This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 16950/0388.
Pelmeg 6 mg solution for injection in pre-filled syringe
Pelmeg 6 mg solution for injection in pre-filled syringe
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Pelmeg is and what it is used for
2. What you need to know before you use Pelmeg
3. How to use Pelmeg
4. Possible side effects
5. How to store Pelmeg
6. Contents of the pack and other information
Pelmeg contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria 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 by your own body.
Pelmeg is used in adult patients to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Your doctor has given you Pelmeg to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Talk to your doctor, pharmacist or nurse before using Pelmeg:
Your doctor will check your blood and urine regularly as Pelmeg can harm the tiny filters inside your kidneys (glomerulonephritis).
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelmeg. Stop using Pelmeg and seek medical attention immediately if you notice any of the symptoms described in section 4.
You should talk to your doctor about your risks of developing cancers of the blood. If you develop or are likely to develop cancers of the blood, you should not use Pelmeg, unless instructed by your doctor.
If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim’s activity.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ask your doctor or pharmacist for advice before taking any medicine. Pelmeg has not been tested in pregnant women. It is important to tell your doctor if you:
If you become pregnant during Pelmeg treatment, please inform your doctor.
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Pelmeg.
Pelmeg has no or negligible effect on the ability to drive or use machines.
This medicine contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg/ml.
This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free’.
Pelmeg is for use in adults aged 18 and over.
Always use Pelmeg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Do not shake Pelmeg vigorously as this may affect its activity.
Your doctor may decide that it would be more convenient for you to inject Pelmeg yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.
For further instructions on how to inject yourself with Pelmeg, please read the section at the end of this leaflet.
If you use more Pelmeg than you should contact your doctor, pharmacist or nurse.
If you have forgotten a dose of Pelmeg, you should contact your doctor to discuss when you should inject the next dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please tell your doctor immediately if you have any of the following or combination of the following side effects:
These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton and on the syringe label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
You may take Pelmeg out of the refrigerator and keep it at room temperature (not above 30 °C) for no longer than 4 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30 °C) it must either be used within 4 days or disposed of.
Do not freeze. Pelmeg may be used if it is accidentally frozen for two periods of less than 72 hours each.
Keep the container in the outer carton in order to protect from light.
Do not use this medicine if you notice it is cloudy or there are particles in it.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Pelmeg is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Each pack contains 1 pre-filled glass syringe with an attached stainless steel needle and needle cap. The syringe is provided with an automatic needle guard.
This leaflet was last revised in October 2021
Before you use a Pelmeg pre-filled syringe with automatic needle guard, read this important information:
Call your doctor or healthcare provider if you have any questions.
Step 1: Prepare
A. Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting. Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.
B. Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.
For safety reasons:
C. Inspect the medicine and pre-filled syringe.
Do not use the pre-filled syringe if:
In all cases, call your doctor or healthcare provider.
Step 2: Get ready
A. Wash your hands thoroughly. Prepare and clean your injection site.
You can use:
Clean the injection site with an alcohol wipe. Let your skin dry.
Do not touch the injection site before injecting.
Do not inject into areas where the skin is tender, bruised, red, or hard.
Avoid injecting into areas with scars or stretch marks.
B. Carefully pull the needle cap straight out and away from your body.
C. Pinch your injection site to create a firm surface.
Step 3: Inject
A. Hold the pinch. INSERT the needle into skin.
B. PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap.
It is important to push down through the “snap” to deliver your full dose.
C. RELEASE your thumb. Then LIFT the syringe off skin.
After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.
Step 4: Finish
A. Discard the used pre-filled syringe and other supplies in a sharps disposal container.
Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Keep the syringe and sharps disposal container out of sight and reach of children.
B. Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.