GETTING STARTED

Start Your Patients on MYCAPSSA and Titrate for Optimal Therapeutic Benefit

Counsel patients on why you are recommending MYCAPSSA.

Discuss a transition plan to MYCAPSSA with your patient.

Titrate dosage based on IGF-I levels and patient’s signs and symptoms.

The starting dose is 40 mg administered as 20mg BID. Titrate in 20 mg increments up to maximum daily dosage of 80 mg. The majority of patients in clinical trials were titrated to a dose of 60 mg or higher.

Educate your patients on how to take MYCAPSSA properly, and encourage adherence.

Start your patients on the 20 mg BID oral dose
Ensure they take MYCAPSSA with a glass of water
Coach them on finding a routine for taking MYCAPSSA on an empty stomach, either 1 hour before or 2 hours after eating

AMRYT Clinical Educators offer dedicated support.

Continued support for you and your patients from initiation of therapy through continued use of MYCAPSSA.

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

CONTRAINDICATIONS
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

WARNINGS AND PRECAUTIONS
MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

Blood sugar, thyroid levels, and vitamin B₁₂levels should be monitored and treated accordingly.

Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

ADVERSE REACTIONS
The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

DRUG INTERACTIONS
The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA.

Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

PREGNANCY
Advise premenopausal females of the potential for an unintended pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch