Pronunciation:

kal-AS-par-jase PEG-ol - mknl

Brand Names:

• Asparlas

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Calaspargase Pegol

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving 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 bloated stomach, pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, weight gain, or yellow eyes or skin. These could be symptoms of a serious liver problem (eg, hepatic veno-occlusive disease).

Side Effects of This Medicine:

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, discomfort, or tightness

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

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.