What is Mycapssa (octreotide)?
Mycapssa is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Acromegaly is a condition due to the production of too much growth hormone by the pituitary gland after the end of adolescence. When there is secretion of too much growth hormone before the end of adolescence, gigantism results. People with pituitary gigantism can truly be giants; they can sometimes end up over 7 or 8 feet in height.
The cardinal manifestations of acromegaly include thickening of the skin, soft tissues, and bones of the hands and feet. These effects are insidious and very slowly progressive. Ultimately, they cause considerable disability (aside from the need for larger rings, gloves, and shoes) including hoarseness, sleep apnea, joint pain, cardiovascular disease, hypertension, insulin resistance, visual impairment and severe headaches.
Octreotide exerts pharmacologic actions similar to the natural hormone somatostatin, but is a more potent inhibitor of GH, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin-releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin, and pancreatic polypeptide.
What are the side effects of Mycapssa (octreotide)?
The following important adverse reactions are described below and elsewhere in the labeling:
- Cholelithiasis and Complications of Cholelithiasis
- Hyperglycemia and Hypoglycemia
- Thyroid Function Abnormalities
- Cardiac Function Abnormalities
- Decreased Vitamin B12 Levels and Abnormal Schilling’s Tests
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
|Blood glucose increased*||14||7|
|Urinary tract infection||7||4|
|Large intestine polyp||7||0|
|*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
|Abdominal pain upper||8|
|Blood glucose increased*||6|
|Upper respiratory tract infection||5|
|*Includes blood glucose increased, hyperglycemia and impaired fasting glucose|
Other Adverse Reactions
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.
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.
In the open-label study, hypothyroidism, increased TSH, or decreased free T4 were reported in 1% of patients.
In the open-label study, bradycardia was reported in 2%, conduction abnormalities in 1%, and arrhythmias/tachycardia in 2% of patients.
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.
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.
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
What is the dosage for Mycapssa (octreotide)?
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.
Recommended Dosage, Titration, And Monitoring
- 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 patientâ€™s signs and symptoms every two weeks during the dose titration or as indicated.
- Titrate the Mycapssa dosage based on IGF-1 levels and patientâ€™s signs and symptoms. Increase the dosage in increments of 20 mg daily.
- For Mycapssa dosages of 60 mg daily, administer as 40 mg in the morning and 20 mg in the evening.
- For Mycapssa dosages of 80 mg daily, administer as 40 mg twice daily.
- The maximum recommended dosage of Mycapssa is 80 mg daily.
- Once the maintenance dosage of Mycapssa is achieved, monitor IGF-1 levels and patientâ€™s signs and symptoms monthly or as indicated.
Dosage Interruptions And Modifications
- If IGF-1 levels remain above the upper normal limit after treatment with the maximum recommended dosage of 80 mg daily or the patient cannot tolerate treatment with Mycapssa, consider discontinuing Mycapssa and switching patient to another somatostatin analog.
- Withdraw Mycapssa therapy periodically to assess disease activity. If IGF-1 levels increase and signs and symptoms recur, resume Mycapssa therapy.
Recommended Dosage In Patients With End Stage Renal Disease
For patients with end-stage renal disease, initiate Mycapssa at a dosage of 20 mg orally once daily. Titrate and adjust the maintenance dosage of Mycapssa based on IGF-1 levels, patient's signs and symptoms and tolerability.
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What drugs interact with Mycapssa (octreotide)?
Effects Of Other Drugs On Mycapssa
|Proton Pump Inhibitors, H2-receptor Antagonists, or Antacids|
|Clinical Impact:||Concomitant administration of Mycapssa with esomeprazole resulted in a decrease in the bioavailability for Mycapssa . Drugs that alter the pH of the upper GI tract (e.g., other proton pump inhibitors (PPIs), H2-receptor antagonists, and antacids) may alter the absorption of Mycapssa and lead to a reduction in bioavailability.|
|Intervention:||Co-administration of Mycapssa with PPIs, H2-blockers, or antacids may require increased doses of Mycapssa.|
Effects Of Mycapssa On Other Drugs
|Clinical Impact:||Concomitant administration of Mycapssa with cyclosporine resulted in a decrease in cyclosporine bioavailability .|
|Intervention:||Adjustment of cyclosporine dose to maintain therapeutic levels may be necessitated.|
|Insulin and Antidiabetic Drugs|
|Clinical Impact:||Mycapssa inhibits the secretion of insulin and glucagon.|
|Intervention:||Monitor blood glucose levels in diabetic patients upon Mycapssa initiation and subsequent dose adjustment. Patients receiving insulin or antidiabetic drugs agents may require dose adjustment of these therapeutic agents.|
|Clinical Impact:||Concomitant administration of Mycapssa with digoxin resulted in a decrease in digoxin peak exposure .|
|Intervention:||Digoxin has a narrow therapeutic ratio and careful assessment of clinical response should be performed when digoxin is concomitantly administered with Mycapssa.|
|Clinical Impact:||Concomitant administration of Mycapssa increases lisinopril bioavailability .|
|Intervention:||Monitor patient’s blood pressure and adjust the dosage of lisinopril if needed.|
|Clinical Impact:||Concomitant administration of Mycapssa with levonorgestrel decreases levonorgestrel bioavailability .|
|Intervention:||Decreased bioavailability may potentially diminish the effectiveness of combined oral contraceptives (COCs) or increase breakthrough bleeding. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when Mycapssa is used with COCs.|
|Clinical Impact:||Concomitant administration of Mycapssa with bromocriptine may increase the systemic exposure of bromocriptine .|
|Intervention:||Dose adjustment of bromocriptine may be necessary.|
|Beta Blocker and Calcium Channel Blockers|
|Clinical Impact:||Mycapssa may cause bradycardia in acromegaly patients.|
|Intervention:||Patients receiving beta blockers or calcium channel blockers may require dose adjustments of these therapeutic agents.|
|Drugs Metabolized by CYP 450 Enzymes|
|Clinical Impact:||Limited published data indicate that somatostatin analogs including Mycapssa may decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of GH.|
|Intervention:||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 monitoring may be required.|
Is Mycapssa (octreotide) safe to take while pregnant or breastfeeding?
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. Transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post-natal study of octreotide at intravenous doses below the clinical dose based on octreotide injection body surface area.
There is no information available on the presence of octreotide in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Studies show that octreotide administered subcutaneously passes into the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for MYCAPSSA and any potential adverse effects on the breastfed child from Mycapssa or from the underlying maternal condition.
Mycapssa (octreotide) is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Acromegaly is a condition due to the production of too much growth hormone by the pituitary gland after the end of adolescence.
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