Description and Brand Names

US Brand Name

  1. Asparlas

Descriptions


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

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of calaspargase pegol-mknl injection in children 1 month to 16 years of age. Safety and efficacy have been established.

Geriatric

No information is available on the relationship of age to the effects of calaspargase pegol-mknl injection in geriatric patients.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems (eg, coagulopathy), severe or symptomatic or
  • Blood clotting problems or
  • Liver disease or
  • Pancreatitis—Use with caution. May make these conditions worse.
  • Blood clots, bleeding problems, or pancreatitis (swelling of the pancreas), serious, history of during previous treatment with this medicine or similar medicines or
  • Liver disease, severe—Should not be used in patients with these conditions.

Proper Use

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.

Precautions

It is very important that your doctor check your or your child's progress closely while receiving this medicine to make sure this medicine 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 (eg, 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 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.

Side Effects

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

  1. Bloating
  2. chills
  3. constipation
  4. dark urine
  5. difficulty breathing
  6. fast heartbeat
  7. fever
  8. indigestion
  9. loss of appetite
  10. nausea
  11. pain in the chest, groin, or legs, especially the calves
  12. pains in the stomach, side, or abdomen, possibly radiating to the back
  13. severe, sudden headache
  14. slurred speech
  15. sudden loss of coordination
  16. sudden, severe weakness or numbness in the arm or leg
  17. vision changes
  18. vomiting
  19. yellow eyes or skin

Less common

  1. Bleeding gums
  2. chest pain or discomfort
  3. confusion
  4. cough
  5. coughing up blood
  6. difficulty in swallowing
  7. dilated neck veins
  8. dizziness
  9. extreme tiredness or weakness
  10. fainting
  11. slow or irregular heartbeat
  12. headache
  13. increased menstrual flow or vaginal bleeding
  14. itching in the genital or other skin areas
  15. lightheadedness
  16. nosebleeds
  17. paralysis
  18. prolonged bleeding from cuts
  19. rapid, shallow breathing
  20. red or black, tarry stools
  21. red or dark brown urine
  22. scaling of the skin
  23. sneezing
  24. sore throat
  25. swelling of the face, fingers, feet, or lower legs
  26. tightness in the chest
  27. 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

  1. 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.