Acromegaly:
Note : For use in patients with persistent disease following surgery or in whom surgery is not appropriate. If clinical and/or biochemical response is inadequate at maximum dosage of lanreotide, consider alternative agents or starting combination therapy (Ref).
SUBQ: Initial: 90 mg every 4 weeks for 3 months; after initial 3 months, adjust dose as necessary based on clinical response, growth hormone (GH) levels, and/or insulin-like growth factor 1 (IGF-1) levels as follows:
GH ≤1 ng/mL, IGF-1 normal, symptoms controlled: SUBQ: Decrease dose to 60 mg every 4 weeks; once stabilized on 60 mg every 4 weeks, may consider regimen of 120 mg every 6 or 8 weeks (extended-interval dosing).
GH >1 to 2.5 ng/mL, IGF-1 normal, symptoms controlled: SUBQ: Continue 90 mg every 4 weeks; once stabilized on 90 mg every 4 weeks, may consider regimen of 120 mg every 6 or 8 weeks (extended-interval dosing).
GH >2.5 ng/mL, IGF-1 elevated and/or symptoms uncontrolled : SUBQ: Increase to 120 mg every 4 weeks. If GH remains >1 ng/mL and/or IGF-1 remains elevated after >6 months, individualized doses of 180 mg every 4 weeks or 120 mg every 3 weeks may be considered (Ref).
Carcinoid syndrome:
Note: For patients experiencing breakthrough symptoms, supplementary doses of SUBQ octreotide may be necessary (Ref).
SUBQ: 120 mg every 4 weeks; in patients already receiving lanreotide for treatment of gastroenteropancreatic neuroendocrine tumors, do not administer an additional dose for carcinoid syndrome.
Gastroenteropancreatic neuroendocrine tumors: SUBQ: 120 mg every 4 weeks until disease progression or unacceptable toxicity.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Acromegaly:
CrCl ≥60 mL/minute: No dosage adjustment necessary.
CrCl <60 mL/minute: Initial dose: 60 mg every 4 weeks for 3 months; adjust dose as necessary based on clinical response, growth hormone levels, and/or insulin-like growth factor 1 levels (refer to adult dosing). Use extended-interval dosing regimens (120 mg every 6 or 8 weeks) with caution.
Carcinoid syndrome or gastroenteropancreatic neuroendocrine tumors:
CrCl ≥30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling, however, total clearance of lanreotide 120 mg is not affected.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Acromegaly:
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate to severe impairment (Child-Pugh classes B and C): Initial dose: 60 mg every 4 weeks for 3 months; adjust dose as necessary based on clinical response, growth hormone levels, and/or insulin-like growth factor 1 levels (refer to adult dosing). Use extended-interval dosing regimens (120 mg every 6 or 8 weeks) with caution.
Carcinoid syndrome or gastroenteropancreatic neuroendocrine tumors: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Hypertension (14%)
Endocrine & metabolic: Diabetes mellitus (≤14%), hyperglycemia (≤14%), hypoglycemia (≤14%)
Gastrointestinal: Abdominal pain (7% to 34%), cholelithiasis (2% to 27%), diarrhea (31%), gallbladder sludge (≤20%), vomiting (5% to 19%)
Immunologic: Antibody development (≤11%)
Local: Bleeding at injection site (≤15%), discomfort at injection site (≤15%), hematoma at injection site (≤15%), induration at injection site (≤17%), injection-site granuloma (≤15%), injection-site nodule (≤17%), injection-site pruritus (≤17%), injection-site reaction (≤15%), pain at injection site (≤17%), rash at injection site (≤15%), residual mass at injection site (≤15%), swelling at injection site (≤15%)
Nervous system: Headache (5% to 16%)
Neuromuscular & skeletal: Musculoskeletal pain (19%)
1% to 10%:
Cardiovascular: Bradycardia (8%)
Endocrine & metabolic: Weight loss (8%)
Gastrointestinal: Constipation (5%), flatulence (6%), loose stools (9%), nausea (9%)
Hematologic & oncologic: Anemia (7%)
Local: Inflammation at injection site (≤6%)
Nervous system: Depression (7%), dizziness (7% to 9%)
Neuromuscular & skeletal: Arthralgia (10%), muscle spasm (5%)
Respiratory: Dyspnea (6%)
<1%:
Endocrine & metabolic: Hypothyroidism
Gastrointestinal: Pancreatitis
Frequency not defined: Cardiovascular: Aortic insufficiency, mitral valve insufficiency, sinus bradycardia
Postmarketing:
Dermatologic: Alopecia (Alvarez-Escola 2015)
Gastrointestinal: Cholangitis, cholecystitis, steatorrhea
Hypersensitivity: Anaphylaxis, angioedema
Local: Abscess at injection site
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
Concerns related to adverse effects:
• Cholelithiasis: May reduce gall bladder motility, leading to gall stone formation (may be dose- or duration-related). Cholelithiasis and complications of cholelithiasis (eg, cholecystitis, cholangitis, pancreatitis) requiring cholecystectomy have been reported.
