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 |  Important Safety Information

Macrilen™ (macimorelin) 60 mg for oral solution

Norditropin® (somatropin) injection 5 mg, 10 mg, 15 mg, 30 mg

Product resources for your patients

Patient-friendly information about our products for growth-related disorders, including patient stories and instructions for use.

Norditropin® (somatropin) injection 5 mg, 10 mg, 15 mg, 30 mg
For pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH) and Prader-Willi Syndrome; short stature associated with Noonan Syndrome, Turner Syndrome, and children born small for gestational age; idiopathic short stature; and for the replacement of endogenous GH in adults with growth hormone deficiency (GHD). Please see full indications.
Macrilen™ (macimorelin) 60 mg for oral solution
For the diagnosis of adult growth hormone deficiency.

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Norditropin® Patient Website
Educational resources for patients, including information about Norditropin® and how to take it, as well as perspectives from real patients and caregivers.
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Prescribing Information | Important Safety Information
Norditropin® Patient Story: Getting Referred to a Specialist
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Norditropin® Patient Story: Getting Referred to a Specialist
Shauna, mom of Aria, discusses finding out that Aria has growth hormone deficiency, and her experience with deciding on seeing a specialist.
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Prescribing Information | Important Safety Information

Learn about a potential treatment option for your patients with select growth-related disorders

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Prescribing Information | Important Safety Information

Learn about a potential treatment option for your patients with select growth-related disorders

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Prescribing Information | Important Safety Information

Prescribing Information | Important Safety Information
Norditropin® Patient Story: 3 Families, 3 Unique Stories
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Norditropin® Patient Story: 3 Families, 3 Unique Stories
Meet moms Amanda, Shauna, and Shannah, and their kids, Emmy, Aria, and Josh. Learn how each child was diagnosed with growth hormone deficiency and their experiences with Norditropin®.
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Prescribing Information | Important Safety Information
Norditropin® Patient Story: Late Diagnosis
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Norditropin® Patient Story: Late Diagnosis
Karla’s story is about listening to her intuition, and advocating for the evaluation and testing that would eventually reveal her son, Brett’s, growth hormone deficiency.
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Norditropin® Travel Permission Form
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Norditropin® Travel Permission Form
A letter you can sign for your patients that informs airport personnel and airline staff that their child is being treated with Norditropin® and they’ll need to pack it in their carry-on luggage.
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Prescribing Information | Important Safety Information
Norditropin® Patient Story: Finding Support
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Norditropin® Patient Story: Finding Support
Leslie talks about how a change in doctors led to 13-year-old Sara’s diagnosis of Turner syndrome, and how helpful it has been to connect with other parents at the Turner Syndrome Society Conference.
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Get details about Macrilen™ efficacy, ordering and more

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Prescribing Information | Important Safety Information

Get details about Macrilen™ efficacy, ordering and more

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Norditropin® Patient Story: Overcoming Obstacles
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Norditropin® Patient Story: Overcoming Obstacles
Amanda shares details of her son, Colton’s, diagnosis of Noonan syndrome, and how their NovoCare® Case Manager provided them with valuable information about the insurance process.
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Prescribing Information | Important Safety Information
Norditropin® Patient Story: Delayed Diagnosis
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Norditropin® Patient Story: Delayed Diagnosis
Shannah reveals how it took years for her son, Josh, to get a growth hormone deficiency diagnosis, and how NovoCare® helped them once he started treatment.
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Prescribing Information | Important Safety Information
Norditropin® Patient Story: The Stim Test
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Norditropin® Patient Story: The Stim Test
Seven-year-old Emmy was diagnosed with growth hormone deficiency after her mom, Amanda, asked her pediatrician for a referral to a pediatric endocrinologist. Find out how it’s been going so far.
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Prescribing Information | Important Safety Information
Norditropin® Patient Story: Part of Daily Life
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Norditropin® Patient Story: Part of Daily Life
Janie-Lyn and Scott knew their daughter, Logan, was small—but they didn't know why. Hear about the moment that convinced them to begin treatment and how they incorporated it into their daily routine.
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Navigating Your Prescription Drug Insurance
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Navigating Your Prescription Drug Insurance
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Macrilen™ Test Patient Preparation Form
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Macrilen™ Test Patient Preparation Form
A form you can fill in and provide to your patients to explain how Macrilen™ works and what to expect from the testing process.
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Selected Important Safety Information for Macrilen™

Warnings and Precautions

  • QT Prolongation: Macrilen™ causes an increase of about 11 msec in the corrected QT (QTc) interval. QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. The concomitant use of Macrilen™ with drugs that are known to prolong the QT interval should be avoided

Indication and Limitation of Use

Macrilen™ (macimorelin) 60 mg for oral solution is indicated for the diagnosis of adult growth hormone deficiency (AGHD).

