Imreplys – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Imreplys, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask a doctor, pharmacist, nurse or healthcare provider.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to a doctor, pharmacist or nurse or healthcare provider. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Imreplys is and what it is used for
Imreplys contains the active substance sargramostim which is similar to a natural protein in the body called granulocyte-macrophage colony- stimulating factor (GM -CSF). GM -CSF helps the bone marrow produce white and platelet blood cells, which are crucial f or fighting infections and healing injuries.
This medicine is used to treat adults and children from birth suddenly exposed to high amounts of radiation. This condition is called: Haematopoietic Sub -syndrome of Acute Radiation Syndrome (H- ARS). Radiation can severely lower white blood cell counts (increasing infection risk), platelet counts (leading to bleeding), and red blood cells, causing anaemia and potential organ damage.
Sargramostim has also been shown to improve blood cell counts in patients with certain blood cancers undergoing chemotherapy or after bone marrow transplant. Like cancer patients, people who have been exposed to radiation and develop H- ARS will have weaken ed immune systems and reduced blood cell counts.
⚠️ 2. What you need to know before you use Imreplys
Do not use Imreplys
- if you are allergic to sargramostim or any of the other ingredients of this medicine (listed in section 6).
- if you have had a serious allergic reaction, including anaphylaxis, to human GM- CSF (sargramostim) or other products that are made from yeast .
Warnings and precautions
Talk to your doctor, pharmacist, nurse or healthcare provider before using Imreplys.
25 A generalised allergy is an uncommon, but serious reaction to Imreplys. This may include a rash over your entire body, hives, trouble breathing, a fast pulse, sweating, and feeling faint. In severe cases, a generalised allergy may be life -threatening. If you think you are having a generalised allergy to Imreplys, stop taking Imreplys and contact a doctor, pharmacist, nurse or healthcare provider immediately.
Exposure to acute or sudden high- dose radiation can be a life -threatening condition. The possible benefit of Imreplys in reducing the threat to life from exposure to high- dose radiation should be considered in comparison to possible risks of taking the medicine.
Some side effects of Imreplys can also be symptoms of radiation exposure , or of other treatments you have received. Contact a doctor, pharmacist, nurse or healthcare provider immediately if after taking Imreplys :
- You develop a fever over 38 ° C
- You notice any signs of infection including chills, sore throat, or congestion (such as a stuffy nose)
- You have trouble breathing, or you develop wheezing, fainting, extensive skin rash, hives, or you feel you are having an allergic reaction
- You experience sudden weight gain or other signs of fluid build- up, such as swollen legs or feet
- You develop chest pain, chest discomfort, or a rapid or irregular pulse If you are concerned about any other side effects or symptoms you may be having, contact a doctor, pharmacist, nurse or healthcare provider.
During sargramostim treatment, where possible, a doctor, pharmacist, nurse or healthcare provider should monitor your blood cell counts. As a result of testing, your Imreplys dose may be adjusted, or your Imreplys treatment may be stopped.
If you have cancer, and in particular if you currently are being treated for cancer, contact your cancer doctor as soon as practical after radiation exposure, whether or not you have started Imreplys.
Other medicines and Imreplys
Tell your doctor, or pharmacist, nurse or healthcare provider if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant, or are planning to have a baby, ask your doctor, or pharmacist or nurse for advice before taking this medicine. Your doctor will consider the benefit and risk of using Imreplys for you and your baby.
It is not known if sargramostim will harm your unborn baby.
Driving and using machines
No effects on the ability to drive or use machines while taking Imreplys have been reported.
💊 3. How to use Imreplys
Always use this medicine exactly as your doctor, pharmacist, nurse or other healthcare provider has told you. Check with them your if you are not sure.
Administration of Imreplys should occur as soon as possible after exposure to acute high doses of radiation.
26 The recommended dose of Imreplys to be injected under the skin (subcutaneous injection) is shown below.
- 7 micrograms/kg in children and adolescents weighing greater than 40 kg, and in adults
- 10 micrograms/kg in children and adolescents weighing 15 kg to 40 kg
- 12 micrograms/kg in newborns, infants or children weighing less than 15 kg Your doctor, pharmacist, nurse or healthcare provider will tell you the right volume to be injected to you or to your child.
