Norditropin nordiflex package insert

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Read the Norditropin NordiFlex package insert to learn about the dosage, administration, and possible side effects of this growth hormone medication. Get all the important information you need before starting treatment.

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Norditropin NordiFlex Package Insert

Norditropin NordiFlex Package Insert Instructions

Introduction

Norditropin NordiFlex is a prescription medicine that contains somatropin, a growth hormone. It is used to treat growth failure in children and adults who lack natural growth hormone. This package insert provides important information on how to use Norditropin NordiFlex correctly.

Important Safety Information

Norditropin NordiFlex should not be used if you have a critical illness caused by certain types of heart or stomach surgery, trauma, or breathing problems.
Do not use Norditropin NordiFlex if you have active cancer or if you are allergic to any of its ingredients.
Inform your healthcare provider if you have a history of diabetes, thyroid problems, or kidney or liver disease.
Follow all instructions provided by your healthcare provider regarding the proper use and storage of Norditropin NordiFlex.

Instructions for Use

Step 1: Preparing for Injection

Wash your hands thoroughly with soap and water.
Clean the injection site with an alcohol swab and let it dry.
Take the Norditropin NordiFlex pen out of the refrigerator and remove the protective cap.

Step 2: Setting the Dose

Each Norditropin NordiFlex pen contains a dial that allows you to set the desired dose. Follow these steps to set the dose:

Hold the pen with the needle pointing up.
Turn the dose selector until the dose indicator shows the desired dose.
Check that the dose selector is set correctly.

Step 3: Injecting the Dose

Follow these steps to inject the dose:

Pinch the injection site to create a fold of skin.
Insert the needle into the fold of skin at a 90-degree angle.
Push the dose button all the way in until the dose indicator returns to zero.
Keep the needle in the skin for at least 6 seconds to ensure the full dose is delivered.
Remove the needle from the skin and dispose of it properly.

Step 4: After the Injection

Replace the protective cap on the Norditropin NordiFlex pen.
Dispose of the used needles and pens in a sharps container.
Wash your hands thoroughly after handling the pen and needles.

Storage and Handling

Store Norditropin NordiFlex in the refrigerator at a temperature between 36°F and 46°F (2°C and 8°C). Do not freeze. Keep the pen in the outer carton to protect it from light. Do not use Norditropin NordiFlex after the expiration date printed on the label.

Conclusion

It is important to carefully follow the instructions provided in this package insert when using Norditropin NordiFlex. If you have any questions or concerns, consult your healthcare provider for further guidance.

What is Norditropin NordiFlex?

Norditropin NordiFlex is a prescription medication that contains somatropin, a synthetic form of human growth hormone (HGH). It is used to treat growth hormone deficiency in both children and adults.

Somatropin is a hormone that is naturally produced by the pituitary gland in the brain. It plays a crucial role in growth and development, as well as maintaining healthy body composition and metabolism.

Norditropin NordiFlex is available in a pre-filled pen device that allows for easy and convenient administration of the medication. The pen is designed to deliver a specific dose of somatropin, making it simple to use for patients of all ages.

It is important to note that Norditropin NordiFlex should only be used under the supervision of a healthcare professional who is experienced in the diagnosis and treatment of growth hormone deficiency. The dosage and duration of treatment will be determined by the healthcare provider based on individual patient needs.

Norditropin NordiFlex is just one brand of somatropin available on the market. Other brands may have different pen devices or packaging, but they all contain the same active ingredient, somatropin.

Overall, Norditropin NordiFlex is a convenient and effective treatment option for individuals with growth hormone deficiency, helping to restore normal growth and development.

Indications and Usage

Norditropin NordiFlex is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH) and adults with either adult-onset or childhood-onset GH deficiency.

Pediatric Patients

Norditropin NordiFlex is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH). The diagnosis of growth hormone deficiency (GHD) should be confirmed before initiating treatment. The diagnosis should be based on clinical features, such as short stature, low growth velocity, and delayed bone age, as well as biochemical markers of GH deficiency.

Norditropin NordiFlex should be used in pediatric patients whose epiphyses are not closed and should be discontinued once the epiphyses have closed.

Adult Patients

Norditropin NordiFlex is indicated for the replacement of endogenous GH in adults with either adult-onset or childhood-onset GH deficiency. The diagnosis of adult GH deficiency should be confirmed by an appropriate GH stimulation test.