• 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- or hypoglycemia. Use with caution in patients with diabetes; may require dosage adjustments in antidiabetic therapy.
• Hypersensitivity: Allergic reactions, including angioedema and anaphylaxis, have been reported.
• Thyroid disorders: Slight decreases in thyroid function have been observed during treatment for acromegaly. The incidence of clinical hypothyroidism is rare.
Disease-related concerns:
• Cardiac disorders: Bradycardia, sinus bradycardia, and hypertension have been observed with therapy. Use with caution in patients with preexisting cardiac disease. 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); 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous:
Generic: 120 mg/0.5 mL (0.5 mL)
Solution, Subcutaneous [preservative free]:
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)
Yes
Solution (Lanreotide Acetate Subcutaneous)
120 mg/0.5 mL (per 0.5 mL): $10,671.19
Solution (Somatuline Depot Subcutaneous)
60 mg/0.2 mL (per 0.2 mL): $7,305.60
90 mg/0.3 mL (per 0.3 mL): $9,729.60
120 mg/0.5 mL (per 0.5 mL): $11,474.40
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous:
Somatuline Autogel: 60 mg/0.5 mL (0.5 mL); 90 mg/0.5 mL (0.5 mL); 120 mg/0.5 mL (0.5 mL)
SUBQ: Administer by deep SUBQ injection (only) slowly over 20 seconds into superior outer quadrant of buttock. 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 in order to reach room temperature. Keep pouch sealed until just prior to injection.
Acromegaly: Long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
Carcinoid syndrome: Treatment of carcinoid syndrome in adults (to reduce the frequency of short acting somatostatin analog rescue therapy).
Gastroenteropancreatic neuroendocrine tumors: Treatment (to improve progression-free survival) of unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
Lanreotide may be confused with octreotide, pasireotide
Somatuline may be confused with Soma, somatropin, SUMAtriptan
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: 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. Risk C: 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. Risk D: Consider therapy modification
Codeine: Somatostatin Analogs may decrease serum concentrations of the active metabolite(s) of Codeine. Specifically, the concentrations of the active metabolite morphine may be reduced. Risk C: Monitor therapy
Copper Cu 64 Dotatate: Somatostatin Analogs may diminish the diagnostic effect of Copper Cu 64 Dotatate. Management: Imaging with copper Cu 64 dotatate positron emission tomography (PET) should be performed just prior to dosing with somatostatin analogs. If on somatostatin analogs, stop long-acting agents 28 days before, and short-acting agents 2 days before, imaging. Risk D: Consider therapy modification
CycloSPORINE (Systemic): Somatostatin Analogs may decrease the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination
Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification
Gallium Ga 68 Dotatate: Somatostatin Analogs may diminish the diagnostic 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: It is recommended to image with gallium Ga 68 dotatate positron emission tomography (PET) 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. Risk D: Consider therapy modification
Gallium Ga 68 Dotatoc: Somatostatin Analogs may diminish the diagnostic effect of Gallium Ga 68 Dotatoc. Management: Imaging with gallium Ga 68 dotatoc 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 dotatoc. Risk D: Consider therapy modification
Herbal Products with Glucose Lowering Effects: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy
Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy
Lutetium Lu 177 Dotatate: Somatostatin Analogs may diminish the therapeutic effect of Lutetium Lu 177 Dotatate. Specifically, the therapeutic effect of Lutetium Lu 177 Dotatate may be diminished if the timing of Somatostatin Analog administration is not carried out as recommended. Management: Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to lutetium Lu 177 dotatate dose. Administer short and long-acting octreotide during treatment as recommended. See full interaction monograph Risk D: Consider therapy modification
Macimorelin: Somatostatin Analogs may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination
Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Opioid Agonists: May diminish the analgesic effect of Somatostatin Analogs. Opioid Agonists may enhance the analgesic effect of Somatostatin Analogs. Risk C: Monitor therapy
Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: 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. Risk C: Monitor therapy
Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification
Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy
Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification
Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification
Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Because normalization of insulin-like growth factor 1 and growth hormone may restore fertility in premenopausal patients with acromegaly, patients who could become pregnant should use adequate contraception during treatment.