Your doctor, pharmacist, nurse or healthcare provider will tell you how long you or your child need to be treated with Imreplys until blood cell counts have sufficiently improved, as determined by blood tests. If it is not possible to do blood tests to det ermine blood cell counts, Imreplys may be stopped after 23 consecutive days of dosing.
Individual patient dose (mcg) Individual patient dose (mcg) = weight (kg) × dose in mcg/kg
- Actual body weight at initiation of treatment should always be used when calculating initial dose.
- Divide total mcg by 250 mcg/mL to determine the number of mL needed.
Adult, or child or adolescent > 40 kg example (80 kg body weight) Individual patient dose (mcg) = 80 kg × 7 mcg/kg = 560 mcg 560 mcg of Imreplys will be needed, i.e., 2 full vials of Imreplys and a partial third vial (the remaining drug in the third vial should be discarded).
560 mcg ÷ 250 mcg/mL = 2.2 mL.
Hence a 3 mL syringe may be needed.
Child or adolescent 15 – 40 kg example (20 kg body weight) Individual patient dose (mcg) = 20 kg × 10 mcg/kg = 200 mcg 200 mcg of Imreplys will be needed, i.e., 1 partial vial of Imreplys (the remaining drug in the vial should be discarded).
200 mcg ÷ 250 mcg/mL = 0.80 mL.
Hence a 1 mL syringe may be needed.
Newborn, infant or child < 15 kg example (5 kg body weight) Individual patient dose (mcg) = 5 kg × 12 mcg/kg = 60 mcg 60 mcg of Imreplys will be needed, i.e., 1 partial vial of Imreplys (the remaining drug in the vial should be discarded).
60 mcg ÷ 250 mcg/mL = 0.24 mL.
Hence a 1 mL syringe may be needed.
Your dose Individual patient dose (mcg) = ___kg × ___mcg/kg = ___mcg ___ mcg of Imreplys will be needed (___full vials, and [ 1 or no ] partial vial [discard any remaining drug if a partial vial is required]). ___ mcg ÷ 250 mcg/mL = ___ mL.
Hence a ___ mL syringe may be needed.
If you inject more Imreplys than you should Contact a doctor, pharmacist, nurse or healthcare provider as soon as practical. A healthcare provider may want to monitor you.
If you forget a dose of Imreplys Do not take a double dose to make up for a forgotten dose.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients taking sargramostim may experience unwanted side effects, most of which are mild to moderate and not serious.
The most serious side effect is a serious allergic reaction (including anaphylaxis); if this happens to you, stop taking Imreplys and contact a doctor, pharmacist, nurse or healthcare provider immediately.
Other important side effects are high fever (over 38 ° C), signs of an infection (such as chills, sore throat, congestion, runny nose), having trouble breathing or wheezing, feeling faint, developing extensive skin rash or hives or other signs of an allergic reaction, having sudden weight gain, swollen legs or feet, or other signs of fluid build-up, chest pain, chest discomfort or rapid or irregular pulse . If you experience any of these side effects, contact a doctor, pharmacist, nurse or healthcare provider immediately.
Very common side effects ( may affect more than 1 in 10 people)
Diarrhoea, vomiting, feeling like you have the flu, feeling tired or weak, muscle aches, abnormal blood test results, headache, back pain, weight loss, stomach pain, gastrointestinal bleeding, bone pain, stomach upset, vomiting blood, joint pain, general body pain, throat pain , feeling tense or worried, and bleeding in the eye.
