Humatrope

Humatrope is a prescription medication used to treat growth failure, short stature, and growth hormone (GH) deficiency in children and adults. Humatrope belongs to a group of drugs called synthetic growth hormone analogues. These drugs 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 into a muscle (intramuscularly) or under the skin (subcutaneously), typically on a daily basis.

Common side effects of Humatrope include injection site reactions, headache, and bone pain.

Humatrope is a prescription medication used in the treatment of growth hormone deficiency in children and adults, short stature associated with Turner syndrome in children, short stature of unknown cause in children, short stature and/or growth failure due to short stature homeobox-containing gene deficiency (SHOX) in children, 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.

• Lilly, Eli & Company

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

Common side effects of Humatrope include the following:

• injection-site reactions
• joint pain
• muscle pain
• swelling of extremities
• carpal tunnel syndrome
• bone pain
• extremity pain and/or stiffness
• headache
• ear infections

This is not a complete list of Humatrope 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:

• 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
• insulin
• hypoglycemic agents; if you are unsure if you are taking any of these medications, consult with your pharmacist
• nelfinavir
• flibanserin
• simeprevir

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

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

• Complications following open heart surgery, abdominal surgery, trauma, and/or acute respiratory failure. Increased mortality has been observed in patients using Humatrope 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 Humatrope 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 Humatrope in pediatric patients with Prader-Willi syndrome. The potential benefits of treatment with Humatrope should be weighed against the increased risks in the setting of pediatric Prader-Willi syndrome. 
• Increased risk of cancer. An increased risk of cancer has been observed in pediatric patients using Humatrope 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 Humatrope.
• Reduced insulin sensitivity. Treatment with Humatrope has been associated with reduced insulin sensitivity. Your physician may monitor your blood glucose levels periodically during treatment with Humatrope. Be sure to inform your physician if you have diabetes before beginning therapy with Humatrope. 
• Increased blood pressure inside your head. Increase blood pressure within the skull, also known as intracranial hypertension, has been reported in a small number of patients treated with Humatrope. 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 Humatrope.
• Reduced effectiveness of Humatrope in the setting of hypothyroidism. If you have hypothyroidism, Humatrope may not be as effective for you. Be sure to inform your physician if you have hypothyroidism before beginning your treatment with Humatrope.
• Leg bone problems in children. Children treated with Humatrope 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 Humatrope, inform your physician.
• Progression of pre-existing scoliosis in children. Children with pre-existing scoliosis may experience disease progression during treatment with Humatrope. Pediatric patients with a history of scoliosis should be carefully monitored by a physician during the entire course of treatment with Humatrope.
• Pancreatitis. There is a slightly increased risk of developing pancreatitis during therapy with Humatrope. Females with Turner syndrome maybe at an even greater risk than others treated with Humatrope. Consult with your physician about your level of risk for developing pancreatitis during treatment with Humatrope.

Do not take Humatrope if you:

• are allergic to Humatrope or to any of its ingredients
• have recently had open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure
• have Prader-Willi syndrome
• have any type of active cancer
• have diabetic eye disease 

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 Humatrope, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Humatrope or to any of its ingredients
• have ever had a stroke
• have diabetes
• have hypothyroidism
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have any type of active cancer
• have diabetic eye disease
• have pancreatitis
• have scoliosis
• 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 high blood pressure

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.

Humatrope falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Humatrope should be given to a pregnant woman only if clearly needed.

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

It is not known if Humatrope 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 Humatrope.

Take Humatrope exactly as prescribed.

Humatrope is available in an injectable form to be given directly into a muscle (intramuscularly) or under the skin (subcutaneously), typically on a daily basis.

Do not mix (reconstitute) Humatrope or inject it until you have been thoroughly trained in the proper techniques by your doctor. Use sterile techniques as instructed by your doctor. Destroy and discard syringes and/or needles after each use. 

Reconstitute Humatrope only with Diluent for Humatrope. Do not use other solutions for reconstitution unless instructed to do so by your doctor. Your doctor will also tell you what size syringe and needle to use and how much diluent to add to the vial of Humatrope. 

