Genotropin GoQuick - Consumer Medicine Information
|Condition:||Adult Human Growth Hormone Deficiency, Pediatric Growth Hormone Deficiency, Prader-Willi Syndrome, Short Stature for Age, Turner's Syndrome|
|Form:||Liquid solution, Subcutaneous (SC), Powder|
|Ingredients:||somatropin, glycine, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous, mannitol; water for injection, mannitol, metacresol|
Human Growth Hormone
About This Medication
What the Medication Is Used For
In children, Genotropin is used to treat the following growth problems:
- If you are not growing properly and you do not have enough of your own growth hormone.
- If you have Turner syndrome. Turner syndrome is a chromosomal error in girls that can affect growth - your doctor will have told you if you have this.
- If you were small or too light at birth. Growth hormone may help you grow taller if you have not been able to catch up or maintain normal growth by two years of age or later.
- If you have idiopathic (unknown cause) short stature.
In adults, Genotropin is used to treat persons with pronounced growth hormone deficiency. This can start during adult life, or it can continue from childhood.
If you have been treated with Genotropin for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth. If severe growth hormone deficiency is confirmed, your doctor will propose continuation of Genotropin treatment.
What It Does
Genotropin is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone which is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop in the right amounts. Recombinant means it is made using bacteria instead of being taken out of human or animal tissue.
When It Should not be Used
- You are allergic (hypersensitive) to somatropin or any of the other ingredients of Genotropin.
- You have an active tumour. Tumours must be inactive and you must have finished your anti-tumour treatment before you start using Genotropin.
- You are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute respiratory failure, accidental trauma or similar conditions). If you are about to have, or have had, a major operation, or go into hospital for any reason, tell your doctor and remind the other doctors you are seeing that you use growth hormone.
- Genotropin has been prescribed to stimulate growth but you have already stopped growing (the growth plates on your long bones are closed).
- In patients with Prader-Willi syndrome who are very obese or have severe breathing problems. There have been reports of deaths in children with Prader-Willi syndrome who were treated with growth hormone and had one or more of the following risk factors: severe obesity, breathing problems, colds or lung infections.
- In patients with diabetic retinopathy, a complication of diabetes that results from damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina).
What the Medicinal Ingredient Is
Genotropin is a recombinant human growth hormone (also called somatropin).
What the Important Nonmedicinal Ingredients Are
Each cartridge in the pre -filled pen contains 5mg, 5.3 mg or 12 mg of somatropin. The Genotropin powder contains glycine, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous and mannitol.
The diluent (solution for dissolving somatropin) contains water for injection, mannitol and metacresol.
What Dosage Form It Comes In
Genotropin is presented in a cartridge with two sections that is contained in a multi-dose, disposable pre-filled pen called GoQuick. One section contains the powder for solution for injection and the other contains the liquid for solution for injection. The powder is white and the liquid is clear.
When mixed together, the powder and the liquid make 1 ml of solution for injection.
Genotropin is available in pack sizes of 1 GoQuick pre- filled pen and 5 GoQuick pre-filled pens. Not all strengths and pack sizes are marketed in Canada.
Warnings and Precautions
Serious Warnings and Precautions
Before taking GENOTROPIN, talk to your doctor or pharmacist if:
- The child has Prader-Willi Syndrome and breathing problems, sleep apnea (not breathing while sleeping), snoring or a respiratory infection.
A doctor trained in hormone and growth disorders must examine the patient to decide if it is safe to use GENOTROPIN.
After the GENOTROPIN powder has been dissolved it must be water-clear and free of particles.
BEFORE using Genotropin, the patient or caregiver should tell the doctor:
- If the patient is at risk of developing diabetes, the doctor will need to monitor their blood sugar level during treatment with Genotropin.
- If the patient has diabetes, they should closely monitor their blood sugar level during treatment with Genotropin and discuss the results with their doctor to determine whether they need to change the dose of their medicines to treat diabetes.
- If the patient is receiving treatment with thyroid hormones it may be necessary to adjust their thyroid hormone dose.