Adult patients with childhood-onset GH deficiency should be reevaluated for growth hormone secretion in adulthood before initiating treatment with Norditropin NordiFlex.

Limitations of Use

The safety and effectiveness of Norditropin NordiFlex in the treatment of patients with Prader-Willi syndrome, Turner syndrome, or chronic renal insufficiency have not been established. Treatment with Norditropin NordiFlex should be discontinued in patients with Prader-Willi syndrome who develop severe respiratory impairment.

Dosage and Administration

General Dosing Information

The dosage and administration of Norditropin NordiFlex should be individualized based on the growth response of each patient.

The recommended dose of Norditropin NordiFlex for pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone is 0.024 to 0.034 mg/kg of body weight per day, administered as a subcutaneous injection.

The recommended dose of Norditropin NordiFlex for pediatric patients with Turner syndrome is 0.045 to 0.067 mg/kg of body weight per day, administered as a subcutaneous injection.

The recommended dose of Norditropin NordiFlex for pediatric patients with Prader-Willi syndrome is 0.035 mg/kg of body weight per day, administered as a subcutaneous injection.

The recommended dose of Norditropin NordiFlex for pediatric patients with short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years is up to 0.067 mg/kg of body weight per day, administered as a subcutaneous injection.

The recommended dose of Norditropin NordiFlex for pediatric patients with idiopathic short stature is up to 0.067 mg/kg of body weight per day, administered as a subcutaneous injection.

The recommended dose of Norditropin NordiFlex for adult patients with growth hormone deficiency is 0.004 to 0.016 mg/kg of body weight per day, administered as a subcutaneous injection.

Administration Instructions

Norditropin NordiFlex should be administered once daily in the evening or divided into smaller doses and administered twice daily.

The injection site should be rotated to avoid lipoatrophy.

The injection should be given subcutaneously into the thigh, buttock, or abdomen.

Patients should be instructed on proper injection technique and should be supervised by a healthcare professional until proper administration is established.

Reconstitution and Storage

Norditropin NordiFlex should not be reconstituted or mixed with any other solution.

After reconstitution, Norditropin NordiFlex should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) and used within 28 days.

Do not freeze or expose to heat.

Missed Dose

If a dose of Norditropin NordiFlex is missed, it should be administered as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule should be resumed.

Monitoring

Patients receiving Norditropin NordiFlex should be monitored regularly by a healthcare professional to assess growth response, evaluate thyroid function, and monitor for the development of antibodies to growth hormone.

Disposal

Used Norditropin NordiFlex pens should be disposed of in accordance with local regulations.

Contraindications

Norditropin NordiFlex is contraindicated in patients with:

Active malignancy
Diabetic retinopathy
Acute critical illness
Hypersensitivity to somatropin or any of the excipients

It is important to note that the safety and efficacy of Norditropin NordiFlex in patients with Prader-Willi syndrome, Turner syndrome, or chronic renal insufficiency have not been established.

Patients with evidence of active malignancy should not be treated with Norditropin NordiFlex. Growth hormone deficiency may be an early sign of an underlying tumor, and the use of growth hormone in patients with active malignancy should be carefully evaluated.

Diabetic retinopathy is a contraindication for treatment with Norditropin NordiFlex. Growth hormone has been shown to increase the risk of progression of diabetic retinopathy, and therefore, patients with this condition should not be treated with Norditropin NordiFlex.

Acute critical illness is also a contraindication for treatment with Norditropin NordiFlex. Patients with acute critical illness, such as those with complications following open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure, should not receive growth hormone therapy.

Patients with a known hypersensitivity to somatropin or any of the excipients of Norditropin NordiFlex should not receive treatment with this medication. Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported in patients receiving growth hormone therapy.

It is important for healthcare providers to carefully evaluate patients for these contraindications before initiating treatment with Norditropin NordiFlex.

