Pelgraz – Pegfilgrastim Uses, Dose And Side Effects


Pelgraz 6 mg Pegfilgrastim Solution for injection in the pre-filled injector

What Pelgraz Is And What It Is Used For

Pelgraz contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced using biotechnology in a bacterium called E. coli. It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte colony-stimulating factor) produced in the body.

Pelgraz is used to reduce the duration of neutropenia (low white blood cell count ) and the occurrence of febrile neutropenia (low white blood cell count with concomitant fever), which may be due to the use of cytotoxic chemotherapy (drugs that destroy fast-growing cells). The white blood cells are important because they help your body fight infections. These blood cells are very sensitive to chemotherapy; this treatment can decrease their number in the body. About the number of white blood cells drops to a low level, there may not be enough left in the body to fight bacteria, and you may become more susceptible to infection.

Your doctor has given you Pelgraz to help your bone marrow (the part of the skeleton where blood cells are formed) form more white blood cells that help your body fight infection.

What You Need To Know Before Using Pelgraz

Do Not Use Pelgraz

  • If you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6).

Warnings And Cautions

Talk to your doctor, pharmacist, or nurse before using Pelgraz if you:

  • An allergic reaction can result in weakness
  • A drop in blood pressure
  • Difficulty breathing
  • Swelling of the face ( anaphylaxis )
  • Redness and swelling
  • Rash
  • Skin with itching
  • If allergic to latex. The grey needle sleeve on the pre-filled syringe contains a latex derivative and may cause severe allergic reactions.
  • Have a cough, fever, and difficulty breathing. This may be a sign of acute respiratory distress syndrome.
  • Suffer from one or more of the following side effects:
    • Swelling or fluid retention may occur while urinating less frequently than usual; breathing difficulties; swollen abdomen and a feeling of satiety; general feeling of tiredness. This can be a symptom of a condition called capillary leakage syndrome, which causes blood to leak from the small blood vessels. See section 4.
  • Suffer from pain in the upper abdomen on the left side of the tip of the left shoulder blade. This may be a sign of splenomegaly.
  • Recently had a severe lung infection ( pneumonia )
    • Fluid in the lungs ( pulmonary edema )
    • Inflammation of the lungs (interstitial lung disease) or abnormal results on chest X-ray (lung infiltration).
  • Know that you have changed the number of blood cells (e.g. increased number of white blood cells or anemia) or decreased the number of platelets, which reduces the blood’s ability to clot ( thrombocytopenia ). Your doctor may want to check this more often than usual.
  • Have sickle cell anemia. Your doctor may want to check this more often than usual.
  • If a patient with breast or lung cancer, as Pelgraz in combination with chemotherapy and radiation therapy may increase the risk of a cancerous stage called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, and easy bruising and bleeding.
  • Suffer from sudden signs of allergy, such as rash, itching or hives, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing. These may be signs of a severe allergic reaction.

You will have regular blood, and urine tests as Pelgraz can damage the small filters in your kidneys ( glomerulonephritis ).

Severe skin reactions (Stevens-Johnson syndrome) have been reported using Pelgraz. Stop using Pelgraz and seek medical attention immediately if you experience any symptoms described in section 4.

Talk to your doctor about the risk of developing blood cancer. If you develop or are at high risk of developing blood cancer, do not use Pelgraz unless your doctor tells you to.

If you have symptoms that indicate inflammation of the aorta (the large blood vessel that carries blood from the heart to the body), this has been reported rarely in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, malaise, back pain, and elevated markers of inflammation (e.g. C-reactive protein and white blood cells ). Tell your doctor if you notice these symptoms.

Impaired treatment response to pegfilgrastim

If you stop responding to treatment with pegfilgrastim or if the response to treatment decreases, your doctor will investigate why. Your doctor will, among other things, check if you have developed antibodies that neutralize the activity of pegfilgrastim.

Children And Young People

The safety and efficacy of Pelgraz in children have not yet been established. Talk to your doctor or pharmacist before taking any medicine.

Other Drugs And Pelgraz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy And Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. Pregnant women have not tried Pelgraz. You must tell your doctor if you:

  • Is pregnant
  • Think you are pregnant
  • Plans to have children

If you become pregnant during treatment with Pelgraz, talk to your doctor.

