Oncaspar - Pegaspar gas uses, dose and side effects

Oncaspar contains pegaspar gas, which is an enzyme (asparaginase) that breaks down asparagine, an important building block of protein that is necessary for cell survival. Normal cells can produce their asparagine while some cancer cells cannot. Oncaspar lowers asparagine levels in blood cancer cells and prevents the cancer cells from growing.

Oncaspar is used to treat acute lymphocytic leukemia (ALL) in children from birth to 18 years and in adults. ALL is a type of cancer in the white blood cells, in which certain immature white blood cells (called lymphoblasts ) begin to grow out of control and thus prevent the production of functioning blood cells. Oncaspar is used with other medicines.

What you need to know before you are given Oncaspar

Do not use Oncaspar

if you are allergic to pegaspar gas or any of the other ingredients of this medicine (listed in section 6).
if you have severe liver disease.
if you have ever had pancreatitis .
if you have ever had heavy bleeding after treatment with asparaginase.
if you have ever had blood clots after treatment with asparaginase.

Tell your doctor if any of these apply to you. If you are the parent of a child being treated with Oncaspar, tell your doctor if any of these apply to your child.

Warnings and cautions

Talk to your doctor before giving Oncaspar. This medicine may not be suitable for you:

If you have had severe allergic reactions to other forms of asparaginase, e.g. itching , redness or swelling of the airways, as severe allergic reactions to Oncaspar may occur.
If you suffer from any bleeding disorder or have had severe blood clots.
If you get a fever. This medicine may make you more susceptible to infection .
If you have had poor liver function or are taking other medicines that can damage your liver. When Oncaspar is used in combination with other cancer treatments, damage to the liver and central nervous system can occur .
If you suffer from abdominal pain. Inflammation of the pancreas, which in some cases has caused death, can occur during treatment with Oncaspar.

This medicine may affect the coagulation factors and increase the risk of bleeding and/or blood clots.

If you are the parent of a child being treated with Oncaspar, tell your doctor if any of the above conditions apply to your child.

During treatment with Oncaspar

During the administration of Oncaspar, you will be closely monitored for one hour after starting treatment for any signs of severe allergic reactions. Medical equipment to treat allergic reactions will be available nearby.

Other monitoring tests

Tests on blood sugar and urine levels, liver and pancreatic function, and other tests will be performed regularly to monitor your health during and after treatment as this medicine may affect your blood and other organs.

Other medicines and Oncaspar

Tell your doctor if you are taking, have recently taken, or might take any other medicines. This is important because Oncaspar can increase the side effects of other medicines through its effect on the liver. The liver plays an important role in getting drugs out of the body. It is also especially important to tell your doctor if you are also taking any of the following medicines:

vaccination with live vaccines within three months of completing your leukemia treatment. This increases the risk of serious infection .
vincristine, another cancer drug. If used at the same time as Oncaspar, there is an increased risk of side effects or allergic reactions.
drugs that impair the blood’s ability to coagulate, such as anticoagulants (eg coumarin / warfarin and heparin ), dipyridamole, acetylsalicylic acid and non-steroidal anti-inflammatory drugs (eg ibuprofen or naproxen ). If used at the same time as Oncaspar, there is a greater risk of bleeding problems.
drugs that require cell division to be effective, e.g. methotrexate (a medicine used to treat cancer and arthritis ) which may have a reduced effect.
prednisone, a steroid drug. If used at the same time as Oncaspar, the effects on the blood’s coagulation capacity will increase .
cytarabine, a drug that can be used in cancer treatment and that can interfere with the effects of Oncaspar.

Oncaspar can also cause changes in liver function, which may affect the way other medicines work.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

You should not use Oncaspar if you are pregnant, as its effects during pregnancy have not been studied. Your doctor will decide if your illness requires treatment. Women who may become pregnant must use reliable contraception during treatment and for at least 6 months after stopping treatment with Oncaspar. Oral contraceptives are not an effective contraceptive during treatment with Oncaspar. Consult your doctor about which contraceptive is best for you to use. Men must also use effective contraception while they or their partners are being treated with Oncaspar.