Always exactly follow your physician's instructions on injection of Humatrope. For additional information on proper administration, you may refer to the following section:

Reconstitution

1. Start by washing your hands
2. Remove and discard plastic caps from tops of vials of diluent and Humatrope
3. Wipe tops of both vials with an alcohol swab
4. Remove needle cover
5. Pull back on syringe plunger to draw up an amount of air equal to the amount of diluent your doctor has prescribed
6. Insert needle in stopper of diluent vial, and inject air into vial
7. Hold vial upside down and, making sure needle tip remains in solution, withdraw the amount of diluent your doctor has prescribed
8. After making sure that no air bubbles are in the syringe, turn vial upright and, holding barrel, remove syringe
9. Insert same needle into vial of Humatrope and gently aim needle tip toward wall of vial
10. Slowly inject the diluent by aiming the stream of liquid against the wall of vial; do not aim it at the white powder at the bottom of the vial
11. To equalize the pressure, withdraw a volume of air equal to the amount of diluent added before removing the syringe from the vial
12. If the needle can be removed from the barrel of the syringe, remove, destroy, and discard the needle; if the needle and syringe are made as 1 unit, destroy and discard the entire unit
13. Swirl the vial with a gentle rotary motion until contents are completely dissolved); do not shake

Preparing the Injection

1. Do not use reconstituted Humatrope if it is cloudy or contains particles; if the needle can be removed from the type of syringe you are using, a new needle should be placed on the syringe before the injection; if the syringe and needle are made as 1 unit, another unit should be used for the injection
2. Before and after injection, the rubber stopper of the vial should be wiped with rubbing alcohol or an alcoholic antiseptic solution to prevent contamination of the contents by repeated needle insertions
3. Remove the needle cover and draw an amount of air into the syringe equal to your dose of Humatrope
4. Insert needle into vial of reconstituted Humatrope and inject the air into the vial
5. Turn the vial upside down, and, making sure needle tip is in solution, withdraw your correct dose; make sure that no air bubbles are in the syringe
6. Remove syringe and replace needle cover
7. Write date of reconstitution on vial label, and discard unused diluent
8. Return unused portion of reconstituted Humatrope to refrigerator and use within 14 days
9. Destroy needle or the needle and syringe after use

Injecting Humatrope

1. Gently tap injection site several times with fingers
2. Wipe the area thoroughly with an alcohol swab; use a circular motion and work outward from the inside of the circle

• Subcutaneous Injection: With the thumb and forefinger, stabilize the skin by spreading or pinching up a large area of skin

1. Holding the syringe at a 90-degree angle to injection site, quickly insert the needle all the way into the skin
2. Slowly inject the solution
3. Remove the needle quickly, and apply pressure over the injection site with a dry gauze pad or cotton ball
4. Rub for several seconds
5. Destroy needle or needle and syringe after use

• Intramuscular Injection: With the thumb and first 2 fingers, press the skin down firmly against a large muscle mass, such as the thigh

1. Holding the syringe at a 90-degree angle to injection site, quickly insert the needle all the way into the skin
2. When the needle is in place, slowly pull back on the plunger, if blood enters the syringe, remove needle, discard syringe and drug, and prepare another injection
3. If no blood enters the syringe, slowly inject the solution
4. Remove the needle quickly, and apply pressure over the injection site with a dry gauze pad or cotton ball
5. Rub for several seconds
6. Destroy needle or needle and syringe after use

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 Humatrope 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 range of Humatrope for the treatment of pediatric growth hormone deficiency is 0.026 mg - 0.043 mg per kilogram of body weight per day injected intramuscularly or subcutaneously.

The recommended dose range of Humatrope for the treatment of pediatric Turner syndrome is up to 0.054 mg per kilogram of body weight per day intramuscularly or subcutaneously.

The recommended dose range of Humatrope for the treatment of pediatric idiopathic short stature is up to 0.053 mg per kilogram of body weight per day intramuscularly or subcutaneously.

The recommended dose of Humatrope for the treatment of pediatric SHOX deficiency is 0.050 mg per kilogram of body weight per day intramuscularly or subcutaneously.

The recommended dose range of Humatrope for the treatment of pediatric small for gestational age syndrome (SGA) is up to 0.067 mg per kilogram of body weight per day intramuscularly or subcutaneously.

The recommended dose range of Humatrope for the treatment of adult growth hormone deficiency is 0.15 mg - 0.3 mg per day injected intramuscularly or subcutaneously, with monthly increases of 0.1 mg - 0.2 mg per day at the discretion of the supervising physician.

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