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Mycapssa Generic Name & Formulations
Legal Class
Rx
General Description
Octreotide (as acetate) 20mg; del-rel caps.
Pharmacological Class
Somatostatin analogue.
How Supplied
Caps—28
Manufacturer
Generic Availability
NO
Mycapssa Indications
Indications
Long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Mycapssa Dosage and Administration
Adult
Swallow whole. Take on an empty stomach (≥1hr before or ≥2hrs after a meal). Initially 20mg twice daily; titrate and increase in 20mg increments, based on IGF-1 levels and response; max 80mg/day. Dose interruptions/modifications: see full labeling. ESRD: initially 20mg once daily.
Children
Not established.
Mycapssa Contraindications
Not Applicable
Mycapssa Boxed Warnings
Not Applicable
Mycapssa Warnings/Precautions
Warnings/Precautions
Diabetes. Thyroid function abnormalities. Assess thyroid function periodically. Cardiac conduction abnormalities. Monitor gallbladder, glucose, vitamin B12 levels. Discontinue and treat if cholelithiasis complications are suspected. Monitor IGF-1 levels every 2 weeks during dose titration and monthly when maintenance dose is achieved, or as indicated. ESRD (see Adult dose). Liver cirrhosis. Fatty liver disease. Elderly. Pregnancy. Nursing mothers.
Mycapssa Pharmacokinetics
See Literature
Mycapssa Interactions
Interactions
Concomitant bradycardia-inducing drugs (eg, β-blockers, calcium channel blockers); may need dose adjustments. Potentiates bromocriptine, CYP450 substrates (eg, quinidine), lisinopril; monitor and adjust dose if needed. Antagonized by PPIs, H2-receptor antagonists, or antacids; may need increased dose of Mycapssa. Antagonizes cyclosporine (adjust dose), digoxin (monitor). Antagonizes levonorgestrel (advise to use alternative non-hormonal contraceptive or back-up method). May need to adjust insulin or antidiabetic agents.
Mycapssa Adverse Reactions
Adverse Reactions
Nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, increased blood glucose, vomiting, abdominal discomfort, dyspepsia, sinusitis, osteoarthritis; gallbladder abnormalities/sludge, hyperglycemia, hypoglycemia, hypothyroidism, cardiac conduction abnormalities, ECG changes, abnormal Schilling's tests.
Mycapssa Clinical Trials
See Literature
Mycapssa Note
Not Applicable
Mycapssa Patient Counseling
See Literature
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