Norditropin

Last updated on RxList: 5/12/2020
Norditropin Side Effects Center

What Is Norditropin?

Norditropin [somatropin (rDNA origin) injection] is a form of human growth hormone used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature at birth with no catch-up growth, and other causes. Norditropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.

What Are Side Effects of Norditropin?

Common side effects of Norditropin include:

Tell your doctor if you have serious side effects of Norditropin including:

  • development of a limp,
  • persistent fatigue,
  • unusual or unexplained weight gain,
  • persistent cold intolerance,
  • persistent slow heartbeat,
  • fast heartbeat,
  • ear pain or itching,
  • hearing problems,
  • joint/hip/knee pain,
  • numbness or tingling,
  • unusual increase in thirst or urination,
  • swelling hands/ankles/feet,
  • change in the appearance or size of any mole,
  • persistent nausea or vomiting, or
  • severe stomach or abdominal pain.

Dosage for Norditropin

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

What Drugs, Substances, or Supplements Interact with Norditropin?

Norditropin may interact with insulin or oral diabetes medicine, steroids, cyclosporine, seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.

Norditropin During Pregnancy and Breastfeeding

Tell your doctor all medications you use. Norditropin should be used only when prescribed during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Norditropin [somatropin (rDNA origin) injection] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Norditropin Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious breathing problems may occur in patients with Prader-Willi syndrome who use somatropin. If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Also 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.

Common side effects may include:

  • pain, itching, or skin changes where the medicine was injected;
  • swelling, rapid weight gain;
  • muscle or joint pain;
  • numbness or tingling;
  • stomach pain, gas;
  • headache, back pain; or
  • cold or flu symptoms, stuffy nose, sneezing, sore throat, ear pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Norditropin (Somatropin Injection)

Norditropin Professional Information

SIDE EFFECTS

The following important adverse reactions are also described elsewhere in the labeling:

  • Increased mortality in patients with acute critical illness [see WARNINGS AND PRECAUTIONS]
  • Sudden death in children with Prader-Willi syndrome [see WARNINGS AND PRECAUTIONS]
  • Neoplasms [see WARNINGS AND PRECAUTIONS]
  • Glucose intolerance and diabetes mellitus [see WARNINGS AND PRECAUTIONS]
  • Intracranial hypertension [see WARNINGS AND PRECAUTIONS]
  • Severe hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Fluid retention [see WARNINGS AND PRECAUTIONS]
  • Hypoadrenalism [see WARNINGS AND PRECAUTIONS]
  • Hypothyroidism [see WARNINGS AND PRECAUTIONS]
  • Slipped capital femoral epiphysis in pediatric patients [see WARNINGS AND PRECAUTIONS]
  • Progression of preexisting scoliosis in pediatric patients [see WARNINGS AND PRECAUTIONS]
  • Pancreatitis [see WARNINGS AND PRECAUTIONS]
  • Lipoatrophy [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin product cannot always be directly compared to the rates observed during the clinical trials performed with another somatropin product, and may not reflect the adverse reaction rates observed in practice.

Pediatric Patients

Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone

In one randomized, open label, clinical study the most frequent adverse reactions were headache, pharyngitis, otitis media and fever. There were no clinically significant differences between the three doses assessed in the study (0.025, 0.05 and 0.1 mg/kg/day).

Short Stature Associated with Noonan Syndrome

NORDITROPINwas studied in 21 pediatric patients, 3 years to 14 years of age at doses of 0.033 mg/kg/day and 0.066 mg/kg/day. After the two-year study, patients continued NORDITROPINtreatment until final height was achieved; randomized dose groups were not maintained. Adverse reactions were later collected retrospectively from 18 pediatric patients; total follow-up was 11 years. An additional 6 pediatric patients were not randomized, but followed the protocol and are included in this assessment of adverse reactions.

The most frequent adverse reactions were upper respiratory infection, gastroenteritis, ear infection, and influenza. Cardiac disorders was the system organ class with the second most adverse reactions reported. Scoliosis was reported in 1 and 4 pediatric patients receiving doses of 0.033 mg/kg/day and 0.066 mg/kg/day respectively. The following additional adverse reactions also occurred once: insulin resistance and panic reaction for the 0.033 mg/kg/day dose group; injection site pruritus, bone development abnormal, depression, and self-injurious ideation in the 0.066 mg/kg/day dose group. Headache occurred in 2 cases in the 0.066 mg/kg/day dose group.

Short Stature Associated with Turner Syndrome

In two clinical studies in pediatric patients that were treated until final height with various doses of NORDITROPIN, the most frequently reported adverse reactions were influenza-like illness, otitis media, upper respiratory tract infection, otitis externa, gastroenteritis, eczema and, impaired fasting glucose. Adverse reactions in study 1 were most frequent in the highest dose groups. Three patients in study 1 had excessive growth of hands and/or feet in the high dose groups. Two patients in study 1 had a serious adverse reaction of exacerbation of preexisting scoliosis in the 0.045 mg/kg/day group.

