Calaspargase pegol-mknl (Intravenous)

Calaspargase pegol-mknl injection is used with other cancer medicines to treat patients with acute lymphoblastic leukemia (ALL), which is a type of white blood cell cancer.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor check your or your child's progress closely while receiving this medicine to make sure it is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (for example, condoms, spermicide) along with your pills during treatment and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Check with your doctor right away if you have loss of appetite, nausea, or pains in your stomach, side, or abdomen, possibly radiating to the back. These could be symptoms of pancreatitis (swelling of the pancreas).

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you or your child have swelling and pain in your arms, legs, or stomach, chest pain, trouble breathing, loss of sensation, confusion, or problems with muscle control or speech.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Research has not shown any specific problems that would limit the usefulness of calaspargase pegol-mknl injection in children aged 1 month to 16 years. Its safety and effectiveness have been established.

Geriatric

There is no information available about how age affects the effects of calaspargase pegol-mknl injection in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In such cases, your doctor might adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Bleeding problems (e.g., coagulopathy), severe or symptomatic, or
• Blood clotting problems, or
• Liver disease, or
• Pancreatitis—Use with caution. It may worsen these conditions.

• Blood clots, bleeding problems, or pancreatitis (swelling of the pancreas), serious, or a history of during previous treatment with this medicine or similar medicines, or
• Severe liver disease—Should not be used in patients with these conditions.

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

• Bloating
• chills
• constipation
• dark urine
• difficulty breathing
• fast heartbeat
• fever
• indigestion
• loss of appetite
• nausea
• pain in the chest, groin, or legs, especially the calves
• pains in the stomach, side, or abdomen, possibly radiating to the back
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• vision changes
• vomiting
• yellow eyes or skin

Less common

• Bleeding gums
• chest pain or discomfort
• confusion
• cough
• coughing up blood
• difficulty in swallowing
• dilated neck veins
• dizziness
• extreme tiredness or weakness
• fainting
• slow or irregular heartbeat
• headache
• increased menstrual flow or vaginal bleeding
• itching in the genital or other skin areas
• lightheadedness
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• rapid, shallow breathing
• red or black, tarry stools
• red or dark brown urine
• scaling of the skin
• sneezing
• sore throat
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• weight gain

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

• Diarrhea

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.

In the U.S.

• Asparlas

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Calaspargase Pegol

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to stay in place for at least 1 hour.

• How does Asparlas (calaspargase pegol-mknl) compare to Oncaspar (pegaspargase)?