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Drug overview for MYCAPSSA (octreotide acetate):
Generic name: octreotide acetate (ok-TREE-oh-tide)
Drug class: Somatostatic Agents
Therapeutic class: Endocrine
Octreotide, a somatostatin analog, is a synthetic polypeptide that is pharmacologically related to the natural hormone somatostatin.
No enhanced Uses information available for this drug.
Generic name: octreotide acetate (ok-TREE-oh-tide)
Drug class: Somatostatic Agents
Therapeutic class: Endocrine
Octreotide, a somatostatin analog, is a synthetic polypeptide that is pharmacologically related to the natural hormone somatostatin.
No enhanced Uses information available for this drug.
DRUG IMAGES
MYCAPSSA DR 20 MG CAPSULE
The following indications for MYCAPSSA (octreotide acetate) have been approved by the FDA:
Indications:
Acromegaly
Professional Synonyms:
Acromegalia
Marie's disease
Marie's syndrome
Indications:
Acromegaly
Professional Synonyms:
Acromegalia
Marie's disease
Marie's syndrome
The following dosing information is available for MYCAPSSA (octreotide acetate):
Dosage of octreotide acetate is expressed in terms of octreotide.
Octreotide acetate is administered by the subcutaneous, IV, IM, or oral route depending on the specific use. Octreotide immediate-release injection is administered by subcutaneous injection orby IV injection or infusion for symptom control in patients with acromegaly, carcinoid tumors, or vasoactive intestinal peptide (VIP) tumors. Subcutaneous injection is the usual route of administration; IV administration generally is reserved for emergency situations (e.g., acute management of carcinoid crisis) that require rapid injection.
Octreotide is also available as a long-acting release (LAR) suspensionfor IM administration in patients with acromegaly, carcinoid tumors, or VIP-secreting tumors who have responded to and tolerated the immediate-release injection. Octreotide LAR suspension shouldnot be administered subcutaneously or IV. The LARinjectablesuspension may be used after tolerance has been established with at least 2 weeks of subcutaneous therapy with immediate-release octreotide. Octreotide is also available as delayed-release capsules for the long-term maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide.
Octreotide is also available as a long-acting release (LAR) suspensionfor IM administration in patients with acromegaly, carcinoid tumors, or VIP-secreting tumors who have responded to and tolerated the immediate-release injection. Octreotide LAR suspension shouldnot be administered subcutaneously or IV. The LARinjectablesuspension may be used after tolerance has been established with at least 2 weeks of subcutaneous therapy with immediate-release octreotide. Octreotide is also available as delayed-release capsules for the long-term maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MYCAPSSA DR 20 MG CAPSULE | Maintenance | Adults take 1 capsule (20 mg) by oral route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for MYCAPSSA (octreotide acetate):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Gallium Ga 68 Dotatate; Gallium Ga 68 Dotatoc/Somatostatin analogs SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Both somatostatin analogs and gallium Ga 68 dotatate/ gallium Ga 68 dotatoc bind to the same somatostatin receptors, resulting in competitive inhibition.(1) CLINICAL EFFECTS: Concurrent use of gallium Ga 68 dotatate/ gallium Ga 68 dotatoc and somatostatin analogs may affect the results of the scan.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: In patients receiving somatostatin analogs, perform the image just prior to dosing with long-acting somatostatin analogs. Short acting somatostatin analogs can be used up to 24 hours before imaging with gallium Ga 68 dotatate or gallium Ga 68 dotatoc. (1) DISCUSSION: Both somatostatin analogs and gallium Ga 68 dotatate/ gallium Ga 68 dotatoc bind to the same somatostatin receptors, resulting in competitive inhibition, which can affect the results of the scan.(1) |
GALLIUM GA-68 DOTATOC, NETSPOT |
| Lutetium Lu 177 dotatate/Long-Acting Somatostatin Analogs SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Somatostatin and somatostatin analogs bind to somatostatin receptors and may interfere with the efficacy of lutetium lu 177 dotatate.(1) CLINICAL EFFECTS: Concurrent administration of lutetium lu 177 dotatate and somatostatin analogs may decrease the efficacy of lutetium lu 177 dotatate.