You may also get a mild fever (less than 38 ° C) about one to 4 hours after an injection, or you may have swelling, redness, and/or discomfort where Imreplys is injected. The skin may become red, painful, or swollen. This may be suggestive of a reaction at the site of injection. This usually will not require you to stop taking sargramostim. If a reaction at the site of the injection occurs, contact a doctor, pharmacist, nurse or other healthcare provider. The following steps may be taken to prevent further r eactions at the site of the injection:
- At least 30 minutes before you plan to inject, remove Imreplys and water for injections vials from the refrigerator and allow them to come to room temperature before injecting
- Use a different injection site each time you inject
- Avoid rubbing the skin before or after injecting
Common side effects (may affect up to 1 in 10 people)
Dilatation of blood vessels .
If you are concerned about these or any other side effects, contact a doctor, pharmacist, nurse or other healthcare provider.
Reporting of side effects
If you get any side effects, including those that are not listed in this leaflet, talk to your doctor, pharmacist, nurse or other healthcare provider. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Imreplys
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 the vial after EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze. Keep the vials in the original outer carton in order to protect from light.
Special precautions:
- If unopened vials reach temperatures up to 25 °C, they are stable up to 1 year when protected from light.
28 • If unopened vials reach temperatures up to 40 °C , they are stable up to 1 month when protected from light.
- Do not expose to more than 1 Gy of ionising radiation. If unopened vials are exposed to up to 1 Gy of ionising radiation, they are stable up to 2 weeks at temperatures up to 40 °C when protected from light.
If you do not have refrigeration, you may store the sealed product at room temperature (15 °C – 25 °C) for up to one year. Sealed vials of Imreplys that have been exposed to temperatures greater than 25 °C and not more than 40 °C may be kept for one month.
After dilution with water for injections, Imreplys solution can be stored in the refrigerator (2 °C – 8 °C) for up to 24 hours.
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 protect the environment.
📦 6. Contents of the pack and other information
What Imreplys contains
- The active substance is sargramostim. Each glass vial contains 250 mcg sargramostim. After reconstitution, each 1 mL contains 250 mcg sargramostim.
- The other excipients are mannitol (E421) , sucrose, trometamol , and hydrochloric acid.
What Imreplys looks like and contents of the pack
Imreplys powder for solution for injection (powder for injection) is a white lyophilised powder supplied in a carton containing five 250 mcg single -dose glass vials.
Marketing Authorisation Holder
Partner Therapeutics Ltd., 28 – 32 Pembroke Street Upper, Dublin 2, Ireland.
D02NT28 Ireland +353.1264.1754 [email protected]
Manufacturer
Paesel + Lorei GmbH & Co KG Nordring 11 D-47495 Rheinberg Germany
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu How to prepare and inject Imreplys Imreplys will be injected under your skin (subcutaneous injection). Your doctor, pharmacist, nurse, or other health care provider will tell you the volume (mL) to be injected .
29 Follow all instructions provided by your doctor, pharmacist, nurse or other health care provider. Do not change your dose or stop Imreplys unless a doctor, pharmacist, nurse or other health care provider tells you to.
Imreplys vials are for single-use only.
More than one vial of Imreplys may be needed for each dose depending on the patient’s weight.
As an example, if an adult patient’s weight is 80 kg, three vials of Imreplys will be needed and each vial will need water for injections to dissolve the drug.
Below is a list of items to use that are not included within the Imreplys package, but are essential for proper administration:
- Water for injections in a vial or ampoule (this is a special type of water which is manufactured specifically for use to prepare medic ines for injections).
- Disposable, metered syringe and needle to add water for injections to dissolve Imreplys in the vial. A filter needle should be used if a glass ampoule of water for injection is used .
- Disposable syringe and needle to inject the Imreplys solution dose after it has been dissolved with the water for injections. Please note that when choosing the right syringe, it is important to ensure that the syringe’s size is adequate to inject the required volume of the drug. Typical syringe sizes (total volume) are 2 mL, 3 mL, and 5 mL.
- Alcohol pads to clean your skin at the site of injection and to clean the tops of the vial(s) and/or ampoule(s)
- Cotton ball or gauze pad
- Adhesive bandage strip
- Needle and syringe disposal container Caregiver/self -administration Imreplys may be self -administered or administered by a caregiver.
Comprehensive instructions for the preparation and administration of the reconstituted Imreplys vial are given in the package leaflet, section 3, “How to use Imreplys”.