  • The safety and diagnostic performance of Macrilen™ have not been established for subjects with a body mass index (BMI) >40 kg/m2

Important Safety Information

Warnings and Precautions

  • QT Prolongation: Macrilen™ causes an increase of about 11 msec in the corrected QT (QTc) interval. QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. The concomitant use of Macrilen™ with drugs that are known to prolong the QT interval should be avoided
  • Potential for False Positive Test Results with Use of Strong CYP3A4 Inducers: Concomitant use of strong CYP3A4 inducers with Macrilen™ can decrease macimorelin plasma levels significantly and thereby lead to a false positive result. Strong CYP3A4 inducers should be discontinued and enough time should be given to allow washout of CYP3A4 inducers prior to test administration
  • Potential for False Negative Test Results in Recent Onset Hypothalamic Disease: Adult growth hormone (GH) deficiency caused by a hypothalamic lesion may not be detected early in the disease process. Macimorelin acts downstream from the hypothalamus and macimorelin stimulated release of stored GH reserves from the anterior pituitary could produce a false negative result early when the lesion involves the hypothalamus. Repeat testing may be warranted in this situation 

Adverse Reactions

  • The most common adverse reactions are dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia

Please click here for Macrilen™ Prescribing Information.

 

Selected Important Safety Information for Norditropin®

Contraindications

Norditropin® is contraindicated in patients with:

  • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin
  • Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death
  • Active Malignancy
  • Hypersensitivity to Norditropin® or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Pediatric patients with closed epiphyses

Indications and Usage

Norditropin® (somatropin) injection is indicated for the treatment of pediatric patients with:

  • growth failure due to inadequate secretion of endogenous growth hormone (GH)
  • short stature associated with Noonan syndrome,
  • short stature associated with Turner syndrome,
  • short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age
  • Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range
  • growth failure due to Prader-Willi syndrome (PWS) 

Norditropin® is also indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)

Important Safety Information

Contraindications

Norditropin® is contraindicated in patients with:

  • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin
  • Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death
  • Active Malignancy
  • Hypersensitivity to Norditropin® or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Pediatric patients with closed epiphyses

Warnings and Precautions

  • Increased mortality in patients with acute critical illness due to complications following open heart or abdominal surgery or multiple accidental trauma, or those with respiratory failure has been reported.
  • Sudden death in pediatric patients with Prader-Willi Syndrome has been reported after initiating treatment with somatropin with one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Evaluate patients for signs of upper airway obstruction and sleep apnea before initiation of treatment.
  • Increased risk of neoplasms: Monitor patients with preexisting tumors for progression or recurrence. In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm, in particular meningiomas, has been reported. Pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies and should be carefully monitored for development of neoplasms. Monitor patients carefully for increased growth, or potential malignant changes, of preexisting nevi.
  • Glucose intolerance and diabetes mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported. Monitor glucose levels in all patients. Doses of concurrent antidiabetic drugs may require adjustment.
  • Intracranial hypertension has been reported in a small number of patients, usually within the first 8 weeks of somatropin treatment. Funduscopic examination should be performed before initiating treatment and periodically thereafter.
  • Severe hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products.
  • Fluid retention in adults (clinically manifesting as edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) may frequently occur and is usually transient and dose-dependent.
  • Hypoadrenalism: Patients who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Norditropin® treatment.
  • Hypothyroidism if undiagnosed/untreated, may prevent an optimal response to Norditropin®, in particular, the growth response in pediatric patients. In patients with GHD, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or adjusted when indicated.
  • Slipped capital femoral epiphysis in pediatric patients may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Pediatric patients with the onset of a limp or complaints of hip or knee pain should be evaluated.
  • Progression of preexisting scoliosis in pediatric patients can occur in patients who experience rapid growth. Patients with a history of scoliosis should be monitored for progression.
  • Pancreatitis: Cases of pancreatitis have been reported. Pancreatitis should be considered in any patient who develops persistent severe abdominal pain.
  • Lipoatrophy: Tissue atrophy may result when somatropin is administrated subcutaneously at the same site over a long period of time. Rotate injection sites when administering Norditropin® to reduce this risk.

Adverse Reactions

  • Other common adverse reactions in adults and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, peripheral edema, flu syndrome, and impaired glucose tolerance

Drug Interactions

  • Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Norditropin®
  • Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatment to avoid both hypoadrenalism and an inhibitory effect on growth
  • Cytochrome P450-Metabolized Drugs: Norditropin® may alter the clearance. Monitor carefully if used with Norditropin®
  • Oral Estrogen: Larger doses of Norditropin® may be required
  • Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin or hypoglycemic agent may be required

Use in Specific Populations

  • Pregnancy and Nursing Mothers: There are limited data with somatropin use in pregnant women and nursing mothers to inform a drug-associated risk for adverse developmental outcomes.
  • Geriatric Use: The safety and effectiveness in patients aged 65 and over has not been evaluated in clinical studies.

Please click here for Norditropin® Prescribing Information.

Growth-Related Disorders
Other Therapy Areas
Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related disorders
Explore hormone replacement therapy
  • Growth-Related Disorders Home
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