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MYTOLAC 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: PrMYTOLAC® [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. The goal of…
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 PrMYTOLAC® 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 PrMYTOLAC®, therefore, heart rate should be monitored in these patients (see Cardiovascular and Monitoring and Laboratory Tests).
• Patients treated with PrMYTOLAC® 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).
• PrMYTOLAC® 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 PrMYTOLAC® 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 PrMYTOLAC® may reduce the intestinal absorption of co- administered drugs. PrMYTOLAC® may decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes.
Caution should be exercised when medicinal products mainly metabolized by CYP3A4 that have a low therapeutic index Serious Warnings and Precautions • Loss of blood glucose control (hypoglycemia in diabetic patients; hyperglycemia) can occur (see Endocrine and Metabolism and Monitoring and Laboratory Tests).
• Gallbladder motility may be reduced and lead to gallstone formation (see Hepatic/Biliary/Pancreatic and Monitoring and Laboratory Tests). 1 Serious Drug Interactions). 2 Drug Interactions Overview). • Concomitant administration of bradycardia-inducing drugs may have an additive effect on the reduction of heart rate associated with PrMYTOLAC® treatment.
1 Adverse Reaction Overview The adverse reactions commonly reported with lanreotide 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 lanreotide or 13 injections of lanreotide).
The dose could be adapted every 4 injections based on GH or IGF-1 levels. The total exposure to lanreotide 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 lanreotide 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 Lanreotide 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) 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.
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. Cardiovascular Lanreotide may lead to a decrease of heart rate without necessarily reaching the threshold of bradycardia in patients without an underlying cardiac problem. In patients suffering from cardiac disorders prior to lanreotide initiation, sinus bradycardia may occur and therefore heart rate should be monitored (see Monitoring and Laboratory Tests).
In 81 patients with baseline heart rates of ≥ 60 beats per minute (bpm) treated with lanreotide in enteropancreatic neuroendocrine tumours (NETs) Study 726, the incidence of heart rate <60 bpm was 23% (19/81) as compared to 16% (15/94) of placebo treated patients; ten patients (12%) had documented heart rates <60 bpm on more than one visit.
The incidence of documented episodes of heart rate <50 bpm as well as the incidence of bradycardia reported as an adverse event was 1% in each treatment group. Initiate appropriate medical management in patients who develop symptomatic bradycardia.
Driving and Operating Machinery Clinical studies in patients with acromegaly, enteropancreatic NETs, or carcinoid syndrome demonstrated that adverse reactions of headache and dizziness were most commonly reported with lanreotide treatment.
Patients should be warned to exercise caution when driving or operating machinery while on treatment with PrMYTOLAC®. Endocrine and Metabolism Pharmacological studies in animals and humans show that lanreotide, like somatostatin and its analogues, inhibits the secretion of insulin and glucagon.
Hence, patients treated with PrMYTOLAC® may experience hypoglycemia or hyperglycemia. Blood glucose levels should be monitored when lanreotide treatment is initiated or when the dose is changed and periodically thereafter, and treatment of diabetic patients should be adjusted accordingly (see Monitoring and Laboratory Tests).
In insulin-dependent patients, insulin requirements may be reduced. Slight decreases in thyroid function have been seen during treatment with lanreotide in PrMYTOLAC® (lanreotide injection) Page 10 of 56 acromegalic patients, though clinical hypothyroidism is rare.
• 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. PrMYTOLAC® (lanreotide injection) Page 5 of 56
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 2 Recommended Dose and Dosage Adjustment, Carcinoid Syndrome). 2 Recommended Dose and Dosage Adjustment Acromegaly Patients should begin treatment with PrMYTOLAC® 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 PrMYTOLAC® dosage to 120 mg every 4 weeks • GH ≤ 1 ng/mL, IGF-1 normal and clinical symptoms controlled: Reduce PrMYTOLAC® 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 PrMYTOLAC® 60 mg or 90 mg may be considered for an extended dosing interval of PrMYTOLAC® 120 mg every 6 or 8 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 Lanreotide in Patients with Acromegaly). Health Canada has not […]
e. those reported in ≥2% of patients for the lanreotide 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 lanreotide, 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. PrMYTOLAC® (lanreotide injection) Page 14 of 56 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 Lanreotide Reported in ≥ 2% of Total Patients on Lanreotide in Study 717 (Safety Population) by Dose of Onset Adverse Event by Body System Lanreotide 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 Malaise Chest Pain 1 (2) 2 (4) 0 (0) 0 (0) 4 (6) 0 (0) 0 (0) 0 (0) 3 (4) 1 (1) 2 (3) 2 (3) 8 (7) 3 (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) 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 1 (2) 1 (2) 5 (8) 1 (2) 1 (1) 1 (1) 6 (6) 3 (3) PrMYTOLAC® (lanreotide injection) Page 15 of 56 Muscle weakness Skeletal pain 1 (2) 0 (0) 0 (0) 1 (2) 1 (1) 1 (1) 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 (2) 0 (0) 2 (3) 3 (3) Skin and Appendages Disorders Alopecia Hair disorder Nail disorder 5 (11) […]
Thyroid function tests are recommended where clinically indicated (see Monitoring and Laboratory Tests). Gastrointestinal The gastrointestinal effects of lanreotide may reduce the intestinal absorption of co- administered drugs. Hepatic/Biliary/Pancreatic Lanreotide may reduce gallbladder motility and lead to gallstone formation.
Gallbladder ultrasonography is therefore advised at the start of treatment and periodically thereafter (see Monitoring and Laboratory Tests). There have been post-marketing reports of gallstones resulting in complications, including cholecystitis, cholangitis, and pancreatitis, requiring cholecystectomy in patients taking lanreotide.
If complications of cholelithiasis are suspected, discontinue PrMYTOLAC® and treat appropriately. In hepatic impairment, an increase in Volume of Distribution, Mean Residence Time, AUC, and half-life were observed. 3 Pharmacokinetics, Hepatic Insufficiency).
Pancreatic exocrine insufficiency (PEI) has been observed in some patients receiving lanreotide therapy mainly for gastroenteropancreatic NETs, but cases have also been reported in patients receiving lanreotide therapy for acromegaly or carcinoid syndrome.
Symptoms of PEI can include steatorrhea, loose stools, abdominal bloating, and weight loss. Screening and appropriate treatment for PEI according to clinical guidelines should be considered in symptomatic patients. 2 Recommended Dose and Dosage Adjustment, Acromegaly).
3 Pharmacokinetics, Pharmacokinetics of Lanreotide in Patients with Acromegaly). 3 Pharmacokinetics, Hepatic Insufficiency). 3 Pharmacokinetics, Hepatic Insufficiency). 5 Post- Market Adverse Drug Reactions). 2 Recommended dose and dosage adjustment, Acromegaly).
Slight decreases in thyroid function have been seen during treatment. Thyroid function tests are recommended where clinically indicated. Acromegaly, Enteropancreatic NETs, and Carcinoid Syndrome In patients suffering from cardiac disorders prior to lanreotide initiation, sinus bradycardia may occur and therefore heart rate should be monitored.
The principal pharmacodynamic interaction that may occur is the inhibition of glucagon secretion which may lead to the onset of hypoglycemia in treated diabetic patients, notably insulin-dependent patients. Thus, the insulin requirements in insulin-dependent diabetic patients may be reduced.
Patients treated with PrMYTOLAC® may experience hypoglycemia or hyperglycemia. Therefore, blood glucose levels should be monitored when PrMYTOLAC® treatment is initiated or when the dosage is attuned, and periodically thereafter. The antidiabetic treatment of […]