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Mycapssa

Last reviewed on RxList: 7/13/2020
Mycapssa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Mycapssa?

Mycapssa (octreotide) is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

What Are Side Effects of Mycapssa?

Side effects of Mycapssa include:

Dosage for Mycapssa

The starting dose of Mycapssa is 40 mg daily, administered as 20 mg orally twice daily. Mycapssa dosage may be adjusted based on IGF-1 levels and patient's signs and symptoms. Increase the dosage of Mycapssa in increments of 20 mg. The maximum recommended dosage of Mycapssa is 80 mg daily.

Mycapssa In Children

Safety and efficacy of Mycapssa in pediatric patients have not been established. In post-marketing reports, serious adverse reactions, including hypoxia, necrotizing enterocolitis, and death, have been reported with octreotide injection use in pediatric patients, most notably in children under 2 years of age.

What Drugs, Substances, or Supplements Interact with Mycapssa?

Mycapssa may interact with other medicines such as:

  • proton pump inhibitors,
  • H2-receptor antagonists,
  • antacids,
  • cyclosporine,
  • insulin and antidiabetic drugs,
  • digoxin,
  • lisinopril,
  • levonorgestrel,
  • bromocriptine,
  • beta-blockers,
  • calcium channel blockers, and
  • drugs metabolized by CYP 450 enzymes (e.g., quinidine)

Tell your doctor all medications and supplements you use.

Mycapssa During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Mycapssa; it is unknown how it could affect a fetus. There is the potential for unintended pregnancy with premenopausal women as the therapeutic benefits of a reduction in GH levels and normalization of IGF-1 concentration in acromegalic females treated with octreotide may lead to improved fertility. It is unknown if Mycapssa passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Mycapssa (octreotide) Delayed-Release Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

About how much does an adult human brain weigh? See Answer
Mycapssa Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe constipation;
  • slow or uneven heartbeats;
  • signs of gallstones--fever, chills, nausea, vomiting, severe pain in your upper stomach spreading to your back, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
  • underactive thyroid--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain.

Common side effects may include:

  • gallstones;
  • nausea, vomiting, diarrhea, stomach pain, gas;
  • headache, back pain; or
  • dizziness, tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mycapssa (Octreotide Oral Capsules)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Mycapssa Professional Information

SIDE EFFECTS

The following important adverse reactions are described below and elsewhere in the labeling:

  • Cholelithiasis and Complications of Cholelithiasis [see WARNINGS AND PRECAUTIONS]
  • Hyperglycemia and Hypoglycemia [see WARNINGS AND PRECAUTIONS]
  • Thyroid Function Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Cardiac Function Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Decreased Vitamin B12 Levels and Abnormal Schilling’s Tests [see WARNINGS AND PRECAUTIONS]

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 may not reflect the rates observed in practice.

MYCAPSSA has been evaluated in patients with acromegaly in a placebo-controlled study [see Clinical Studies] and an open-label baseline-controlled study. The data reflect exposure of 183 patients to MYCAPSSA for a mean duration of 29 weeks. In the overall study population, 56% were female and the average age of patients was 54.3 years. Adverse reactions occurring ≥ 5% and greater than placebo for the placebo-controlled study are presented in Table 1 and adverse reactions occurring ≥ 5% in the open-label study are presented in Table 2.

Table 1: Adverse Reactions Occurring ≥ 5% and Greater than Placebo in a Placebo-Controlled Study with MYCAPSSA in Acromegaly Patients

MYCAPSSA %
(N=28)
PLACEBO %
(N=28)
Diarrhea2921
Nausea2111
Blood glucose increased*147
Vomiting140
Abdominal discomfort1411
Dyspepsia114
Sinusitis110
Osteoarthritis110
Urinary tract infection74
Pain70
Large intestine polyp70
Cholelithiasis74
*Includes blood glucose increased, hyperglycemia and glycosylated hemoglobin increased

Table 2: Adverse Reactions Occurring ≥ 5% in an Open- Label Study with MYCAPSSA in Acromegaly Patients

MYCAPSSA %
(N=155)
Headache33
Nausea30
Arthralgia26
Asthenia22
Hyperhidrosis21
Diarrhea18
Peripheral swelling16
Dyspepsia8
Abdominal pain upper8
Abdominal distension7
Nasopharyngitis7
Influenza7
Blood glucose increased*6
Vomiting6
Flatulence6
Back pain6
Abdominal pain5
Dizziness5
Fatigue5
Upper respiratory tract infection5
Hypertension5
*Includes blood glucose increased, hyperglycemia and impaired fasting glucose

Other Adverse Reactions

Gallbladder Abnormalities

In the placebo-controlled study, in patients treated with MYCAPSSA, acute cholecystitis occurred in 4% of patients.