Lanreotide may be used for patients with acromegaly who are trying to conceive; discontinue once pregnancy is confirmed (ESE [Luger 2021]). The Endocrine Society suggests discontinuing long-acting formulations of somatostatin analogs approximately 2 months before attempts to conceive; short-acting octreotide may be used until conception if needed (ES [Katznelson 2014]).
Information related to the use of lanreotide for the treatment of acromegaly in pregnancy is limited (de Menis 1999; Teltayev 2017). If treatment for acromegaly is required during pregnancy for worsening symptoms (eg, headaches or evidence of tumor growth), alternative agents are recommended. Monitoring of insulin-like growth factor 1 (IGF-1) and/or growth hormone (GH) is not recommended during pregnancy, as an active placental GH variant present in maternal blood limits the usefulness of the results (ES [Katznelson 2014]; ESE [Luger 2021]).
Information related to the use of lanreotide in pregnant patients with gastroenteropancreatic neuroendocrine tumors is limited (Meoni 2020).
It is not known if lanreotide is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant (including possible effects on glucose metabolism and bradycardia), breastfeeding is not recommended by the manufacturer during treatment and for 6 months after the last lanreotide dose.
Serum growth hormone (GH) and insulin-like growth factor 1 (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); blood glucose, glycemic control and antidiabetic regimen (patients with diabetes mellitus) should be assessed following initiation, then periodically or following dosage adjustments; thyroid function (if clinically indicated); heart rate; gallbladder monitoring. Monitor for cholelithiasis if clinically indicated; routine gallbladder ultrasound is not necessary (ES [Katznelson 2014]).
Age-normalized serum insulin-like growth factor 1 (IGF-1) and a random growth hormone (GH) <1 mcg/L correlate with control of acromegaly; consider targeting postoperative GH level <0.4 mcg/L if ultra-sensitive GH assay is available; use of the same IGF-1 and GH assay in the same patient throughout management is suggested (ACG [Melmed 2018], ES [Katznelson 2014]).
Lanreotide is a synthetic octapeptide analogue of natural somatostatin which is a peptide inhibitor of multiple endocrine, neuroendocrine, and exocrine mechanisms. Lanreotide 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. Lanreotide reduces GH secretion and also reduces the levels of insulin-like growth factor 1.
Distribution: 15.14 L (Trocóniz 2009)
Bioavailability: 69% to ~78%
Half-life elimination: 23 to 30 days
Time to peak, plasma: 7 to 12 hours (Trocóniz 2009)
Excretion: Urine (<5% as unchanged drug); feces (<0.5% as unchanged drug)
Altered kidney function: In patients with ESRD, there is approximately a 2-fold decrease in total serum clearance, with a consequent 2-fold increase in half-life and AUC.
Hepatic function impairment: A 30% reduction in clearance was observed in patients with moderate to severe hepatic impairment.
Older adult: Compared with healthy younger subjects, elderly subjects showed an 85% increase in half-life and a 65% increase in mean residence time.
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