calaspargase pegol

Action and Spectrum

Actions and Spectrum:

Actions:

The action of calaspargase pegol interferes with the production of asparagine, an amino acid required for cell growth and replication. In cells, asparagine is synthesized from aspartic acid, and the enzyme asparagine synthase catalyzes this reaction. calaspargase pegol acts as an alternative form of asparagine synthase, effectively blocking the production of asparagine. Hence, limits the growth and replication of cancer cells.

Spectrum:

The spectrum of calaspargase pegol activity includes treating ALL in pediatric and adult patients. It is combined with other chemotherapy agents as part of a multi-drug regimen to achieve maximum efficacy against cancer cells.

Drug Interaction

Adverse Reaction

Frequency Defined

10%:

Elevated transaminase (52%)

Increased bilirubin (20%)

Hypersensitivity (7-21%)

Abnormal clotting studies (14%)

Pancreatitis (18%)

1-10%:

Sepsis (5%)

Dyspnea (4%)

Cardiac failure (2%)

Diarrhea (9%)

Hemorrhages (4%)

Fungal infection (3%)

Pneumonia (3%)

Arrhythmia (2%)

Black Box Warning

Contraindication / Caution

Contraindication/Caution:

Contraindications:

Allergy: Patients with a known allergy to calaspargase pegol or any of its components should not use this medication.

Infection: Patients with an active infection should not receive calaspargase pegol until the infection has been treated and resolved.

Immune system suppression: calaspargase pegol can suppress the immune system, increasing the risk of infections. Patients with a history of immunodeficiency should be monitored closely.

Low blood cell counts: calaspargase pegol reduces the number of blood cells, including WBCs, RBCs, and platelets. Patients should have their blood counts regularly monitored during treatment.

Other medications: Patients taking other medications, including prescription and over-the-counter drugs, should inform their healthcare provider. Some medications may interact with calaspargase pegol and affect its efficacy or increase the risk of side effects.

Cautions:

Pregnancy and breast-feeding: It is unknown whether calaspargase pegol is safe for pregnant or breastfeeding women. Women should consult their healthcare provider before starting treatment, if they are pregnant or planning pregnancy.

Pregnancy / Lactation

Pregnancy consideration:

No data is available regarding the use in pregnant women.

Breastfeeding warnings:

No data is available regarding the secretion of the drug in breast milk.

Pregnancy category:

Category A: well-controlled and satisfactory studies do not show risk to the fetus in the first/later trimester.

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.

Category N: No data is available for the drug under this category.

Pharmacology

Pharmacology:

calaspargase pegol breaks down the amino acid asparagine, an essential nutrient for cancer cells, into aspartic acid and ammonia. By reducing the levels of asparagine in the body, calaspargase pegol can help reduce leukemia cells’ growth and survival.

Pharmacodynamics:

Opioid agonism: buprenorphine is a partial agonist at the mu-opioid receptors, which activates these receptors to produce a certain level of pain relief. Still, it does not activate them to the same extent as a full opioid agonist. It reduces the risk of overdose, respiratory depression, and addiction compared to full opioid agonists.

Ceiling effect: buprenorphine has a ceiling effect, which means that as the dose of the drug increases, its effects will plateau, and further increases in the dose will not produce a proportionate increase in effects. It reduces the risk of overdose and toxicity associated with buprenorphine use.

Pharmacokinetics:

Absorption

Peak plasma is achieved in 1.17 hours

The peak plasma concentration is 1.62 units/ml

The area under the curve for the initial 25 days is 16.9 day·unit/mL

Area under the curve for infinite time is 25.5 day·unit/mL

Distribution

The steady-state volume of distribution is 2.96L

Metabolism

calaspargase pegol is metabolized in the liver

Elimination

The half-life of the drug is 16.1 days

The rate of clearance is 0.147 L/day

Adminstartion

Administration:

Preparation: calaspargase pegol is usually prepared by a pharmacist and then administered by a healthcare provider. Store the medication at 2°C to 8°C. It should not be used if the solution is discolored or contains particles.

Infusion site: calaspargase pegol is typically infused into a giant arm or chest vein. Clean the infusion site with an antiseptic solution before the infusion.

Infusion technique: calaspargase pegol is infused using a sterile, disposable infusion set. The infusion set should be connected to the patient’s vein using a needle or catheter. The medication should be infused for a period of 30 minutes to 1 hour.

Patient Information Leaflet

Patient information leaflet

Generic Name: calaspargase pegol

Pronounced: kal-AS-par-jase PEG-ol

Why do we use calaspargase pegol?

calaspargase pegol (trade name Asparlas) is a prescription medication used to treat acute lymphoblastic leukemia (ALL), a type of cancer affecting the blood and bone marrow.