In the open-label study, cholelithiasis occurred in 4.5% of patients and bile duct obstruction, bile duct stone, acute cholecystitis and jaundice occurred in 1% of patients each.

Hypoglycemia/Hyperglycemia

In the placebo-controlled study, 18% of patients treated with MYCAPSSA and 4% of patients treated with placebo developed at least one glucose value above the upper normal limit. All patients with abnormal glucose values were asymptomatic. Asymptomatic hypoglycemia was reported in 4% of patients.

In the open-label study 16% of patients developed a glucose value above the upper limit of normal. Asymptomatic hypoglycemia was reported in 4% and symptomatic hypoglycemia was reported in 1% of patients. Diabetes was reported in 1% of patients.

Hypothyroidism

In the open-label study, hypothyroidism, increased TSH, or decreased free T4 were reported in 1% of patients.

Cardiac

In the open-label study, bradycardia was reported in 2%, conduction abnormalities in 1%, and arrhythmias/tachycardia in 2% of patients.

Gastrointestinal

Gastrointestinal symptoms were the most commonly reported adverse reactions with MYCAPSSA.

In the placebo-controlled study, gastrointestinal adverse reactions were reported in 68% of patients treated with MYCAPSSA. These adverse reactions were diarrhea, nausea, vomiting, abdominal discomfort, dyspepsia, large intestinal polyp, abdominal pain, constipation, and flatulence. The adverse reactions were mild to moderate, occurred mostly during the initial 3 months of treatment, and resolved on treatment within a median duration of 8 days.

In the open-label study, gastrointestinal adverse reactions were reported in 57% of patients. Gastrointestinal adverse reactions occurring in ≥ 1% of patients were nausea, diarrhea, dyspepsia, abdominal pain, abdominal distention, vomiting, flatulence, constipation, gastroesophageal reflux disease, abdominal discomfort, frequent bowel movement, gastritis, hemorrhoids, dry mouth, and gastrointestinal motility disorder. Large intestinal polyp was reported in 1 patient. The adverse reactions were mostly mild to moderate, occurred during the initial 2 months of treatment, and resolved on treatment within a median of 13 days. Ten patients discontinued treatment due to gastrointestinal adverse reactions.

Immunogenicity

As with all therapeutic peptides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other octreotide acetate products may be misleading.

No antibodies to the octreotide peptide from MYCAPSSA were detected in 149 patients assessed in the open label study throughout 13 months of treatment.

Postmarketing Experience

The following adverse reactions have been identified during the post-approval use of octreotide acetate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Blood and lymphatic: pancytopenia, thrombocytopenia
  • Cardiac: myocardial infarction, cardiac arrest, atrial fibrillation
  • Ear and labyrinth: deafness
  • Endocrine: diabetes insipidus, adrenal insufficiency in patients 18 months of age and under, pituitary apoplexy
  • Eye: glaucoma, visual field defect, scotoma, retinal vein thrombosis
  • Gastrointestinal: intestinal obstruction, peptic/gastric ulcer, abdomen enlarged
  • General and administration site: generalized edema, facial edema
  • Hepatobiliary: gallbladder polyp, fatty liver, hepatitis
  • Immune: anaphylactoid reactions including anaphylactic shock
  • Infections and infestations: appendicitis
  • Laboratory abnormalities: increased liver enzymes, CK increased, creatinine increased
  • Metabolism and nutrition: diabetes mellitus
  • Musculoskeletal: arthritis, joint effusion, Raynaud’s syndrome
  • Nervous System: convulsions, aneurysm, intracranial hemorrhage, hemiparesis, paresis, suicide attempt, paranoia, migraines, Bell’s palsy, aphasia
  • Renal and urinary: renal failure, renal insufficiency
  • Reproductive and breast: gynecomastia, galactorrhea, libido decrease, breast carcinoma
  • Respiratory: status asthmaticus, pulmonary hypertension, pulmonary nodule, pneumothorax aggravated
  • Skin and subcutaneous tissue: urticaria, cellulitis, petechiae
  • Vascular: orthostatic hypotension, hematuria, gastrointestinal hemorrhage, arterial thrombosis of the arm

Read the entire FDA prescribing information for Mycapssa (Octreotide Oral Capsules)

Related Resources for Mycapssa

© Mycapssa Patient Information is supplied by Cerner Multum, Inc. and Mycapssa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

About how much does an adult human brain weigh? See Answer

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