Mycapssa

What is Mycapssa?

• Mycapssa (octreotide capsule, delayed release) is a somatostatin analog used to treat acromegaly in people who have been treated successfully with octreotide injection or lanreotide injection.

Octreotide

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What are the uses of this medicine?

• Mycapssa (octreotide capsule, delayed release) is an oral prescription medicine used in the long-term maintenance treatment of acromegaly in people for whom initial treatment with octreotide or lanreotide has been effective and tolerated.

How does this medicine work?

• The acetate salt of a synthetic long-acting cyclic octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin.
• Octreotide is a more potent inhibitor of growth hormone, glucagon, and insulin than somatostatin.
• Similar to somatostatin, this agent also suppresses the luteinizing hormone response to gonadotropin-releasing hormone, decreases splanchnic blood flow, and inhibits the release of serotonin, gastrin, vasoactive intestinal peptide (VIP), secretin, motilin, pancreatic polypeptide, and thyroid stimulating hormone.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have liver cirrhosis or liver problems
• have kidney problems
• are pregnant or plan to become pregnant. It is not known if Mycapssa will harm your unborn baby. Mycapssa may increase your chance of becoming pregnant.
• are breastfeeding or plan to breastfeed

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• antacids such as aluminum hydroxide/magnesium hydroxide (Maalox), calcium carbonate (Tums) or calcium carbonate and magnesium (Rolaids)
• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• bromocriptine (Cycloset, Parlodel)
• calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), nifedipine (Adalat, Procardia), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• digoxin (Lanoxin), H2 blockers such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac)
• insulin and oral medications for diabetes
• levonorgestrel (Mirena, Skyla)
• lisinopril (Qbrelis, Zestril)
• proton-pump inhibitors such as lansoprazole (Prevacid), omeprazole (Prilosec), and pantoprazole (Protonix)
• quinidine (in Nuedexta)

• If you take oral contraceptives. Use an alternative non-hormonal method of contraception or a back-up method while taking Mycapssa.

Is this medicine FDA approved?

• Octreotide (Mycapssa) was approved for medical use in the European Union in 2022.
• As of June 2020, octreotide (Mycapssa) is the first and only oral somatostatin analog (SSA) approved by the FDA.

How should this medicine be used?

Recommended dosage:

• Initiate Mycapssa at a dosage of 40 mg daily, administered as 20 mg orally twice daily.
• 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.
• Titrate the Mycapssa dosage, based on IGF-1 levels and patient's signs and symptoms. Increase the dosage in increments of 20 mg.
• The maximum recommended dosage is 80 mg daily.
• Once the maintenance dosage of Mycapssa is achieved, monitor IGF-1 levels and patient's signs and symptoms monthly or as indicated.

Recommended Dosage in Patients with End Stage Renal Disease:

• 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.

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

Administration:

• Octreotide comes as a capsule to take by mouth.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-release capsules: 20 mg.

This medicine is available in fallowing brand namesː Mycapssa

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea
• diarrhea
• joint pain
• weakness
• sweating a lot

Mycapssa can cause serious side effects, including:

• gallbladder problems
• blood sugar problems
• thyroid problems
• heart rhythm problems
• low vitamin B12 levels in your blood

What special precautions should I follow?

• Advise patients to contact their healthcare provider if they experience signs or symptoms of gallstones (cholelithiasis) or complications of cholelithiasis (e.g., cholecystitis, cholangitis and pancreatitis).
• Mycapssa alters the balance between the counter-regulatory hormones, insulin, glucagon, and growth hormone, which may result in hypoglycemia, or hyperglycemia, or diabetes mellitus. Advise patients to contact their healthcare provider if they have problems with blood sugar levels, either hyperglycemia or hypoglycemia.
• Mycapssa suppresses the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Inform patients that their thyroid function will be assessed periodically during treatment.
• Cardiac conduction abnormalities and other ECG changes including QT prolongation, axis shifts, early repolarization, low voltage, R/S transition, and early R wave progression, have occurred during treatment with octreotide. Inform patients to contact the health care provider in case they notice irregular heartbeat.
• Mycapssa may alter absorption of dietary fats in some patients. Decreased vitamin B12 levels and abnormal Schilling's tests have been observed in some patients receiving octreotide. Monitor vitamin B12 levels during treatment with Mycapssa.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatic steatosis, hepatomegaly, lactic acidosis, flushing, diarrhea, lethargy, weakness, and weight loss.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• Safety and efficacy of Mycapssa in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: octreotide acetate
• Inactive ingredients: polyvinylpyrrolidone (PVP-12), sodium caprylate, magnesium chloride, polysorbate 80, glyceryl monocaprylate, glyceryl tricaprylate, gelatin, gelatin capsules, and Acryl-EZE® (methacrylate).

Who manufactures and distributes this medicine?

• Amryt Pharmaceuticals DAC.
• Dublin, Ireland

What should I know about storage and disposal of this medication?

• Before first use, store unopened wallets of Mycapssa in a refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• After first use, store opened wallets at room temperature between 68°F to 77°F (20°C to 25°C) for up to 1 month.

• Dailymed label info on Mycapssa
• FDA Mycapssa

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