Genotropin MiniQuick - 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)|
|Ingredients:||recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous, water for injection, mannitol|
Human Growth Hormone
About This Medication
What the Medication Is Used For
In children, Genotropin MiniQuick 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 MiniQuick 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 MiniQuick 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 MiniQuick treatment.
What It Does
Genotropin MiniQuick 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 MiniQuick.
- You have an active tumour. Tumours must be inactive and you must have finished your anti-tumour treatment before you start using Genotropin MiniQuick.
- 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 MiniQuick 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
The active substance is recombinant somatropin.
What the Important Nonmedicinal Ingredients Are
Each syringe contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2.0 mg of somatropin. The other ingredients in the powder are: glycine, mannitol, sodium dihydrogen phosphate anhydrous, and disodium phosphate anhydrous. The ingredients in the liquid are: water for injection and mannitol.
Genotropin MiniQuick does not contain preservatives.
What Dosage Form It Comes In
Genotropin MiniQuick 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 0.25 ml of solution for injection.
Genotropin MiniQuick is available in pack sizes of 4 syringes, 7 syringes and 28 syringes. Not all strengths and pack sizes are marketed in Canada.
Warnings and Precautions
Serious Warnings and Precautions
Before taking Genotropin MiniQuick, 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 MiniQuick.
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 MiniQuick 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.
Injecting Genotropin MiniQuick
Genotropin MiniQuick 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 MiniQuick . Always inject Genotropin MiniQuick exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
If you cannot remember what to do, do not try to do your injection. Ask your doctor to show you again.
You can take your growth hormone out of the refrigerator half an hour before your injection. This lets it warm up slightly and can make your injections more comfortable.
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 it, 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.
If you use more Genotropin MiniQuick 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 MiniQuick
Do not take a double dose to make up for a forgotten dose.
It is best to take your growth hormone regularly. If you forget to take 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 MiniQuick
Ask for advice from your doctor before you stop using Genotropin MiniQuick .
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Detailed Instructions for use
Genotropin MiniQuick is a syringe used to mix and administer a single dose of Genotropin MiniQuick (growth hormone).
Each Genotropin MiniQuick comes preloaded with a cartridge with two sections and a needle. If you need additional needles, ask for the same Becton Dickinson Micro-Fine needles provided with the . The injection volume is always 0.25 ml.
The Genotropin MiniQuick is disposable; after you have administered a dose, dispose of it as described by your pharmacist.
The diagram below identifies the different components.
The cartridge of Genotropin MiniQuick contains the growth hormone powder in one section and a liquid in the other. When you turn the plunger rod clockwise, the growth hormone powder and the liquid mix and the powder dissolves.
|1. Peel the paper covering from the injection needle.
Attach the needle onto the Genotropin MiniQuick by pushing it down and turning it until it no longer can turn. Make sure the needle is positioned squarely onto the end of the rubber stopper before screwing it to the Genotropin MiniQuick .
|2. Hold the Genotropin MiniQuick with the needle pointing upwards. Turn the plunger rod clockwise until it will go no further.
DO NOT shake the solution. Mix it gently. Shaking the solution could make your growth hormone foam and damage the active substance. Check the solution for clarity, and only use clear solutions that are particle free.
|3. Remove the inner and outer protective caps of the needle.|
|4. Pinch a fold of skin at the injection site firmly and push the needle into the skinfold.|
|5. Push the plunger rod as far as possible to inject the entire content of the Genotropin MiniQuick . Wait a few seconds before withdrawing the needle to ensure that all the growth hormone is injected.|
|6. After injection replace the outer protective cap on the needle. Follow your standard guidelines for disposal of syringe and needle.|
Is it a problem if I see air bubbles in the syringe?
No. There is no need to remove the air from Genotropin MiniQuick . The small amount of air in the syringe has no consequence on the injection.
What should I do if there is resistance when I turn the plunger rod (step 2) or when I make the injection (step 5)?
The resistance could be because the needle has been inserted at an angle into the rubber stopper.
Carefully replace the outer protective cap (the opaque white one) over the needle and unscrew counter clockwise to remove the needle. Hold the syringe with the needle -end pointing up and reposition the needle squarely on top of the syringe. Screw the needle into the syringe.
What should I do if the needle is damaged or bent?
Discard the needle and use a new needle with the MiniQuick.
|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 MiniQuick 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.
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 MiniQuick, contact your doctor or treatment center.
How to Store It
Keep out of the reach and sight of children.
Do not use Genotropin MiniQuick 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°C to 8°C) until the expiry date. It can be stored for up to 6 months unrefrigerated (at or below 25°C) . During and/or at the end of this 6 months 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 container in the outer carton in order to protect your Genotropin MiniQuick from light.
After mixing the powder with the liquid, you should use your growth hormone immediately. If necessary you can store it in the refrigerator (2 C to 8 C) for up to 24 hours in the outer carton in order to protect your Genotropin MiniQuick from light. If you do not use it within 24 hours, do not use it.
Do not freeze or expose Genotropin MiniQuick to frost. If it freezes, do not use it.
Do not use Genotropin MiniQuick if you notice particles, if the solution is not clear or if it has frozen.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
Never throw away needles or empty syringes 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.
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)