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of lutetium lu 177 dotatate recommends the following: - Before initiating lutetium lu 177 dotatate, discontinue long-acting somatostatin analogs for at least 4 weeks prior to initiation. Administer short-acting somatostatin analogs as needed; discontinue at least 24 hours prior to initiation of lutetium lu 177 dotatate. - During lutetium lu 177 dotatate treatment, administer long-acting octreotide 30 mg intramuscularly between 4 and 24 hours after each lutetium lu 177 dotatate dose. Do not administer long-acting octreotide within 4 weeks of each subsequent lutetium lu 177 dotatate dose. Short-acting octreotide may be given for symptomatic management during lutetium lu 177 dotatate treatment, but must be withheld for at least 24 hours before each lutetium lu 177 dotatate dose. - Following lutetium lu 177 dotatate treatment, continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing lutetium lu 177 dotatate until disease progression or for up to 18 months following treatment initiation.(1) DISCUSSION: Somatostatin and somatostatin analogs bind to somatostatin receptors and may interfere with the efficacy of lutetium lu 177 dotatate.(1) |
LUTATHERA |
| Copper Cu 64 Dotatate/Long-Acting Somatostatin Analogs SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Both somatostatin analogs and copper Cu 64 dotatate bind to the same somatostatin receptors (SSTR2), resulting in competitive inhibition.(1) CLINICAL EFFECTS: Concurrent use of copper Cu 64 dotatate and somatostatin analogs may affect the results of the scan.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: In patients receiving somatostatin analogs, perform the image just prior to dosing with long-acting somatostatin analogs. For patients on long-acting somatostatin analogs, a washout period of 28 days is recommended prior to imaging. For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging.(1) DISCUSSION: Both somatostatin analogs and copper Cu 64 dotatate bind to the same somatostatin receptors (SSTR2), resulting in competitive inhibition, which can affect the results of the scan.(1) |
DETECTNET |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Cyclosporine/Octreotide SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Octreotide may interfere with the enterohepatic circulation of cyclosporine or may delay or inhibit the absorption of cyclosporine.(2) CLINICAL EFFECTS: The concurrent administration of octreotide and cyclosporine may result in a decrease in cyclosporine levels. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Cyclosporine levels should be monitored in patients receiving concurrent therapy with cyclosporine and octreotide. The dosage of cyclosporine may need to be adjusted if octreotide is added to or discontinued from cyclosporine therapy. Octreotide may need to be discontinued. DISCUSSION: In a study, 23 of 65 pancreas transplant patients were treated octreotide. During octreotide therapy, the dosage of oral cyclosporine required to maintain therapeutic levels increased. In addition 15 patients required supplemental intravenous cyclosporine to maintain cyclosporine levels.(2) In a case report, a cadaver renal and whole-pancreas transplant recipient was treated for a fistula with octreotide. Cyclosporine blood levels slowly decreased despite an increase in cyclosporine dosage (from 180 mg to 300 mg daily). When the cyclosporine level decreased below 100 ng/ml, intravenous cyclosporine was administered. Octreotide was discontinued when the patient developed graft rejection. Cyclosporine levels returned to baseline and the rejection was reversed.(1) In another case report, cyclosporine levels dropped below detection when octreotide was added to his therapy. The patient was successfully treated for graft rejection and octreotide was discontinued.(3) These authors reported a total of nine patients in whom cyclosporine levels decreased following the addition of octreotide to cyclosporine.(4) In a study of 10 patients with severe diarrhea following bone marrow transplantation, cyclosporine dosage requirements increased by 50% in two subjects following the addition of octreotide.(5) |
CYCLOSPORINE, CYCLOSPORINE MODIFIED, GENGRAF, NEORAL, SANDIMMUNE |
| Pegvisomant/Somatostatin Analogues SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is unknown. CLINICAL EFFECTS: Concurrent use may result in an increased risk of hepatotoxicity.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The Canadian manufacturer of pegvisomant states that the concurrent use of pegvisomant and somatostatin analogues may lead to markedly increase hepatic enzymes in patients treated with this combination.(1) DISCUSSION: Based on post marketing studies, there was marked hepatic elevations (greater than 10 times the upper limit of normal (ULN) which was reported in 3 out of 26 patients treated with the combination of pegvisomant and octreotide. The ranges for the elevations for ALT and AST ranged from 13 to 45 times the ULN within three months of treatment. All three patients recovered after discontinuation of treatment.(1) |
SOMAVERT |
The following contraindication information is available for MYCAPSSA (octreotide acetate):
Drug contraindication overview.
