Drugplain

Mycapssa 20 mg/1

Octreotide · CAPSULE, DELAYED RELEASE · Amryt Pharmaceuticals Designated Activity Company

No Recall History
Plain English

Mycapssa is a capsule, delayed release containing octreotide at 20 mg/1, taken oral. Manufactured by Amryt Pharmaceuticals Designated Activity Company.

Key Facts

Brand Name
Mycapssa
Generic Name
Octreotide
NDC Code (Product)
69880-120
Manufacturer
Amryt Pharmaceuticals Designated Activity Company
Strength
20 mg/1
Dosage Form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
NDA208232
Drug Class
Somatostatin Analog [EPC]
Marketing Start
07/06/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use700 reports
drug ineffective683 reports
diarrhoea543 reports
death380 reports
nausea367 reports
fatigue316 reports
malignant neoplasm progression243 reports
abdominal pain228 reports
vomiting215 reports
drug ineffective for unapproved indication186 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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 ). For patients with end-stage renal disease, initiate at a dosage of 20 mg orally once daily. Titrate and adjust the maintenance dosage based on IGF-1 levels, patient's signs and symptoms and tolerability (‎ 2.4 ). 2.1 Important Administration Instructions 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. Swallow MYCAPSSA capsules whole. Do not crush or chew the capsules. …

Contraindications

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.

Drug 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 ). Bromocriptine: dose adjustment of bromocriptine may be necessary (‎ 7 ). Beta Blocker and Calcium Channel Blockers : dose adjustment of beta blockers or calcium channel blockers may be necessary (‎ 7 ). Drugs Metabolized by CYP 450 Enzymes: 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 mon…

Adverse Reactions

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 (‎ 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and …

Frequently Asked Questions

What is Mycapssa used for?

Mycapssa contains Octreotide. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.

Is Mycapssa a controlled substance?

Mycapssa is not classified as a controlled substance by the DEA.

What is the generic name for Mycapssa?

The generic name for Mycapssa is Octreotide. There are 11 other brand versions of Octreotide.

What is the NDC code for Mycapssa 20 mg/1?

The NDC (National Drug Code) for Mycapssa 20 mg/1 is 69880-120, listed by Amryt Pharmaceuticals Designated Activity Company.

Product NDC

69880-120

Package NDC

69880-120-28

Other Mycapssa Dosages

Other Octreotide Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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