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Sandostatin LAR

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Sandostatin LAR

Sandostatin LAR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sandostatin LAR Depot (octreotide acetate) is used to treat acromegaly. It is also used to reduce flushing episodes and watery diarrhea caused by cancerous tumors (carcinoid syndrome) or tumors called vasoactive intestinal peptide tumors (VIP adenomas). It is in a class of medications called octapeptides. Common side effects include nausea, vomiting, loose/oily stools, constipation, stomach upset, gas, bloating, dizziness, or headache. Pain and irritation at the injection site may also occur.

Dosing of Sandostatin depends on the condition being treated and the response of the patient. Sandostatin may interact with bromocriptine, cyclosporine, diuretics (water pills), diabetes medication, or medicine for heart disease or high blood pressure. Sandostatin may restore the normal ability to become pregnant in females with acromegaly who have infertility. Females of childbearing age should discuss reliable forms of birth control with the doctor. During pregnancy, this medication should be used only when prescribed. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Sandostatin LAR Depot (octreotide acetate) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sandostatin LAR in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • slow or uneven heartbeats;
  • severe stomach pain or tenderness, severe constipation;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • unusual weakness, loss of energy, weight gain, joint or muscle pain, swelling in your neck or throat (enlarged thyroid);
  • low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery); or
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects may include:

  • diarrhea, constipation;
  • stomach pain or discomfort, gas, bloating;
  • nausea or vomiting; or
  • headache, dizziness.

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 Sandostatin LAR (Octreotide Acetate Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sandostatin LAR Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, loose/oily stools, constipation, stomach upset, or gas may occur. Pain and irritation at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of gallbladder/liver problems (e.g., fever, stomach/abdominal pain, severe nausea/vomiting, yellowing eyes/skin, unexplained pain in the back/right shoulder), signs of underactive thyroid (e.g., unexplained weight gain, cold intolerance, slow heartbeat, severe constipation, unusual/extreme tiredness, growth/lump/swelling on the front of the neck), worsening heart condition symptoms (e.g., trouble breathing, slow/fast/irregular heartbeat), numbness/tingling of the arms/legs.

This medication may infrequently cause changes in blood sugar, especially if you have diabetes. Symptoms of high blood sugar include increased thirst and urination. Symptoms of low blood sugar include nervousness, shakiness, sweating, fast heartbeat, and hunger. Follow your doctor's instructions to treat low blood sugar (e.g., eat a quick source of sugar such as glucose gel/tablets, table sugar, or honey, or drink fruit juice or non-diet soda). Tell your doctor immediately if you experience symptoms of high or low blood sugar while taking this medication. Monitor your blood sugar levels as directed by your doctor. Your doctor may need to adjust your diabetes medications.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sandostatin LAR (Octreotide Acetate Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sandostatin LAR FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 trial of another drug and may not reflect the rates observed in practice.

Acromegaly

The safety of Sandostatin LAR in the treatment of acromegaly has been evaluated in three phase 3 studies in 261 patients, including 209 exposed for 48 weeks and 96 exposed for greater than 108 weeks. Sandostatin LAR was studied primarily in a double-blind, cross-over manner. Patients on subcutaneous Sandostatin Injection were switched to the LAR formulation followed by an open-label extension. The population age range was 14-81 years old and 53% were female. Approximately 35% of these acromegaly patients had not been treated with surgery and/or radiation. Most patients received a starting dose of 20 mg every 4 weeks intramuscularly. Dose was up or down titrated based on efficacy and tolerability to a final dose between 10-60 mg every 4 weeks. Table 1 below reflects adverse events from these studies regardless of presumed causality to study drug.

Table 1: Adverse Events Occurring in ≥ 10% of Acromegalic Patients in the Phase 3 Studies

WHO Preferred Term Phase 3 Studies (Pooled)
Number (%) of Subjects with AE's 10 mg/20 mg/30 mg
(n=261) n (%)
Diarrhea 93 (35.6)
Abdominal Pain 75 (28.7)
Flatulence 66 (25.3)
Influenza-Like Symptoms 52 (19.9)
Constipation 46 (17.6)
Headache 40 (15.3)
Anemia 40 (15.3)
Injection Site Pain 36 (13.8)
Cholelithiasis 35 (13.4)
Hypertension 33 (12.6)
Dizziness 30 (11.5)
Fatigue 29 (11.1)

The safety of Sandostatin LAR in the treatment of acromegaly was also evaluated in a postmarketing randomized phase 4 study. 104 patients were randomized to either pituitary surgery or 20 mg of Sandostatin LAR. All the patients were treatment na´ve ('de novo'). Crossover was allowed according to treatment response and a total of 76 patients were exposed to Sandostatin LAR. Approximately half of the patients initially randomized to Sandostatin LAR were exposed to Sandostatin LAR up to 1 year. The population age range was between 20-76 years old and 45% were female, 93% were Caucasian, and 1% Black. The majority of these patients were exposed to 30 mg every 4 weeks. Table 2 below reflects the adverse events occurring in this study regardless of presumed causality to study drug.

Table 2: Adverse Events Occurring in ≥ 10% of Acromegalic Patients in Phase 4 Study

WHO Preferred Term Phase 4 Study SAS LAR
N=76 n (%)
Phase 4 Study Surgery
N=64 n (%)
Diarrhea 36 (47.4) 2 (3.1)
Cholelithiasis 29 (38.2) 3 (4.7)
Abdominal Pain 19 (25.0) 2 (3.1)
Nausea 12 (15.8) 5 (7.8)
Alopecia 10 (13.2) 5 (7.8)
Injection Site Pain 9 (11.8) 0
Abdominal Pain Upper 8 (10.5) 0
Headache 8 (10.5) 6 (9.4)
Epistaxis 0 7 (10.9)

Gallbladder Abnormalities

Single doses of Sandostatin Injection have been shown to inhibit gallbladder contractility and decrease bile secretion in normal volunteers. In clinical trials with Sandostatin Injection (primarily patients with acromegaly or psoriasis) in patients who had not previously received octreotide, the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation). The incidence of stones or sludge in patients who received Sandostatin Injection for 12 months or longer was 52%. The incidence of gallbladder abnormalities did not appear to be related to age, sex, or dose but was related to duration of exposure.

In clinical trials 52% of acromegalic patients, most of whom received Sandostatin LAR Depot for 12 months or longer, developed new biliary abnormalities including gallstones, microlithiasis, sediment, sludge, and dilatation. The incidence of new cholelithiasis was 22%, of which 7% were microstones.

Across all trials, a few patients developed acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis, or pancreatitis during octreotide therapy or following its withdrawal. One patient developed ascending cholangitis during Sandostatin Injection therapy and died. Despite the high incidence of new gallstones in patients receiving octreotide, 1% of patients developed acute symptoms requiring cholecystectomy.

Glucose Metabolism - Hypoglycemia/Hyperglycemia

In acromegaly patients treated with either Sandostatin Injection or Sandostatin LAR Depot, hypoglycemia occurred in approximately 2% and hyperglycemia in approximately 15% of patients [see WARNINGS AND PRECAUTIONS].

Hypothyroidism

In acromegaly patients receiving Sandostatin Injection, 12% developed biochemical hypothyroidism, 8% developed goiter, and 4% required initiation of thyroid replacement therapy while receiving Sandostatin Injection. In acromegalics treated with Sandostatin LAR Depot, hypothyroidism was reported as an adverse event in 2% and goiter in 2%. Two patients receiving Sandostatin LAR Depot required initiation of thyroid hormone replacement therapy [see WARNINGS AND PRECAUTIONS].

Cardiac

In acromegalics, sinus bradycardia ( < 50 bpm) developed in 25%; conduction abnormalities occurred in 10% and arrhythmias developed in 9% of patients during Sandostatin Injection therapy. The relationship of these events to octreotide acetate is not established because many of these patients have underlying cardiac disease [see WARNINGS AND PRECAUTIONS].

Gastrointestinal

The most common symptoms are gastrointestinal. The overall incidence of the most frequent of these symptoms in clinical trials of acromegalic patients treated for approximately 1 to 4 years is shown in Table 3.

