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SOMATULINE AUTOGEL is a brand name for Lanreotide, supplied as a solution (extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SOMATULINE® AUTOGEL® [lanreotide (as lanreotide acetate) injection] is indicated for: • The long-term treatment of adult patients with acromegaly due to pituitary tumours who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. • The relief of symptoms associated with acromegaly.…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment, Acromegaly and Monitoring and Laboratory Tests, Acromegaly). • Slight decreases in thyroid function have been observed during treatment. Thyroid function tests are recommended where clinically indicated (see Endocrine and Metabolism and Monitoring and Laboratory Tests, Acromegaly).
• Patients with moderate or severe hepatic or renal impairment should start treatment with SOMATULINE® AUTOGEL® 60 mg followed by dose adjustments. 2 Recommended Dose and Dosage Adjustment, Acromegaly). Acromegaly, Enteropancreatic NETs, and Carcinoid Syndrome • Sinus bradycardia may occur in patients suffering from cardiac disorders prior to treatment initiation with SOMATULINE® AUTOGEL®, therefore, heart rate should be monitored in these patients (see Cardiovascular and Monitoring and Laboratory Tests).
• Patients treated with SOMATULINE® AUTOGEL® may experience hypoglycemia or hyperglycemia. Blood glucose levels should be monitored when treatment is initiated or when the dose is changed and periodically thereafter, and treatment of diabetic patients should be adjusted accordingly (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Endocrine and Metabolism and Monitoring and Laboratory Tests).
• SOMATULINE® AUTOGEL® may reduce gallbladder motility and lead to gallstone formation. Gallbladder ultrasonography is recommended at the start of treatment and periodically thereafter. If complications of cholelithiasis are suspected, discontinue SOMATULINE® AUTOGEL® and treat appropriately (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatic/Biliary/Pancreatic and Monitoring and Laboratory Tests).
1 Serious Drug Interactions). • The gastrointestinal effects of SOMATULINE® AUTOGEL® may reduce the intestinal absorption of co-administered drugs. SOMATULINE® AUTOGEL® may decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes.
2 Drug Interactions Overview). • Concomitant administration of bradycardia-inducing drugs may have an additive effect on the reduction of heart rate associated with SOMATULINE® AUTOGEL® treatment. 2 Drug Interactions Overview). 2 Recommended Dose and Dosage Adjustment, Acromegaly).
4 Geriatrics). Enteropancreatic NETs • There is no recommended dose adjustment for mild or moderate renal impairment. 2 Recommended Dose and Dosage Adjustment, Enteropancreatic NETs). Carcinoid Syndrome • There is insufficient information to recommend a dose for patients with renal or hepatic impairments of any severity.
1 Adverse Reaction Overview The adverse reactions commonly reported with SOMATULINE® AUTOGEL® administration are predominantly local (at injection site) and gastrointestinal. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Acromegaly Study 717 Study 717 was a randomized, double-blind placebo-controlled study, conducted in 108 acromegalic patients treated for one year. Patients received a total of 13 injections at 28 day intervals (one injection of placebo plus 12 injections of SOMATULINE® AUTOGEL® or 13 injections of SOMATULINE® AUTOGEL®).
The dose could be adapted every 4 injections based on GH or IGF-1 levels. The total exposure to SOMATULINE® AUTOGEL® over the three phases of the study is summarized below. 7 86, 400 1 [Cumulative lanreotide dose/duration of active treatment] x 28 2 [Date of last lanreotide dose – date of first lanreotide dose] + 28 Most Commonly Reported Treatment Emergent Adverse Events (TEAEs) The incidence of TEAEs for SOMATULINE® AUTOGEL® 60 mg, 90 mg, and 120 mg compared to placebo as investigated during the first phase of Study 717 are provided in Table 3.
Table 3:
Most commonly (≥5%) reported TEAEs during the double-blind phase (1 month = 1 injection) in Study 717 (Safety Population) by dose Preferred Term SOMATULINE® AUTOGEL® Placebo (N= 25) Total (N= 108)* 60 mg (N= 27) 90 mg (N=27) 120 mg (N= 29) Overall (N=83) N (%) N (%) N (%) N (%) N (%) N (%) Any adverse event 11(41) 19 (70) 20 (69) 50 (60) 9 (36) 59 (55) Diarrhea 3 (11) 10 (37) 13 (45) 26 (31) 0 26 (24) Abdominal Pain 2 (7) 2 (7) 2 (7) 6 (7) 1 (4) 7 (6) Bradycardia 3 (11) 2 (7) 2 (7) 7 (8) 0 7 (6) SOMATULINE® AUTOGEL® (lanreotide injection) Page 14 of 57 Weight decrease 2 (7) 4 (15) 1 (3) 7 (8) 0 7 (6) Anemia 1 (4) 4 (15) 1 (3) 6 (7) 0 6 (6) Flatulence 0 2 (7) 3 (10) 5 (6) 0 5 (5) *Total number of patients included in the safety population for this study phase is 108.
