Pituitary News, Issue 16 - Summer 2000.

The Foundation strives to stay abreast of developments in endocrinology and to keep our members up to date about them. As there have recently been developments in the area of Growth hormone, with the introduction of new delivery devices, a liquid preparation and one which needs no refrigeration, we have asked Sister Oscar-Hazel Donaldson of St Mary's Hospital, London to write about these new products and how patients feel about them.

Sister Oscar-Hazel Donaldson
St Marys Hospital, London

For the pituitary patient who is prescribed growth hormone (GH), the year 2000 has seen the advent of a host of new questions: are they using International Units or milligrams, liquid or powder format, pen or disposable? It is, of course, a reflection of the numerous changes seen recently for users of GH, and more changes can be forecast for the near future. For the patient, this greater choice of products will make it easier to find a system to suit their needs.

Until recently there was little choice in available products; all needed reconstitution and refrigeration and most were calculated in International Units. However, worldwide harmonisation of the dosing of GH by June 2001 will lead to the labelling of GH products in milligrams and changes towards this are already in place, with many products now dual-labelled in International Units (IU) and milligrams (mg) or in milligrams only. To a patient who is only familiar with International Units the new system of labelling may seem a little daunting.

However, it is not only the labelling of products that has changed. Other new advances in GH have included new improved delivery systems, and the introduction of preservative-free GH and also of liquid GH.

At the end of 1999, Pharmacia & Upjohn launched Genotropin Miniquick, which is based on the design of the original two-compartment cartridge, but uses fixed-dose, single-use injection devices which are preservative free and can be stored at room temperature for up to three months. The devices are currently dual-labelled with both International Units and milligrams, a factor appreciated by some patients who are finding the switch from International Units to milligrams confusing.

Initially, the product was available in five strengths, but recently the range has been increased to ten different strengths, starting from 0.2 mg (0.6 IU) and increasing in strengths of 0.2 mg (0.6 IU) to a highest single dose of 2 mg (6 IU). This has increased the number of patients for whom it is suitable.

The advantages of a system which needs no refrigeration has obvious benefits for its users. The cool bag for business trips is no longer required and the worries about there being a refrigerator in the hotel room on holiday are rendered obsolete.

Genotropin Miniquick comes boxed in sevens, which is helpful to patients, or their carers, who have worries about compliance "I used to be worried that I might have forgotten a dose with the old system", one patient remarked recently, "and I could never tell from looking at my pen, but now I can tell by looking at the box". The device is equally helpful to the parents of children who self-inject as compliance is easily checked, simply by examining the box.

One GH user who is on a dose not offered by the Genotropin Miniquick system, but is heading for a trekking holiday in South America, remarked that she had originally intended to leave her pen at home for three weeks. Now, however she intends to ask her GP to prescribe the closest dosage to that which she normally takes just for the duration of her holiday.

The only negative comment made about the system was the waste disposal issue of disposing of seven syringes a week, but on the whole these new devices have been well received by GH users.

The end of 1999 also saw the launch of Norditropin SimpleXx, the world's first liquid GH in an integrated pen system. It is one of a range of new Novo Nordisk products, as the company has also developed the NordiPen system and, for the needle-shy patient, the NordiPenMate.

Norditropin SimpleXx requires no reconstitution and is available in 5 mg (15 IU), 10 mg (30 IU) and 15 mg (45 IU) cartridges. The cartridges are colour-coded, which makes identification easier and the NordiPen system is colour-coded to match, so that there is the added safety feature of there being no risk of inserting the wrong strength cartridge into the pen.

The pens themselves come in two designs, Classic and Graphic or, as one user put it recently, plain and pretty! One might have suspected that the Graphic design was aimed at the younger age group of GH users, but in practice they are turning out to be just as popular with adults.

The dose is set by turning the dose dial at the top of the pen, and the dose window shows the selected dose in a slightly magnified form which makes it easy to distinguish. The possible incrementation in dosage varies between the pens. The dosage from the 5mg/1.5ml pen can be increased by 0.05mg, allowing for doses of between 0.05mg and 1.25mg . The 10mg/1.5ml and the 15mg/1.5ml pens allow for increases of 0.1mg and provide dosage from 0.1mg to 4.0mg. This allows for accurate fine tuning of GH dosage.

For the needle-shy user, Novo Nordisk have also developed the new NordiPenMate. This is an optional auto-insertion accessory that can be attached to the Nordipen and, when connected, hides the needle from view. The needle is inserted into the skin upon the activation of a push button. The system is of benefit, not only to the needle-shy, but also to the patient who experiences problems with manual needle insertion.

Users of the Novo Nordisk system can benefit from a home delivery service.

For children who are taking GH, Ferring Pharmaceuticals has recently introduced ZomaJet2, a "no-needle" system which delivers precisely measured volumes of GH into the subcutaneous tissue (i.e under the skin) in less than one third of a second. Ferring also provide a Home Healthcare Service, which includes specialist training and ongoing support from a nurse specialist home delivery of medical equipment and the collection of clinical waste from home.

All of the new products on the market seem to have been well received by the patients using them, and new products are appearing shortly, including the new Genotropin pen which has the dosage display in milligrams and with colour-coded buttons for dosage reset and inject.

For all GH users, the availability of new products and new delivery systems has been good news. The new products on the market have generally been well received, and ongoing research and development are leading to the possibility of even more new products in the not-too-distant future.

Since this article in issue 16 of Pituitary News (Summer 2000), we have been asked by Novo Nordisk to bring the following to patient's attention:

Norditropin freeze dried/Norditropin powder will be discontinued from March 1st 2001. This does not effect the availability of Norditropin SimpleXx (liquid growth hormone), which was launched in December 1999.

1. Genotropin Pen by Pharmacia & Upjohn.
2. NordiPen by Novo Nordisk Pharmaceuticals Ltd.
3. ZomaJet2 by Ferring Pharmaceuticals.