NordiFlex®

About the NordiFlex® pen



What is the NordiFlex® pen?

The NordiFlex® pen is a liquid recombinant human growth hormone for subcutaneous injection under the skin. The active ingredient is somatropin, which is synthetic and identical to natural growth hormone produced by the body.

The NordiFlex® pen was the first liquid growth hormone formulation administered in a multi-dose, prefilled, disposable injection device.

As the NordiFlex® pen contains a liquid growth hormone formulation, no mixing or reconstitution is required prior to injection.

One NordiFlex® pen is sufficient for treatment for up to 4 weeks – depending on the dose. Prior to each injection, a new NovoFine® needle should be inserted onto the NordiFlex® pen.

What is in the NordiFlex® pen?

The NordiFlex® pen contains liquid Norditropin® somatropin, which is the active ingredient, and which is bioequivalent to freeze-dried Norditropin® somatropin. The NordiFlex® pen also contains the following inactive ingredients: mannitol, histidine, poloxamer 188, phenol, and water for injection.

What is the NordiFlex® pen used to treat?

In children, the NordiFlex® pen is used to treat growth failure caused by growth hormone deficiency (GHD), SGA, Turner syndrome, skeletal dysplasia, and chronic renal disease. In adults, the NordiFlex® pen is used to treat growth hormone deficiency in adults (GHDA).

Before starting treatment, is there anything a patient should be sure to tell the physician?

Yes. If you have diabetes or have/have had cancer or another type of tumour, make sure the physician knows this before beginning treatment with the NordiFlex® pen.

Can the NordiFlex® pen be used with other medication?

The NordiFlex® pen may be used with most other medication, but it is important to tell your physician about all medications (both those prescribed by a physician and those available without a prescription) that you are taking, especially glucocorticoids, sex steroids, or thyroid hormone. If you receive insulin, the dose may have to be adjusted.

Are there situations when the NordiFlex® pen should not be used?

The NordiFlex® pen should not be used if the patient is allergic to phenol or any of the other ingredients, has received a kidney transplant, is pregnant, is breast-feeding, has cancer or other forms of active tumour, or is receiving treatment for a tumour.

How much should I inject?

Your physician will tell you how much you should inject and how and when the injections should be given. In children the dose will be based on weight or body surface area, whereas in adults the dose is based on effectiveness of therapy. A higher dose may be required for women. Be sure to follow the dosing schedule given by the physician. Do not change the dose without consulting your physician.

How should the NordiFlex® pen be stored?

Prior to use, the shelf-life is 2 years stored at 2–8°C/35–48°F. Protect from direct sun light, and do not freeze.

Your NordiFlex® pen is designed to work with precision. It should be handled with care to prevent it from becoming damaged. Protect it against dirt and dust.

For details on how to store the NordiFlex® pen, please read the Instructions for Use leaflet provided in the pack.

When a new NordiFlex® pen is started, how long can it be used?

After first opening, the 5 mg and 10 mg NordiFlex® pens can be kept safely at up to 25°C/77°F, for an in-use period of 3 weeks. Alternatively, 4 weeks stored at 2–8°C/35–48°F.

The 15 mg NordiFlex® pen should always be kept in the refrigerator at 2–8°C/35–48°F. After first opening, the 15 mg NordiFlex® pen can be used for 4 weeks.

Does the NordiFlex® pen expire?

Yes. Discard any pen that is past the expiration date printed on the pen.

How should the NordiFlex® pen be cleaned?

You can clean your NordiFlex® pen by wiping it with moistened cotton wool and mild detergent. Do not wash or lubricate the pen or soak it in alcohol. This may damage the mechanism. Remove dirt and dust with a soft brush.

The NordiFlex® pen must only be used as described in the Instructions for Use leaflet contained in each box. The manufacturer cannot be held responsible for any problems that may occur with the equipment if you have not followed these instructions.

What should I do if no growth hormone appears when I prime the NordiFlex® pen?

Repeat dialling one click until a drop of growth hormone appears at the tip of the needle. If not, repeat the procedure no more than 6 times. If a drop of growth hormone still does not appear, the pen is faulty and must not be used.

If considered faulty, return it to your doctor or pharmacy for a new one.

What should I do if no growth hormone appears when I prime the NordiFlex® pen, and the push-button will not go in?

The needle may not be attached tightly enough. Put the outer cap back on the needle, and tighten it in a clockwise direction.

Or, the needle may be blocked. Change the needle and prime your pen until growth hormone appears at the needle tip.

If none of the above resolves this query, check to make sure the NordiFlex® pen is not empty.

What should I do if the dial-a-dose selector is not at 0 when it is time to dial the dose?

Turn the dial back to zero – by turning the pen cap opposite of when dialling a dose.

What should I do if I have dropped my NordiFlex® pen on a hard surface?

Check the pen for cracks or damage. If all appears intact, prime the pen (see the Instructions for Use leaflet), and try injecting into a wash-basin. If growth hormone is ejected, the delivery system should be working perfectly.

What should I do if my NordiFlex® pen seems broken or defective?

Do not try to repair a faulty NordiFlex® pen.

If you find that your NordiFlex® pen is not working properly, return it to your doctor or pharmacy for a new one.



For answers to more of your questions about growth, growth disorders, and growth hormone therapy, visit www.heightmatters.org

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NovoFine®
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NordiFlex PenMateTM
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HeightMattersTM
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