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Lanreotide

Pronunciation

(lan REE oh tide)

Index Terms

  • Lanreotide (Long-Acting Aqueous)
  • Lanreotide Acetate
  • Lanreotide Autogel

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Somatuline Depot: 120 mg/0.5 mL (0.5 mL); 60 mg/0.2 mL (0.2 mL); 90 mg/0.3 mL (0.3 mL)

Brand Names: U.S.

  • Somatuline Depot

Pharmacologic Category

  • Somatostatin Analog

Pharmacology

Synthetic octapeptide analogue of somatostatin which is a peptide inhibitor of multiple endocrine, neuroendocrine, and exocrine mechanisms. Displays a greater affinity for somatostatin type 2 (SSTR2) and type 5 (SSTR5) receptors found in pituitary gland, pancreas, and growth hormone (GH) secreting neoplasms of pituitary gland and a lesser affinity for somatostatin receptors 1, 3, and 4. Reduces GH secretion and also reduces the levels of insulin-like growth factor 1.

Distribution

Vss: ~0.2 L/kg (Somatuline Canadian labeling 2015)

Metabolism

Extensively within GI tract after biliary excretion (Somatuline Canadian labeling 2015)

Excretion

Urine (<5% as unchanged drug); feces (<0.5% as unchanged drug)

Time to Peak

Mean: 7 to 12 hours (Somatuline Canadian labeling 2015)

Half-Life Elimination

Depot: 23 to 30 days

Protein Binding

79% to 83% (Somatuline Canadian labeling 2015)

Special Populations: Renal Function Impairment

In patients with ESRD, there is approximately a 2-fold decrease in total serum clearance, with a consequent 2-fold increase in AUC.

Special Populations: Hepatic Function Impairment

A 30% reduction in clearance was observed in patients with moderate to severe hepatic impairment.

Special Populations: Elderly

Compared with healthy younger subjects, elderly subjects showed an 85% increase in half-life and a 65% increase in mean residence time.

Use: Labeled Indications

US labeling:

Acromegaly: Long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

Gastroenteropancreatic neuroendocrine tumors: Treatment (to improve progression-free survival) of unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Canadian labeling:

Acromegaly: Long-term treatment of patients with acromegaly due to pituitary tumors who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option; relief of symptoms associated with acromegaly.

Enteropancreatic neuroendocrine tumors: Treatment (to delay progression) of enteropancreatic neuroendocrine tumors in patients with grade 1 or a subset of grade 2 (equivalent to Ki67 <10%) unresectable, locally advanced, or metastatic disease.

Contraindications

Hypersensitivity to lanreotide or any component of the formulation

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to somatostatin or related peptides; complicated, untreated bile duct lithiasis

Dosing: Adult

US labeling:

Acromegaly: SubQ: Initial dose: 90 mg once every 4 weeks for 3 months; after initial 90 days of therapy, adjust dose based on clinical response of patient, growth hormone (GH) levels, and/or insulin-like growth factor 1 (IGF-1) levels as follows:

GH ≤1 ng/mL, IGF-1 normal, symptoms stable: 60 mg once every 4 weeks; once stabilized on 60 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing)

GH >1 to 2.5 ng/mL, IGF-1 normal, symptoms stable: 90 mg once every 4 weeks; once stabilized on 90 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing)

GH >2.5 ng/mL, IGF-1 elevated and/or uncontrolled symptoms: 120 mg once every 4 weeks

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs): SubQ: 120 mg once every 4 weeks until disease progression or unacceptable toxicity

Canadian labeling:

Acromegaly: SubQ: Initial dose: 90 mg once every 4 weeks for 3 months; after initial 90 days of therapy, adjust dose based on clinical response of patient, growth hormone (GH) levels, and/or insulin-like growth factor 1 (IGF-1) levels as follows:

GH ≤1 ng/mL, IGF-1 normal, symptoms stable: 60 mg once every 4 weeks; once stabilized on 60 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing)

GH >1 to 2.5 ng/mL, IGF-1 normal, symptoms stable: 90 mg once every 4 weeks; once stabilized on 90 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing)

GH >2.5 ng/mL, IGF-1 elevated and/or uncontrolled symptoms: 120 mg once every 4 weeks

Enteropancreatic neuroendocrine tumors (NETs): SubQ: 120 mg once every 4 weeks, continue until disease progression

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acromegaly: Adolescents ≥16 years (Canadian labeling): Refer to adult dosing.

Dosing: Renal Impairment

Acromegaly:

CrCl 60 to 89 mL/minute: No dosage adjustment necessary.

CrCl ≤59 mL/minute: Initial dose: 60 mg once every 4 weeks for 3 months; adjust dose based on clinical response of patient, GH levels, and/or IGF-1 levels; use of an extended-interval dose of 120 mg once every 6 or 8 weeks should be done with caution.

Gastroenteropancreatic or enteropancreatic neuroendocrine tumors (GEP-NETs):

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment

Acromegaly:

Mild impairment: No dosage adjustment necessary.

Moderate to severe impairment: Initial dose: 60 mg once every 4 weeks for 3 months; adjust dose based on clinical response of patient, GH levels, and/or IGF-1 levels; use of an extended-interval dose of 120 mg once every 6 or 8 weeks should be done with caution.

Gastroenteropancreatic or enteropancreatic neuroendocrine tumors (GEP-NETs): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Reconstitution

Allow to reach room temperature by removing sealed pouch from refrigerator 30 minutes prior to administration; keep in sealed pouch until just prior to administration.

Administration

Administer by deep subcutaneous injection into superior outer quadrant of buttocks. Alternate injection sites between the right and left sides from one injection to the next. Remove sealed pouch from refrigerator 30 minutes prior to administration.