1 Pregnant Women 12/2022 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 06/2023 11 STORAGE, STABILITY AND DISPOSAL 08/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
1 INDICATIONS ............................................................................................................... 1 Pediatrics .............................................................................................................
2 Geriatrics ............................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................. 1 Dosing Considerations .........................................................................................
2 Recommended Dose and Dosage Adjustment..................................................... 3 Reconstitution ...................................................................................................... 4 Administration ......................................................................................................
5 Missed Dose ........................................................................................................ 8 5 OVERDOSAGE.............................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................... 8 7 WARNINGS AND PRECAUTIONS ............................................................................... 1 Special Populations ...........................................................................................
• Lanreotide injection is contraindicated in patients who are hypersensitive to this drug (see Immune), or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTH, COMPOSITION AND PACKAGING.
• Lanreotide injection is contraindicated in patients who are hypersensitive to somatostatin or related peptides. • Lanreotide injection is contraindicated in patients with complicated, untreated lithiasis of the bile ducts. SOMATULINE® AUTOGEL® (lanreotide injection) Page 5 of 57
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2 Recommended Dose and Dosage Adjustment, Carcinoid Syndrome). 2 Recommended Dose and Dosage Adjustment Acromegaly Patients should begin treatment with SOMATULINE® AUTOGEL® 90 mg given via deep subcutaneous route, at 4 week intervals for 3 months.
5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled: Increase SOMATULINE® AUTOGEL® dosage to 120 mg every 4 weeks • GH ≤ 1 ng/mL, IGF-1 normal and clinical symptoms controlled: Reduce SOMATULINE® AUTOGEL® dosage to 60 mg every 4 weeks Thereafter, the dose should be adjusted according to the response of the patient as judged by a reduction in symptoms and/or in GH and/or IGF-1 levels.
3 Pharmacokinetics, Hepatic Insufficiency and Renal Insufficiency). Patients who are controlled on SOMATULINE® AUTOGEL® 60 mg or 90 mg may be considered for an extended dosing interval of SOMATULINE® AUTOGEL® 120 mg every 6 or 8 SOMATULINE® AUTOGEL® (lanreotide injection) Page 7 of 57 weeks.
GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate the persistence of patients’ response. Continued monitoring of patients’ response with dose adjustments for biochemical and clinical symptom control is recommended.
3 Pharmacokinetics, Pharmacokinetics of SOMATULINE® AUTOGEL® in Patients with Acromegaly). 1 Pediatrics). It is not necessary to alter the starting dose in geriatric patients aged 65 years […]
e. those reported in ≥2% of patients for the SOMATULINE® AUTOGEL® Study 717 are presented in Table 4 by dose of onset. The majority of AEs observed in this study were mild to moderate in intensity. This table includes all TEAEs which began after the injection of SOMATULINE® AUTOGEL®, therefore it excludes TEAEs which occurred in patients receiving placebo in the initial double-blind phase.
The number of patients included in each dose group is based on the total number of patients who received at least one dose at that dose level; also provided is the total across the three dose groups. The injections were well tolerated.
Injection site reactions, primarily reports of injection site mass and injection site pain, were infrequently reported over the 52-week study occurring in 9% and 9% of patients, respectively.
