CinnaTropin®

What is it?

What is CinnaTropin^®?

CinnaTropin^® is the brand name of recombinant growth hormone (somatropin). Each CinnaTropin^® pre-filled pen contains 5 or 10 mg of somatropin as ready-to-use solution. CinnaTropin^® is available in a pack containing 1 sterile pre-filled pen and patient information leaflet.

Indications

What is CinnaTropin^® used for?

• CinnaTropin^® is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH).
• CinnaTropin^® is indicated for the treatment of pediatric patients with short stature associated with Turner syndrome.
• CinnaTropin^® is indicated for the treatment of pediatric patients with short stature associated with Noonan syndrome.
• CinnaTropin^® is indicated for the treatment of pediatric patients with short stature associated with Parder-Willi syndrome.
• CinnaTropin^® is indicated for the treatment of pediatric patients with short stature associated with chronic renal insufficiency.
• CinnaTropin^® is indicated for the treatment of pediatric patients who have Idiopathic Short Stature (ISS).
• CinnaTropin^® is indicated for children born small for gestational age (SGA) who failed to show catch-up growth by 4 years of age or later.
• CinnaTropin^® is indicated for the treatment of adults with childhood-onset or adult-onset growth hormone deficiency.

Contraindications

Who should not use CinnaTropin^®?

Do not use CinnaTropin^® if:

• you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.
• you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stop breathing during sleep).
• you have cancer or other tumors.
• you are allergic to somatropin or any of the ingredients in CinnaTropin^®.
• your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy).
• you are a child with closed bone growth plates (epiphyses).

Important information

What should you know while about CinnaTropin^®?

• Use with caution in diabetic patients. These patients may require adjustment of their doses of insulin and/or other hypoglycemic agents.
• Call your healthcare provider at once if you have pain in your knees or hips or limp in walking.
• Call your healthcare provider at once if you have a headache, nausea, vomiting, or visual change.

What other drugs could affect CinnaTropin^®?

Tell your healthcare provider about all your other medicines, especially:

• birth control pills or hormone replacement therapy;
• insulin or oral diabetes medicine;
• a steroid (prednisone, dexamethasone, methylprednisolone, and others).

Other drugs may affect somatropin, including prescription and over-the-counter medicines, vitamins, and herbal products.

How to use CinnaTropin^®?

Your healthcare provider will prescribe the dose that is right for you.

Is CinnaTropin^® safe during pregnancy and breastfeeding?

Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment or if you are breast-feeding a baby.

What happens if you miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time. Call your healthcare provider if you miss a dose.

What happens if you overdose?

If you think there has been an overdose, call your poison control center or get medical care right away.

How should CinnaTropin^® be used?

CinnaTropin^® is injected under the skin (subcutaneous). Read the detailed Instructions for Use.

Side Effects

What are some side effects of CinnaTropin®?

Like all medicines, CinnaTropin^® can cause side effects, although not everybody gets them. Tell your healthcare provider or get medical help right away if you have any of the following signs or symptoms:

Edema, headache, paresthesia, hypothyroidism, nausea, vomiting, pain at injection site, injection site reaction, flatulence, abdominal pain, arthralgia, otitis, and upper respiratory tract infection.

These are not all the possible side effects of CinnaTropin^®.

Storage

How to store CinnaTropin^®?

• Keep CinnaTropin^® out of the reach of children.
• Do not use if the solution is cloudy, leaking, or has particles.
• Before you use CinnaTropin^® pens for the first time:

        - Store your new, unused CinnaTropin^® pen in a refrigerator between 2°C and 8°C (36°F to 46°F).

        - Do not freeze CinnaTropin^®.

        - Keep CinnaTropin^® away from direct light.

        - Do not use CinnaTropin^® that has been frozen or in temperatures warmer than 25°C (77°F).

        - Do not use CinnaTropin^® after the expiration date printed on the carton and the pen.

• After you use CinnaTropin^® pens and there is still medicine left:

            - Store remaining CinnaTropin^® in the refrigerator between 2°C and 8°C (36°F to 46°F) and use within 4 weeks,

            -  or Store remaining CinnaTropin^® at room temperature no warmer than 25°C (77°F) and use within 3 weeks.