Somatuline Depot Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Somatuline Depot (lanreotide) is an injection used for the long-term treatment of acromegaly in patients who do not respond to, or cannot opt for, surgery or radiotherapy. The goal of treatment with acromegaly is to reduce growth hormone levels to normal. Adverse reactions or side effects that have been reported can include gastrointestinal disorders and headache. Somatuline Depot does not interact well with insulin or other oral hypoglycemic medications.
Somatuline Depot injection is administered every 4 weeks as directed by your doctor. Your doctor may change your dose of Somatuline Depot or the length of time between your injections. Your doctor will tell you how long you need to receive Somatuline Depot. It is not known if Somatuline Depot will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant, and if you are breastfeeding or plan to breastfeed. It is not known if Somatuline Depot passes into your breast milk. Talk to your doctor about the best way to feed your baby if you receive Somatuline Depot.
Somatuline Depot (lanreotide) 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Somatuline Depot in Detail - Patient Information: Side Effects
Stop using lanreotide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- slow or uneven heartbeats;
- gallbladder problems (pain in your upper right stomach area with nausea and vomiting);
- thyroid problems (may be detected by blood tests);
- pale skin, weakness, easy bruising or bleeding;
- low blood sugar (headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, nausea); or
- high blood sugar (increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin).
Less serious side effects may include:
- nausea, vomiting;
- diarrhea, constipation;
- mild stomach pain or gas;
- weight loss;
- joint pain; or
- pain, itching, or skin lump where injection was given.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Somatuline Depot (lanreotide) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Somatuline Depot FDA Prescribing Information: Side Effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Studies Experience
The data described below reflect exposure to Somatuline Depot in 416 acromegalic patients in seven studies. One study was a fixed-dose pharmacokinetic study. The other six studies were open-label or extension studies, one had a placebo controlled run-in period and another had an active control. The population was mainly Caucasian (329/353, 93%) with a median age of 53.0 years of age (range 19-84 years). Fifty-four subjects (13%) were age 66-74 and eighteen subjects (4.3%) were ≥ 75 years of age. Patients were evenly matched for gender (205 males and 211 females). The median average monthly dose was 91.2 mg (e.g., 90 mg injected via the deep subcutaneous route every 4 weeks) over 385 days with a median cumulative dose of 1290 mg. Of the patients reporting acromegaly severity at baseline (N=265), serum GH levels were < 10 ng/mL for 69% (183/265) of the patients and ≥ 10 ng/mL for 31% (82/265) of the patients.
The most commonly reported adverse reactions reported by > 5% of patients who received Somatuline Depot (N=416) in the overall pooled safety studies in acromegaly patients were gastrointestinal disorders (diarrhea, abdominal pain, nausea, constipation, flatulence, vomiting, loose stools), cholelithiasis and injection site reactions.
Tables 1 and 2 present adverse reaction data from clinical studies with Somatuline Depot in acromegalic patients. The tables include data from a single clinical study and pooled data from seven clinical studies.
Adverse Reactions in Parallel Fixed-Dose Phase of Study 1
The incidence of treatment-emergent adverse reactions for Somatuline Depot 60 mg, 90 mg, and 120 mg by dose as reported during the first 4 months (fixed-dose phase) of Study 1 [see Clinical Studies], are provided in Table 1.
Table 1 : Adverse Reactions at an Incidence > 5%
Lanreotide Overall and Occurring at Higher Rate in Drug than Placebo:
Placebo-Controlled and Fixed-Dose Phase of Study 1 by Dose
|Placebo-Controlled Double-Blind Phase Weeks 0 to 4||Fixed-Dose Phase Double-Blind + Single-Blind Weeks 0 to 20|
|Lanreotide 60 mg
|Lanreotide 90 mg
|Lanreotide 120 mg
|Disorders||1 (4%)||30 (36%)||12 (35%)||21 (58%)||27 (73%)||60 (56%)|
|Diarrhea||0||26 (31%)||9 (26%)||15 (42%)||24 (65%)||48 (45%)|
|Abdominal pain||1 (4%)||6 (7%)||3 (9%)||6 (17%)||7 (19%)||16 (15%)|
|Flatulence||0||5 (6%)||0 (0%)||3 (8%)||5 (14%)||8 (7%)|
|Application Site Disorders (Injection site mass/ pain/ reaction/ inflammation)||0 (0%)||5 (6%)||3 (9%)||4 (11%)||8 (22%)||15 (14%)|
|Liver and Biliary System|
|Disorders||1 (4%)||3 (4%)||9 (26%)||7 (19%)||4 (11%)||20 (19%)|
|Cholelithiasis||0||2 (2%)||5 (15%)||6 (17%)||3 (8%)||14 (13%)|
|Heart Rate & Rhythm Disorders||0||8 (10%)||7 (21%)||2 (6%)||5 (14%)||14 (13%)|
|Bradycardia||0||7 (8%)||6 (18%)||2 (6%)||2 (5%)||10 (9%)|
|Red Blood Cell Disorders||0||6 (7%)||2 (6%)||5 (14%)||2 (5%)||9 (8%)|
|Anemia||0||6 (7%)||2 (6%)||5 (14%)||2 (5%)||9 (8%)|
|Metabolic & Nutritional Disorders||3 (12%)||13 (16%)||8 (24%)||9 (25%)||4 (11%)||21 (20%)|
|Weight decrease||0||7 (8%)||3 (9%)||4 (11%)||2 (5%)||9 (8%)|
|A patient is counted only once for each body system and
Dictionary = WHOART.
