Genotropin

Genotropin (somatropin) is a recombinant form of human growth hormone (HGH, hGH) important for the growth of bones and muscles.

Genotropin is used to treat growth failure in children and adults who lack natural growth hormone (growth hormone deficiency). This includes people with short stature due to Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes.

Genotropin works by behaving like natural human growth hormone, binding to the growth hormone receptor on target cells, which signals skeletal growth, muscle growth, and protein production. Human growth hormone is produced naturally in the pituitary gland at the base of the brain. If the pituitary gland doesn’t make enough, or any, human growth hormone, it causes growth-related disorders.

Genotropin is given as an injection under the skin (subcutaneous injection) using the Genotropin pen device or the Genotropin Miniquick. The Genotropin dose is 6 or 7 injections per week.

Genotropin Pfizer Inc., a Division of Pharmacia & Upjohn Co.

Genotropin injection is FDA-approved to be used for growth failure in:

Pediatric patients who have:

• growth failure due to an inadequate secretion of endogenous growth hormone
• Prader-Willi syndrome (PWS) which has been confirmed by appropriate genetic testing
• Turner syndrome
• idiopathic short stature (ISS), also called non-growth hormone-deficient short stature in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.

Adult patients as a replacement of endogenous growth hormone in adults with growth hormone deficiency who have:

• Adult Onset (AO) Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
• Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

The weekly dose should be divided into 6 or 7 subcutaneous (under the skin) injections using the Genotropin Pen or Genotropin Miniquick. Genotropin must not be injected intravenously.

A healthcare provider will teach you how to properly use the medication by yourself.

Do not inject the subcutaneous injection (under the skin) into the same place two times in a row.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Do not use Genotropin if you don't understand all the instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not shake the medicine. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Genotropin is available as Genotropin Pen Device and Genotropin Miniquick. Read the full directions for your device or read the full Instructions for Use.

Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before.

Avoid areas that are bony, bruised, red, sore, or hard. You should also avoid areas of the skin that have scars or skin problems.

Clean the injection site with the alcohol swab.

Genotropin Pen device instructions

• Firmly pinch a fold of skin at the injection area. Use the Genotropin Pen device to push the needle fully into the skin fold at a 90° angle.
• Push the pen device injection button until it clicks. Wait while counting slowly for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected.

Genotropin Miniquick instructions

• Remove the outer needle cover and the inner needle cover from the needle of the Genotrophin Miniquick. Save the outer needle cover.
• Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90°angle.
• Push the plunger rod in as far as it will go, to inject all of the medicine in the Genotropin Miniquick into the fold of skin.
• Wait a few seconds to be sure that all of the growth hormone solution has been injected. Pull out the needle.
• Replace the outer needle cover on the needle.

Genotropin Miniquick: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg in a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge (without preservative)

Genotropin 12 mg Pen, Genotropin Pen Device 5mg in a single-patient-use two-chamber cartridge (with preservative). Genotropin cartridges need to be inserted into the Genotropin pen device

Genotropin pen replacement. The pen has a use period of 2 years starting from the first use by the patient.

Genotropin pen needle size is 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needles.

You should not use Genotropin Miniquick or Genotropin Pen if you have cancer, diabetic retinopathy, or if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems. You should not use this medicine if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma.

You should not use Genotropin Miniquick or Genotropin Pen if you are allergic to the active ingredient somatropin, benzyl alcohol, m-cresol, or if you have:

• a serious illness due to lung failure, or complications from recent surgery, injury, or medical trauma;
• closed epiphyses;
• active cancer;
• eye problems caused by diabetes (diabetic retinopathy); or
• you are being treated for Prader-Willi syndrome, and you are overweight or have severe breathing problems (including sleep apnea).

To make sure Genotropin Pen or Genotropin Miniquick is safe for you, tell your doctor if you have:

• cancer (especially during childhood);
• diabetes;
• breathing problems, sleep apnea (breathing stops during sleep);
• a pituitary gland disorder;
• abnormal curvature of the spine (scoliosis);
• underactive thyroid;
• a head injury or brain tumor; or
• childhood brain cancer and radiation treatment.

In some cases, Genotropin should not be used in a child. Certain brands of somatropin contain an ingredient that can cause serious side effects or death in very young infants or premature babies. Do not give this medicine to a child without medical advice.

Tell your doctor if you are pregnant or breastfeeding.

Common side effects of Genotropin may include:

• pain, itching, or skin changes where the medicine was injected;
• swelling, rapid weight gain;
• muscle or joint pain;
• numbness or tingling;
• stomach pain, gas;
• headache, back pain, or
• cold or flu symptoms, stuffy nose, sneezing, sore throat, ear pain.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious Genotropin side effects

Serious breathing problems may occur in patients with Prader-Willi syndrome who use Genotropin injection. If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Also, call your doctor at once if you have:

• pain in your knees or hips, walking with a limp;
• ear pain, swelling, warmth, or drainage;
• numbness or tingling in your wrist, hand, or fingers;
• severe swelling or puffiness in your hands and feet;
• changes in behavior;
• vision problems, unusual headaches;
• changes in the shape or size of a mole;
• pain or swelling in your joints, or onset of a limp or complaints of hip or knee pain
• pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting;
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;
• increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• signs of an adrenal gland problem - extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Genotropin is given as a subcutaneous injection.

Recommend Genotropin doses for:

• Pediatric GHD is 0.16 to 0.24 mg/kg/week
• Prader-Willi syndrome is 0.24 mg/kg/week
• Small for gestational age is up to 0.48 mg/kg/week
• Turner syndrome is 0.33 mg/kg/week
• Idiopathic short stature is up to 0.47 mg/kg/week.
• Adult GHD either a non-weight-based or a weight-based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-I concentrations

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 doctor if you miss more than 3 doses in a row.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

Tell your doctor about all your other medicines, especially:

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

This list is not complete. Other drugs may affect Genotropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Genotropin 12mg, 5mg single-patient-use cartridges:

• Store in refrigerator at 36°F to 46°F (2°C to 8°C) until the expiration date.
• Store in the package to protect from light.
• Do not freeze.

After reconstitution

• Store under refrigeration at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days.
• Store the pen (with the cartridge) with the pen cap on.
• Store in the pen box to protect from light.
• Do not shake.
• Discard the cartridge and any unused medication after 28 days.
• Use a Genotropin Pen 5, a medical device, to reconstitute the 5 mg two-chamber cartridge, and use a Genotropin Pen 12 to reconstitute the 12 mg two-chamber cartridge.

Genotropin Miniquick

• Store under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date.
• If needed, it may be stored for up to 3 months at room temperature at or below 77°F (25°C) before reconstitution.
• Do not freeze.

Genotropin Pfizer Inc, Division - Pharmacia & Upjohn Co, NY, NY 10017.