Universal reference book for medicines
Product name: ONCASPAR (ONCASPAR)

Active substance: pegaspargase

Type: Antitumor preparation

Manufacturer: medac (Germany) manufactured by ENSON (USA)
Composition, form of production and packaging
The solution for intravenous and / or injection is
colorless, transparent or slightly opalescent.

1 ml of 1 fl.

gas petroleum gas 750 IU * 3750 IU *

Excipients: sodium dihydrogen phosphate, sodium hydrophosphate, sodium chloride, water d / and.

* The activity of Oncaspar is expressed in international units (IU) in accordance with the recommendations of the International Biochemical Union.
1 IU L-asparaginase is defined as the amount of enzyme required to produce 1 μmol ammonium / min at pH 7.3 and temperature 37 ° C.
5 ml - bottles (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

Pegasus is the result of covalent binding of native L-asparaginase, synthesized by the E. coli microorganism, with monomethoxypolyethylene glycol.
The mechanism of action of pegasasprasis does not differ from that of native L-asparaginase and consists in the enzymatic destruction of the amino acid L-asparagine, which is in the blood plasma. It is believed that for tumor lymphoblasts, unlike healthy cells, this amino acid is irreplaceable, since they are not able to synthesize L-asparagine, necessary for their normal vital activity. Destruction of the amino acid L-asparagine in the blood plasma by L-asparagine in the blood plasma leads to deficiency of L-asparagine in tumor lymphoblasts, causes a violation of protein synthesis and death of tumor cells.
PHARMACOKINETICS

The peak of the concentration of pegaspargas in blood plasma after intravenous administration correlates with the administered dose.
The volume of distribution is equivalent to the volume of the plasma. The half-life of pegaspargas in blood plasma is 5.73 + 3.24 days and significantly longer than the half-life of native asparaginase - 1.28 + 0.35 days. At the end of the hour intravenous infusion of pegasus, amino acid L-asparagine is not detected in the blood plasma, while the L-asparaginase values ​​available for determination remain in the plasma for at least 15 days after the first administration of pegasas.
INDICATIONS

Onkaspar is used in combination with other antitumor drugs for re-induction therapy of acute lymphoblastic leukemia in children and adults when they develop hypersensitivity to native forms of L-asparaginase.

DOSING MODE

Usually Oncaspar is used in combination with other cytostatics.
In the monotherapy regime, Onkaspar is used only if it is impossible to use other drugs included in the combined treatment regimens for some reason. Onkaspar can be used as part of induction, consolidation and maintenance therapy.
When selecting an individual dose should be guided by the data of the medical literature.

The recommended dose of Oncaspar is 2500 IU / m 2 of body surface every 14 days.
Children with a body surface of more than 0.6 m 2 are administered 2500 IU / m 2 every 14 days. 82.5 IU / kg body weight is administered to children with a body surface of less than 0.6 m 2 . The drug is administered intramuscularly or intravenously.
Intramuscular administration is preferred because of the reduced risk of hepatotoxicity, coagulopathy, gastrointestinal and renal disorders compared with intravenous administration.

If intravenously prescribed, Onkaspar should be administered dropwise for 1-2 hours in 100 ml of a 0.9% solution of sodium chloride or a 5% solution of dextrose.

With intramuscular administration, the on-instantly administered volume of Oncaspar should not exceed 2 ml for children and 3 ml for adults .
If it is necessary to introduce a larger volume of the drug, it should be injected through several injections at different locations. If the solution is cloudy or there is a deposit, Oncaspar can not be used. Do not shake!
SIDE EFFECT

Hypersensitivity reactions: observed in approximately 5% of patients;
may be acute, be delayed; manifested in the form of local erythema, urticaria, itching, swelling, tenderness and inflammation at the injection site, fever, myalgia, difficulty breathing, bronchospasm, tachycardia, skin rashes, lowering blood pressure, down to anaphylactic shock. Conducted intradermal tests do not exclude the risk of anaphylactic reactions.
On the part of the gastrointestinal tract: approximately half of patients have a decrease in appetite, nausea, vomiting, constipation, diarrhea, flatulence, abdominal pain, inflammation of the mucous membranes of the gastrointestinal tract.

From the side of the pancreas: in rare cases, acute pancreatitis, increased levels of amylase and lipase in the blood serum;
very rarely - hemorrhagic pancreatitis or pancreatic necrosis, in some cases with a fatal outcome. There are separate reports on the formation of pseudocysts in the pancreas (up to 4 months after the end of treatment). One case of a combination of pancreatitis with acute mumps has been described. Violation of the endocrine function of the pancreas can manifest itself, mainly in the violation of glucose metabolism. Cases of diabetic ketoacidosis and hyperosmolar hyperglycemia are described, which in most cases are stopped by the appointment of exogenous insulin.
On the part of the liver: most often - increased levels of alkaline phosphatase, ALT, ACT, LDH and bilirubin.
There are separate reports on the development of cholestasis, jaundice, fatty liver degeneration and hepatocellular necrosis. A dose-dependent decrease in albumin occurs in most patients during the treatment with pegaspargase. Hypoalbuminemia can be the cause of peripheral edema.
From the hemopoietic system: moderate myelosuppression (leukopenia, thrombocytopenia, anemia).
These changes, as a rule, do not affect the conduct of therapy.Individual cases of autoimmune anemia are described on the background of treatment with pegasasgas.
From the coagulation system of blood: hypofibrinogenemia, lengthening of prothrombin time, lengthening of partial thromboplastin time and decrease in the level of antithrombin III.
There were also thromboses of the superficial and deep veins, thrombosis of the sagittal sinus, arterial thrombosis and thrombosis of venous catheters, and DIC syndrome. It is also known about clinically expressed hemorrhagic syndrome, sometimes fatal, increased bleeding and ecchymosis.
From the side of the nervous system: headache, dizziness, convulsions, weakness, paresthesia, agitation, depression, hallucinations, confusion, increased drowsiness, capable of progressing to coma.
Rarely - Parkinsonism syndrome (tremor and progressive increase in muscle tone). After the treatment, these side effects passed independently.
From the urinary system: often - a dose-dependent increase in the level of urea in the blood serum.
There may be hyperuricemia. Single cases of acute renal failure are described.
From the skin and skin appendages: skin manifestations of allergic reaction to pegasaspasis (erythema, skin rash, skin itching) are possible.
One case of the development of epidermal necrolysis (Lyell's syndrome) is described.
From the side of the thyroid and parathyroid glands: in some cases, transient and secondary hypothyroidism, a decrease in thyroxine-binding globulin were observed.There are reports of individual cases of hypoparathyroidism.

