Pfizer Limited has notified us of a manufacturing defect in the dosing mechanism of some Genotropin GoQuick pens which are used to administer somatropin. The defect has been found to create the possibility of the dose being set to one extra click beyond the dose selected and indicated in the memory window when the patient turns the dose knob with excessive force. This may result in a small increase in the dosage administered compared to the preset dose:
An additional 0.05mg of Genotropin for the 5.3mg Go Quick pre-filled pen
An additional 0.15mg of Genotropin for the 12mg GoQuick pre-filled pen
All unexpired batches of Genotropin GoQuck are within the scope of this issue although not all pens within these batches are affected. No complaints or adverse reactions relating to this issue have been received by the company to date.
In order to avoid product shortages, affected batches are not being recalled. Healthcare professionals are asked to remind patients to follow the instruction to align the dose settings in order to avoid the potential for an incorrect dose being administered. Should a patient inform you that they have discovered a defective device, please contact Pfizer’s endocrine helpline see details below.
ow to use GENOTROPIN
GENOTROPIN is given by injection under the skin (sub-cutaneous). It is important to use a different site every day to prevent wasting of skin fat at the injection site.
Your doctor, nurse or pharmacist will tell you how many milligrams (mg) of GENOTROPIN you must use and how often.
You will be taught to mix and inject your GENOTROPIN using a re-usable Pfizer reconstitution device (GENOTROPIN Mixer) or administration device (GENOTROPIN Pen), or a disposable pre-filled pen .
Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.
Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor’s advice.
If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.
Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.
It is important to use the correct cartridge with the correct pen. GENOTROPIN pens and cartridges are colour coded to help you match the cartridge to the corresponding pen. You must only use:
GENOTROPIN Pen 5 (green) with GENOTROPIN 5 mg cartridges (green);
GENOTROPIN Pen 12 (purple) with GENOTROPIN 12 mg cartridges (purple).
The GENOTROPIN 5 mg GoQuick pen is colour coded green. The GENOTROPIN 12 mg GoQuick pen is colour coded purple.
It is a good idea to refer to the instruction sheet you receive each time you mix and inject.
It is very important that you use your GENOTROPIN exactly as you have been instructed.
Use your GENOTROPIN in the evening if possible. Normally, growth hormone is made by the body at night. Giving the injection at night helps to copy this process.
Tell your doctor, nurse or pharmacist if you forget to use your GENOTROPIN. Do not use a double dose to make up for the dose you missed.
Do not stop using your GENOTROPIN without your doctor’s permission. Missing injections can reduce effectiveness and you risk being taken off growth hormone altogether.