Hello, dear readers of our website!

The HGH Bangkok team has prepared this quick reference guide covering everything you need to know about CinnaTropin® .

• 30 IU (equivalent to 10 mg)
• 1 sterile pre-filled injection pen (1.5 mL)
• For subcutaneous use only

What is CinnaTropin® and what is it used for?

CinnaTropin® contains somatropin , a biosynthetic recombinant human growth hormone (HGH).

CinnaTropin® is used to treat growth disorders in children with:

• Growth hormone deficiency (partial or complete lack of natural growth hormone production)
• Turner syndrome (a genetic disorder that can affect growth)
• Chronic kidney disease with impaired growth
• Short stature in children born small for gestational age (SGA)
• Noonan syndrome (a genetic disorder that can affect growth)

Growth Hormone Replacement Therapy in Adults

In adults, CinnaTropin® is used as replacement therapy for growth hormone deficiency when growth hormone production has been reduced since childhood or lost during adulthood as a result of a tumor, tumor treatment, or diseases affecting the pituitary gland.

If you received growth hormone treatment during childhood, your growth hormone status should be reassessed after your final height has been reached. If growth hormone deficiency is confirmed, treatment should be continued.

What You Need to Know Before Using CinnaTropin®

Do not use CinnaTropin® if:

• You are allergic to somatropin, phenol, or any of the other ingredients of this medicine (listed in Section 6).
• You have undergone a kidney transplant.
• You have an active tumor (cancer).
• You are critically ill due to an acute condition, such as following open-heart surgery, abdominal surgery, multiple severe injuries, or acute respiratory failure.
• Your growth has already been completed (your growth plates have closed) and you do not have growth hormone deficiency.

Warnings and Precautions

Talk to your doctor before using CinnaTropin® if:

• You have diabetes mellitus.
• You have ever had cancer or any other type of tumor.
• You experience frequent headaches, worsening vision, nausea, or vomiting.
• You have a thyroid disorder.
• Your child has scoliosis. During periods of rapid growth, spinal curvature may worsen, so your doctor will monitor it regularly.
• You or your child develops a limp or experiences hip or leg pain while walking during treatment.
• You are over 60 years of age or have been receiving somatropin therapy as an adult for more than five years.
• You have kidney disease, as your kidney function should be monitored regularly by your doctor.
• You are receiving glucocorticoid replacement therapy, as your dose may need to be adjusted.
• You or your child develops severe abdominal or back pain after using CinnaTropin®. This may be a sign of inflammation of the pancreas (pancreatitis), and you should seek immediate medical attention.

Other Medicines and CinnaTropin®

Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.

It is especially important to inform your doctor if you are taking:

• Glucocorticoids — using these medicines together with CinnaTropin® may affect final height in children, and the glucocorticoid dose may need to be adjusted.
• Cyclosporine (an immunosuppressive medicine).
• Insulin — your insulin dose may need to be adjusted.
• Thyroid hormones.
• Gonadotropins (hormones that stimulate the reproductive glands).
• Anticonvulsant (antiepileptic) medicines — dose adjustments may be required.
• Oral estrogens or other sex hormones.

How to Use CinnaTropin®

HOW TO INJECT CINNATROPIN: STEP-BY-STEP INSTRUCTIONS FOR USE

Always use this medicine exactly as prescribed by your doctor. If you are unsure how to use it, consult your doctor or pharmacist.

Children

Growth Hormone Deficiency (GHD)

• 0.025–0.035 mg/kg per day or 0.7–1.0 mg/m² per day

Turner Syndrome

• 0.045–0.067 mg/kg per day or 1.3–2.0 mg/m² per day

Chronic Kidney Disease

• 0.050 mg/kg per day or 1.4 mg/m² per day

Children Born Small for Gestational Age (SGA)

• 0.035 mg/kg per day or 1.0 mg/m² per day

Noonan Syndrome

• The recommended dose is 0.066 mg/kg per day , although in some cases 0.033 mg/kg per day may be sufficient.

Treatment should be discontinued once the growth plates (epiphyseal plates) have closed.

Adults

Growth Hormone Replacement Therapy

The dosage should be individualized according to each patient’s needs.

For patients with childhood-onset growth hormone deficiency , therapy is usually restarted at 0.2–0.5 mg per day , with subsequent dose adjustments based on IGF-1 (Insulin-like Growth Factor-1) levels.

For patients with adult-onset growth hormone deficiency , the recommended starting dose is 0.1–0.3 mg per day .

The dose should be increased gradually, approximately once a month , depending on the clinical response, possible side effects, and blood IGF-1 levels.

Women may require higher doses than men. Over time, men generally become more sensitive to IGF-1. This is particularly important for women taking oral estrogens , as they may require higher doses, while men may experience excessive treatment effects if doses are not adjusted appropriately.

The need for somatropin decreases with age. Maintenance doses vary considerably between individuals but rarely exceed 1.0 mg per day .