- If the patient is taking growth hormone to stimulate growth and walk with a limp or if they start to limp during their growth hormone treatment due to pain in their hip, they should inform their doctor.
- If the patient develops a strong headache, visual disturbances or vomiting they should inform their doctor about it.
- If their doctor confirms that the patient has developed inflammation of the muscles near the injection site because of the preservative metacresol, they should use a Genotropin product without metacresol.
- If the patient is receiving Genotropin for growth hormone deficiency following a previous tumour, they should be examined regularly for recurrence of the tumour.
- If the patient is a survivor of childhood cancer.
- If the patient, especially a child, develops severe abdominal pain (inflammation of the pancreas).
- If the patient is, or plans to become pregnant or is breast-feeding.
- If the patient develop a limp while being treated with GENOTROPIN.
- If the patient has Turner syndrome and develops an ear infection or headaches her doctor should be told about these problems.
- If the patient has hypopituitarism and is receiving standard hormone replacement therapy, the doctor should monitor the hormone replacement therapy closely during GENOTROPIN treatment.
After starting Genotropin treatment some patients may need to start thyroid hormone replacement.
Progression of pre-existing scoliosis (curvature of the spine) can occur in children who have rapid growth.
The patient should not use Genotropin if they are pregnant or are trying to become pregnant.
Interactions With This Medication
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
You should tell your doctor if you are using:
- medicines to treat diabetes,
- thyroid hormones,
- synthetic adrenal hormones (corticosteroids),
- sex hormones (for example estrogens),
- cyclosporine (a medicine that weakens the immune system after transplantation),
- medicines to control epilepsy (anticonvulsants).
Your doctor may need to adjust the dose of these medicines or the dose of Genotropin.
Proper Use of This Medication
The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you. Everyone is different. Your doctor will advise you about your individualized dose of Genotropin in milligrams (mg) from either your body weight in kilograms (kg), as well as your treatment schedule. Do not change the dosage and treatment schedule without consulting your doctor.
Children with growth hormone deficiency:
0.16-0.24 mg/kg body weight per week. Higher doses can be used. When growth hormone deficiency continues into adolescence, Genotropin should be continued until completion of physical development.
Children with Turner syndrome: 0.33 mg/kg body weight per week.
Children with idiopathic short stature:
UP TO 0.47 mg/kg body weight per week
Children born smaller or lighter than expected and with growth disturbance:
UP TO 0.48 mg/kg body weight per week. Your doctor will determine the most appropriate dose and length of treatment. Treatment should be discontinued if: i) after the first year if you are not responding or ii) if you have reached your final height and stopped growing.
Adults with growth hormone deficiency:
You should start with 0.15-0.3 mg per day.
This dosage should be gradually increased or decreased according to blood test results as well as clinical response and side effects.
Follow the instructions given to you by your doctor.
Genotropin is intended for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under your skin. Your doctor should have already shown you how to use Genotropin. Always inject Genotropin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Read carefully the GoQuick Instructions for Use included in this package leaflet. You must use the pen as described in the Instructions for Use.
The needle must be screwed on to the GoQuick pen before mixing. Use a new needle before each injection. Needles must not be re-used.
Preparing the injection
You can take your Genotropin out of the refrigerator up to 2 hours before your injection. This lets it warm up slightly and can make your injections more comfortable. Once the injection is administered, the reconstituted solution must be returned to the refrigerator. The cycle can be repeated over the allowable 4 week period.
The two-chamber cartridge that contains both the growth hormone and the dissolving liquid is contained in the GoQuick pen. The growth hormone and the dissolving liquid are mixed together by twisting the cartridge holder (see the detailed steps in Instructions for Use). Dissolve the powder by gently tipping the GoQuick pen back and forth 5-10 times until the powder is dissolved.
When you are mixing your Genotropin, DO NOT SHAKE the pen. Mix it gently. Shaking the solution could make your growth hormone foam and damage the active substance. Check the solution and do not inject if the solution is cloudy or has particles in it.