*Hypersensitivity to octreotide or any ingredient in the formulation.
*Hypersensitivity to octreotide or any ingredient in the formulation.
There are 0 contraindications.
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Biliary calculus |
| Bradycardia |
| Cardiac arrhythmia |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Gallbladder disease |
| Hepatic cirrhosis |
| Untreated hypothyroidism |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Diabetes mellitus |
| Exocrine pancreatic insufficiency |
| Hypoglycemic disorder |
| Vitamin b12 deficiency |
The following adverse reaction information is available for MYCAPSSA (octreotide acetate):
Adverse reaction overview.
Adverse effects reported in at least 20% of patients receiving octreotideLAR for carcinoid syndrome include back pain, fatigue, headache, abdominal pain, nausea, and dizziness. Adverse effects reported in greater than 10% of patients receiving immediate-release octreotide for acromegaly include biliary tract abnormalities (gallstones, biliary sludge, duct dilatation), diarrhea, loose stools, nausea, abdominal discomfort, sinus bradycardia, hyperglycemia, and biochemical hypothryroidism. Adverse effects reported in at least 20% of patients receiving octreotideLAR for acromegaly include diarrhea, cholelithiasis, abdominal pain, and flatulence. Adverse effects reported in greater than 10% of patients receiving oral octreotide (Mycapssa(R)) include nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
Adverse effects reported in at least 20% of patients receiving octreotideLAR for carcinoid syndrome include back pain, fatigue, headache, abdominal pain, nausea, and dizziness. Adverse effects reported in greater than 10% of patients receiving immediate-release octreotide for acromegaly include biliary tract abnormalities (gallstones, biliary sludge, duct dilatation), diarrhea, loose stools, nausea, abdominal discomfort, sinus bradycardia, hyperglycemia, and biochemical hypothryroidism. Adverse effects reported in at least 20% of patients receiving octreotideLAR for acromegaly include diarrhea, cholelithiasis, abdominal pain, and flatulence. Adverse effects reported in greater than 10% of patients receiving oral octreotide (Mycapssa(R)) include nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
There are 41 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bradycardia Cardiac arrhythmia |
Biliary calculus Hypothyroidism Steatorrhea |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute myocardial infarction Acute pancreatitis Anaphylaxis Anemia Aphasia Appendicitis Atrial fibrillation Atrioventricular block Cellulitis Cholestasis Diabetes insipidus Diabetes mellitus Gastrointestinal hemorrhage Gastrointestinal obstruction Hearing loss Hemiparesis Hepatitis Hyperbilirubinemia Hyperglycemia Hypoglycemic disorder Intracranial bleeding Kidney disease with reduction in glomerular filtration rate (GFr) Kidney stone Ocular hypertension Pancytopenia Paranoid disorder Pituitary apoplexy Pulmonary hypertension Renal failure Seizure disorder Suicidal Thrombocytopenic disorder Thrombosis of retinal vein Thrombotic disorder Visual field defect |
There are 49 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Back pain Constipation Diarrhea Disorder of the digestive system Fatigue Flatulence Hyperhidrosis Injection site sequelae Loose stools Nausea Peripheral edema Sinusitis Vomiting |
Depression Discolored feces Dizziness Dyspepsia Flushing General weakness Headache disorder Pruritus of skin Tenesmus Visual changes |
| Rare/Very Rare |
|---|
|
Abdominal distension Alopecia Arthralgia Arthritis Bell's palsy Edema Fever Flu-like symptoms Galactorrhea not associated with childbirth Gynecomastia Hematuria Libido changes Memory impairment Migraine Oligomenorrhea Orthostatic hypotension Paresthesia Peripheral sensory neuropathy Petechiae Polyp of gallbladder Raynaud's phenomenon Scotomata Urticaria Vitamin b12 deficiency Weight loss |
The following precautions are available for MYCAPSSA (octreotide acetate):
Safety and efficacy of octreotide immediate-release injection, long-acting release (LAR) injectable suspension, and the oral preparation have not been established in pediatric patients. Controlled clinical trials to evaluate the safety and effectiveness of octreotide injection in pediatric patientsyounger than 6 years of age have not been performed. In postmarketing reports, serious adverse events, including hypoxia, necrotizing enterocolitis, and death, have been reported with octreotide use in children, most notably in children under 2 years of age.
