Drug Interaction:
Antineuoplastic agents include- Interferon ALFA 2a, Interferon ALFA -2b, Interferon ALFA -n3, Levamisole, Altretamine, Cladribine, Hydroxyurea, Aldesleukin, Paclitaxel, Docetaxel,Tretinion, Procarbazine,Dacarbazine, Gemcitabine, Mitotane, Asparaginase, Pegaspargase,Porfimer Sodium
Depletion of serum proteins by pegaspargase may increase the toxicity of other drugs which are protein bound. Pegasaprgase may interfere with the action of methotrexate.
Indication:
Oncaspar® (pegaspargase) injection, for intramuscular or intravenous use
Initial U.S. Approval: 1994
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 04/2014
Approved by FDA on February 1, 1994
Pegasperagase 3750 IU/5ml
Indication-
Indicated as a component of multi agent chemotherapeutic regimen for the treatment of
patients with acute lymphoblastic leukemia who are hypersensitive to asparaginase
Approved by FDA on 07-03--2014 (Ref- FDA approved List- 2014)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Pegasperagase 3750 IU/5ml 07-03-2014
Indicated as a component of Multi-agent Chemotherapeutic Regimen for
the treatment of Patients with acute Lymphoblastic Lrukemia who are
hypertensive to Aspariginase
Acute lymphoblastic leukemia
Antineuoplastic agents include- Interferon ALFA 2a, Interferon ALFA -2b, Interferon ALFA -n3, Levamisole, Altretamine, Cladribine, Hydroxyurea, Aldesleukin, Paclitaxel, Docetaxel,Tretinion, Procarbazine,Dacarbazine, Gemcitabine, Mitotane, Asparaginase, Pegaspargase,Porfimer Sodium
Adverse Reaction:
Anaphylactic reactions, Dyspnea, injection site hypersenstivity, Lip edema, Rash, urticaria, Abdominal pain, Chills, pain in etremetites, Hypotension, Tachycardia, Thrombosis, Anorexia, Diarrhea, Jaundice, abnormal liver function test, Decreased anticoagulant effect.
Contra-Indications:
Pancreatitis or a history of pancreatitis, patients who have had significant hemorrhagic events associated with prior L-asparaginae therapy.
Special precautions: Carefully monitor and adjust the therapeutic regimen according to response and toxicity. Drug may be a contact irritant and the solution must be handled with care.
Dosages/ Overdosage Etc:
Approved by FDA on February 1, 1994
Indications: Acute lymphoblastic leukemia
Dosage: Recommended dose is 2500iu/m2 every 14 days either by IM or Iv route of application
Patient Information:
PATIENT COUNSELING INFORMATION
1. Serious Allergic Reactions
Inform patients of the possibility of serious allergic reactions, including anaphylaxis,
and to seek immediate medical care for any swellings or difficulty breathing.
2. Thrombosis
Inform patients to seek immediate medical attention for severe headache,
arm or leg swelling, acute shortness of breath, or chest pain.
3. Pancreatitis
Advise patients to seek immediate medical attention for severe abdominal pain.
4. Glucose Intolerance
Advise patients to immediately report excessive thirst or increase in the volume
or frequency of urination.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
The mechanism of action of Oncaspar® is thought to be based on selective killing
of leukemic cells due to depletion of plasma asparagine. Some leukemic cells
are unable to synthesize asparagine due to a lack of asparagine synthetase
and are dependent on an exogenous source of asparagine for survival.
Depletion of asparagine, which results from treatment with the enzyme L-asparaginase,
kills the leukemic cells. Normal cells, however, are less affected by the depletion
due to their ability to synthesize asparagine
:
2. Pharmacokinetics
Pharmacokinetic assessments were based on an enzymatic assay measuring
asparaginase activity. Serum pharmacokinetics were assessed in 34 newly
diagnosed pediatric patients with standard-risk ALL in Study 1 following
intramuscular administration of 2,500 International Units/m2 .
The elimination half-life of Oncaspar® was approximately 5.8 days during the
induction phase. Similar elimination half-lives were observed during
Delayed Intensification 1 and Delayed Intensification 2
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C.
Animal reproduction studies have not been conducted with Oncaspar® .
It is also not known whether Oncaspar® can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity.
Oncaspar® should be given to a pregnant woman only if clearly needed.
2. Nursing Mothers
It is not known whether Oncaspar® is excreted in human milk. Because many drugs
are excreted in human milk and because of the potential for serious adverse
reactions in nursing infants from Oncaspar®, a decision should be made to
discontinue nursing or discontinue the drug, taking into account the importance
of the drug to the mother.
3. Geriatric Use
Clinical studies of Oncaspar® did not include sufficient numbers of subjects
aged 65 years and older to determine whether they respond differently than
younger subjects.