In Study 1, the adverse reactions of diarrhea, abdominal pain and flatulence increased in incidence with increasing dose of Somatuline Depot.
Adverse Reactions In Long-Term Clinical Trials
Table 2 provides the most common adverse reactions that occurred in 416 acromegalic patients treated with Somatuline Depot in seven studies. The analysis of safety compares adverse reaction rates of patients at baseline from the two efficacy studies, to the overall pooled data from seven studies. Patients with elevated GH and IGF-1 levels were either na´ve to somatostatin analog therapy or had undergone a 3-month washout [see Clinical Studies].
Table 2 : Adverse Reactions at an Incidence > 5.0%
in Overall Group Reported in Clinical Studies
|System Organ Class||Number and Percentage of Patients|
|Studies 1 & 2
|Overall Pooled Data
|Patients with any Adverse Reactions||157||92||356||86|
|General disorders and administration site conditions||51||30||91||22|
|(Injection site pain /mass /induration /nodule /pruritus)||28||17||37||9|
|Musculoskeletal and connective tissue disorders||44||26||70||17|
|Nervous system disorders||34||20||80||19|
Dictionary - MedDRA 7.1
In addition to the adverse reactions listed in Table 2, the following reactions were also seen:
- Sinus bradycardia occurred in 7% (12) of patients in the pooled Study 1 and 2 and in 3% (13) of patients in the overall pooled studies.
- Hypertension occurred in 7% (11) of patients in the pooled Study 1 and 2 and in 5% (20) of patients in the overall pooled studies.
- Anemia occurred in 7% (12) of patients in the pooled Study 1 and 2 and in 3% (14) of patients in the overall pooled studies.
Gastrointestinal Adverse Reactions
In the pooled clinical studies of Somatuline Depot therapy, a variety of gastrointestinal reactions occurred, the majority of which were mild to moderate in severity. One percent of acromegalic patients treated with Somatuline Depot in the pooled clinical studies discontinued treatment because of gastrointestinal reactions.
Pancreatitis was reported in < 1% of patients.
Gallbladder Adverse Reactions
In clinical studies involving 416 acromegalic patients treated with Somatuline Depot, cholelithiasis and gallbladder sludge were reported in 20% of the patients. Among 167 acromegalic patients treated with Somatuline Depot who underwent routine evaluation with gallbladder ultrasound, 17.4% had gallstones at baseline. New cholelithiasis was reported in 12.0% of patients. Cholelithiasis may be related to dose or duration of exposure [see Cholelithiasis and Gallbladder Sludge].
Injection Site Reactions
In the pooled clinical studies, injection site pain (4.1%) and injection site mass (1.7%) were the most frequently reported local adverse drug reactions that occurred with the administration of Somatuline Depot. In a specific analysis 20 of 413 patients (4.8%) presented indurations at the injection site. Injection site adverse reactions were more commonly reported soon after the start of treatment and were less commonly reported as treatment continued. Such adverse reactions were usually mild or moderate but did lead to withdrawal from clinical studies in two subjects.
Glucose Metabolism Adverse Reactions
In the clinical studies in acromegalic patients treated with Somatuline Depot, adverse reactions of dysglycemia (hypoglycemia, hyperglycemia, diabetes) were reported by 14% (47/332) of patients and were considered related to study drug in 7% (24/332) of patients [see Hyperglycemia and Hypoglycemia].
Cardiac Adverse Reactions
In the pooled clinical studies, sinus bradycardia (3.1%) was the most frequently observed heart rate and rhythm disorder. All other cardiac adverse drug reactions were observed in < 1% of patients. The relationship of these events to Somatuline Depot could not be established because many of these patients had underlying cardiac disease [see Cardiovascular Abnormalities].
A comparative echocardiography study of lanreotide and another somatostatin analog demonstrated no difference in the development of new or worsening valvular regurgitation between the two treatments over one year. The occurrence of clinically significant mitral regurgitation (i.e., moderate or severe in intensity) or of clinically significant aortic regurgitation (i.e., at least mild in intensity) was low in both groups of patients throughout the study.
Other Adverse Reactions
For the most commonly occurring adverse reactions in the pooled analysis, diarrhea, abdominal pain and cholelithiasis, there was no apparent trend for increasing incidence with age. GI disorders and renal and urinary disorders were more common in patients with documented hepatic impairment; however, the incidence of cholelithiasis was similar between groups.
Laboratory investigations of acromegalic patients treated with Somatuline Depot in clinical studies show that the percentage of patients with putative antibodies at any time point after treatment is low ( < 1% to 4% of patients in specific studies whose antibodies were tested). The antibodies did not appear to affect the efficacy or safety of Somatuline Depot.
As adverse reactions experienced post approval use 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.
The profile of reported adverse reactions for Somatuline Depot was consistent with that observed for treatment-related adverse reactions in the clinical studies. Those reported most frequently being gastrointestinal disorders (abdominal pain, diarrhea, and steatorrhea), hepatobiliary disorders (cholecystitis), and general disorders and administration site conditions (injection site reactions). Occasional cases of pancreatitis have also been observed.
Read the entire FDA prescribing information for Somatuline Depot (lanreotide) »
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