Somatuline Depot Side Effects

Please note - some side effects for Somatuline Depot may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Somatuline Depot - for the Consumer

Somatuline Depot

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Somatuline Depot:

Constipation; diarrhea; gas; headache; joint pain; mild stomach pain or discomfort; minor redness, pain, or swelling at the injection site; nausea; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Somatuline Depot:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dizziness; severe or persistent headache; severe or persistent nausea, stomach pain, or vomiting; slow or irregular heartbeat; symptoms of gallstones (eg, sudden pain around the upper right stomach area, right shoulder area, or between your shoulder blades; yellowing of the skin or eyes; fever with chills); unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Somatuline Depot Side Effects - for the Professional

Somatuline Depot

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 (14)], 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
Body System   Preferred Term	Placebo (N=25) N (%)	Lanreotide Overall (N=83) N (%)	Lanreotide 60 mg (N=34) N (%)	Lanreotide 90 mg (N=36) N (%)	Lanreotide 120 mg (N=37) N (%)	Lanreotide Overall (N=107) N (%)
A patient is counted only once for each body system and preferred term.
Dictionary = WHOART.
Gastrointestinal System 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	0 (0%)	5 (6%)	3 (9%)	4 (11%)	8 (22%)	15 (14%)
(Injection site mass/ pain/ reaction/ inflammation)
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%)

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 naive to somatostatin analog therapy or had undergone a 3-month washout [see Clinical Studies (14)].

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
	(N = 170)		(N = 416)
	N	%	N	%
Dictionary - MedDRA 7.1
Patients with any Adverse Reactions	157	92	356	86
Gastrointestinal disorders	121	71	235	57
Diarrhea	81	48	155	37
Abdominal pain	34	20	79	19
Nausea	15	9	46	11
Constipation	9	5	33	8
Flatulence	12	7	30	7
Vomiting	8	5	28	7
Loose stools	16	9	23	6
Hepatobiliary disorders	53	31	99	24
Cholelithiasis	45	27	85	20
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
Arthralgia	17	10	30	7
Nervous system disorders	34	20	80	19
Headache	9	5	30	7

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 (5.1)].

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 (5.2)].

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 (5.4)].

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.

Postmarketing Experience

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 and diarrhea) and general disorders and administration site conditions (injection site reactions). Occasional cases of pancreatitis have also been observed.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

One percent of acromegalic patients treated with lanreotide in the pooled clinical studies discontinued treatment because of gastrointestinal reactions.

New cholelithiasis was reported in 12.0% of patients. Cholelithiasis may be related to dose or duration of exposure.

Gastrointestinal side effects including diarrhea (37%), cholelithiasis and gallbladder sludge (20%), abdominal pain (19%), nausea (11%), constipation (8%), flatulence (7%), vomiting (7%), and loose stools (6%) have been reported (percentages are from overall pooled data). A lethal case of acute necrotizing pancreatitis has also been reported.

Hepatic

Hepatic side effects including cholelithiasis (20%) have been reported. (Percentage is from overall pooled data.)

Local

Local side effects injection site pain (4.1%), injection site mass (1.7%), induration, nodule, and pruritus have been reported. (Percentage is from overall pooled data.)

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 lead to withdrawal from clinical studies in two subjects.

Musculoskeletal

Musculoskeletal side effects including arthralgia (7%) have been reported. (Percentage is from overall pooled data.)

Nervous system

Nervous system side effects including headache (7%) have been reported. (Percentage is from overall pooled data.)

Cardiovascular

In patients without underlying cardiac disease, lanreotide may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to lanreotide treatment, sinus bradycardia may occur. Care should be taken when initiating treatment with lanreotide in patients with bradycardia.

Cardiovascular side effects including hypertension (5%) and sinus bradycardia (3%) have been reported. (Percentage is from overall pooled data.)

Hematologic

Hematologic side effects including anemia (3%) have been reported. (Percentage is from overall pooled data.)

Metabolic

Metabolic side effects including dysglycemia have been reported. In clinical studies of acromegalic patients treated with lanreotide, adverse reactions of dysglycemia (hypoglycemia, hyperglycemia, diabetes) were reported by 14% of patients and were considered related to study drug in 7% of patients.

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