Forsteo (teriparatide): Use when travelling

The storage instructions for Forsteo are as follows (Summary of Product Characteristics):

Store in a refrigerator (2°C-8°C) at all times. The pen should be returned to the refrigerator immediately after use. Do not freeze.

However, when travelling, the travel (cool) bag and gel packs can be used. Forsteo can be kept out of the fridge for a maximum of 36 hours up to 25°C during its 28 day in use period (Data on file).

Information available regarding travel with Forsteo:

• The Forsteo travel (cool) bag is intended only for occasional use when travelling. Do not store the travel bag itself in the freezer or refrigerator. Do not store the travel bag in a car boot (Data on file).

• It is recommended that the gel packs be frozen solid before using the travel bag. If the gel packs cannot be frozen solid, they should be refrigerated. The frozen gel packs, when properly placed in the travel bag, are insulated from the Forsteo Pen and do not make direct contact with the pen to ensure that the medicine does not freeze (0°C or 32°F) (Data on file).

  • Koolit^® gel packs consist of a water-soluble starch or cellulose in a plastic pouch. All Koolit refrigerants are made of high quality, non-toxic materials but are not intended for human consumption. Users who notice leaking, or puffing of the bag should dispose and request new refrigerant packs.

  • Recommended Disposal: These water-based Koolit refrigerants are suitable for disposal in normal waste streams. To recycle, simply cut open a thawed gel pack and dispose of its liquid content in the normal waste stream. The pouch may be recycled in centers that accept plastic.

• 36 hours is the total travel time allowed per device as long as the provided travel bag is used for travelling with the Forsteo pen and the temperature that the pen is exposed to during travel does not exceed 25°C or 77°F (room temperature) (Data on file).

• To ensure the cool bag remains at the correct temperature for 36 hours the gel packs must be replaced every 11 hours (Data on file).

• The Forsteo Pen should be returned to the refrigerator as soon as possible when arriving at the travel destination (Data on file).

• A little advanced planning is needed when travelling by air.

  • A doctor’s letter/prescription label may be required to verify the Forsteo pen belongs to the patient. Check the requirements with the airline.

  • The Forsteo Travel Bag should be brought onto the aeroplane as a carry-on. The temperature in the checked luggage area is not always controlled and may become too hot or too cold.

  • The Forsteo pen can be passed through a standard airport security scanner when travelling by air. Lilly have completed a study that showed that Forsteo is not altered by x-ray radiation found in airport scanners. Multiple passes through scanners required by the connecting and return flights of typical airline travel should not damage the Forsteo pen (Data on file).

References

Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Forsteo EU Summary of Product Characteristics, Utrecht, The Netherlands: Eli Lilly Nederland B.V.