It is unknown whether pegaspar gas is excreted in human milk. As a precautionary measure, breast-feeding should be discontinued during treatment with Oncaspar and not resumed until after stopping treatment with Oncaspar.

Driving and using machines

Avoid driving or using machines while taking this medicine, as it may make you drowsy, tired, or confused.

Oncaspar contains sodium

This medicine contains less than 1 mmol sodium per dose, ie essentially ‘sodium-free’.

How to get Oncaspar

Treatment with Oncaspar has been prescribed by a doctor who has experience in medicines used to treat cancer. Your doctor will decide which dose of the medicine is needed and how often, based on your age and body surface area calculated by your height and weight.

This drug is given as a solution by injection into a muscle, or into a vein if this is more appropriate.

If you take more Oncaspar than you should

Because doctors will administer the drug, it is very unlikely that you will get more than you need.

In the unlikely event of an accidental overdose, you will be closely monitored by medical personnel and given appropriate treatment.

If you have any further questions on the use of this product, ask your doctor.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

Tell your doctor immediately if you get any of the following side effects:

Very common (may affect more than 1 in 10 people)

Inflammation or other disorders of the pancreas ( pancreatitis ) that cause severe abdominal pain that can spread to the back, vomiting, increased blood sugar levels
Severe allergic reactions with symptoms such as skin rash, itching , swelling, hives , shortness of breath, rapid heartbeat and drop in blood pressure
Blood clots
Fever with low white blood cell count .

Common (may affect up to 1 in 10 people)

Heavy bleeding or bruising
Severe tremors (seizures) and unconsciousness
Severe infection with very high fever
Liver problems (eg discoloration of the skin or urine or faeces and laboratory results indicating elevated levels of liver enzymes or bilirubin ).

Rare (may affect up to 1 in 1,000 patients)

Liver failure
Jaundice
Blocked bile flow from the liver (cholestasis)
Degradation of liver cells (liver cell necrosis)

No known frequency (can not be calculated from the available data)

Severe skin reaction called toxic epidermal necrolysis
Loss of kidney function (eg change in urine production, swollen feet and ankles)
Stroke
Severe allergic reaction that may cause unconsciousness and be life-threatening (anaphylactic shock ).

Other side effects ar

Tell your doctor if you get any of the following:

Very common (may affect more than 1 user in 10)

Altered function of the pancreas
Weight loss
Pain in the legs (may be a symptom of thrombosis ), chest pain or shortness of breath (may be a symptom of a blood clot in the lungs, called pulmonary embolism )
Decreased appetite, general weakness, vomiting, diarrhea, nausea
Elevated blood sugar levels

Common (may affect up to 1 in 10 people)

Reduced number of red blood cells
Accumulation of fluid in the abdominal cavity ( ascites )
Fever and flu-like symptoms
Cold sores
Pain in the back, joints or abdomen
High levels of fat and cholesterol in the blood, low levels of potassium in the blood.

Rare (may affect up to 1 in 1,000 people)

Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome characterized by headache, confusion, seizures and vision loss that passes after a while.

No known frequency (can not be calculated from the available data)

Decreased number of white blood cells and platelets
Fast heartbeat
Fever
Cysts in the pancreas, swelling of the salivary glands.
High levels of urea in the blood, antibodies to Oncaspar, high levels of ammonia in the blood, decreased blood sugar levels
Drowsiness, confusion, slight twitching of the fingers.

How to store Oncaspar

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. date. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C).

Do not freeze.

After dilution, the solution should be used immediately. If immediate use is not possible, the diluted solution can be stored at 2 ° C-8 ° C for up to 48 hours.

Do not use this medicine if you notice that the solution is cloudy or has visible particles.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is pegaspar gas. One ml of solution contains 750 units of pegaspar gas. One vial of 5 ml solution contains 3,750 units of pegaspar gas.

The other ingredients are sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, and water for injections (see section 2 “Oncaspar contains sodium”).

What the medicine looks like and contents of the pack

Oncaspar is a clear, colorless solution for injection in a glass bottle. Each pack contains 1 vial.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Servier Laborierires Servier

50, rue Carnot

92284 Suresnes cedex

France

Manufacturer

The Laboratories Servier Industrie

905 Route de Saran

45520 Gidy