Small for Gestational Age (SGA) with No Catch-up Growth by Age 2-4 Years

In a study, 53 pediatric patients were treated with 2 doses of NORDITROPIN(0.033 or 0.067 mg/kg/day) to final height for up to 13 years (mean duration of treatment 7.9 and 9.5 years for girls and boys, respectively). The most frequently reported adverse reactions were influenza-like illness, upper respiratory tract infection, bronchitis, gastroenteritis, abdominal pain, otitis media, pharyngitis, arthralgia, headache, gynecomastia, and increased sweating. One pediatric patient treated with 0.067 mg/kg/day for 4 years was reported with disproportionate growth of the lower jaw, and another patient treated with 0.067 mg/kg/day developed a melanocytic nevus. 4 pediatric patients treated with 0.067 mg/kg/day and 2 pediatric patients treated with 0.033 mg/kg/day of NORDITROPIN had increased fasting blood glucose levels after 1 year of treatment. In addition, small increases in mean fasting blood glucose and insulin levels after 1 and 2 years of NORDITROPIN treatment appeared to be dose-dependent.

In a second study, 98 Japanese pediatric patients were treated with 2 doses of NORDITROPIN(0.033 or 0.067 mg/kg/day) for 2 years or were untreated for 1 year. Adverse reactions were otitis media, arthralgia and impaired glucose tolerance. Arthralgia and transiently impaired glucose tolerance were reported in the 0.067 mg/kg/day treatment group.

Idiopathic Short Stature

In two open-label clinical studies with another somatropin product in pediatric patients, the most common adverse reactions were upper respiratory tract infections, influenza, tonsillitis, nasopharyngitis, gastroenteritis, headaches, increased appetite, pyrexia, fracture, altered mood, and arthralgia.

Growth Failure Due to Prader-Willi Syndrome

In two clinical studies in pediatric patients with PWS carried out with another somatropin product, the following adverse reactions were reported: edema, aggressiveness, arthralgia, benign intracranial hypertension, hair loss, headache, and myalgia.

Adult Patients

Adults with Growth Hormone Deficiency

Adverse reactions with an incidence of ≥5% occurring in patients with AO GHD during the 6 month placebo-controlled portion of a clinical trial for NORDITROPINare presented in Table 1.

Table 1 – Adverse Reactions with ≥5% Overall Incidence in Adult Onset Growth Hormone Deficient Patients Treated with NORDITROPIN During a Six Month Placebo-Controlled Clinical Trial

Placebo
(N=52)
NORDITROPIN
(N=53)
Adverse Reactions%%
Peripheral Edema842
Edema025
Arthralgia1519
Leg Edema415
Myalgia815
Infection (non-viral)813
Paraesthesia611
Skeletal Pain211
Headache69
Bronchitis09
Flu-like symptoms48
Hypertension28
Gastroenteritis88
Other Non-Classifiable Disorders (excludes accidental injury)68
Increased sweating28
Glucose tolerance abnormal26
Laryngitis66
Type 2 diabetes mellitus05

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to NORDITROPINwith the incidence of antibodies to other products may be misleading. In the case of growth hormone, antibodies with binding capacities lower than 2 mg/mL have not been associated with growth attenuation. In a very small number of patients treated with somatropin, when binding capacity was greater than 2 mg/mL, interference with the growth response was observed.

In clinical trials, GH deficient pediatric patients receiving NORDITROPINfor up to 12 months were tested for induction of antibodies, and 0/358 patients developed antibodies with binding capacities above 2 mg/L. Amongst these patients, 165 had previously been treated with other somatropin formulations, and 193 were previously untreated naive patients. Eighteen of 76 children (~24%) treated with NORDITROPINfor short stature born SGA developed anti-rhGH antibodies.

Post-Marketing Experience

Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune system disorders - Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema

Skin - Increase in size or number of cutaneous nevi

Endocrine disorders - Hypothyroidism

Metabolism and nutrition disorders - Hyperglycemia

Musculoskeletal and connective tissue disorders -Slipped capital femoral epiphysis- Legg-Calvé-Perthes disease

Investigations - Increase in blood alkaline phosphatase level - Decrease in serum thyroxin (T4) levels

Gastrointestinal - Pancreatitis

Neoplasm - Leukemia has been reported in a small number of GH deficient children treated with somatropin, somatrem (methionylated rhGH) and GH of pituitary origin

Read the entire FDA prescribing information for Norditropin (Somatropin Injection)

© Norditropin Patient Information is supplied by Cerner Multum, Inc. and Norditropin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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