Registered Kenya · PPB

HAMSYL

PEGASPARGASE 3750 IU/ 5 ML (I.E. 750 IU/ML)

H2025/CTD12586/26468 3750 IU/ 5 ML (I.E. 750 IU/ML) GENERIC/BIOSIMILARS INN generic

What it does

Pegaspargase is a medication used to treat certain types of cancer, particularly in children and young adults.

Commonly used for: acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Hard to find? We help patients in Kenya source rare medicines. We don't sell or dispense medicines - licensed pharmacies do.

Source this medicine

Registration & product details

Registration no.
H2025/CTD12586/26468
Registration date
-
Expiry date
2030 November 07
Status
Registered
Active ingredient
PEGASPARGASE 3750 IU/ 5 ML (I.E. 750 IU/ML)
Strength
-
Pack size
PRIMARY PACK:USP TYPE I GLASS,SEAL F/OFF, PLASTIC TRAY LID AND CARTON
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Lazor Pharmaceuticals
Country of origin
FOREIGN
Manufacturer location
14 Joy Avenue, Ajao Estate, Lagos 102214, Lagos, Nigeria

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:17:42 · updated 2026-10-20 02:12:53

Drug Interactions

4
Check interactions

Pharmacodynamic Warnings

Pegaspargase appears in TABLE 1: Drugs that cause hepatotoxicity

Pegaspargase appears in TABLE 15: Drugs that cause myelosuppression

Unknown (4)

Imatinib - increases risk of hepatotoxicity

Pegaspargaseispredictedtoincreasetheriskof hepatotoxicitywhengivenwithimatinib.rTheoretical → AlsoseeTABLE15p.1520

Unknown Theoretical

Methotrexate - affects efficacy

Pegaspargase affects the efficacy of methotrexate. Also see TABLE 1 p. 1517 → Also see TABLE 15 p. 1520

Unknown Anecdotal

Vincaalkaloids - increases risk of neurotoxicity

Pegaspargasepotentiallyincreasestheriskofneurotoxicity whengivenwithvincaalkaloids(vincristine).Vincristineshould betaken3to24hoursbeforepegaspargase,p.1025.r Anecdotal →AlsoseeTABLE1p.1517 →AlsoseeTA

Unknown Anecdotal

Vincristine - increases risk of neurotoxicity

Pegaspargasepotentiallyincreasestheriskofneurotoxicity whengivenwithvincaalkaloids(vincristine).Vincristineshould betaken3to24hoursbeforepegaspargase,p.1025.r Anecdotal →AlsoseeTABLE1p.1517 →AlsoseeTA

Unknown Anecdotal

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Pegaspargase is a medication used to treat certain types of cancer, particularly in children and young adults.

What it treats

  • acute lymphoblastic leukemia (ALL)
  • lymphoblastic lymphoma

How it works

This medicine works by breaking down certain proteins that cancer cells need to grow, helping to stop the spread of cancer.

Who it's for

It is mainly for children and young adults diagnosed with specific blood cancers.

Cautions

  • • Be careful if you are taking other medicines that can harm the liver.
  • • Avoid medications that may lower blood cell counts.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Pegaspargase

BNF-referenced

Pegaspargase is a recombinant form of L-asparaginase, an enzyme that hydrolyzes L-asparagine to L-aspartate and ammonia. It is primarily used in the treatment of acute lymphoblastic leukaemia, particularly in combination with other antineoplastic agents. Due to its mechanism of action, it is effective in malignancies that lack the ability to synthesize L-asparagine, leading to inhibited tumor growth.

Indications

  • Acute lymphoblastic leukaemia (in combination with other antineoplastic drugs)

Dosage

Children: Refer to the BNF for Children for specific pediatric dosing guidelines.

Adults: For adults aged 22 years and over, the recommended dose is 2000 units/m2 every 14 days. For those aged 18-21 years, the dose is 2500 units/m2 every 14 days.

Mechanism of action

Pegaspargase acts by breaking down L-asparagine, an amino acid that certain malignant cells cannot synthesize. The depletion of L-asparagine leads to cell cycle arrest and apoptosis in these cells, effectively inhibiting their growth and proliferation.

Pharmacodynamics

The pharmacodynamic effects of pegaspargase involve the reduction of asparagine levels in the bloodstream, which is critical for the survival of certain leukemic cells. This results in increased cytotoxicity to these cells, leading to a therapeutic effect in treating acute lymphoblastic leukaemia.

Pharmacokinetics

Pegaspargase is administered either intramuscularly or intravenously. It has a prolonged half-life compared to native L-asparaginase due to its pegylation, which reduces immunogenicity and increases stability in circulation. The enzyme is metabolized by the liver and excreted primarily via the kidneys. Monitoring of serum asparaginase activity, plasma glucose levels, and coagulation profiles is recommended during treatment.

Contra-indications

  • History of pancreatitis
  • History of serious hemorrhagic event with previous L-asparaginase therapy
  • History of serious thrombosis with previous L-asparaginase therapy

Adverse effects

  • Hypoglycaemia
  • Pancreatitis
  • Cholestasis
  • Icterus
  • Hepatic cell necrosis
  • Hepatic failure
  • Serious hypersensitivity reactions including anaphylaxis
  • Hyperammonaemia
  • Drowsiness
  • Confusion
  • Diabetic ketoacidosis

Interactions

  • Increased risk of hepatotoxicity with imatinib
  • Affects efficacy when used with methotrexate
  • Increased risk of neurotoxicity with vinca alkaloids
  • Increased risk of neurotoxicity with vincristine

Precautions

  • Concomitant use of other hepatotoxic drugs, particularly in pre-existing hepatic impairment
  • Monitor plasma and urine glucose levels during treatment
  • Monitor coagulation profile at baseline and periodically during and after treatment
  • Patients should be monitored for signs of hypersensitivity
  • Patients should be counselled about the effects on driving and performance of skilled tasks

Pregnancy

Manufacturer advises to avoid unless essential, due to potential risks.

Breast-feeding

Manufacturer advises to avoid, as no information is available.

Storage

Store in a refrigerator between 2–8°C.

Formulations

  • Pegaspargase 10 mg vial for injection
  • Pegaspargase 25 mg vial for injection
BNF 85 (British National Formulary) p.1045 BNF for Children 2019-2020 p.595 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.