If you do not receive any other instructions from your doctor, you must stop breastfeeding if you use Pelgraz.

Driving And Using Machines

Pelgraz has no or negligible effect on the ability to drive and use machines.

Pelgraz Contains Sorbitol (E420) And Sodium

This medicine contains 30 mg sorbitol in each pre-filled injector, equivalent to 50 mg/ml.

This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, i.e. essentially ‘sodium-free.’ It is next to “sodium-free.”

How To Use Pelgraz

  • Pelgraz is intended for use by adults from 18 years of age.
  • Always use Pelgraz exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The usual dose is a 6 mg subcutaneous injection ( injection under the skin) with a pre-filled injector. Dose one should give at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
  • Avoid vigorous shaking of Pelgraz as this may affect the effect.

How To Inject Yourself With Pelgraz

Your doctor may decide that you should inject Pelgraz yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if your doctor or nurse has not shown you what to do.

Below are instructions on how to inject yourself with Pelgraz. For your illness to be treated, however, close and continuous contact with a doctor is required. If you are unsure how to inject one or have any questions, ask your doctor or nurse for help.

How Do I Take Pelgraz Injections myself?

Injection should be made into the tissue just under the skin, a so-called subcutaneous injection.


To give yourself a subcutaneous injection, you need the following:

  • A pre-filled injector with Pelgraz;
  • An alcohol compress.

What should I do before giving myself a subcutaneous injection of Pelgraz?

  1. Take the pre-filled injector out of the refrigerator.
  2. Check the expiration date on the pre-filled injector label (EXP). Do not use it if the date has passed on the last day of the month indicated if it has been stored outside the refrigerator for more than 72 hours or is otherwise unusable.
  3. Check the appearance of Pelgraz. It must be a clear and colourless liquid. If the liquid contains particles, do not use it.
  4. Injection one feels more comfortable if you let the pre-filled injector lie for 30 minutes to reach room temperature or warm it gently in your hand for a few minutes. Do not heat Pelgraz in any other way (e.g. do not heat the syringe in the microwave or hot water).
  5. Wash your hands thoroughly.
  6. Find a comfortable, clean place with good lighting, and ensure you have everything you need (pre-filled injector and alcohol compress) within reach.

How do I prepare my injection with Pelgraz?

Before injecting Pelgraz, do the following:

  • Choose a clean place with good lighting to administer the drug.
  • Check the expiration date on the packaging. Do not use it if the expiration date has passed.
  • Develop a spirit compress and a container for stabbing and cutting objects.


Wash your hands with soap under running warm water.
Choose an injection site (abdomen or thigh if the patient injects himself, with the addition of the alternative back of the arm with the help of health care professionals or caregivers).
Clean the injection site: use an alcohol swab to clean the area. Allow airing dry.

1. Before injection

Inspect the liquid in the window. Check for colour changes, turbidity, or large particles.
Remove the bottom cover: turn and pull the bottom cover to remove it. Keep your hands away from the needle cover after removing the cover. Do not replace the cover. Discard the bottom lid immediately. Do not inject if you drop the pre-filled injector after removing the cap. Inject within 5 minutes after removing the bottom cover.

2. Injection

Place the injector directly against the skin (approximately 90 degrees).
Push the handle straight down. The medicine is injected when you press. Do this at a speed that is comfortable for you. Do not lift the injector during the injection.
Injection one is completed when you have pressed down the handle as far as possible, you hear a clicking sound, and the orange body is no longer visible.
Lift straight up. The yellow ribbon indicates that the needle cover is locked.

3. Disposal

Discard the used Pelgraz pre-filled injector. Place the injector in an approved container for stabbing and cutting objects. The regulations vary depending on the region. Ask your doctor or pharmacist how to dispose of the injector properly. Do not dispose of the injector in household waste.


Ask your doctor or nurse for help and advice if you have problems.

If You Use More Pelgraz Than You Should 

If you take more Pelgraz, you should contact a doctor, pharmacist, or nurse.

If You Forget To Take Pelgraz

If you inject Pelgraz yourself and have missed your dose, you should contact your doctor to discuss when you should inject the next dose.

If You Stop Taking Pelgraz

Your doctor will tell you when to stop taking Pelgraz. It is perfectly normal to receive several treatments with Pelgraz.