Other: febrile reactions in the form of fever, chills (occur within 2-5 hours after administration and are usually stopped on their own);
in rare cases, it is possible to raise the temperature to life-threatening values. Reactions at the site of administration (including pain, inflammation or flushing), general malaise, weight loss, secondary infections, sepsis, septic shock.
CONTRAINDICATIONS

- pancreatitis at the time of initiation of treatment or in the anamnesis;

- serious hemorrhagic complications associated with L-asparaginase therapy in history;

- severe allergic reactions in history (generalized urticaria, bronchospasm, laryngeal edema, lower blood pressure) or severe adverse reactions to Onkaspar;

- Pregnancy and the period of breastfeeding.

PREGNANCY AND LACTATION

Contraindicated in pregnancy and during lactation.

APPLICATION FOR CHILDREN

The application is possible according to the dosing regimen.

SPECIAL INSTRUCTIONS

Oncaspar should be administered under the supervision of a specialist who has experience in the use of antitumor drugs.

Hypersensitivity reactions, including life-threatening anaphylaxis, are more common in patients with known hypersensitivity to other forms of L-asparaginase.
The risk of hypersensitivity reactions increases with repeated use, but in rare cases such reactions can occur even with the first administration of Onkaspar.
The routine rule should be to monitor the patient within 1 hour after the end of the drug administration and availability of available resuscitative equipment and drugs for the treatment of anaphylaxis (epinephrine, oxygen, glucocorticosteroid preparations, etc.).
In case of allergic reactions, the drug should be stopped immediately and the necessary medical measures taken. When carrying out polychemotherapy with the use of Onkaspara, severe toxic damage of the liver and nervous system can occur. Onkaspar should be used with caution in combination with hepatotoxic agents, especially in the presence of hepatic dysfunction.
For early detection of pancreatitis, the serum level of amylase should be determined regularly.
If signs of pancreatitis develop, Oncaspar treatment should be discontinued.
In connection with the risk of developing hyperglycemia in the treatment of Onkaspar, glucose in the blood and sugar in the urine need to be monitored.
When the blood glucose level is exceeded, 10-11 mmol / l shows the use of insulin and the introduction of infusion therapy. Risk factors for hyperglycemia: age over 10 years, overweight and Down's syndrome.
When using Oncaspar together with hepatotoxic drugs, monitoring of liver function is required.

Since Oncaspar acts on plasma proteins, it is necessary to monitor fibrinogen, prothrombin time and partial thromboplastin time.
To prevent the development of nephropathy associated with increased formation of uric acid as a result of the decay of a large number of leukocytes, it is recommended that allopurinol is administered, an increase in the intake of the liquid basifying urine. Women and men during Oncaspar treatment should use reliable methods of contraception.
In case of accidental contact with the skin or mucous membranes, thorough washing with water (mucous membranes) or water with soap (skin) for 15 minutes is necessary.

Some side effects of Onkaspar can adversely affect the ability to drive and perform potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions (especially with simultaneous intake of alcohol).

OVERDOSE

The antidote for Onkaspar is unknown.
Anaphylactic reactions require immediate administration of epinephrine, glucocorticosteroids, antihistamines and the use of oxygen.
3 patients received 10,000 IU / m 2 Oncaspar in / in the drip.
One of them showed a slight increase in serum liver transaminases, another developed a rash 10 minutes after the start of the infusion, which occurred after slowing the rate of infusion and prescribing antihistamines. The third patient had no side effects.
DRUG INTERACTION

The inhibition of serum protein by Oncasporum may increase the toxicity of other drugs that bind to the protein.

Also, in the process of suppressing protein synthesis and cell replication, Oncaspar can influence the action of such drugs as methotrexate, whose pharmacotherapeutic effect requires cellular replication.

Onkaspar can increase the toxicity of other drugs, affecting liver function.
It is necessary to pay attention to the joint appointment of Onkaspar with drugs that affect blood clotting and platelet aggregation, such as coumarin, heparin, dipyridamole, aspirin, or non-steroidal anti-inflammatory drugs.
The use of uricosuric antidotal drugs may increase the risk of nephropathy associated with increased uric acid formation.
During Oncaspar treatment, alcohol should be avoided.
TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Keep out of reach of children and in the dark place at a temperature of 2-8 ° C.
Do not freeze!
Shelf life - 2 years.

Do not use after the expiration date printed on the package.

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