Warnings and Precautions

Before using Norditropin NordiFlex, it is important to be aware of the following warnings and precautions:

Allergic Reactions: Some individuals may experience allergic reactions to Norditropin NordiFlex. If you notice any signs of an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing, seek medical attention immediately.
Diabetes: Norditropin NordiFlex may affect blood sugar levels, so it is important to closely monitor blood glucose levels in individuals with diabetes. Adjustments to diabetes medication may be necessary.
Intracranial Hypertension: Rare cases of intracranial hypertension, characterized by severe headache, visual changes, nausea, and vomiting, have been reported in individuals using growth hormone. If these symptoms occur, a thorough examination should be conducted to rule out intracranial hypertension.
Prader-Willi Syndrome: Individuals with Prader-Willi syndrome may be at an increased risk of developing breathing problems while using Norditropin NordiFlex. Regular monitoring of respiratory function is recommended.
Neoplasms: There have been reports of increased risk of neoplasms, including leukemia and relapse of preexisting malignancies, in individuals treated with growth hormone. Close monitoring for signs of neoplasms is advised.
Fluid Retention: Norditropin NordiFlex may cause fluid retention, particularly in adults. This can lead to swelling in the extremities and may exacerbate existing conditions such as heart failure. If symptoms of fluid retention occur, consult a healthcare professional.
Hypothyroidism: Growth hormone therapy may unmask previously undiagnosed central (secondary) hypothyroidism or worsen existing hypothyroidism. Regular thyroid function monitoring is recommended.
Interactions with Other Medications: Norditropin NordiFlex may interact with certain medications, including glucocorticoids and insulin. It is important to inform your healthcare provider about all medications you are taking to avoid potential interactions.

These warnings and precautions are not exhaustive. It is important to read the full package insert and consult with a healthcare professional before using Norditropin NordiFlex.

Adverse Reactions

The most common adverse reactions reported during treatment with Norditropin NordiFlex include:

Injection site reactions, such as pain, redness, or swelling
Headache
Local allergic reactions, such as rash or hives
Fluid retention
Muscle or joint pain
Increased blood sugar levels
Increased levels of liver enzymes
Enlargement of the breasts in males
Unusual tiredness or weakness
Abnormal growth of hands or feet
Increased pressure in the skull (intracranial hypertension)

If any of these adverse reactions persist or worsen, or if you experience any other unusual or severe side effects, contact your healthcare provider immediately.

It is important to note that this is not a complete list of all possible adverse reactions associated with Norditropin NordiFlex. Consult your healthcare provider or refer to the full prescribing information for a comprehensive list.

Adverse Reactions Reported in Clinical Trials

System Organ Class
Adverse Reaction

General disorders and administration site conditions	Injection site reactions, such as pain, redness, or swelling
Nervous system disorders	Headache
Immune system disorders	Local allergic reactions, such as rash or hives
Metabolism and nutrition disorders	Fluid retention
Musculoskeletal and connective tissue disorders	Muscle or joint pain
Endocrine disorders	Increased blood sugar levels
Hepatobiliary disorders	Increased levels of liver enzymes
Reproductive system and breast disorders	Enlargement of the breasts in males
General disorders and administration site conditions	Unusual tiredness or weakness
Endocrine disorders	Abnormal growth of hands or feet
Nervous system disorders	Increased pressure in the skull (intracranial hypertension)

Drug Interactions

Concomitant use of Norditropin NordiFlex with other drugs may lead to drug interactions. It is important to inform your healthcare provider about all the medications you are currently taking, including prescription drugs, over-the-counter drugs, and herbal supplements.

Drugs that may increase the effect of Norditropin NordiFlex:

Corticosteroids: Co-administration of Norditropin NordiFlex with corticosteroids may increase the risk of fluid retention and edema.
Estrogens: Estrogens may increase the effect of Norditropin NordiFlex by increasing the sensitivity of growth plates to growth hormone.
Insulin and other antidiabetic drugs: The dosage of insulin and other antidiabetic drugs may need to be adjusted when used concomitantly with Norditropin NordiFlex.

Drugs that may decrease the effect of Norditropin NordiFlex:

Glucocorticoids: Glucocorticoids may decrease the growth-promoting effect of Norditropin NordiFlex.

Drugs that may alter the clearance of Norditropin NordiFlex:

CYP450 inducers and inhibitors: Drugs that induce or inhibit the activity of cytochrome P450 enzymes may alter the clearance of Norditropin NordiFlex.

Other drug interactions:

Thyroid hormones: Thyroid hormones may increase the clearance of Norditropin NordiFlex.
Sex hormones: Sex hormones may affect the response to Norditropin NordiFlex.

