Octreotide
Generic Name: octreotide
Brand Names:
Mycapssa
11 DESCRIPTION MYCAPSSA delayed release capsules contain octreotide acetate, a somatostatin analog. Octreotide is known chemically as L-cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)].
Overview
11 DESCRIPTION MYCAPSSA delayed release capsules contain octreotide acetate, a somatostatin analog. Octreotide is known chemically as L-cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)].
Uses
1 INDICATIONS AND USAGE MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION Take MYCAPSSA orally with a glass of water on an empty stomach, at least 1 hour before a meal or at least 2 hours after a meal ( 2.1 ). Initiate MYCAPSSA at a dosage of 40 mg daily, administered as 20 mg orally twice daily ( 2.2 ). Monitor insulin-like growth factor 1 (IGF-1) levels and patient's signs and symptoms every two weeks during the dose titration or as indicated ( 2.2 ). Titrate the MYCAPSSA dosage, based on IGF-1 levels and patient's signs and symptoms. Increase the dosage in increments of 20 mg ( 2.2 ). The maximum recommended dosage is 80 mg daily ( 2.2 ). Once the maintenance dosage of MYCAPSSA is achieved, monitor IGF-1 levels and patient's signs and symptoms monthly or as indicated ( 2.2 ).
Side Effects
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.1) ] Hyperglycemia and Hypoglycemia [see Warnings and Precautions (5.2) ] Thyroid Function Abnormalities [see Warnings and Precautions (5.3) ] Cardiac Function Abnormalities [see Warnings and Precautions (5.4) ] Steatorrhea and Malabsorption of Dieatary Fats [see Warnings and Precautions (5.5) ] Changes in Vitamin B 12 Levels [ see Warnings and Precautions (5.6) ] Most common adverse reactions (incidence >10 %) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, osteoarthritis...
Interactions
7 DRUG INTERACTIONS Proton Pump Inhibitors, H2-receptor Antagonists, or Antacids: may decrease bioavailability of MYCAPSSA and the MYCAPSSA dose may need to be increased ( 7 ). Cyclosporine : may have decreased bioavailability and require dose adjustment ( 7 ). Insulin and Antidiabetic Drugs: patients receiving insulin or antidiabetic drugs agents may require dose adjustment ( 7 ). Digoxin: exposure may be decreased and assessment of clinical response to digoxin should be performed ( 7 ). Lisinopril: bioavailability may be increased, monitor patient's blood pressure and adjust dose of lisinopril if needed ( 7 ). Levonorgestrel: counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives ( 7 ).
Warnings
5 WARNINGS AND PRECAUTIONS Cholelithiasis and Complications of Cholelithiasis: Monitor periodically. Discontinue if complications of cholelithiasis are suspected ( 5.1 ). Hypoglycemia or Hyperglycemia: Monitor glucose and adjust antidiabetic treatment as needed ( 5.2 ). Thyroid Function Abnormalities: Hypothyroidism may occur. Assess thyroid function periodically ( 5.3 ). Cardiac Function: Bradycardia, arrhythmia, or conduction abnormalities may occur. Drugs that have bradycardia effects may need dosage adjustments ( 5.4 , 7.2 ). Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. 4 CONTRAINDICATIONS Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide [see Adverse Reactions (6.3) ]. Hypersensitivity to octreotide or any of the components of MYCAPSSA.
Pregnancy
8.1 Pregnancy Risk Summary Available data from case reports with octreotide acetate use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with MYCAPSSA. No adverse developmental effects were observed with intravenous administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7 and 13 times, respectively, the clinical dose based on octreotide injection body surface area.
Storage
Storage Until first use, store unopened wallets of MYCAPSSA refrigerated at 2° to 8°C (36° to 46°F). Do not freeze. After first use, opened wallets may be stored at 20° to 25°C (68° to 77°F) for up to 1 month.
Frequently Asked Questions
What is Octreotide used for?▼
1 INDICATIONS AND USAGE MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide ( 1 ).
What are the side effects of Octreotide?▼
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.1) ] Hyperglycemia and Hypoglycemia [see Warnings and Precautions (5.2) ] Thyroid Function Abnormalities [see Warnings and Precautions (5.3) ] Cardiac Function Abnormalities [see Warnings and Precautions (5.4) ] Steatorrhea and Malabsorption of Dieatary Fats [see Warnings and Precautions (5.5) ] Changes in Vitamin B 12 Levels [ see Warnings and Precautions (5.6) ] Most common adverse reactions (incidence >10 %) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, osteoarthritis...
Can I take Octreotide during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from case reports with octreotide acetate use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with MYCAPSSA. No adverse developmental effects were observed with intravenous administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7 and 13 times, respectively, the clinical dose based on octreotide injection body surface area.
What are the important warnings for Octreotide?▼
5 WARNINGS AND PRECAUTIONS Cholelithiasis and Complications of Cholelithiasis: Monitor periodically. Discontinue if complications of cholelithiasis are suspected ( 5.1 ). Hypoglycemia or Hyperglycemia: Monitor glucose and adjust antidiabetic treatment as needed ( 5.2 ). Thyroid Function Abnormalities: Hypothyroidism may occur. Assess thyroid function periodically ( 5.3 ). Cardiac Function: Bradycardia, arrhythmia, or conduction abnormalities may occur. Drugs that have bradycardia effects may need dosage adjustments ( 5.4 , 7.2 ). Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. 4 CONTRAINDICATIONS Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide [see Adverse Reactions (6.3) ]. Hypersensitivity to octreotide or any of the components of MYCAPSSA.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.