Table 3: Number (%) of Acromegalic Patients with Common G.I. Adverse Events

Adverse Event Sandostatin Injection S.C.Three Times Daily
n=114
Sandostatin LAR Depot Every 28 Days
n=261
n % n %
Diarrhea 66 (57.9) 95 (36.4)
Abdominal Pain or Discomfort 50 (43.9) 76 (29.1)
Nausea 34 (29.8) 27 (10.3)
Flatulence 15 (13.2) 67 (25.7)
Constipation 10 (8.8) 49 (18.8)
Vomiting 5 (4.4) 17 (6.5)

Only 2.6% of the patients on Sandostatin Injection in U.S. clinical trials discontinued therapy due to these symptoms. No acromegalic patient receiving Sandostatin LAR Depot discontinued therapy for a G.I. event.

In patients receiving Sandostatin LAR Depot, the incidence of diarrhea was dose related. Diarrhea, abdominal pain, and nausea developed primarily during the first month of treatment with Sandostatin LAR Depot. Thereafter, new cases of these events were uncommon. The vast majority of these events were mild-to-moderate in severity.

In rare instances, gastrointestinal adverse effects may resemble acute intestinal obstruction, with progressive abdominal distention, severe epigastric pain, abdominal tenderness, and guarding.

Dyspepsia, steatorrhea, discoloration of feces, and tenesmus were reported in 4%-6% of patients.

In a clinical trial of carcinoid syndrome, nausea, abdominal pain, and flatulence were reported in 27%-38% and constipation or vomiting in 15%-21% of patients treated with Sandostatin LAR Depot. Diarrhea was reported as an adverse event in 14% of patients but since most of the patients had diarrhea as a symptom of carcinoid syndrome, it is difficult to assess the actual incidence of drug-related diarrhea.

Pain at the Injection Site

Pain on injection, which is generally mild-to-moderate, and short-lived (usually about 1 hour) is dose related, being reported by 2%, 9%, and 11% of acromegalics receiving doses of 10 mg, 20 mg, and 30 mg, respectively, of Sandostatin LAR Depot. In carcinoid patients, where a diary was kept, pain at the injection site was reported by about 20%-25% at a 10-mg dose and about 30%-50% at the 20-mg and 30-mg dose.

Antibodies to Octreotide

Studies to date have shown that antibodies to octreotide develop in up to 25% of patients treated with octreotide acetate. These antibodies do not influence the degree of efficacy response to octreotide; however, in two acromegalic patients who received Sandostatin Injection, the duration of GH suppression following each injection was about twice as long as in patients without antibodies. It has not been determined whether octreotide antibodies will also prolong the duration of GH suppression in patients being treated with Sandostatin LAR Depot.

Carcinoid and VIPomas

The safety of Sandostatin LAR in the treatment of carcinoid tumors and VIPomas has been evaluated in one phase 3 study. Study 1 randomized 93 patients with carcinoid syndrome to Sandostatin LAR 10 mg, 20 mg, or 30 mg in a blind fashion or to open-label Sandostatin Injection subcutaneously. The population age range was between 25-78 years old and 44% were female, 95% were Caucasian and 3% Black. All the patients had symptom control on their previous Sandostatin subcutaneous treatment. 80 patients finished the initial 24 weeks of Sandostatin exposure in Study 1. In Study 1, comparable numbers of patients were randomized to each dose. Table 4 below reflects the adverse events occurring in > 15% of patients regardless of presumed causality to study drug.

Table 4: Adverse Events Occurring in ≥ 15% of Carcinoid Tumor and VIPoma Patients in Study 1

WHO Preferred Term Number (%) of Subjects with (n=93)
Sc
N=26
10 mg
N=22
20 mg
N=20
30 mg
N=25
Abdominal Pain 8 (30.8) 8 (35.4) 2 (10.0) 5 (20.0)
Arthropathy 5 (19.2) 2 (9.1) 3 (15.0) 2 (8.0)
Back Pain 7 (26.9) 6 (27.3) 2 (10.0) 2 (8.0)
Dizziness 4 (15.4) 4 (18.2) 4 (20.0) 5 (20.0)
Fatigue 3 (11.5) 7 (31.8) 2 (10.0) 2 (8.0)
Flatulence 3 (11.5) 2 (9.1) 2 (10.0) 4 (16.0)
Generalized Pain 4 (15.4) 2 (9.1) 3 (15.0) 1 (4.0)
Headache 5 (19.2) 4 (18.2) 6 (30.0) 4(16.0)
Musculoskeletal Pain 4 (15.4) 0 1 (5.0) 0
Myalgia 0 4 (18.2) 1 (5.0) 1 (4.0)
Nausea 8 (30.8) 9 (40.9) 6 (30.0) 6 (24.0)
Pruritus 0 4 (18.2) 0 0
Rash 1 (3.8) 0 3 (15.0) 0
Sinusitis 4 (15.4) 0 1 (5.0) 3 (12.0)
URTI 6 (23.1) 4 (18.2) 2 (10.0) 3 (12.0)
Vomiting 3 (11.5) 0 0 4 (16.0)

Gallbladder Abnormalities

In clinical trials, 62% of malignant carcinoid patients who received Sandostatin LAR Depot for up to 18 months developed new biliary abnormalities including jaundice, gallstones, sludge, and dilatation. New gallstones occurred in a total of 24% of patients.

Glucose Metabolism - Hypoglycemia/Hyperglycemia

In carcinoid patients, hypoglycemia occurred in 4% and hyperglycemia in 27% of patients treated with Sandostatin LAR Depot [see WARNINGS AND PRECAUTIONS].

Hypothyroidism

In carcinoid patients, hypothyroidism has only been reported in isolated patients and goiter has not been reported [see WARNINGS AND PRECAUTIONS].

Cardiac

Electrocardiograms were performed only in carcinoid patients receiving Sandostatin LAR Depot. In carcinoid syndrome patients, sinus bradycardia developed in 19%, conduction abnormalities occurred in 9%, and arrhythmias developed in 3%. The relationship of these events to octreotide acetate is not established because many of these patients have underlying cardiac disease [see WARNINGS AND PRECAUTIONS].

Other Clinical Studies Adverse Events

Other clinically significant adverse events (relationship to drug not established) in acromegalic and/or carcinoid syndrome patients receiving Sandostatin LAR Depot were malignant hyperpyrexia, cerebral vascular disorder, rectal bleeding, ascites, pulmonary embolism, pneumonia and pleural effusion.

Postmarketing Experience

The following adverse reactions have been identified during the postapproval use of Sandostatin. 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.

Myocardial infarction has been observed in the postmarketing setting, mainly in patients with cardiovascular risk factors. Hypoadrenalism has been reported in some reports in patients 18 months of age and under.

Additional events reported in the postmarketing setting include anaphylactoid reactions, including anaphylactic shock, cardiac arrest, renal failure, renal insufficiency, convulsions, atrial fibrillation, aneurysm, hepatitis, increased liver enzymes, gastrointestinal hemorrhage, pancreatitis, pancytopenia, thrombocytopenia, arterial thrombosis of the arm, retinal vein thrombosis, intracranial hemorrhage, hemiparesis, paresis, deafness, visual field defect, aphasia, scotoma, status asthmaticus, pulmonary hypertension, diabetes mellitus, intestinal obstruction, peptic/gastric ulcer, appendicitis, creatinine increased, CK increased, arthritis, joint effusion, pituitary apoplexy, breast carcinoma, suicide attempt, paranoia, migraines, urticaria, facial edema, generalized edema, hematuria, orthostatic hypotension, Raynaud's syndrome, glaucoma, pulmonary nodule, pneumothorax aggravated, cellulitis, Bell's palsy, diabetes insipidus, gynecomastia, galactorrhea, gallbladder polyp, fatty liver, abdomen enlarged, libido decrease, and petechiae.

Read the entire FDA prescribing information for Sandostatin LAR (Octreotide Acetate Injection) »

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Sandostatin LAR - User Reviews

Sandostatin LAR User Reviews

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