The majority of these pediatric patients had serious underlying co-morbid conditions and the relationship of such adverse events to octreotide has not been established. Octreotide LARinjectable suspension (40 mg once monthly) has been investigated in a randomized, placebo-controlled study in pediatric patients 6-17 years of age withhypothalamic obesity secondary to cranial insult+. Efficacy was not demonstrated and treatment with octreotide was not associated with unexpected adverse events; however, new cholelithiasis was reported in 33% of children receiving octreotide.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
The majority of these pediatric patients had serious underlying co-morbid conditions and the relationship of such adverse events to octreotide has not been established. Octreotide LARinjectable suspension (40 mg once monthly) has been investigated in a randomized, placebo-controlled study in pediatric patients 6-17 years of age withhypothalamic obesity secondary to cranial insult+. Efficacy was not demonstrated and treatment with octreotide was not associated with unexpected adverse events; however, new cholelithiasis was reported in 33% of children receiving octreotide.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate and controlled studies of octreotide in pregnant women, and the drug should be used during pregnancy only when clearly needed. In cases with a known outcome, no congenital malformations have been reported among patients with acromegaly exposed to octreotide during the first trimester, including women electing to continue the drug throughout pregnancy. The women were exposed to 100-300 mcg/day of octreotide immediate-release or 20-30 mg once a month of octreotide LAR suspension.
Animal reproduction studies conducted with octreotide at doses up to 16 times the highest recommended human dose based on body surface area (BSA) have not revealed evidence of harm to the fetus. Transient growth retardation of rat offspring was observed atIV octreotide doses of 0.02-1 mg/kg per day which are below the maximum recommended human dose of 1.5mg/day,
based on body surface area; this is possibly a consequence of growth hormone inhibition by octreotide. There are insufficient data with octreotide LAR suspension in pregnant womento inform drug-associated-risk for major birth defects and miscarriage.
Animal reproduction studies conducted with octreotide at doses up to 16 times the highest recommended human dose based on body surface area (BSA) have not revealed evidence of harm to the fetus. Transient growth retardation of rat offspring was observed atIV octreotide doses of 0.02-1 mg/kg per day which are below the maximum recommended human dose of 1.5mg/day,
based on body surface area; this is possibly a consequence of growth hormone inhibition by octreotide. There are insufficient data with octreotide LAR suspension in pregnant womento inform drug-associated-risk for major birth defects and miscarriage.
Octreotide is present in rat milk following subcutaneous injection;however, there is no information regarding the presence of octreotide in human milk. Consider the benefits of breast-feeding and the importance of octreotide to the woman along with potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.
Clinical trials of octreotide did not include sufficient numbers of patients 65 years of age or older to determine whether such patients respond differently than younger patients. In a small number of patients 65 years of age or older treated with the oral preparation (Mycapssa(R)), no overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between geriatric patients and younger adults, but greater sensitivity of some older individuals cannot be ruled out.
Half-life increased by 46% andclearance decreasedby 26% following administration of immediate-release octreotide injection in an elderly population. Dosage of octreotide should be selected with caution and generally initiated at the lower end of the dosing range because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.
Half-life increased by 46% andclearance decreasedby 26% following administration of immediate-release octreotide injection in an elderly population. Dosage of octreotide should be selected with caution and generally initiated at the lower end of the dosing range because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.
The following prioritized warning is available for MYCAPSSA (octreotide acetate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for MYCAPSSA (octreotide acetate)'s list of indications:
| Acromegaly | |
| E22.0 | Acromegaly and pituitary gigantism |
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