10 mg / 2 ml (30 IU) solution for injection
somatropin
WHAT NUTROPINAQ IS AND WHAT IT IS USED FOR
NutropinAq is indicated for:
NutropinAq contains somatropin which is a recombinant growth hormone that is similar to the human natural growth hormone that the body produces. Recombinant is meant that it is made outside the body through a special process. Growth hormone is a chemical messenger that is produced in a small gland in the brain called the pituitary gland. In children, it tells the body to grow, helps the skeleton to develop normally, and later in adulthood, the growth hormone helps maintain a normal physique and metabolism.
In children, NutropinAq is used:
- when your body does not produce enough growth hormone and you therefore do not grow properly.
- when you have Turner syndrome . Turner syndrome is a genetic disorder in girls (lack of a female sex chromosome) that prevents growth.
- when your kidneys are damaged and they have lost their ability to function normally with an impact on growth.
In adults, NutropinAq is used:
- If your body does not produce enough growth hormone as an adult. This can start in adulthood or continue from when you were a child.
Benefits of using this drug
In children, it helps the body to grow and the skeleton to develop normally.
In adults, it helps maintain a normal physique and metabolism e.g. lipid balance and glucose level.
BEFORE YOU USE NUTROPINAQ
Do not use NutropinAq
- if you are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6).
- to children if the skeleton has already stopped growing.
- if you have an active tumor (cancer). Tell your doctor if you have or have had an active tumor . Tumors must be inactive and you must have stopped your anti-tumor treatment before starting treatment with NutropinAq.
- if you have complications after a major operation (open heart or abdominal surgery), multiple injuries after an accident, acute respiratory failure or similar conditions.
Take special care with NutropinAq
Talk to your doctor or pharmacist before using NutropinAq.
- Contact a doctor immediately if you experience vision changes, severe or recurrent headaches, along with nausea or vomiting, especially at the beginning of treatment. This may be a sign of a temporary increase in pressure in the brain (intracranial hypertension).
- Ask your doctor for advice if you start to limp or have hips or knees when you grow up.
- If you notice a curvature of the spine (scoliosis), you will need to be examined often by a doctor, as scoliosis can increase in all children who grow quickly.
- Your doctor should monitor you for high blood sugar ( hyperglycaemia ) during treatment with NutropinAq. If you are being treated with insulin , your doctor may need to adjust your insulin dose. If you have diabetes and severe / worsening eye disease, you should not be treated with NutropinAq.
- Doctors should check your thyroid function regularly and prescribe appropriate treatment if necessary. If you have an underactive thyroid gland that leads to low levels of thyroid hormone ( hypothyroidism ), this should be treated before starting your NutropinAq treatment. If your hypothyroidism is not treated, NutropinAq may not work.
- If you are receiving replacement therapy with glucocorticoids, you should see a doctor regularly as your glucocorticoid dose may need to be adjusted.
- If you have previously had a tumor (cancer) and in particular one that has affected the brain, your doctor should pay extra attention and examine you regularly to check that no tumor has returned.
- A few patients with growth hormone deficiency, who have been treated with growth hormone , have developed leukemia (blood cancer). However, it has not been proven that there is a link between it and growth hormone treatment .
- If you are having a kidney transplant, treatment with NutropinAq should be stopped.
- If you have complications after a major operation (open heart or abdominal surgery), multiple injuries after an accident, acute respiratory failure or similar conditions, your doctor will decide if it is safe to continue with NutropinAq treatment.
- There may be an increased risk of developing inflammation of the pancreas ( pancreatitis ), which causes severe pain in the abdomen and back. Contact your doctor if you or your child has a stomach ache after taking NutropinAq.
- If you have Prader Willi syndrome, you should not be treated with NutropinAq unless you also have growth hormone deficiency.
Pregnancy and breastfeeding
You should stop taking NutropinAq if you are pregnant.
Caution should be exercised when breastfeeding during treatment with NutropinAq.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No effect on the ability to drive or use machines has been observed with NutropinAq.
NutropinAq is almost “sodium free”
This medicine contains less than 1 mmol sodium (23 mg) per ampoule, ie essentially ‘sodium-free’.
HOW TO USE NUTROPINAQ
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
NutropinAq treatment should be performed under the regular supervision of a physician experienced in growth hormone deficiency.
The dose of NutropinAq to be injected is determined by your doctor. Do not change the dosage without consulting your doctor. The recommended dose is:
In children with growth hormone deficiency:
0.025 – 0.035 mg/kg body weight is injected daily under the skin ( subcutaneous injection ).
