Genotropin

Genotropin is a prescription medication used to treat growth failure, short stature, and growth hormone (GH) deficiency in children and adults. Genotropin belongs to a group of drugs called synthetic growth hormone analogues. These work to treat growth failure, short stature, and growth hormone deficiency by mimicking the effects of natural growth hormone in the body.

This medication is available in an injectable form to be given directly under the skin (subcutaneously), typically on a daily basis.

Common side effects of Genotropin include joint pain, swelling of extremities, and upper respiratory tract infections.

Genotropin is a prescription medication used in the treatment of growth hormone deficiency in children and adults due to several different medical conditions, growth failure associated with Turner syndrome in children, growth failure associated with Prader-Willi syndrome in children, short stature of unknown cause in children, growth failure in small for gestational age (SGA) children, and both adult-onset and childhood-onset hypopituitarism.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pfizer U.S. Pharmaceuticals Group

• Pharmacia and Upjohn Company

• Pharmacia, Inc.

Serious side effects have been reported with Genotropin. See the “Genotropin Precautions” section.

Common side effects of Genotropin include the following:

• joint pain
• muscle pain
• swelling of extremities
• stiffness of extremities
• joint pain
• extremity pain 
• headache
• upper respiratory tract infections

This is not a complete list of Genotropin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• insulin
• cyclosporine
• nelfinavir
• flibanserin
• ulipristal
• simeprevir
• hypoglycemic agents; if you are unsure if you are taking any of these medications, consult with your pharmacist
• corticosteroid medications; if you are unsure if you are taking any of these medications, consult with your pharmacist
• oral estrogen-containing medications; if you are unsure if you are taking any of these medications, consult with your pharmacist

This is not a complete list of Genotropin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Genotropin including the following: 

• Reduced insulin sensitivity. Treatment with Genotropin has been associated with reduced insulin sensitivity. Your physician may monitor your blood glucose levels periodically during treatment with Genotropin. Be sure to inform your physician if you have diabetes before beginning therapy with Genotropin. 
• Increased blood pressure inside your head. Increased blood pressure within the skull, also known as intracranial hypertension, has been reported in a small number of patients treated with Genotropin. Patients with Turner syndrome may be at an increased risk for this. Consult with your physician about your risk for developing intracranial hypertension before beginning treatment with Genotropin.
• Pancreatitis. There is a slightly increased risk of developing pancreatitis during therapy with Genotropin. Females with Turner syndrome maybe at an even greater risk than others treated with Genotropin. Consult with your physician about your level of risk for developing pancreatitis during treatment with Genotropin.
• Progression of pre-existing scoliosis in children. Children with pre-existing scoliosis may experience disease progression during treatment with Genotropin. Pediatric patients with a history of scoliosis should be carefully monitored by a physician during the entire course of treatment with Genotropin.
• Increased risk of ear infections and heart problems in the setting of Turner syndrome. Patients with Turner syndrome have shown to have a higher risk of ear infections and heart problems while taking Genotropin. Be sure to inform your physician if you have a history of heart problems before beginning therapy with Genotropin.
• Increased risk of cancer. An increased risk of cancer has been observed in pediatric patients using Genotropin who have previously had cancer and were treated with radiation. If you or your child is a cancer survivor who was treated with radiation, be sure to inform your physician before beginning treatment with Genotropin.
• Leg bone problems in children. Children treated with Genotropin and undergoing rapid growth may experience certain leg bone problems. If you or your child begins to limp or complains of hip and/or knee pain during treatment with Genotropin, inform your physician.
• Reduced effectiveness of Genotropin in the setting of hypothyroidism. If you have hypothyroidism, Genotropin may not be as effective for you. Be sure to inform your physician if you have hypothyroidism before beginning your treatment with Genotropin.
• Complications following open heart surgery, abdominal surgery, trauma, and/or acute respiratory failure. Increased mortality has been observed in patients using Genotropin who have acute critical illness including those who have had open heart surgery, abdominal surgery, trauma, and/or acute respiratory failure. The potential benefits of treatment with Genotropin should be weighed against the increased risks in these situations.
• Increased risk of mortality in pediatric patients with Prader-Willi syndrome. There have been reports of fatalities after initiating treatment with Genotropin in pediatric patients with Prader-Willi syndrome. The potential benefits of treatment with Genotropin should be weighed against the increased risks in the setting of pediatric Prader-Willi syndrome. 

Do not take Genotropin if you:

• are allergic to Genotropin or to any of its ingredients
• have recently had open heart surgery, abdominal surgery, multiple accidental trauma, and/or acute respiratory failure
• have Prader-Willi syndrome, are obese, and have a history of upper airway obstruction and/or sleep apnea
• have any type of active cancer
• have diabetic eye disease 
• have closed growth plates

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Genotropin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Genotropin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Genotropin or to any of its ingredients
• have scoliosis
• have high blood pressure
• have any type of active cancer
• have ever had a stroke
• have recently had open heart surgery, abdominal surgery, multiple accidental trauma, and/or acute respiratory failure
• have Prader-Willi syndrome
• have had any bone fractures or other bone problems in your hips and/or legs
• have diabetic eye disease
• have pancreatitis
• have diabetes
• have hypothyroidism
• are breastfeeding or plan to breastfeed
• are pregnant or plan to become pregnant

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Genotropin falls into category B. There are no well-done studies that have been done in humans with Genotropin. In animal studies, pregnant animals were given this medication, and the babies did not show any major medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Genotropin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Genotropin.