Table 4:
Treatment Emergent Adverse Events Related to SOMATULINE® AUTOGEL® Reported in ≥ 2% of Total Patients on SOMATULINE® AUTOGEL® in Study 717 (Safety Population) by Dose of Onset Adverse Event by Body System SOMATULINE® AUTOGEL® 60 mg (N = 46) 90 mg (N = 66) 120 mg (N = 74) Total (N = 107*) N (%) N (%) N (%) N (%) Any AE 23 (50) 33 (50) 51 (69) 72 (67) Application Site Disorders Injection site mass Injection site pain Injection site reaction Injection site bleeding 2 (4) 3 (7) 0 (0) 0 (0) 2 (3) 3 (5) 1 (2) 1 (2) 7 (9) 4 (5) 2 (3) 1 (1) 10 (9) 10 (9) 3 (3) 2 (2) General Disorders Fatigue Back Pain 1 (2) 2 (4) 4 (6) 0 (0) 3 (4) 1 (1) 8 (7) 3 (3) Malaise Chest Pain 0 (0) 0 (0) 0 (0) 0 (0) 2 (3) 2 (3) 2 (2) 2 (2) Cardiovascular Disorders Hypertension aggravated Heart murmur 2 (4) 0 (0) 2 (3) 0 (0) 1 (1) 2 (3) 5 (5) 2 (2) Central & Peripheral Nervous System Disorders Dizziness Headache Vertigo 2 (4) 2 (4) 0 (0) 0 (0) 0 (0) 2 (3) 2 (3) 2 (3) 0 (0) 4 (4) 4 (4) 2 (2) GI System Disorders Diarrhea Abdominal pain Flatulence Nausea Vomiting Constipation Dyspepsia Anorexia 10 (22) 5 (11) 2 (4) 3 (7) 1 (2) 1 (2) 1 (2) 0 (0) 19 (29) 8 (29) 3 (5) 2 (3) 0 (0) 1 (2) 4 (6) 1 (2) 34 (46) 10 (14) 7 (9) 5 (7) 3 (4) 2 (3) 1 (1) 2 (3) 50 (47) 21 (20) 11 (10) 10 (9) 4 (4) 4 (4) 6 (6) 3 (3) SOMATULINE® AUTOGEL® (lanreotide injection) Page 15 of 57 Heart Rate and Rhythm Disorders Bradycardia 7 (15) 5 (8) 3 (4) 14 (13) Liver and Biliary System Disorders Cholelithiasis and/or gallbladder sludge Gallbladder disorder Bilirubinemia Hepatomegaly 8 (17) 3 (7) 1 (2) 0 (0) 8 (12) 3 (5) 1 (2) 1 (2) 18 (24) 2 (3) 0 (0) 1 (1) 32 (30) 8 (7) 2 (2) 2 (2) Metabolic and Nutritional Disorders Hyperglycemia Weight Decrease Hypoglycemia Hypercholesterolemia Phosphatase Alkaline Increased 3 (7) 3 (7) 1 (2) 2 (4) 0 (0) 2 (3) 3 (5) 1 (2) 1 (2) 1 (2) 3 (4) 3 (4) 0 (0) 0 (0) 1 (1) 8 (7) 9 (8) 2 (2) 2 (2) 2 (2) Musculo-Skeletal System Disorders Arthralgia Myalgia Muscle weakness Skeletal pain 1 (2) 1 (2) 1 (2) 0 (0) 5 (8) 1 (2) 0 (0) 1 (2) 1 (1) 1 (1) 1 (1) 1 (1) 6 (6) 3 (3) 2 (2) 2 (2) Myo Endo Pericardial & Valve Disorders Heart Valve disorders Aortic stenosis Aortic valve incompetence Myocardial infarction 0 (0) 1 (2) 1 (2) 0 (0) 1 (2) 0 (0) 2 (3) 0 (0) 2 (3) 1 (1) 0 (0) 2 (3) 3 (3) 2 (2) 2 (2) 2 (2) Psychiatric Disorders Depression Nervousness 1 (2) 1 (2) 1 (2) 0 (0) 0 (0) 1 (1) 2 (2) 2 (2) Red Blood Cell Disorders Anemia 2 (4) 2 (3) 2 (3) 6 (6) Respiratory System Disorders Dyspnea 1 […]
1 Pregnant Women ......................................................................................... 2 Breast-feeding.............................................................................................. 3 Pediatrics .....................................................................................................
4 Geriatrics ..................................................................................................... 12 8 ADVERSE REACTIONS ............................................................................................. 1 Adverse Reaction Overview ...............................................................................
2 Clinical Trial Adverse Reactions......................................................................... 3 Less Common Clinical Trial Adverse Reactions ................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .........................................................................................................
5 Post-Market Adverse Reactions ......................................................................... 20 9 DRUG INTERACTIONS .............................................................................................. 1 Serious Drug Interactions ..................................................................................
2 Drug Interactions Overview ................................................................................ 3 Drug-Behavioural Interactions ............................................................................ 4 Drug-Drug Interactions.......................................................................................
5 Drug-Food Interactions ...................................................................................... 6 Drug-Herb Interactions....................................................................................... 7 Drug-Laboratory Test Interactions......................................................................
22 10 CLINICAL PHARMACOLOGY .................................................................................... 1 Mechanism of Action .................................................................................... 2 Pharmacodynamics......................................................................................
3 Pharmacokinetics ......................................................................................... 25 11 STORAGE, STABILITY AND DISPOSAL ................................................................... 32 12 SPECIAL HANDLING INSTRUCTIONS......................................................................
33 PART II: SCIENTIFIC INFORMATION ................................................................................... 34 13 PHARMACEUTICAL INFORMATION ......................................................................... 34 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication ........................................................................... 35 15 MICROBIOLOGY ........................................................................................................ 42 16 NON-CLINICAL TOXICOLOGY ..................................................................................
42 PATIENT MEDICATION INFORMATION ............................................................................... 47 SOMATULINE® AUTOGEL® (lanreotide injection) Page 4 of 57 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SOMATULINE® AUTOGEL® […]