NordiLet® - FAQ

NordiLet®
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About the NordiLet® pen



What is the NordiLet® pen?

The NordiLet® pen is a liquid growth hormone formulation administered in a multi-dose, prefilled, disposable injection device. The NordiLet® pen contains liquid recombinant human growth hormone for subcutaneous injection under the skin. The active ingredient is somatropin, which is synthetic and is identical to natural growth hormone produced by the body.

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

What is in the NordiLet® pen?

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

What is the NordiLet® pen used to treat?

In children, the NordiLet® 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 NordiLet® 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 NordiLet® pen.

Can the NordiLet® pen be used with other medication?

The NordiLet® pen may be used with most other medication, but it is important to tell your physician about all medications (i.e. 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 NordiLet® pen should not be used?

The NordiLet® 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 it should be injected. 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 in women. Be sure to follow the dosing schedule given by the physician. Do not change the dose without consulting your physician.

How should the NordiLet® 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 NordiLet® 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 NordiLet® pen, please read the Instructions for Use leaflet provided in the pack.

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

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

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

Does the NordiLet® pen expire?

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

How should the NordiLet® pen be cleaned?

You can clean your NordiLet® 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 NordiLet® pen must only be used as described in the Instructions for Use leaflet contained in the 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 my NordiLet® pen seems broken or defective?

Do not try to repair a faulty NordiLet® pen.

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

What should I do if no growth hormone appears when I prime the NordiLet® 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 NordiLet® 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 NordiLet® 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 NordiLet® 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.

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