Other Adverse Reactions
In the placebo-controlled study, in patients treated with MYCAPSSA, acute cholecystitis occurred in 4% of patients.
In the open-label study, cholelithiasis occurred in 4.5% of patients and bile duct obstruction, bile duct stone, acute cholecystitis and jaundice occurred in 1% of patients each.
In the placebo-controlled study, 18% of patients treated with MYCAPSSA and 4% of patients treated with placebo developed at least one glucose value above the upper normal limit. All patients with abnormal glucose values were asymptomatic. Asymptomatic hypoglycemia was reported in 4% of patients.
In the open-label study 16% of patients developed a glucose value above the upper limit of normal. Asymptomatic hypoglycemia was reported in 4% and symptomatic hypoglycemia was reported in 1% of patients. Diabetes was reported in 1% of patients.
In the open-label study, hypothyroidism, increased TSH, or decreased free T4 were reported in 1% of patients.
In the open-label study, bradycardia was reported in 2%, conduction abnormalities in 1%, and arrhythmias/tachycardia in 2% of patients.
Gastrointestinal symptoms were the most commonly reported adverse reactions with MYCAPSSA.
In the placebo-controlled study, gastrointestinal adverse reactions were reported in 68% of patients treated with MYCAPSSA. These adverse reactions were diarrhea, nausea, vomiting, abdominal discomfort, dyspepsia, large intestinal polyp, abdominal pain, constipation, and flatulence. The adverse reactions were mild to moderate, occurred mostly during the initial 3 months of treatment, and resolved on treatment within a median duration of 8 days.
In the open-label study, gastrointestinal adverse reactions were reported in 57% of patients. Gastrointestinal adverse reactions occurring in ≥ 1% of patients were nausea, diarrhea, dyspepsia, abdominal pain, abdominal distention, vomiting, flatulence, constipation, gastroesophageal reflux disease, abdominal discomfort, frequent bowel movement, gastritis, hemorrhoids, dry mouth, and gastrointestinal motility disorder. Large intestinal polyp was reported in 1 patient. The adverse reactions were mostly mild to moderate, occurred during the initial 2 months of treatment, and resolved on treatment within a median of 13 days. Ten patients discontinued treatment due to gastrointestinal adverse reactions.
As with all therapeutic peptides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other octreotide acetate products may be misleading.
No antibodies to the octreotide peptide from MYCAPSSA were detected in 149 patients assessed in the open label study throughout 13 months of treatment.
The following adverse reactions have been identified during the post-approval use of octreotide acetate. Because these reactions 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.
- Blood and lymphatic: pancytopenia, thrombocytopenia
- Cardiac: myocardial infarction, cardiac arrest, atrial fibrillation
- Ear and labyrinth: deafness
- Endocrine: diabetes insipidus, adrenal insufficiency in patients 18 months of age and under, pituitary apoplexy
- Eye: glaucoma, visual field defect, scotoma, retinal vein thrombosis
- Gastrointestinal: intestinal obstruction, peptic/gastric ulcer, abdomen enlarged
- General and administration site: generalized edema, facial edema
- Hepatobiliary: gallbladder polyp, fatty liver, hepatitis
- Immune: anaphylactoid reactions including anaphylactic shock
- Infections and infestations: appendicitis
- Laboratory abnormalities: increased liver enzymes, CK increased, creatinine increased
- Metabolism and nutrition: diabetes mellitus
- Musculoskeletal: arthritis, joint effusion, Raynaud’s syndrome
- Nervous System: convulsions, aneurysm, intracranial hemorrhage, hemiparesis, paresis, suicide attempt, paranoia, migraines, Bell’s palsy, aphasia
- Renal and urinary: renal failure, renal insufficiency
- Reproductive and breast: gynecomastia, galactorrhea, libido decrease, breast carcinoma
- Respiratory: status asthmaticus, pulmonary hypertension, pulmonary nodule, pneumothorax aggravated
- Skin and subcutaneous tissue: urticaria, cellulitis, petechiae
- Vascular: orthostatic hypotension, hematuria, gastrointestinal hemorrhage, arterial thrombosis of the arm
|Proton Pump Inhibitors, H2-receptor Antagonists, or Antacids|
|Clinical Impact:||Concomitant administration of MYCAPSSA with esomeprazole resulted in a decrease in the bioavailability for MYCAPSSA [See Clinical Pharmacology (12.3)]. Drugs that alter the pH of the upper GI tract (e.g., other proton pump inhibitors (PPIs), H2-receptor antagonists, and antacids) may alter the absorption of MYCAPSSA and lead to a reduction in bioavailability.|
|Intervention:||Co-administration of MYCAPSSA with PPIs, H2-blockers, or antacids may require increased doses of MYCAPSSA.|
|Clinical Impact:||Concomitant administration of MYCAPSSA with cyclosporine resulted in a decrease in cyclosporine bioavailability [see Clinical Pharmacology (12.3)].|
|Intervention:||Adjustment of cyclosporine dose to maintain therapeutic levels may be necessitated.|
|Insulin and Antidiabetic Drugs|
|Clinical Impact:||MYCAPSSA inhibits the secretion of insulin and glucagon.|
|Intervention:||Monitor blood glucose levels in diabetic patients upon MYCAPSSA initiation and subsequent dose adjustment. Patients receiving insulin or antidiabetic drugs agents may require dose adjustment of these therapeutic agents.|
|Clinical Impact:||Concomitant administration of MYCAPSSA with digoxin resulted in a decrease in digoxin peak exposure [see Clinical Pharmacology (12.3)].|
|Intervention:||Digoxin has a narrow therapeutic ratio and careful assessment of clinical response should be performed when digoxin is concomitantly administered with MYCAPSSA.|
|Clinical Impact:||Concomitant administration of MYCAPSSA increases lisinopril bioavailability [see Clinical Pharmacology (12.3)].|
|Intervention:||Monitor patient’s blood pressure and adjust the dosage of lisinopril if needed.|
|Clinical Impact:||Concomitant administration of MYCAPSSA with levonorgestrel decreases levonorgestrel bioavailability [see Clinical Pharmacology (12.3)].|
|Intervention:||Decreased bioavailability may potentially diminish the effectiveness of combined oral contraceptives (COCs) or increase breakthrough bleeding. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with COCs.|
|Clinical Impact:||Concomitant administration of MYCAPSSA with bromocriptine may increase the systemic exposure of bromocriptine [see Clinical Pharmacology (12.3)].|
|Intervention:||Dose adjustment of bromocriptine may be necessary.|
|Beta Blocker and Calcium Channel Blockers|
|Clinical Impact:||MYCAPSSA may cause bradycardia in acromegaly patients.|
|Intervention:||Patients receiving beta blockers or calcium channel blockers may require dose adjustments of these therapeutic agents.|
|Drugs Metabolized by CYP 450 Enzymes|
|Clinical Impact:||Limited published data indicate that somatostatin analogs including MYCAPSSA may decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of GH.|
|Intervention:||Concomitant use with other drugs mainly metabolized by CYP3A4 that have a narrow therapeutic index (e.g., quinidine) should be used with caution and increased monitoring may be required.|
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