Indication and Important Safety Information | Full Prescribing Information

Symptoms and diagnosis of acromegaly & gigantism

Most patients with acromegaly present with florid symptoms, which can surface in various systems. Diagnosing acromegaly involves the recognition of symptoms and assessment of autonomous secretion of growth hormone (GH).8

Symptoms of acromegaly8

Diagnosis of acromegaly

Diagnosis is made through a combination of biochemical assays and neuroradiological imaging:6,9



Local tumor effects

  • Pituitary enlargement
  • Visual-field defects
  • Cranial-nerve palsy
  • Headache

Somatic systems

  • Acral enlargement, including thickness of soft tissue of hands and feet

Musculoskeletal system

  • Gigantism
  • Prognathism
  • Jaw malocclusion
  • Arthralgias and arthritis
  • Carpal tunnel syndrome
  • Acroparesthesia
  • Proximal myopathy
  • Hypertrophy of frontal bones

Skin and gastrointestinal system

  • Hyperhidrosis
  • Oily texture
  • Skin tags
  • Colon polyps

Cardiovascular system

  • Left ventricular hypertrophy
  • Asymmetric septal hypertrophy
  • Cardiomyopathy
  • Hypertension
  • Congestive heart failure

Pulmonary system

  • Sleep disturbances
  • Sleep apnea (central and obstructive)
  • Narcolepsy

Visceromegaly

  • Tongue
  • Thyroid gland
  • Salivary glands
  • Liver
  • Spleen
  • Kidney
  • Prostate

Endocrine and metabolic systems

  • Reproduction
    • Menstrual abnormalities
    • Galactorrhea
    • Decreased libido, impotence, low levels of sex hormone-binding globulin
  • Multiple endocrine neoplasia type 1
    • Hyperparathyroidism
    • Pancreatic islet-cell tumors
  • Carbohydrate
    • Impaired glucose tolerance
    • Insulin resistance and hyperinsulinemia
    • Diabetes mellitus
  • Lipid
    • Hypertriglyceridemia
  • Mineral
    • Hypercalciuria, increased levels of 25-hydroxyvitamin D3
    • Urinary hydroxyproline
  • Electrolyte
    • Low renin levels
    • Increased aldosterone levels
  • Thyroid
    • Low thyroxine-binding-globulin levels
    • Goiter

An IGF-1 assay - Measurement of serum insulin-like growth factor (IGF-1) is a reliable indicator of GH status in acromegaly. There should be appropriate age and gender matched reference intervals. Serum IGF-1 is the best biochemical marker of clinical disease activity. The laboratory should participate in an External Quality Assurance Program and should be able to present individual IGF-1 results as a standard deviation score.9

Measuring GH during an Oral Glucose Tolerance Test (OGTT) - GH response to an OGTT offers valuable information when there is a discrepancy between IGF-1 and GH levels. In acromegaly, GH secretion is typically non-suppressible during an OGTT. The criteria for adequate suppression need to be defined for each specific GH assay.9

Pituitary magnetic resonance imaging (MRI) - In 95% of cases, there is a tumor in the pituitary, which is located within the sella turcica-a bony saddle-like formation at the base of the cranium. The sella turcica in acromegalic patients is deformed and increased in volume. Imaging techniques are useful to locate the tumor and to determine its size. Pituitary MRI is the neuroradiological examination of choice for diagnosing acromegaly. A computed tomography scan can also be used to confirm the size of the adenoma and its spread.6

 

Read about treatment options.

Learn more about the goals of therapy for acromegaly and the options available for treatment, including Somatuline® Depot (lanreotide) Injection (lanreotide) Injection.

 
 

How to inject Somatuline® Depot (lanreotide) Injection

Somatuline® Depot (lanreotide) Injection is injected in an easy, two-step injection process.1 Learn more about injecting Somatuline® Depot (lanreotide) Injection.

 
 

Who should take Somatuline® Depot (lanreotide) Injection

Somatuline® Depot (lanreotide) Injection is indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation. It is also for patients who cannot tolerate surgery or radiation.1 Find out more about who should take Somatuline® Depot (lanreotide) Injection.

 

Indication and Important Safety Information

Somatuline® Depot (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.

Lanreotide may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed. Patients treated with Somatuline Depot may experience hypoglycemia or hyperglycemia. Glucose level monitoring is recommended and antidiabetic treatment adjusted accordingly. Lanreotide may lead to a decrease in heart rate. Use with caution in at-risk patients.

Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline Depot 60 mg.

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline Depot should be used during pregnancy only if the potential benefit justifies risk to the fetus.

A decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Somatuline Depot may decrease the bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.

Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments. Somatuline Depot may reduce the intestinal absorption of coadministered drugs. Caution should be used.

The most common adverse reactions (incidence >5%) are diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reaction (9%), flatulence (7%), arthralgia (7%), and loose stools (6%).

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