Remember to wash your hands and clean your skin first.
Inject your growth hormone at about the same time every day. Bedtime is a good time because it is easy to remember. It is also natural to have a higher level of growth hormone at night.
Most people do their injections into their thigh or their bottom. Do your injection in the place you have been shown by your doctor. Fatty tissue of the skin can shrink at the site of injection. To avoid this, use a slightly different place for your injection each time. This gives your skin and the area under your skin time to recover from one injection before it gets another one in the same place.
Remember to put your Genotropin back in the refrigerator straight after your injection.
If You use More Genotropin Than You Should
If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or “not yourself”, and you might faint.
If You Forget to use Genotropin
Do not use a double dose to make up for a forgotten dose.
It is best to use your growth hormone regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a note of any missed injections and tell your doctor at your next check-up.
If You Stop Using Genotropin
Ask for advice from your doctor before you stop using Genotropin.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Side Effects and What to Do About Them
Like all medicines, Genotropin can cause side effects, although not everybody gets them.
Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Formation of antibodies to the injected growth hormone but these do not seem to stop the growth hormone from working.
- Temporary reddening, itchiness or pain at the injection site.
- Numbness / tingling,
- Stiffness in the arms and legs, joint pain, muscle pain,
- Water retention (which shows as puffy fingers or swollen ankles). These symptoms may be seen for a short time at the start of treatment, but they disappear spontaneously or when the dosage is lowered.
These common side effects in adults may start within the first months of treatment and may either stop spontaneously or if your dose is reduced.
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
- Numbness / tingling,
- Stiffness in the arms and legs, joint pain, muscle pain,
- Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of treatment).
- Pain or burning sensation in the hands or underarms (known as Carpal Tunnel Syndrome).
Rare side effects (likely to occur in fewer than 1 in 1,000 patients) include:
- Type 2 diabetes mellitus,
- Intracranial hypertension (increased pressure within the skull due to swelling of the brain) which causes symptoms such as a strong headache that doesn’t go away, vision problems, nausea or vomiting. Call your doctor if the patient has any of these symptoms.
Very rare side effects (likely to occur in fewer than 1 in 10,000 patients) include:
The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in a different place each time.
A very rare side effect that can occur because of the preservative metacresol is inflammation of the muscles near the injection site. If your doctor confirms that you have developed this, you should use a Genotropin product without metacresol.
Slipped capital femoral epiphysis and Legg-Calve-Perthes disease may be considered by your doctor if discomfort or pain in the hip or knee is experienced whilst being treated with Genotropin.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
This is not a complete list of side effects. For any unexpected effects while taking Genotropin, contact your doctor or treatment center.
How to Store It
Keep out of the reach and sight of children.
Do not use Genotropin after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Before mixing the powder with the liquid, your growth hormone should be stored in a refrigerator (2° to 8°C) until no later than the expiry date. It can be stored for a maximum of 4 weeks unrefrigerated (at or below 25 C). During and/or at the end of the 4 weeks period, the product should not be put back in the refrigerator. After this it must be discarded.
Genotopin is sensitive to light. You should keep the GoQuick pen in the outer carton in order to protect your Genotropin from light.
After mixing the powder with the liquid, Genotropin must be stored in a refrigerator (2° to 8°C), for up to 4 weeks. The reconstituted solution can remain at room temperature for up to 2 hours prior to each injection. Once the injection is administered, the reconstituted solution must be returned to the refrigerator. The cycle can be repeated over the allowable 4 week period. If you use the needle guard, store your pen with the needle guard and black cap in place. If you do not use the needle guard, store your pen with the white pen cap in place. See the Instructions for Use. These measures will help to protect your Genotropin from light.
Do not freeze or expose Genotropin to frost. If it freezes, do not use it.
Never throw away needles with your ordinary garbage. When you have finished with a needle, you must discard it carefully so that no-one will be able to use it or prick themselves on it. You can get a special “sharps” bin from your hospital or growth clinic.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at www.pfizer.ca or can be obtained by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001 (Medical Information)