It is important to consult with your healthcare provider before starting, stopping, or changing the dosage of any medications while using Norditropin NordiFlex.

Use in Specific Populations

Pregnancy

There are no adequate and well-controlled studies of Norditropin NordiFlex in pregnant women. Norditropin NordiFlex should be used during pregnancy only if clearly needed and with caution.

Lactation

It is not known whether Norditropin NordiFlex is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Norditropin NordiFlex is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Norditropin NordiFlex in pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone have been established based on evidence from clinical trials. The recommended dosage of Norditropin NordiFlex in pediatric patients with growth failure is based on body weight and should be determined by a healthcare professional experienced in the diagnosis and management of pediatric patients with growth failure.

Geriatric Use

Clinical studies of Norditropin NordiFlex did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Impairment

No specific studies have been conducted to evaluate the pharmacokinetics of Norditropin NordiFlex in patients with renal impairment. Norditropin NordiFlex is predominantly eliminated via the liver, therefore, renal impairment is not expected to have a significant impact on the pharmacokinetics of Norditropin NordiFlex.

Hepatic Impairment

No specific studies have been conducted to evaluate the pharmacokinetics of Norditropin NordiFlex in patients with hepatic impairment. Norditropin NordiFlex is predominantly eliminated via the liver, therefore, hepatic impairment is not expected to have a significant impact on the pharmacokinetics of Norditropin NordiFlex.

Overdosage

Acute overdosage with Norditropin NordiFlex may result in hypoglycemia (low blood sugar) initially, followed by hyperglycemia (high blood sugar). Symptoms of hypoglycemia may include sweating, tremors, dizziness, headache, confusion, irritability, or weakness. Symptoms of hyperglycemia may include increased thirst, frequent urination, blurred vision, or fatigue.

In case of acute overdosage, appropriate supportive treatment should be initiated as soon as possible. This may include providing glucose or glucagon to treat hypoglycemia or insulin to treat hyperglycemia.

Long-term overdosage with Norditropin NordiFlex may result in signs and symptoms of acromegaly (excessive growth of hands, feet, and facial features). If signs of acromegaly develop, treatment with Norditropin NordiFlex should be discontinued.

Monitoring of blood glucose levels and growth hormone levels may be necessary to assess the effects of an acute or long-term overdosage.

If you suspect an overdose of Norditropin NordiFlex, contact your healthcare provider or seek medical attention immediately.

How Supplied/Storage and Handling

How Supplied:

Norditropin NordiFlex is supplied in a pre-filled pen device containing a cartridge with human growth hormone solution.
Each Norditropin NordiFlex pen is supplied with a package insert and an instruction for use leaflet.
Norditropin NordiFlex is available in the following strengths: 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL.

Storage:

Store Norditropin NordiFlex in the refrigerator at 2°C to 8°C (36°F to 46°F).
Do not freeze Norditropin NordiFlex.
Keep the pen cap on when not in use to protect it from light.
Do not use Norditropin NordiFlex if it has been frozen or exposed to excessive heat.

Handling:

Before using Norditropin NordiFlex, check the cartridge for any signs of damage or leakage. Do not use if the cartridge is damaged or leaking.
Do not share your Norditropin NordiFlex pen with others, even if the needle is changed.
Dispose of used needles and pens in a puncture-resistant container.

Additional Instructions:

Read the package insert and instruction for use leaflet carefully before using Norditropin NordiFlex.
Follow the instructions provided by your healthcare provider for using Norditropin NordiFlex.
Do not use Norditropin NordiFlex if the solution is cloudy or discolored.
Do not use Norditropin NordiFlex after the expiration date printed on the pen label or carton.
Keep Norditropin NordiFlex and all medications out of the reach of children.

Table 1. Summary of How Supplied/Storage and Handling

Strength
Package Size
Storage Conditions

5 mg/1.5 mL	1 pen	Refrigerate at 2°C to 8°C (36°F to 46°F), do not freeze
10 mg/1.5 mL	1 pen	Refrigerate at 2°C to 8°C (36°F to 46°F), do not freeze
15 mg/1.5 mL	1 pen	Refrigerate at 2°C to 8°C (36°F to 46°F), do not freeze