If You Miss a Dose

Administer your next dose at the usual scheduled time.

Do not use a double dose to make up for a missed dose.

If You Use More CinnaTropin® Than You Should

If you inject more somatropin than prescribed, contact your doctor immediately.

Long-term overdose may result in abnormal growth and other disorders associated with excessive exposure to growth hormone.

Pregnancy and Breastfeeding

Pregnancy

• If you become pregnant while using CinnaTropin®, discontinue treatment and inform your doctor immediately.

Breastfeeding

• Do not use this medicine while breastfeeding, as somatropin may pass into breast milk.

Possible Side Effects

Like all medicines, CinnaTropin® can cause side effects, although not everyone experiences them.

Side Effects That May Occur in Both Children and Adults (Frequency Not Known)

• Skin rash
• Wheezing
• Swelling of the eyelids, face, or lips
• Sudden severe allergic reaction (anaphylaxis)

These symptoms may indicate a serious allergic reaction and require immediate medical attention.

The following symptoms may also occur:

• Headache
• Blurred or worsening vision
• Nausea
• Vomiting

These may be signs of increased intracranial pressure .

Other possible side effects include:

• Decreased blood thyroxine levels
• Hyperglycemia (elevated blood glucose levels)

If you experience any of these side effects, contact your doctor as soon as possible. Stop using CinnaTropin® and resume treatment only after receiving medical advice.

During treatment, antibodies to somatropin have been reported in rare cases.

Elevated liver enzyme levels have also been reported.

There have been isolated reports of leukemia and recurrence of brain tumors in patients receiving somatropin. However, to date, there is no convincing evidence that these conditions were caused by somatropin.

Currently, there is no evidence that somatropin is responsible for the development of these diseases.

If you believe you have developed any of the conditions described above, consult your doctor immediately.

Additional Side Effects in Children

Uncommon (may affect up to 1 in 100 children)

• Headache
• Redness, itching, or pain at the injection site
• Enlargement of breast tissue in boys (gynecomastia)

Rare (may affect up to 1 in 1,000 children)

• Skin rash
• Muscle and joint pain
• Swelling of the hands and feet due to fluid retention

In rare cases, children receiving CinnaTropin® have experienced hip or knee pain and limping. These symptoms may be associated with disorders affecting the head of the femur, such as Legg-Calvé-Perthes disease or Slipped Capital Femoral Epiphysis (SCFE) , and may not be directly related to CinnaTropin® treatment.

In clinical studies involving children with Turner syndrome , increased growth of the hands and feet relative to overall body growth was reported in some cases.

Clinical studies have also shown that high doses of CinnaTropin® may increase the risk of ear infections in children with Turner syndrome.

If any of these side effects become severe, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. Your dose may need to be adjusted.

Additional Side Effects in Adults

Very Common (may affect more than 1 in 10 adults)

• Swelling of the hands and feet caused by fluid retention

Common (may affect up to 1 in 10 adults)

• Headache
• Tingling, numbness, “pins and needles,” or pain, mainly in the fingers
• Joint pain and stiffness
• Muscle pain

Uncommon (may affect up to 1 in 100 adults)

• Type 2 diabetes mellitus
• Carpal tunnel syndrome
• Tingling and pain in the fingers and hands
• Itching (sometimes severe) and pain at the injection site
• Muscle stiffness
• Enlargement of breast tissue in men (gynecomastia)

How to Store CinnaTropin®

• Keep this medicine out of the sight and reach of children.
• Before first use, store the CinnaTropin® pre-filled injection pen in its original packaging at 2–8°C (36–46°F) .
• After first use, the pen may be stored:
  • at room temperature (up to 25°C / 77°F) for up to 3 weeks ; or
  • in a refrigerator (2–8°C / 36–46°F) for up to 4 weeks .
• Do not freeze.
• Keep the injection pen in its original carton to protect it from light.
• Do not use this medicine after the expiry date printed after EXP on the carton and label.
• Do not use CinnaTropin® if the packaging is damaged or shows signs of tampering.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures help protect the environment.

Contents of the Pack and Additional Information

What CinnaTropin® Contains

Active ingredient

• Somatropin

Other ingredients

• Mannitol
• Histidine
• Poloxamer 188
• Phenol
• Water for Injection

What CinnaTropin® Looks Like and Pack Contents

CinnaTropin® is a clear, colorless solution supplied in a 1.5 mL glass cartridge , ready for use in a pre-filled CinnaTropin® injection pen .

Pack Contents

• 1 pre-filled CinnaTropin® injection pen
• Official Patient Information Leaflet

IU to mg Conversion Table for CinnaTropin® 10 mg (30 IU)

This conversion table allows you to quickly determine the equivalent dose in milligrams (mg) for the selected number of International Units (IU) when using CinnaTropin® 10 mg (30 IU) .

IU to mg Conversion Table