Storage

Store at 2°C to 8°C (36°F to 46°F). Protect from light; store in the original package.

Drug Interactions

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Monitor therapy

Bretylium: May enhance the bradycardic effect of Bradycardia-Causing Agents. Bretylium may also enhance atrioventricular (AV) blockade in patients receiving AV blocking agents. Monitor therapy

Bromocriptine: Somatostatin Analogs may increase the serum concentration of Bromocriptine. Somatostatin Analogs may also delay bromocriptine absorption and time to maximum plasma concentrations. Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Avoid combination

Codeine: Somatostatin Analogs may decrease the metabolism of Codeine. The formation of two major codeine metabolites (morphine and norcodeine) may be impaired by somatostatin analogs. Monitor therapy

CycloSPORINE (Systemic): Somatostatin Analogs may decrease the serum concentration of CycloSPORINE (Systemic). Consider therapy modification

Gallium Ga 68 Dotatate: Somatostatin Analogs may diminish the therapeutic effect of Gallium Ga 68 Dotatate. Specifically, a false negative PET scan may occur if Gallium GA 68 Dotatate is used during treatment with somatostatin analogs. Management: Imaging with gallium Ga 68 dotatate positron emission tomography (PET) should be performed just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hours before imaging with gallium Ga 68 dotatate. Consider therapy modification

Herbs (Hypoglycemic Properties): May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Monitor therapy

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Monitor therapy

MAO Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Pegvisomant: Somatostatin Analogs may enhance the adverse/toxic effect of Pegvisomant. Specifically, this combination may increase the risk for significant elevations of liver enzymes. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Quinolone Antibiotics: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

Adverse Reactions

>10%:

Cardiovascular: Bradycardia (3% to 18%), hypertension (5% to 14%)

Central nervous system: Headache (5% to 16%)

Endocrine & metabolic: Weight loss (5% to 11%), dysglycemia (≤7%; includes diabetes, hyperglycemia, and hypoglycemia)

Gastrointestinal: Diarrhea (26% to 65%; dose related), abdominal pain (7% to 34%; dose related), vomiting (5% to 19%), flatulence (≤14%; dose related), nausea (9% to 11%)

Hematologic: Anemia (3% to 14%)

Hepatic: Cholelithiasis (2% to 27%), gallbladder sludge (20%)

Local: Injection site reaction (6% to 22%; induration 5%; pain 4%; mass 2%)

Neuromuscular & skeletal: Musculoskeletal pain (19%)

1% to 10%:

Cardiovascular: Sinus bradycardia (3% to 7%)

Central nervous system: Dizziness (9%), depression (7%)

Gastrointestinal: Loose stools (6% to 9%), constipation (5% to 8%)

Immunologic: Antibody development (<1 % to 4%)

Neuromuscular & skeletal: Arthralgia (7% to 10%)

<1% (Limited to important or life-threatening): Cholecystitis, decreased heart rate, dysautonomia, hypersensitivity, hypothyroidism, pancreatitis, valvular regurgitation (aortic, mitral)

Warnings/Precautions

Concerns related to adverse effects:

• Cholelithiasis: May reduce gall bladder motility, leading to gall stone formation (may be dose- or duration-related); may require periodic monitoring (consider ultrasonography at baseline and periodically thereafter).

• Gastrointestinal effects: Diarrhea and loose stools may occur (may affect intestinal absorption of concurrently-administered medication); abdominal pain may also occur.

• Hyper-/hypoglycemia: Inhibition of insulin and glucagon secretion may affect glucose regulation, leading to hyper-/hypoglycemia. Carefully monitor blood glucose levels with the initiation of therapy and with dosage alterations. Use with caution in patients with diabetes; may require dosage adjustments in antidiabetic therapy.

• Hypersensitivity: Allergic reactions, including angioedema and anaphylaxis, have been reported.

• Hypothyroidism: Decreases (slight) in thyroid function have been observed during therapy; may require monitoring of thyroid function tests.

Disease-related concerns:

• Cardiac disorders: Bradycardia, sinus bradycardia, and hypertension have been observed with therapy. Use with caution in patients with preexisting cardiac disease; monitor heart rate. Patients without preexisting cardiac disease may experience a decrease in heart rate though not to the level of bradycardia. Appropriate medical therapy should be initiated if patients develop symptomatic bradycardia.

• Hepatic impairment: Use with caution in patients with acromegaly with moderate to severe hepatic impairment (systemic exposure may be increased); lower doses are recommended at therapy initiation. Lanreotide has not been studied in patients with neuroendocrine tumors with hepatic impairment.

• Renal impairment: Use with caution in patients with acromegaly with moderate to severe renal impairment; lower initial doses are recommended.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Monitoring Parameters

Serum GH and IGF-1 at 3 months and as clinically indicated in acromegaly patients (obtain levels 6 weeks after dose adjustment when switching to extended-interval dosing), glucose levels, thyroid function (where clinically indicated); heart rate, consider gall bladder ultrasonography (baseline and periodically during therapy)

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies. Information related to the use of lanreotide in pregnancy is limited (deMenis, 1999) and it is recommended to discontinue therapy during pregnancy (Chandraharan 2003; Melmed 2012).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flatulence, diarrhea, constipation, joint pain, muscle pain, injection site pain or irritation, or weight loss. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating), signs of gallstones (pain in the upper right abdominal area, right shoulder area, or between the shoulder blades; yellow skin or eyes; or fever with chills), severe nausea, severe vomiting, severe abdominal pain, severe dizziness, passing out, severe headache, bradycardia, arrhythmia, depression, shortness of breath, or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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