Imreplys vial(s) and the items for proper administration should be kept out of the reach of children.
Step 1: Prepare Wash your hands thoroughly with soap and water. Dry them with a clean towel.
Please look at the date of expiry on the Imreplys vial and other supplies to ensure that the product(s) have not expired.
For each dose, place needed Imreplys and water for injections on a clean, well -lit surface, and allow them to reach room temperature before preparing an injection.
- Do not try to warm products by using a heat source such as hot water or microwave.
- Do not leave Imreplys vial(s) in direct light. Keep vial(s) in the box until time of use.
- Do not shake Imreplys.
Remove the dark blue plastic cap(s) from the Imreplys vial and the cap(s)/tops from the water for injections vial(s ). Do not remove the vial stoppers . Do not remove the silver -coloured metal ring around the top(s) of the vial(s) .
Figure demonstrates step for a Imreplys vial.
30 If using ampoule(s) of water for injections, clean with an alcohol pad prior to opening. To open a glass ampoule, it should be held in an upright position.
Check all fluid is removed from neck of ampoule. If not, gently flick the top of the ampoule until the fluid runs back down into it. If there is a dot on the ampoule, ensure the dot is facing away from you. Use a gauze pad or paper towel to hold the top of the ampoule, protecting your fingers. Hold the ampoule in one hand, using the other hand to snap the neck of the ampoule away from you. If using a plastic ampoule, twist the top of the ampoule until it is removed .
Clean each vial stopper with a new alcohol pad for each vial. Let vial air dry by themselves (do not blow on them).
Step 2. Withdraw the water for injections into a syringe Repeat Steps 2 and 3 for each Imreplys vial needed for your dose as prescribed by your doctor, pharmacist, nurse, or other healthcare provider .
Locate the needle and syringe to withdraw the water for injections. A filter needle should be used if a glass ampoule is used. If the needle is not attached to the syringe, attach it onto the syringe with the needle cap still on.
If a water for injections vial is used : Pull the needle cap off straight and away from your body. Do not allow the needle to touch anything. Pull back on the plunger of the syringe to add 1 mL of air to the syringe.
Insert the needle straight down in the centre of the rubber stopper on the water for injections vial.
Push the syringe plunger down to push all air from the syringe into the vial. Keep your finger on the plunger so the air does not come back into the syringe.
Keep the needle in the vial and turn the vial upside down. Make sure the liquid is covering the needle tip.
Keep the vial upside down and slowly pull back on the syringe plunger until 1 mL of water for injections is in the syringe barrel before removing syringe and needle from the vial. If there are air bubbles in the syringe, gently tap the syringe barrel with your finger until the air bubbles rise to the needle end of the syringe. Gently push the plunger up to push the air bubbles out of the syringe. Repeat these steps as needed until you have 1 mL of water for injections in the syringe with no air bubbles.
Remove syringe with attached needle from vial, discard vial, and go to Step 3.
If a water for injections ampoule is used : Pull the filter needle cap off straight and away from your body. Do not allow the needle to touch anything.
31 Insert the filter needle straight down in the water for injections ampoule.
Make sure the liquid is covering the filter needle tip. Slowly pull back on the syringe plunger until 1 mL of water for injections is in the syringe barrel. If there are air bubble s in the syringe, remove syringe with filter needle attached from ampoule and point upward. Gently tap the syringe barrel with your finger until the air bubbles rise to the needle end of the syringe. Gently push the plunger up to push the air bubbles out of the syringe. Repeat these steps as needed until you have 1 mL of water for injections in the syringe with no air bubbles. Remove filter needle from syringe. Attach new needle (filter not needed) for next step. Discard ampoule and go to Step 3.
Step 3. Dissolve the Imreplys p owder with the water for injections y ou withdrew in Step 2.
Insert the needle on the syringe containing water for injections through the centre of the rubber stopper on the Imreplys vial stopper.
Slowly push the syringe plunger down until all water for injections from the syringe is in the Imreplys vial.
Pull the syringe and needle completely out of the vial of Imreplys and discard into the needle and syringe disposal container.
Keeping the Imreplys vial upright on a flat surface, gently turn the Imreplys vial in a circular pattern until the powder is completely dissolved and the solution is clear and colourless. Do not shake the vial. Once reconstituted, it must be stored in a refrigerator at 2 to 8°C, and used within 24 hours. Do not store above 8°C. Do not freeze.
Repeat Steps 2 and 3 for each Imreplys vial needed for your dose as prescribed by your doctor, pharmacist, nurse, or other health care provider .
Step 4. Withdraw the Imreplys solution into a syringe Review your prescription to confirm what volume (mL) of Imreplys solution you should inject under the skin.
Place the vial(s) of Imreplys solution on a flat surface. If the vial(s) is cold, allow it to warm to room temperature for at least 30 minutes.
Clean the Imreplys vial stopper(s) with a new alcohol pad. Let it air dry.
Locate the needle and syringe to withdraw Imreplys solution. If the needle is not attached to the syringe, attach it onto the syringe with the needle cap still on.
Pull the needle cap off straight and away from your body pointing up. Do not allow the needle to touch anything.
Keep the Imreplys solution vial(s) upright on a flat surface and insert the needle straight down through the centre of the stopper.
32 Keep the needle in the vial and turn the vial upside down (if needed). Make sure the Imreplys solution is covering the needle tip.
Slowly pull back on the syringe plunger to fill the syringe barrel to the correct amount (mL) that matches the dose listed on your prescription. Multiple vials of Imreplys solution may be needed.
Keep the needle in the vial and check for air bubbles in the syringe.
If there are air bubbles in the syringe, gently tap the syringe barrel with your finger until the air bubbles rise to the top of the syringe. Gently push the plunger to push the air bubbles out of the syringe.
Keep the needle tip in the liquid and pull the plunger back to the number on the syringe barrel that matches your dose (mL). Repeat these steps as needed.
Check again to make sure you have the correct dose in the syringe. It is important that you use the exact dose prescribed by a doctor, pharmacist, nurse, or other healthcare provider.
DO NOT remove the needle from the vial. Lie the vial down on its side with needle still in the vial.
Step 5: Select and prepare an i njection s ite Clean the area immediately around the injection site you plan to use with an alcohol pad. Let your skin dry. Do not touch this area again before injecting.
Do not use the same injection site area you used for the previous injection. Avoid injecting into areas where the skin is burnt or broken (ulcerated), painful, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
You may use any of the following sites for an injection:
- Thigh
- Stomach area except for a 5 cm area right around your navel or belly button
- Outer area of upper arm (only if someone else is giving you the injection) The preferred administration site for infants and paediatric patients is the thigh .
33 Step 6: Inject Imreplys solution u nder the skin ( subcutaneously)
Remove the syringe and needle that contains your prescribed Imreplys dose
from the vial .
Pinch your injection site between your thumb and first finger. Be careful not to touch the injection site itself. Keep skin pinched while injecting.
Hold the syringe with your other hand. Insert the needle into the skin quickly at a 45-to-90-degree angle. There will be less discomfort or pain the more quickly you insert the needle into the pinched skin.
Using slow and constant pressure, push the syringe plunger until all of the Imreplys solution is injected.
When done, gently pull the needle out of your skin.
Cover the site with cotton ball or gauze if there is blood. Apply an adhesive bandage strip over the cotton ball or gauze, if needed. Do not rub the injection site.
Step 7: Proper disposal Do the following:
Appropriately discard all supplies as described below.
After one use
- Immediately discard syringe with needle into a needle and syringe disposal container.
- Immediately discard used Imreplys vial into an appropriate waste container.
- Make sure all other materials are discarded into proper containers.
The syringe, needle, Imreplys vial, and water for injections must NEVER be reused.
If you do not have a needle or syringe disposal container, you may use a household container that is a puncture -resistant, leak -proof container.
Important: Always keep the needle and syringe disposal container out of the reach of children.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Imreplys (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1924).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.