iMedi.co.uk

Saizen 5.83mg/Ml Solution For Injection


■MerckSerono    1 iMERCK

11.

PACKAGE LEAFLET: INFORMATION FOR THE USER

saizerf 5.83 mg/ml

solution for injection somatropin

Read all of this leaflet carefully before you start

using this medicine:

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you . Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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.

In this leaflet:

1.    What Saizen is and what it is used for

2.    Before you use Saizen

3.    How to use Saizen

4.    Possible side effects

5.    How to store Saizen

6.    Further information

1. WHAT SAIZEN IS AND WHAT IT IS USED FOR

Saizen is a growth hormone. Saizen's main action is to increase growth in children and adolescents and to treat adults with growth hormone deficiency.

The growth hormone (somatropin) contained in Saizen is almost the same as human's natural growth hormone except that it is made outside the body by a process called "recombinant DNA technology" (genetic engineering).

Saizen is used:

In children and adolescents:

•    in the treatment of children with short stature who have failed to grow because their body produces no growth hormone or insufficient levels of growth hormone

•    in the treatment of girls who have failed to grow due to gonadal dysgenesis (also referred to as Turner Syndrome), confirmed by a test on the chromosomes

•    in the treatment of pre-pubertal children who have failed to grow due to chronic renal failure, a condition in which kidneys are damaged

•    in the treatment of growth problems in children who were born small and who have not reached normal height by the age of 4 years or later.

In adults:

•    in the treatment of adults with a marked lack of growth hormone (growth hormone deficiency).

This therapy is given to adults who have a serious growth hormone deficiency that has been medically diagnosed by a test.

The doctor or pharmacist will be able to explain why this medicine has been given to you or to your child.

2. BEFORE YOU USE SAIZEN
Do not use Saizen and tell your doctor

•    If you (or your child) are allergic (hypersensitive) to somatropin or any of the other ingredients of Saizen

•    If you have been told that your child's bones have stopped growing and that he/she has therefore reached his/her final height.

•    If you have an active tumour (cancer). Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with Saizen.

•    If you or your child have an acute critical illness, suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions.

Treatment with Saizen has to be stopped in children with chronic kidney disease at time of kidney transplantation.

Take special care with Saizen

Saizen therapy should be carried out under regular guidance of a doctor who is experienced in the diagnosis and management of patients with growth hormone deficiency.

Shortly after Saizen is given, you (or your child) may feel shaky or light-headed due to low blood sugar levels. These feelings will quickly disappear. Your (or your child's) blood sugar levels may then rise above normal 2-4 hours after administration. Since treatment with growth hormone can alter how your body handles sugar, your (oryour child's) sugar levels will be tested regularly by a doctor. Somatropin may cause you (oryour child's) blood sugar to increase.

If you (oryour child) are diabetic or a member of your family has diabetes, your doctor will monitor closely your blood sugar level and may adjust the treatment for diabetes while you are being treated with Saizen.

Please be aware that you may need regular eye tests after having this medicine.

Saizen may affect how your thyroid works. Your doctor may test your blood for levels of thyroid hormones and prescribe another hormone if you (or your child) are found to have developed a lack of thyroid hormone.

Saizen may cause fluid retention in adult patients. This may appear as swelling and joint or muscle pain. If you feel these symptoms tell your doctor who may decide to adjust your dose of Saizen.

If you have had a tumour in your childhood and were treated with Saizen, there is an increased risk to develop a new tumour. If in the past you (or your child) have had a condition affecting the brain, e.g. a tumour, the doctor will examine you (or your child) regularly to check that this has not come back again.

Rarely Saizen may cause an inflammation of the pancreas, which causes severe pain in the abdomen and back. Please consider this especially if your child suffers from stomach ache and contact your doctor.



Some patients may develop swelling of the brain, while taking Saizen. If you (or your child) suffer from a bad or recurrent headache, problems with your eyesight, feel sick (nausea) and/or being sick (vomiting), contact your doctor immediately. In this case it may be necessary to stop the growth hormone treatment, although treatment may be re-started at a later date. If the symptoms of brain swelling come back, treatment with Saizen should be discontinued.

When the medicine is injected into the same place over a long period of time, it can cause damage to this area. It is therefore important to keep changing the injection site. Your doctor or pharmacist can speak to you about which parts of the body should be used (see HOW TO USE SAIZEN).

Some children with growth hormone deficiency have developed leukaemia (increased number of white blood cells), whether or not they have received treatment with growth hormone. However there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors. No cause and effect relationship with growth hormone treatment has been proven.