In girls with Turner syndrome:
Up to 0.05 mg/kg body weight is injected daily under the skin ( subcutaneous injection ).
In children with renal impairment:
Up to 0.05 mg/kg body weight is injected daily under the skin ( subcutaneous injection ).
You can continue NutropinAq treatment until you have a kidney transplant.
In adults with growth hormone deficiency:
Low initial doses of 0.15 – 0.3 mg are injected daily under the skin ( subcutaneous injection ). Thereafter, your doctor may increase the dose depending on how you respond to treatment. The final dose rarely exceeds 1.0 mg/day. In general, the lowest dose one that gives effect should be given to you.
The treatment with NutropinAq is a long-term treatment. Ask your doctor for more information.
The dose of NutropinAq to be injected is determined by your doctor. You should inject NutropinAq daily under the skin ( subcutaneous injection ). You must change the injection site every day to prevent skin damage.
NutropinAq is provided as a multi-dose solution. If the solution is cloudy when taken from the refrigerator, the contents must not be injected. Spin gently. Do not shake vigorously, as the protein can then be denatured.
You should use the NutropinAq Pen to inject NutropinAq. You will need to use a new sterile injection needle for each injection. At the beginning of treatment, it is recommended that a doctor or nurse give you an injection and teach you to use the NutropinAq Pen. After this training, you will be able to inject yourself or get an injection from a trained relative.
If you use more NutropinAq than you should
If you have been given more NutropinAq than you should, contact your doctor for advice.
If you inject too much NutropinAq, your blood sugar level may drop and become too low and then increase too much (hyperglycemia).
If you inject too much NutropinAq over a long period (years), you may find that certain parts of your body such as ears, nose, lips, tongue, and jaw grow too much (gigantism and/or acromegaly ).
If you forget to take NutropinAq
Do not take a double dose to make up for a forgotten dose. Continue with your usual dose the next day and tell your doctor at your next visit.
If you stop using NutropinAq
Talk to your doctor before stopping using NutropinAq. If you stop using NutropinAq too soon or use it for too long, the results of the treatment will not be as expected.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any change or growth of birthmarks and/or skin spots (melanocyte nevus). If you have a tumor or regrowth of a previous tumor (as confirmed by a doctor), treatment with NutropinAq should be stopped immediately. This side effect is less common, it can affect up to 1 in 100 people.
Tell your doctor immediately if you experience vision changes, severe or recurrent headaches, along nausea or vomiting. This may be a sign of a temporary increase in pressure in the brain ( intracranial hypertension ). If you have intracranial hypertension, your doctor may decide to temporarily reduce or stop taking NutropinAq.
Treatment can be started again after the episode is over. This side effect is rare, it can occur in up to 1 in 1000 users.
Other side effects are:
Very common (may affect more than 1 user in 10)
Swelling of the hands and feet due to accumulation of fluid (peripheral edema ), sometimes associated with local muscle pain ( myalgia ) and joint pain ( arthralgia ). These side effects usually occur in adults early in treatment and are short-lived. Edema was reported as a common side effect in children.
Common (may affect up to 1 in 10 people)
Underactivity of the thyroid gland leads to low levels of thyroid hormone ( hypothyroidism ). If your hypothyroidism is not treated, NutropinAq may not work. Your doctor should check your thyroid function regularly and prescribe appropriate treatment if necessary.
Decreased ability to absorb sugar ( glucose ) from the blood, leading to high blood sugar ( hyperglycemia ). Your doctor will monitor you for signs of this during treatment with NutropinAq. If you are being treated with insulin, your doctor may need to adjust your insulin dose.
A feeling of weakness ( asthenia ) and increased muscle tension (increased muscle tone ).
Pain, bleeding, bruising, rash and itching at the injection site. These can be avoided by using the correct injection technique and changing the injection site.
Some patients may develop antibodies (a type of protein produced by the body) to somatropin. When these antibodies were found in patients, they did not prevent them from growing.
Uncommon (may affect up to 1 in 100 people)
Decreased number of red blood cells in the blood ( anemia ), low blood sugar (hypoglycemia), and increase in phosphate levels ( hyperphosphatemia ).
Personality changes or deviant behavior.
Persistent stinging, burning sensation, pain, and/or numbness in the palms of the hands due to a nerve being pinched in the wrist ( carpal tunnel syndrome ).
