Norditropin Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Norditropin Injection contains somatropin, a recombinant human growth hormone identical to the hormone naturally made by the body. It is used to treat growth failure and short stature in children due to various causes, as well as growth hormone deficiency in adults. It comes as a clear, colorless liquid in prefilled dial-a-dose pens injected under the skin.

What is Norditropin Injection

Norditropin is a prescription medicine that contains human growth hormone, identical to the growth hormone made by the human body. It comes as a clear, colorless liquid in prefilled dial-a-dose pens for injection under the skin.

Norditropin Injection uses

• Growth failure in children due to low or no growth hormone (growth hormone deficiency)
• Short stature in children with Noonan syndrome
• Short stature in children with Turner syndrome
• Short stature in children born small for gestational age (SGA) who have not caught up in growth by age 2 to 4 years
• Idiopathic Short Stature (ISS) in children
• Growth failure due to Prader-Willi syndrome (PWS) in children
• Growth hormone deficiency in adults (adult onset or childhood onset)

Benefits of Norditropin Injection

• Helps children with growth hormone problems grow taller
• Promotes catch-up growth in children born small for gestational age
• Helps restore more normal growth hormone levels in adults who do not make enough
• Can improve body composition in adults by increasing lean body mass and decreasing body fat

How Norditropin Injection works

Norditropin contains a man-made version of human growth hormone that is identical to the hormone your body naturally produces. It attaches to growth hormone receptors on cells, which triggers the body to make more of a substance called IGF-1. This leads to growth of bones and muscles in children, and affects how the body builds protein, uses sugar, and breaks down fat.

Norditropin Injection dosage

Your doctor will tell you how much Norditropin to use; this depends on factors such as body weight and body surface area. Inject under the skin in the evening, 6 or 7 days per week. Injection sites should be rotated (for example between the stomach area, buttocks, upper legs, or upper arms) to help prevent damage to the fat and tissue under the skin.

Use a new needle for each injection; do not share your pen or needles with anyone else, even if the needle is changed. Check that the liquid is clear and colorless before each injection; do not use it if it looks cloudy or contains particles. Do not shake the pen vigorously at any time.

If you miss a dose at the usual time, give the next dose as normal the next evening; do not inject extra to make up for a missed dose. Do not stop using this medicine or change the dose without first checking with your doctor. Older adults may be started on a lower dose with smaller increases than younger adults, since they may be more sensitive to side effects.

Available forms and strengths

• Prefilled pen (FlexPro) for injection under the skin, available in 5 mg/1.5 mL (orange), 10 mg/1.5 mL (blue), and 15 mg/1.5 mL (green) strengths
• Prefilled pen (NordiFlex) for injection under the skin, available in 5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL, and 30 mg/3 mL strengths
• Cartridges for use with NordiPen delivery devices, in 5 mg/1.5 mL and 15 mg/1.5 mL strengths

Side effects of Norditropin Injection

Common

• Headache
• Abnormal sensation, tingling, or burning (paraesthesia)
• Bone pain or stiffness
• Muscle pain or stiffness (myalgia, arthralgia)
• Fluid retention (swelling of hands and feet)
• Carpal tunnel syndrome
• Redness and itching around the injection site
• High blood sugar (hyperglycemia)
• Sugar in the urine (glucosuria)
• Upper respiratory infection, fever, sore throat, ear infection, flu-like symptoms

Serious

• Severe allergic reaction (rash, wheezing, swelling of eyelids/face/lips, trouble breathing, complete collapse)
• Increased pressure in the skull (intracranial hypertension) causing headaches, vision problems, nausea or vomiting
• Return or growth of tumors, including a possible increased risk of a second cancer in childhood cancer survivors treated with head/brain radiation
• New or worsening high blood sugar or diabetes
• Decreased thyroid hormone levels (hypothyroidism)
• Decreased cortisol levels (hypoadrenalism)
• Hip or knee pain or limping in children (slipped capital femoral epiphysis), which can lead to bone tissue death (osteonecrosis)
• Worsening curvature of the spine (scoliosis)
• Severe, persistent abdominal pain, which could be a sign of pancreatitis
• Loss of fat and tissue weakness at the injection site (lipoatrophy)
• Middle ear infection or hearing problems, especially in patients with Turner syndrome
• High risk of death in people with critical illness after heart or stomach surgery, trauma, or serious breathing problems
• High risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems

Warnings and precautions

• Do not use this medicine if you have a critical illness following heart or stomach surgery, major trauma, or serious breathing problems, as it has been linked to a higher risk of death in this situation.
• Do not use this medicine in children with Prader-Willi syndrome who are severely obese or have severe breathing problems, including sleep apnea, because of reports of sudden death.
• Do not use if you have active cancer or another tumor that has not finished treatment, since growth hormone can affect tumor growth.
• Do not use if you have certain severe eye problems caused by diabetes (diabetic retinopathy).
• This medicine should not be used in children whose bone growth plates have already closed.
• Do not use if you are allergic to somatropin or any ingredient in this medicine.
• This medicine may increase pressure in the skull, usually within the first 8 weeks of treatment; your doctor should check your eyes before and during treatment.
• This medicine can decrease insulin sensitivity and may unmask previously undiagnosed diabetes; blood sugar should be checked periodically during treatment.
• Never share your pen or needles with another person, even if you change the needle, because this could spread infection.
• Cases of inflammation of the pancreas (pancreatitis) have been reported; seek medical care for severe, persistent stomach pain.
• Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine could harm an unborn baby, and it should only be used during pregnancy if clearly needed.
• It is not known if this medicine passes into breast milk. Talk with your doctor to decide together whether you should use this medicine while breastfeeding.
• If you have kidney problems, your doctor will closely monitor your kidney function during treatment, and may need to stop the medicine if kidney function declines.
• Be careful before driving or using machines or tools until you know how this medicine affects you.

Storage

• Store unused pens in a refrigerator between 36°F to 46°F (2°C to 8°C), in the outer carton to protect from light
• Do not freeze. Do not use if the medicine has been frozen
• Do not store directly next to the refrigerator cooling element
• Keep away from direct light and heat
• Do not use after the expiration date printed on the carton and the pen
• After the first injection, either keep the pen refrigerated (36°F to 46°F / 2°C to 8°C) and use within 4 weeks, or keep it at room temperature no warmer than 77°F (25°C) and use within 3 weeks (some strengths must stay refrigerated after first use - check your specific pen's instructions)
• Throw away any unused medicine after the in-use storage period ends
• Keep out of the reach and sight of children
• Dispose of used needles right away in a puncture-resistant sharps container; do not throw loose needles in household trash

When to see a doctor

• Get medical help right away if you notice signs of a serious allergic reaction, such as swelling of the face, lips, mouth or tongue, trouble breathing, wheezing, severe itching, skin rash or redness, dizziness, fainting, or a fast or pounding heartbeat.
• Contact your doctor right away if you or your child has severe or recurring headaches, vision problems, nausea, or vomiting, as these may be signs of increased pressure around the brain.
• Get medical help right away if your child develops a limp or complains of hip or knee pain, which could be a sign of a serious bone problem.
• Tell your doctor right away if you or your child develops new or severe, persistent abdominal pain, as this could signal inflammation of the pancreas.
• Contact your healthcare provider if you have darkening of the skin, severe fatigue, dizziness, weakness, or unexplained weight loss, which could indicate low cortisol levels.
• If you think you have used too much of this medicine, contact your doctor or go to the emergency department right away, even if you feel fine.
• Tell your doctor if you notice marked changes in behavior, new headaches, vision changes, or changes in skin pigmentation or in the appearance of moles, as these could be signs of tumor-related problems.

Alternatives

• Genotropin
• Humatrope
• Omnitrope