Norditropin
Pronunciation: Nor-dee-tro-pin
Generic name: somatropin
Brand name: Norditropin FlexPro
Dosage form: injection for subcutaneous use
Drug class: Growth hormones
What is Norditropin?
Norditropin is used to treat growth hormone deficiency (GHD) in adults and children and other growth-related disorders in children. It is given as a subcutaneous (under the skin) injection using the FlexPro pen, usually once a day.
Norditropin (somatropin) is a man-made form of human growth hormone, that is identical to growth hormone made by the human body. It works by replacing missing growth hormone in the body and tells bones, muscles, organs, and other tissues in the body to grow by adding more cells.
Norditropin gained FDA approval on June 20, 2000. Somatropin was originally approved on October 16, 1986.
FDA Approvals and indications
Norditropin is FDA approved to treat:
- children who are not growing because of low or no growth hormone
- children who are short (in stature) and who have Noonan syndrome or Turner syndrome
- children who are short (in stature) because they were born small (small for gestational age-SGA) and have not caught up in growth by age 2 to 4 years
- adults who did not make enough growth hormone when they were children or when they became adults.
Norditropin side effects
The most common side effects of Norditropin include:
- headaches
- muscle pain
- joint stiffness
- high blood sugar (hyperglycemia)
- sugar in your urine (glucosuria)
- pain, itching, or skin changes where the medicine was injected.
Other common side effects include:
- swelling, rapid weight gain;
- numbness or tingling;
- stomach pain, gas;
- back pain;
- cold or flu symptoms, stuffy nose, sneezing, sore throat, ear pain.
Serious side effects and warnings
Norditropin may cause serious side effects, including:
- high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems
- high risk of death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea. Call your doctor right away if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring
- return of tumor or cancerous growths
- high blood sugar (hyperglycemia)
- increase in pressure in the skull (intracranial hypertension). If you have headaches, eye problems, nausea or vomiting, swollen hands and feet due to fluid retention contact your healthcare provider right away
- serious allergic reactions. Get medical help right away if you have the following symptoms:
- swelling of your face, lips, mouth, or tongue
- trouble breathing
- wheezing
- severe itching
- skin rashes, redness, or swelling
- dizziness or fainting
- fast heartbeat or pounding in your chest
- sweating
- decrease in a hormone called cortisol. Your healthcare provider will do blood tests to check your cortisol levels
- decrease in thyroid hormone levels. Your healthcare provider will do blood tests to check your thyroid hormone levels
- hip and knee pain or a limp in children (slipped capital femoral epiphysis)
- worsening of curvature of the spine (scoliosis)
- middle ear infection, hearing problems or ear problems in people with Turner syndrome, redness, itching and tissue
- weakness in the area of the skin you inject
- increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your healthcare provider will do blood tests to check this.
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;
- 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.
These are not all the possible side effects of Norditropin.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Novo Nordisk at 1-888-668-6444.
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Before receiving
Do not use Norditropin if you:
- have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems
- are a child with Prader-Willi syndrome who is severely obese or has breathing problems, including sleep apnea
- have cancer or other tumors
- have certain types of eye problems caused by diabetes
- are a child with closed bone growth plates (epiphyses)
- are allergic to somatropin or any of the ingredients in Norditropin.
Before receiving Norditropin tell your doctor about all your medical conditions including if you have ever had:
- cancer (especially during childhood), a brain tumor, or radiation treatment
- diabetes
- breathing problems, sleep apnea (breathing stops during sleep)
- a pituitary gland disorder
- abnormal curvature of the spine (scoliosis)
- underactive thyroid
- a head injury.
Tell your doctor if you are pregnant or breastfeeding.
How should I use the Norditropin FlexPro Pen?
Read the detailed Instructions for Use that come with Norditropin.
The Norditropin FlexPro Pen is injected under the skin (subcutaneously) of your hips, stomach area (abdomen), buttocks, upper legs (thighs), upper arms, or as otherwise instructed by your healthcare provider.
- It is usually given once daily.
- A healthcare provider can teach you how to properly use the medication by yourself.
- Change the injection site every day to avoid fat loss under the skin (lipoatrophy).
Norditropin comes in 4 different dosage strengths. Your healthcare provider will prescribe the dose that is right for you:
- 5 mg/1.5 mL (orange)
- 10 mg/1.5 mL (blue)
- 15 mg/1.5 mL (green)
- 30 mg/3 mL (purple).
Norditropin FlexPro pens are for use by 1 person only.
- Do not share your Norditropin pen and needles with another person. You may give another person an infection or get an infection from them.
Dosing information
Norditropin should be administered subcutaneously (under the skin).
- Pediatric GHD: 0.024 to 0.034 mg/kg/day, 6 to 7 times a week
- Noonan Syndrome: Up to 0.066 mg/kg/day
- Turner Syndrome: Up to 0.067 mg/kg/day
- SGA: Up to 0.067 mg/kg/day
- Adult GHD: 0.004 mg/kg/day to be increased as tolerated to not more than 0.016 mg/kg/day after approximately 6 weeks, or a starting dose of approximately 0.2 mg/day (range, 0.15 to 0.30 mg/day) increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day.
What happens if I 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 doctor if you miss more than 3 doses in a row.
What happens if I overdose?
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.
What other drugs will affect Norditropin FlexPro Pen?
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)
- certain medications metabolized by cytochrome P450-liver enzymes.