Hip problems may occur more commonly in children with hormone or kidney problems. If your child has chronic renal failure, which can occur when kidneys are damaged, he or she should be examined periodically for evidence of bone disease. It is uncertain whether the bone disease in children with hormone or kidney problems is affected by growth hormone therapy. X-rays of the hip should be obtained prior to initiating therapy. If your child develops a limp or complains of hip or knee pain while being treated with Saizen, tell your doctor.

Treatment with Saizen will be stopped in children with chronic kidney failure at the time of kidney transplant.

Saizen is not indicated for the long-term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi Syndrome, unless they also have a diagnosis of growth hormone deficiency. There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi Syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.

Growth hormone should generally not be used by people who are seriously ill.

If you do not respond to the therapy with Saizen, you may have developed antibodies to growth hormone. Your doctor will conduct appropriate tests to determine this.

If you are over 60 years old or if you are taking Saizen for a long time you should be examined more freguently by your doctor. As there is less experience both in the treatment of older people and in prolonged treatment with Saizen, special care is reguired.

Using other medicines

It is usually safe to take other medicines. However, if you (or your child) are using corticosteroids, it is important to tell the doctor or pharmacist. These medicines could interact with Saizen and therefore your doctor may need to adjust the dose of these medicines or your Saizen dose. Corticosteroids are used to treat several illnesses including asthma, allergies, kidney rejection and rheumatoid arthritis.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking any medicine.

There is currently insufficient evidence from human studies on the safety of growth hormone treatment during pregnancy and breast feeding. Saizen should be discontinued, if pregnancy occurs.

If you become pregnant tell your doctor immediately. Consult your doctor before taking Saizen if you are breast feeding.

Driving and using machines

No studies on the effects of Saizen on the ability to drive and use machines have been performed.

Somatropin-containing products have no influence on the ability to drive and use machines.

3. HOW TO USE SAIZEN

Always use Saizen exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

It is recommended that Saizen be administered at bedtime.

The dose and freguency of administration of Saizen will be decided by your doctor and will depend on your (or your child's) body weight or body surface area.

Children and adolescents:

•    Short stature due to a lack of, or insufficient levels of natural growth hormone:

0.7-1.0 mg/m2 body surface area each day or 0.025-0.035 mg/kg body weight each day by subcutaneous administration (under the skin).

•    Growth failure in girls due to gonadal dysgenesis (Turner Syndrome):

1.4    mg/m2 body surface area per day or 0.045-0.050 mg/kg body weight each day by subcutaneous administration (under the skin).

If your daughter is treated for Turner Syndrome and she receives non-androgenic anabolic steroids as well , growth response may be enhanced. Ask your doctor or pharmacist if you are not sure about these drugs.

•    Growth failure in pre-pubertal children due to chronic renal failure, a condition in which kidneys are damaged:

1.4    mg/m2 body surface area, approximately egual to 0.045-0.050 mg/kg body weight each day by subcutaneous administration (under the skin).

•    Growth problems in children who were born small: 1 mg/m2 body surface area, approximately egual to 0.035 mg/kg body weight each day by subcutaneous administration (under the skin).

Adults:

•    Growth Hormone Deficiency in adults:

At the start, low doses of 0.15-0.30 mg each day are recommended by subcutaneous injection (under the skin). The dose will be adjusted in stages by your doctor. The recommended final dose of growth hormone rarely exceeds 1.0 mg/day. In


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general the lowest efficacious dose that works for you should be administered. If you are older or overweight, a lower dose may be necessary.

Method and route of administration

The dose and frequency of administration of Saizen will be decided by your doctor and will depend on your (oryour child's) size or body weight. In general Saizen should be administered each day by subcutaneous injection (under the skin).

Important information

For administration of Saizen, please read the following instructions carefully.

When the medicine is injected into the same place every time for a long time, it can cause damage. It is important to keep changing the place where you have your injection. Your doctor or pharmacist can speak to you about which part of the body you should use. Do not use any areas in which you feel lumps, firm knots, depressions, or pain; talk to your doctor or pharmacist about anything you find. Clean the skin at the injection site with soap and water.

The cartridge containing the solution of Saizen is ready to be used for administration with your cool, click needle-free auto-injectors or easypod autoinjector.

Place all elements needed for the injection of the solution on a clean surface and wash your hands with soap and water.

The solution should be clear to slightly opalescent with no particles and without visible signs of deterioration. If the solution contains particles, it must not be injected.

