Calaspargase Pegol

Calaspargase Pegol is a prescription medication indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients aged 1 month to 21 years.

• Calaspargase Pegol is available under the following different brand names: Asparlas, calaspargase Pegol-mknl

Common side effects of Calaspargase Pegol include:

• elevated transaminase
• increased bilirubin
• pancreatitis
• abnormal clotting studies
• diarrhea
• hypersensitivity
• shortness of breath
• bleeding
• pneumonia
• abnormal heart rate

Serious side effects of Calaspargase Pegol include:

• hives
• itching
• redness
• feeling light-headed
• wheezing
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• easy bruising, unusual bleeding
• high blood sugar (increased thirst, increased urination, dry mouth, fruity breath odor)
• pancreatitis (severe pain in your upper stomach spreading to your back, nausea, and vomiting
• liver problems, including symptoms such as loss of appetite, stomach pain (upper right side), dark urine, and jaundice (yellowing of the skin or eyes)
• signs of a blood clot - headache, sudden numbness or weakness, blurred vision, chest pain, swelling or redness in an arm or leg

Rare side effects of Calaspargase Pegol include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

Injectable solution

• 3750 units/5 mL (750 units/mL) in single-dose vials

Acute lymphoblastic leukemia

Pediatric dosage

• Recommended premedication
  • Premedicate patients with acetaminophen, an H-1 receptor blocker (such as diphenhydramine), and an H-2 receptor blocker (such as famotidine) 30-60 minutes before administration to decrease the risk for and severity of both infusion and hypersensitivity reactions
• Children younger than 1 month: Safety and efficacy not established
• Children aged 1 month and older: 2500 units/m2 IV no more frequently than every 21 days

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Calaspargase Pegol has no noted severe interactions with any other drugs.
• Calaspargase Pegol has serious interactions with the following drugs:
  • dienogest/estradiol valerate
  • drospirenone
  • ethinylestradiol
  • levonorgestrel oral
  • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate
• Calaspargase Pegol has moderate interactions with no other drugs.
• Calaspargase Pegol has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase
• History of serious thrombosis, pancreatitis, or hemorrhagic events during previous L-asparaginase therapy
• Severe hepatic impairment

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Calaspargase Pegol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Calaspargase Pegol?”

Cautions

• Pancreatitis reported; inform patients of signs and symptoms, which, if untreated, could be fatal; assess serum amylase and/or lipase levels; discontinue if pancreatitis is suspected and permanently discontinue if confirmed
• Serious thrombotic events, including sagittal sinus thrombosis, reported; discontinue if a thrombotic event occurs
• Hemorrhage associated with increased PT, PTT, and hypofibrinogenemia reported; consider appropriate replacement therapy with severe or symptomatic coagulopathy
• Hypersensitivity
  • Premedicate patients 30-60 min before administration of therapy
  • Grade 3-4 hypersensitivity, including anaphylaxis, reported
  • Symptoms may include angioedema, lip swelling, eye swelling, erythema, decreased blood pressure, bronchospasm, dyspnea, pruritus, or rash
  • Because of this risk, administer in a clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis (eg, epinephrine, oxygen, intravenous steroids, antihistamines) and observe patients for 1 hour after administration
  • Discontinue calaspargase Pegol in case of serious hypersensitivity
• Hepatoxicity
  • Hepatotoxicity and abnormal liver function, including elevated transaminases, bilirubin, reduced serum albumin, and plasma, can occur
  • Evaluate bilirubin and transaminases at least weekly during treatment cycles and through at least 6 weeks after the last dose
  • Discontinue if serious liver toxicity occurs; provide supportive care

Pregnancy and Lactation

• There are no available data on the use of calaspargase Pegol in pregnant women to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Based on studies in pregnant animals, calaspargase Pegol can cause fetal harm when administered to pregnant women
• Conduct pregnancy testing in women of reproductive potential before initiating treatment
• Contraception
  • Advise women of reproductive potential to avoid becoming pregnant while receiving calaspargase Pegol
  • Effective contraceptive methods, including a barrier method, should be used during treatment and for at least 3 months after the last dose
  • Because there is potential for an indirect interaction between calaspargase Pegol and oral contraceptives, concomitant use is not recommended
  • Advise women of reproductive potential to use effective nonhormonal contraceptive methods during treatment
• Lactation
  • There are no data on the presence of calaspargase Pegol in human milk, its effects on the breastfed child, or on milk production
  • Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child, advise lactating women not to breastfeed while receiving calaspargase Pegol and for 3 months after the last dose