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

Possible Pelgraz Side Effects

This medicine can cause side effects like all medicines, although not everybody gets them.

If you get any of the following side effects, talk to your doctor straight away:

  • Swelling or fluid retention may occur while urinating less frequently than usual; breathing difficulties; swollen abdomen and a feeling of satiety; and a general feeling of tiredness. These symptoms often develop rapidly.

These symptoms may signify a less common condition (which may affect up to 1 in 100 people) called “capillary leakage syndrome,” which causes blood to leak from small blood vessels into the body. This condition must treat immediately.

Very common pelgraz injection side effects ( may affect more than 1 user in 10) :

  • Skeletal pain. Your doctor may recommend what you can take to relieve skeletal pain.
  • Headache and nausea.

Common side effects ( may affect up to 1 in 10 people) :

  • Injection site pain.
  • General joint and muscle pain.
  • Chest pain that is not due to heart disease or heart attack.
  • Some changes in blood values ​​may occur, but these are detected during routine blood tests. Your white blood cells may increase over a limited period. The number of platelets can decrease, which can lead to bruising.

Uncommon pelgraz injection side effects( may affect up to 1 in 100 people) :

  • Allergy-like reactions, including redness and swelling, rash, and raised itchy skin areas.
  • Severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
  • Increased spleen size.
  • Anthrax. Some cases of anthrax were fatal. You must contact your doctor immediately if you experience pain in the upper left side of the abdomen or up against the left shoulder, as this may indicate problems with the spleen.
  • Breathing problems. If you have a cough, fever, and difficulty breathing, consult a doctor.
  • Sweets syndrome (plum-coloured, raised, painful skin changes on the arms and legs and sometimes on the face and neck with fever) has occurred, but other factors may be important.
  • Cutaneous vasculitis ( inflammation of the blood vessels of the skin).
  • Damage to the small filters in the kidneys ( glomerulonephritis ).
  • Redness at the injection site.
  • Abnormal blood samples ( lactate dehydrogenase, uric acid, and alkaline phosphatase).
  • Abnormal blood tests for liver function ( alanine aminotransferase and aspartate aminotransferase ).
  • Bloody cough (hemoptysis).
  • Blood disorders ( myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML].

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

  • Inflammation of the aorta (the large blood vessel that carries blood from the heart to the body), see section 2.
  • Bleeding in the lung.
  • Stevens-Johnson syndrome can start as reddish, target-like, or round spots on the torso, often with blisters in the middle. Skin peeling and sores in the mouth, throat, nose, genitals, and eyes may also occur. These reactions are often preceded by fever and flu-like symptoms. If you develop any of these symptoms, stop using Pelgraz and contact your doctor immediately or seek medical attention. See also section 2

How To Store Pelgraz

  • Keep this medicine out of sight and reach of children.
  • Do not use this medicine after the expiry date stated on the carton and the pre-filled injector label (EXP). The expiration date is the last day of the specified month.
  • Store in a refrigerator (2 ° C ‑ 8 ° C).
  • Pelgraz can be stored at room temperature (maximum 25 ± 2 ° C) for 72 hours. Pelgraz stored at room temperature for more than 72 hours should be discarded. If you have questions about storage, talk to a doctor, nurse, or pharmacist.
  • Do not freeze. Accidental freezing for a maximum of 24 hours does not impair the stability of Pelgraz.
  • The pre-filled injector must be stored in the carton. Sensitive to light.
  • Do not use this medicine if it is cloudy or contains particles.

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

Contents Of The Pack And Other Information

Content Declaration

  • The active substance is pegfilgrastim. Each pre-filled injector contains 6 mg of pegfilgrastim in a 0.6 ml solution.
  • The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20, and water for injections (see section 2).

What The Medicine Looks Like And The Contents Of The Pack

  • Pelgraz is a clear, colourless solution for injection in a pre-filled injector with a needle. A pre-filled injector contains 0.6 ml of solution.
  • Pelgraz is supplied in packs of 1 pre-filled injector in a mono carton with alcohol compress.

Marketing Authorization Holder And Manufacturer

Marketing Authorization Holder

Accord Healthcare SLU

World Trade Center, Moll de Barcelona, ​​s / n,

Edifici Est 6ª planta,

08039 Barcelona,



Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow




Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV,

Winthontlaan 200,

3526 kV Utrecht,


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