Take Genotropin exactly as prescribed.

Genotropin is available in an injectable form to be given directly under the skin (subcutaneously), typically on a daily basis.

Do not inject Genotropin until you have been thoroughly trained in the proper techniques by your doctor. Always exactly follow your physician's instructions on injection of Genotropin. For additional information on proper administration, you may refer to the following section:

Preparation

• Wash your hands well with soap and water before using Genotropin

Attaching the Needle        

1. Pull off the front cap 
2. Unscrew the metal front part from the plastic body 
3. Peel off the foil from the needle
4. Push and screw the needle onto the metal front part of the pen

Inserting the Two-Chamber Cartridge of Genotropin       

1. Open the cartridge pack and take out a cartridge
2. Check that the color on the cartridge matches the color around the plastic body window 
3. Hold the metal front part upright, and insert the cartridge metal cap first
4. Push the cartridge firmly into place

Preparing the Pen           

1. Press the red release button; the injection button will pop-up 
2. Turn the injection button as far as it will go in the opposite way to the arrows on the injection button; this will draw back the plunger rod 
3. Check that the plunger rod is not visible through the window; do not proceed if the plunger rod is visible, as the medication will not be properly mixed

Mixing your Genotropin          

1. Make sure that a needle is attached to the metal front part
2. While holding your pen upright, gently screw the metal front part and the plastic body back together; this mixes the liquid and the powder 
3. Gently tip the pen from side to side to help dissolve the powder completely 
4. Do not shake your pen, as this might stop the growth hormone working; check that the solution is clear in the cartridge window
5. If you see particles, or if the solution is not clear, do not inject it; instead, remove the cartridge and use a new one

Releasing Trapped Air           

1. Remove both the outer needle cover and inner needle cap
2. Dispose of the inner needle cap; be careful not to touch the exposed needle
3. Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body 
4. Hold your pen with the needle pointing upwards
5. Gently tap the metal front part with your finger to move any air bubbles to the top
6. Push the injection button all the way in; you will see a drop of liquid appear at the needle tip; any trapped air has now been released 
7. If no liquid appears, press the red release button, then turn the injection button in the direction of the arrow until it clicks once

Fitting the Needle Guard      

1. The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury; you can choose to use the needle guard, if desired
2. Grip the sides of the needle guard, push it over the needle until it snaps in place; never push the needle guard on the end
3. Be careful not to touch the exposed needle

Dialing Up Your Prescribed Dose

1. Press the red release button to reset your pen; the button will pop-up and the dose display window will read '0.0'
2. Turn the injection button (in the direction of the arrow) until your prescribed dose is displayed
3. If you turn the button too far, turn it back the other way until your correct dose is displayed

Injecting your Genotropin           

1. Choose and prepare an appropriate injection area, as directed by your healthcare provider
2. Firmly pinch a fold of skin at the injection area
3. Push needle fully into the skin fold at a 90° angle
4. Push the injection button until it clicks; wait at least 5 seconds, and then withdraw the needle from the skin; this makes sure the entire dose has been injected 

Discarding the Needle and Storing the Genotropin         

1. Pull off the needle guard, gripping the sides; be careful not to push on the end 
2. Remove the needle as instructed by your healthcare provider, and discard it in a proper disposal container; never reuse a needle
3. Push on the front cap, and put your pen back in its protective case
4. Store your pen (with cartridge) in the refrigerator [36°F to 46°F (2°C to 8°C)] until your next injection

Replacing the Cartridge          

1. Press the red release button to reset your pen 
2. Turn the injection button (in the opposite direction to the arrow on the injection button) as far as it will go; this will draw back the plunger rod
3. Unscrew the metal front part and remove the empty cartridge
4. Discard the empty cartridge as instructed by your healthcare provider
5. To insert a new cartridge and prepare your pen for reuse

Disposing of used Needles, cartridges and your Genotropin

• Your healthcare provider will instruct you on how to discard your used needles and other medical waste in an appropriate puncture resistant disposal container such as sharps (medical waste) container. You may also contact your local health department for more information. There may be special state or local laws for properly disposing of used needles, other medical waste and sharps containers.
• Do not throw needles or sharps containers in the household trash without first checking your state and local laws
• Do not recycle the sharps container
• Always keep your sharps container in a safe place and out of reach of children

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Genotropin at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

The recommended dose of Genotropin for the treatment of pediatric growth failure due to Prader-Willi syndrome is 0.24 mg per kilogram of body weight divided into 6-7 doses per week injected subcutaneously.

The recommended dose range of Genotropin for the treatment of pediatric idiopathic short stature is up to 0.47 mg per kilogram of body weight divided into 6-7 doses per week injected subcutaneously.

If you take too much Genotropin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store your pen (with cartridge) in the refrigerator at 36°F to 46°F (2°C to 8°C)
• Do not freeze
• Keep this and all medicines out of the reach of children