OTHER ADVERSE EVENTS 16%-20%
Other adverse events (relationship to drug not established) in acromegalic and/or carcinoid syndrome patients receiving Sandostatin LAR® Depot were upper respiratory infection, flu-like symptoms, fatigue, dizziness, headache, malaise, fever, dyspnea, back pain, chest pain, arthropathy.
OTHER ADVERSE EVENTS 5%-15%
Other adverse events (relationship to drug not established) occurring in an incidence of 5%-15% in patients receiving Sandostatin LAR® Depot were: Body As a Whole: asthenia, rigors, allergy
Cardiovascular: hypertension, peripheral edema
Central and Peripheral Nervous System: paresthesia, hypoesthesia
Gastrointestinal: dyspepsia, anorexia, hemorrhoids
Hearing and Vestibular: earache
Heart Rate and Rhythm: palpitations
Hematologic: anemia
Metabolic and Nutritional: dehydration, weight decrease
Musculoskeletal System: myalgia, leg cramps, arthralgia
Psychiatric: depression, anxiety, confusion, insomnia
Resistance Mechanism: viral infection, otitis media
Respiratory System: coughing, pharyngitis, rhinitis, sinusitis
Skin and Appendages: rash, pruritus, increased sweating
Urinary System: urinary tract infection, renal calculus
OTHER ADVERSE EVENTS 1%-4%
Other events (relationship to drug not established), each occurring in an incidence of 1%-4% in patients receiving Sandostatin LAR® Depot and reported by at least 2 patients were: Application Site: injection site inflammation
Body As a Whole: syncope, ascites, hot flushes
Cardiovascular: cardiac failure, angina pectoris, hypertension aggravated
Central and Peripheral Nervous System: vertigo, abnormal gait, neuropathy, neuralgia, tremor, dysphonia, hyperkinesia, hypertonia
Gastrointestinal: rectal bleeding, melena, gastritis, gastroenteritis, colitis, gingivitis, taste perversion, stomatitis, glossitis, dry mouth, dysphagia, steatorrhea, diverticulitis
Hearing and Vestibular: tinnitus
Heart Rate and Rhythm: tachycardia
Liver and Biliary: jaundice
Metabolic and Nutritional: hypokalemia, cachexia, gout, hypoproteinemia
Platelet, Bleeding, Clotting: pulmonary embolism, epistaxis
Psychiatric: amnesia, somnolence, nervousness, hallucinations
Reproductive, Female: menstrual irregularities, breast pain
Reproductive, Male: impotence
Resistance Mechanism: cellulitis, renal abcess, moniliasis, bacterial infection
Respiratory System: bronchitis, pneumonia, pleural effusion
Skin and Appendages: alopecia, urticaria, acne
Urinary System: incontinence, albuminuria
Vascular: cerebral vascular disorder, phlebitis, hematoma
Vision: abnormal vision
RARE ADVERSE EVENTS
Other events (relationship to drug not established) of potential clinical significance occurring rarely (<1%) in clinical trials of octreotide either as Sandostatin® Injection or Sandostatin LAR® Depot, or reported post-marketing in patients with acromegaly, carcinoid syndrome, or other disorders include: Body As a Whole: anaphylactoid reactions, including anaphylactic shock, facial edema, generalized edema, abdomen enlarged, malignant hyperpyrexia
Cardiovascular: aneurysm, myocardial infarction, angina pectoris, aggravated, pulmonary hypertension, cardiac arrest, orthostatic hypotension
Central and Peripheral Nervous System: hemiparesis, paresis, convulsions, paranoia, pituitary apoplexy, visual field defect, migraine, aphasia, scotoma, Bell's palsy
Endocrine Disorders: hypoadrenalism, diabetes insipidus, gynecomastia, galactorrhea
Gastrointestinal: G.I. hemorrhage, intestinal obstruction, hepatitis, increase in liver enzymes, fatty liver, peptic/gastric ulcer, gallbladder polyp, appendicitis, pancreatitis
Hearing and Vestibular: deafness
Heart Rate and Rhythm: atrial fibrillation
Hematologic: pancytopenia, thrombocytopenia
Metabolic and Nutritional: renal insufficiency, creatinine increased, CK increased, diabetes mellitus
Musculoskeletal: Raynaud's syndrome, arthritis, joint effusion
Neoplasms: breast carcinoma, basal cell carcinoma
Platelet, Bleeding, and Clotting: arterial thrombosis of the arm
Psychiatric: suicide attempt, libido decrease
Reproductive, Female: lactation, nonpuerperal
Respiratory: pulmonary nodule, status asthmaticus, pneumothorax
Skin and Appendages: cellulitis, petechiae, urticaria
Urinary System: renal failure, hematuria
Vascular: intracranial hemorrhage, retinal vein thrombosis
Vision: glaucoma
ANTIBODIES TO OCTREOTIDE
Studies to date have shown that antibodies to octreotide develop in up to 25% of patients treated with octreotide acetate. These antibodies do not influence the degree of efficacy response to octreotide; however, in two acromegalic patients who received Sandostatin® Injection, the duration of GH suppression following each injection was about twice as long as in patients without antibodies. It has not been determined whether octreotide antibodies will also prolong the duration of GH suppression in patients being treated with Sandostatin LAR® Depot.
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