Storage of immunoglobulins

Why am I receiving this leaflet?

This leaflet is for any person who is treated with immunoglobulins at home under the care of Cambridge University Hospitals (CUH). The leaflet provides advice on how to store immunoglobulins safely within the temperature range recommended by the manufacturer. This will ensure the immunoglobulin will work as it is intended.

General storage of immunoglobulins

Some brands of immunoglobulins should be stored at room temperature (up to 25°C). Other brands need to be stored in a fridge (2-8°C). The specific storage requirements of your brand of immunoglobulins will be written on the outer box of your medicine and in the product patient information leaflet (package insert). Please store your immunoglobulin in line with the printed recommendations. It is also important to keep your medicine:

• out of the reach of children
• out of direct sunlight
• in the original box until ready to be used.

Some immunoglobulins are recommended to be kept in a fridge but can be kept out of the fridge for a one-off period at room temperature. This is helpful because it avoids the need for an additional fridge in your home. The duration of this period depends on the brand, but is typically at least 6 months. It is important that once the immunoglobulin has reached room temperature it is not put back into the fridge unless this is specifically advised by a pharmacist.

Vials supplied by the homecare company may have an amended expiry date on the dispensing label. If not, you should amend the expiry date in line with the stability data in the product packaging. You should always plan to use up all stock from your previous delivery before using stock from a new delivery.

When you begin immunoglobulin therapy, you should be told if your brand of immunoglobulin needs to be stored in a fridge. We aim to provide you with a pharmacy-grade fridge to store your immunoglobulin where a fridge is needed. If you believe you require a fridge but do not have one, please contact your clinical nurse specialist.

If your immunoglobulin can be stored at room temperature

Store the immunoglobulin in a cupboard where possible. This will protect the medicine from sunlight and will be slightly cooler than the temperature of the room. A larder or cupboard in a cool room in the house is ideal.

Do not store your immunoglobulin in a room with strong heat sources such as the kitchen or above a radiator. The majority of room-temperature immunoglobulins should be stored below 25°C; the exception to this is Flebogamma DIF which may be stored up to 30°C.

If your immunoglobulin is stored in a fridge

If your brand of immunoglobulin needs to be stored in a fridge, this fridge will be delivered by the company that delivers your immunoglobulin (the homecare company). Fridges supplied by the homecare company on behalf of the hospital should have an external panel showing the fridge temperature.

The following good practice advice should be followed where possible:

DO:

• Check the temperature of the fridge on the external panel periodically to ensure it is maintaining a temperature between 2-8°C.
  • If the reading is above or below this temperature, please tell the homecare company. They are responsible for the good working order of the fridge.
• Allow your immunoglobulin to reach room temperature before you inject it (at least 30 minutes). This will decrease the chance of a skin reaction in the area you inject.

DO NOT:

• Do not store immunoglobulins in a fridge with a freezer compartment (‘ice-box’) inside the fridge as the immunoglobulin could freeze. If necessary, a fridge-freezer where the fridge and freezer are separate compartments can be used instead.
• Do not store your immunoglobulin in the fridge you use for food and drink. Raw or uncooked food such as uncooked meat or cheese in particular may increase the risk of contaminating your medicine. If absolutely necessary (for instance if your medicines fridge is malfunctioning), ensure raw and uncooked foods are stored on shelves below any medicines.

Hot weather

During hot weather, if the outside daytime temperature is above 25°C for several days, or above 30°C on any single day, this may increase the temperature inside your home to above 25°C. At these times it is even more important to find a cool place in the house to store your immunoglobulin. We do not routinely recommend measuring the temperature of rooms as domestic thermometers are not always sufficiently accurate. However, if you think your immunoglobulin has been stored at a temperature greater than the maximum temperature stated on the original box, you may contact your homecare company or the pharmacy Medicines Helpline service for further advice.

In extremely hot weather conditions where the temperature inside your house is significantly above 25°C, it may be appropriate to temporarily store your immunoglobulin in a fridge for a single continuous period of time to avoid exposure of your medicine to very high temperatures. In this circumstance care must be taken to avoid freezing the immunoglobulin and ensure your immunoglobulin is on a shelf higher than raw or uncooked meat or dairy products. Avoid repeated cooling and heating as this can affect the quality of your medicine. Please contact your clinical nurse specialist or the pharmacy Medicines Helpline service for further advice.

If you have sufficient stock in your home to continue your treatment, consider delaying your next delivery of immunoglobulin from the homecare company until after a period of very hot weather has passed.

Travel

If you are planning to travel at a time you would be due a dose of immunoglobulin, please contact your clinical nurse specialist for further advice. With some extra precautions, it may be possible for you to bring your immunoglobulin with you when travelling. Sometimes we will arrange for the medicine to be given in a different way to cover the time you will be away from home. If you are travelling to another country with immunoglobulins, we recommend carrying a letter from your prescriber or GP saying that this is a prescribed treatment for you. If you are travelling in an aeroplane, ensure your immunoglobulin is carried in hand luggage.

If you think your immunoglobulins have not been stored at recommended temperatures

Contact Pharmacy Medicines Helpline service on 01223 217502 or via the CUH medicines information email who will provide information on whether the immunoglobulin can still be used or whether it will need to be discarded.

You will be asked to provide information on:

• The brand name of the immunoglobulin, the number of vials affected and the batch number(s) and expiry date(s) stated on the box.
• Details of the storage issue, including if possible how long the medicine has been exposed to a temperature above the recommended temperature, and what the highest temperature was (if known).
• Provide your details including name, hospital number, date of birth and how you would like to be contacted.

MyChart

We would encourage you to sign up for MyChart. This is the electronic patient portal at Cambridge University Hospitals that enables patients to securely access parts of their health record held within the hospital’s electronic patient record system (Epic). It is available via your home computer or mobile device

More information is available on the MyChart information section on our website.