Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Hypoglycemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Abnormalities [see Warnings and Precautions ( 5.3 )] Thyroid Function Abnormalities [see Warnings and Precautions ( 5.4 )] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are: Acromegaly : (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions.
( 6.1 ) GEP-NET : (>10%): abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis.
( 6.1 ) Carcinoid Syndrome : (≥5% and at least 5% greater than placebo): headache, dizziness and muscle spasm.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd.
at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience 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.
The safety of Lanreotide Injection was established from adequate and well-controlled studies of another lanreotide injection product [see Clinical Studies ( 14 )] .
Adverse reactions observed in these adequate and well-controlled studies are described below.
Acromegaly The data described below reflect exposure to lanreotide injection 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.
5 WARNINGS AND PRECAUTIONS Cholelithiasis and Complications of Cholelithiasis : Monitor periodically.
Discontinue if complications of cholthiasis are suspected.
Gallstones may occur;
consider periodic monitoring.
( 5.1 ) Hyperglycemia and Hypoglycemia : Glucose monitoring is recommended and antidiabetic treatment adjusted accordingly.
Like all medications, Lanreotide Acetate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: