Asparlas every 21 days. Your dose may be adjusted if you have certain side effects. Follow all instructions from your health care provider on when to return for your next IV infusion.
What Should I Expect When I Receive Asparlas?
You may receive some of the following medicines before your infusion to lower your risk of having an infusion-related reaction.
- Acetaminophen
- An antihistamine, such as diphenhydramine
- An H2 receptor blocker, such as famotidine
While you are getting your infusion, your health care provider will observe you for signs of infusion reactions. Let your health care provider know right away if you have any of the following symptoms during or after receiving your infusion.
- Fever or chills
- Joint or muscle pain
- Redness of your face and neck
- Trouble breathing
- Chest pain
- Hives
- Nausea or vomiting
Your health care provider may slow down the rate of the infusion, pause the infusion, or stop the infusion if you have any infusion reactions.
What Serious Side Effects Do I Need to Know About?
Angioedema
Let your health care provider know right away if you have any symptoms of angioedema after receiving Asparlas. Medicines that contain L-asparaginase have caused this allergic-type reaction in some people. Severe angioedema can cause swelling in the areas of your body below.
- Face
- Throat
- Larynx (your voice box)
- Uvula (the little piece of skin that hangs from the back of your throat)
- Arms
- Hands
- Legs or feet
Swelling can also happen in your genitals or intestines, which may cause stomach pain. If you are having a hard time breathing, you need to get help right away.
Pancreatitis
Some people who were treated with Asparlas got pancreatitis. Let your health care provider know right away if you have any symptoms of pancreatitis, which may include the following.
- Moderate to serious pain in the upper left part of your belly
- Pain that wraps around to your back like a band
- Nausea and vomiting
- Shortness of breath
- A fast heart rate
- Fever
- Low blood pressure
- Bleeding (bruises or nosebleeds)
Your health care provider will likely draw blood to measure your levels of two digestive enzymes — amylase and lipase. People with pancreatitis usually have high levels of these enzymes in their blood. Your health care provider may stop treatment with Asparlas if you get pancreatitis.
Blood Clots
Some people who have used L-asparaginase treatments got thrombosis, or blood clots. Let your health care provider know right away if you have any of the following symptoms.
- Trouble speaking
- Vision problems
- Seizures
- Sudden or severe headache
- Weakness on one side of the body
- Arm or leg swelling
- Shortness of breath
- Chest pain
Your health care provider may stop treatment with Asparlas if you have thrombosis.
Liver Disease
Liver damage, called hepatotoxicity, happened in some people treated with Asparlas. Asparlas may also increase the risk of blocked blood vessels in the liver, which can be life-threatening. Your health care provider may draw blood to measure liver enzymes. Let your health care provider know right away if you have any of the following symptoms.
- Jaundice
- Sudden weight gain
- Swelling in the stomach
- Pain or tenderness in the right upper part of the stomach
Your health care provider may stop treatment with Asparlas if you have severe liver damage.
Bleeding
Let your health care provider know if you have any unusual bleeding or bruising while using Asparlas, or if you have any of the following symptoms.
- Pink, red, or brown urine (pee)
- Vomit with blood that looks like coffee grounds
- Red or black stools (looks like tar)
- Coughing up blood clots
How Was Asparlas Studied for Acute Lymphoblastic Leukemia?
To see if Asparlas worked for ALL, researchers looked at data from 124 people with ALL. All were treated with Asparlas together with other chemotherapy. Asparlas was given on day seven of the first major chemotherapy treatment (induction therapy). Beginning with week seven of treatment, it was given every three weeks for 10 doses.
The median age of people in this study was 11.5 years, meaning that half of people were younger and half were older. About 50% were male and 82% were White, 5% were Asian, 4% were Black or African American, 2% were Native Hawaiian or Pacific Islander, and 7% were of other or unknown race.
To see if Asparlas worked, researchers looked at the level of L-asparaginase activity in the blood. A minimum level of activity is needed in order for the medicine to work. Almost all (99%) of these people still had the minimum required level of L-asparaginase activity in their blood at weeks six, 12, 18, 24, and 30.
Your results may differ from what was seen in clinical studies.
How Do I Know if Asparlas Is Working?
You may not see changes right away. It may take weeks to months before your health care provider can tell if Asparlas is working for you. Your health care provider will consider factors such as blood tests, scans, and symptoms, to know if your ALL is getting better.
Is There Any Cost Assistance Available for Asparlas?
There may be cost assistance to help you afford Asparlas. You may have options even if you do not have health insurance. Your health care provider can help you get started, or you can call ServierONE at 800-813-5905, Monday through Friday, 8 a.m. to 8 p.m. ET or by emailing [email protected]. You can also visit www.servierone.com/patient/financial-support/asparlas."