How to perform your daily self-administration of Saizen

For instructions on how to load the cartridge into the cool.click needle-free auto-injectors or easypod auto-injector and inject the solution of Saizen, please carefully read the corresponding instruction manual provided with each auto-injector. Intended users of easypod are primarily children starting from the age of 7 up to adults. Use of the devices by children should always be made under adult's supervision.

Frequency of administration

It is recommended that Saizen be administered at bedtime.

Duration of treatment

Your child should stop using this treatment when he or she reaches a satisfactory adult height or his or her bones cannot grow any longer, as assessed by his or her doctor. Treatment with Saizen will be stopped in children with chronic kidney failure at the time of kidney transplant.

If you use more Saizen than you should

If you inject too much Saizen ,you should tell your doctor as it may be necessary to change slightly the dose to make up for this. Injecting too much can lead to changes in blood sugar levels which could mean that you (or your child) will feel shaky and lightheaded. If this happens contact your doctor as soon as possible.

If you forget to use Saizen

If you miss a dose, tell your doctor as it may be necessary to slightly change the dose to make up for this.

If you stop taking Saizen

Do not stop taking Saizen without speaking with your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Saizen can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience strong and recurrent headaches associated with feeling sick (nausea), vomiting or sight disturbances. These are symptoms of a side effect called benign intracranial hypertension and it is uncommon.

Side effects may occur with certain frequencies, which are defined as follows:

•    common: affects 1 to 10 users in 100

•    uncommon: affects 1 to 10 users in 1,000

•    rare: affects 1 to 10 users in 10,000

•    very rare: affects less than 1 user in 10,000

•    not known: frequency cannot be estimated from the available data.

Common side effects:

•    Redness and itching at the site of injection If this appearsto be particularly troublesome,you should discuss this with your doctor.

•    Oedema (swelling), muscle pain, joint pain, and joint disorders in adult users. These side-effects appear usually early in the treatment and are short-lived.

•    (Isolated) headache.

Uncommon side effects:

•    Carpal tunnel syndrome that is characterized by persistent stinging, burning sensation, pain and/ or numbness in the hand.

•    Oedema (swelling), muscle pain, joint pain, and joint disorders in children. These side-effects appear usually early in the treatment and are short-lived.

Very rare side effects:

•    Slipped capital femoral epiphysis (a hip problem that starts if the growing end of the thigh bone slips from the ball of the hip joint) and avascular necrosis of the femoral head. If your child shows an unexplained limp and hip or knee pain, please contact your doctor or pharmacist.

•    Growth hormone treatment may reduce the levels of thyroid hormone. This can be tested by your doctor and if necessary your doctor will prescribe the adequate treatment.

You (oryour child) can experience high blood sugar

further to growth hormone treatment.

Leukemia has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.

Rarely an inflammation of the pancreas has been reported in patients treated with growth hormone.

Very rarely a patient could develop antibodies (type of protein that helps protect the body) to somatropin. These are usually not associated with any side effects and do not usually interfere with growth.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. HOW TO STORE SAIZEN

Keep out of the reach and sight of children.

Do not use Saizen after the expiry date which is stated on the cartridge after EXP. The expiry date refers to the last day of that month.

Store the unused Saizen cartridge in a refrigerator (2°C-8°C) in the original package to protect from light. Do not freeze.

After first injection, use within 28 days.

After first injection, the Saizen cartridge or the easypod auto-injector containing the Saizen cartridge has to be stored in a refrigerator (2°C-8°C) for a maximum of 28 days, of which up to 7 consecutive days can be outside of a refrigerator at or below 25°C. When stored outside of the refrigerator for up to 7 consecutive days, the Saizen cartridge must be returned to the refrigerator and used within 28 days after first injection.

When using the easypod auto-injector, the cartridge is kept in the device. The cool.click needle-free autoinjector should be stored outside of a refrigerator always separately from the Saizen cartridge. Protect the used cartridge from light.

Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist howto dispose of medicines no longer reguired. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Saizen contains

The active substance is somatropin (Recombinant Human Growth Hormone) 6 mg.

The other ingredients are sucrose, poloxamer 188, phenol, citric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection.

What Saizen looks like and contents of the pack

Saizen 5.83 mg/ml is a solution for injection in a prefilled cartridge (type 1 glass) with a plunger stopper (rubber) and a crimp cap (aluminium and rubber), containing a nominal value of 1.03 ml solution (6 mg somatropin).

Pack sizes of 1 and 5 cartridges.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Merck Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK.

Manufacturer

Merck Serono SpA, Modugno, Bari, Italy

This leaflet was last approved in February 2015

TW820284

N1210201F    02/15


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