This list is not complete. Other drugs may affect Norditropin FlexPro Pen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
How should I store Norditropin?
Store your new, unused Norditropin pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
- Do not freeze or expose Norditropin to heat.
- Keep Norditropin away from direct light.
- Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC).
- Do not use Norditropin after the expiration date printed on the carton and the pen.
After you use Norditropin FlexPro pens and there is still medicine left:
- Store remaining Norditropin in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or
- Store remaining Norditropin at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks.
Keep Norditropin and all medicines out of the reach of children.
Ingredients
Active ingredient: somatropin
Inactive ingredients: Histidine, Poloxamer 188, Phenol, Mannitol, HCl/NaOH (as needed) and Water for Injection.
Norditropin FlexPro pens are available in the following strengths:
- 5 mg/1.5 mL (orange)
- 10 mg/1.5 mL (blue)
- 15 mg/1.5 mL (green)
- 30 mg/3 mL (purple).
Who makes the Norditropin FlexPro pen?
Norditropin is manufactured by Novo Nordisk, a global pharmaceutical company headquartered in Bagsværd, Denmark (a suburb of Copenhagen). Novo Nordisk is one of the world's largest producers of diabetes medications and treatments, including insulin, but they also produce other pharmaceutical products like Norditropin, which is a brand of human growth hormone (somatropin).
Norditropin Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 11 for Norditropin.
Accretropin (somatropin) - Emergent Biosolutions Canada Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 5 mg/mL Discontinued, Voluntarily Revoked |
View Accretropin information in detail.
Genotropin (somatropin) - Pharmacia & Upjohn Company LLC
Formulation type | Strength |
---|---|
Multi-Dose Cartridge | 12 mg |
Multi-Dose Cartridge | 5 mg |
Pre-Filled Syringe | 0.2 mg |
Pre-Filled Syringe | 0.4 mg |
Pre-Filled Syringe | 0.6 mg |
Pre-Filled Syringe | 0.8 mg |
Pre-Filled Syringe | 1.2 mg |
Pre-Filled Syringe | 1.4 mg |
Pre-Filled Syringe | 1.5 mg Discontinued |
Pre-Filled Syringe | 1.6 mg |
Pre-Filled Syringe | 1.8 mg |
Pre-Filled Syringe | 1 mg |
Pre-Filled Syringe | 2 mg |
View Genotropin information in detail.
Humatrope (somatropin) - Eli Lilly and Company
Formulation type | Strength |
---|---|
Multi-Dose Cartridge | 12 mg |
Multi-Dose Cartridge | 24 mg |
Multi-Dose Cartridge | 6 mg |
Single-Dose Vial | 2 mg Discontinued |
Single-Dose Vial | 5 mg Discontinued |
View Humatrope information in detail.
Norditropin (somatropin) - Novo Nordisk Inc.
Formulation type | Strength |
---|---|
Autoinjector | 10 mg/1.5 mL |
Autoinjector | 15 mg/1.5 mL |
Autoinjector | 30 mg/3 mL |
Autoinjector | 5 mg/1.5 mL |
Multi-Dose Cartridge | 10 mg/1.5 mL Discontinued |
Multi-Dose Cartridge | 15 mg/1.5 mL Discontinued |
Multi-Dose Cartridge | 5 mg/1.5 mL Discontinued |
Nutropin (somatropin) - Genentech, Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 10 mg Discontinued, Voluntarily Revoked |
Multi-Dose Vial | 5 mg Discontinued, Voluntarily Revoked |
View Nutropin information in detail.
Nutropin AQ (somatropin) - Genentech, Inc.
Formulation type | Strength |
---|---|
Autoinjector | 10 mg/2 mL |
Autoinjector | 20 mg/2 mL |
Autoinjector | 5 mg/2 mL |
Multi-Dose Cartridge | 10 mg/2 mL Discontinued |
Multi-Dose Cartridge | 20 mg/2 mL Discontinued |
Vial | 10 mg/2 mL Discontinued |
View Nutropin AQ information in detail.
Omnitrope (somatropin) - Sandoz Inc.
Formulation type | Strength |
---|---|
Multi-Dose Cartridge | 10 mg/1.5 mL |
Multi-Dose Cartridge | 5 mg/1.5 mL |
Multi-Dose Vial | 5.8 mg |
Single-Dose Vial | 1.5 mg Discontinued |
View Omnitrope information in detail.
Saizen (somatropin) - EMD Serono, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 4 mg Discontinued, Voluntarily Revoked |
Single-Dose Vial | 5 mg Discontinued, Voluntarily Revoked |
Single-Dose Vial | 6 mg Discontinued, Voluntarily Revoked |
Single-Dose Vial | 8.8 mg Discontinued, Voluntarily Revoked |
View Saizen information in detail.
Serostim (somatropin) - EMD Serono, Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 4 mg |
Single-Dose Cartridge | 6 mg/0.5 mL Discontinued |
Single-Dose Vial | 5 mg |
Single-Dose Vial | 6 mg |
View Serostim information in detail.
Zomacton (somatropin) - Ferring Pharmaceuticals Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 10 mg |
Multi-Dose Vial | 4.8 mg Discontinued |
Multi-Dose Vial | 5 mg |
View Zomacton information in detail.
Zorbtive/Serostim (somatropin) - EMD Serono, Inc.
Formulation type | Strength |
---|---|
Multi-Dose Vial | 8.8 mg Discontinued |
View Zorbtive/Serostim information in detail.
References
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