Rapid involuntary eye movements ( nystagmus ), swelling of the optic nerve in the eye (papilloedema), double vision ( diplopia ), headache, drowsiness, and dizziness ( vertigo ).
Increased heart rate ( tachycardia ) and high blood pressure ( hypertension ).
Vomiting, abdominal pain, gas in the stomach ( flatulence ), and nausea.
Sensitive and dry skin (exfoliative dermatitis ), the altered thickness of the skin, heavy hair growth on the face and body ( hirsutism ), hives ( urticaria ).
Lateral curvature of the spine (scoliosis). If you have scoliosis, you need to be examined often to see if the curvature increases.
A bone disease where the upper part of the bone (femur) slides apart from the hip (displacement in the upper femoral epiphysis). This usually occurs in rapidly growing patients. Patients with diseases of the hormonal system are more likely to develop displacement in the upper femoral epiphysis.
Decreased muscle size (muscle atrophy), joint pain ( arthralgia ), and skeletal pain.
Involuntary urine leakage (urinary incontinence), increased urination frequency ( pollakiuria ), and increased urine output ( polyuria ).
Uterine bleeding (uterine bleeding), genital discharge, and breast enlargement ( gynecomastia ).
Local loss/increase of fat in the skin (lipodystrophy, atrophy/hypertrophy at the injection site).
Enlarged lymphatic tissue in the upper part of the pharynx (adenoid) with symptoms similar to those of enlarged tonsils (see Rare).
Rare (may affect up to 1 in 1,000 people)
Elevated blood sugar (hyperglycemia, diabetes mellitus ). Diabetes mellitus can lead to increased urination, thirst, and hunger. If you experience any of these symptoms, tell your doctor.
Enlarged tonsils lead to snoring, difficulty breathing or swallowing, short-term pauses in sleep ( sleep apnea ), or fluid in the ear and ear infections. If this proves to be particularly troublesome, you should discuss this with your doctor.
An abnormal sensation of tingling or numbness ( paresthesia ), abnormal skeletal development, a disease affecting skeletal growth (osteochondrosis), and muscle weakness.
Other rare side effects observed with NutropinAq include itching all over the body, rash, blurred vision, weight gain, dizziness, diarrhea, swelling of the face, fatigue, pain, fever, depression, and difficulty sleeping (insomnia).
Indication-specific adverse reactions noted during clinical trials
In children with a growth hormone deficiency, tumors in the brain ( central nervous system ) were reported as common side effects. Of the 236 patients included in the clinical trials, three patients had a tumor of the central nervous system. Of the three patients with a central nervous system tumor, two patients suffered from a recurrence of a tumor in the cerebellum (medulloblastoma) and one patient with a tumor containing histiocytes (histiocytoma). See also section “warnings and precautions”.
Girls with Turner syndrome reported abnormally heavy menstrual bleeding as a common side effect.
Children with renal impairment reported peritonitis, bone rot, and increased levels of blood creatinine as common side effects. They are at greater risk of developing increased pressure in the brain ( intracranial hypertension ), with the greatest risk at the beginning of treatment, although children with organic growth hormone deficiency and Turner syndrome also have an increased risk.
Adults with growth hormone deficiency reported abnormal tingling or numbness ( paresthesia ), abnormally high blood sugar levels, excess fat in the blood, insomnia, joint problems, osteoarthritis (degrading joint disease), muscle weakness, back pain, chest pain, and breast enlargement ( habitual breast enlargement ).
HOW TO STORE NUTROPINAQ
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2ºC-8ºC).
Do not freeze.
Store blisters in the outer carton.
After the first use, the cartridge can be stored for up to 28 days at 2 ° C – 8 ° C. Do not remove the ampoule used from the NutropinAq Pen between injections.
Do not use NutropinAq if you notice that the solution is cloudy.
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.
FURTHER INFORMATION
Content declaration
The active substance in NutropinAq is somatropin *.
* Somatropin is a human growth hormone produced in Escherichia coli cells by recombinant DNA technology.
The other ingredients are sodium chloride, liquid phenol, polysorbate 20, sodium citrate, anhydrous citric acid, and water for injections.
What the medicine looks like and contents of the pack
NutropinAq is a solution for injection (in a cartridge (10mg / 2ml) – pack sizes 1, 3 and 6). The solution for multi-dose use is clear and colorless.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
Manufacturer
IPSEN PHARMA BIOTECH SAS, Signes Plateau Activity Park, CD no 402, 83870 Signes, France