Sandostatin LAR

octreotide acetate

Sandostatin, Sandostatin LAR

Pharmacologic class: Somatostatin analog

Therapeutic class: Antidiarrheal

Pregnancy risk category B

Action

Suppresses secretion of serotonin, serotonin metabolites, and gastrohepatic peptides, increasing fluid and electrolyte absorption from GI tract. Also suppresses growth hormone, insulin, and glucagon.

Availability

Depot injection: 10 mg, 20 mg, 30 mg

Injection: 0.05 mg/ml, 0.1 mg/ml, and 0.5 mg/ml in 1-ml ampules; 0.2 mg/ml and 1 mg/ml in 5-ml vials

Indications and dosages

Diarrhea and flushing associated with carcinoid tumors

Adults: 100 to 600 mcg (Sandostatin) subcutaneously or I.V. daily in two to four divided doses for 2 weeks. Then, depending on response, 20 mg (LAR Depot) I.M. q 4 weeks for 2 months.

Diarrhea caused by vasoactive intestinal peptide tumors (VIPomas)

Adults: 200 to 300 mcg (Sandostatin) subcutaneously or I.V. daily in two to four divided doses for 2 weeks. Then, depending on response, 20 mg (LAR Depot) I.M. q 2 weeks for 2 months.

Acromegaly

Adults: 50 to 100 mcg (Sandostatin) subcutaneously or I.V. two or three times daily. Then, depending on response, 20 mg (LAR Depot) I.M. q 4 weeks for 3 months. Then adjust based on growth hormone levels.

Dosage adjustment

• Renal impairment

Off-label uses

• Dumping syndrome (postprandial hypotension)
• GI and pancreatic fistulas
• Variceal bleeding

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• gallbladder disease, renal impairment, hyperglycemia or hypoglycemia, fat malabsorption
• pregnant or breastfeeding patients
• children.

Administration

• When giving subcutaneously, rotate administration site with each injection.

Don't give LAR Depot I.V.
• Mix I.M. solution and inject deep into gluteal muscle over 3 minutes. Don't use deltoid.
• For I.V. administration, dilute in 50 to 200 ml of dextrose 5% in water or normal saline solution. Infuse over 15 to 30 minutes.
• Know that octreotide suppression test and octreotide scintigraphy may be done to determine if drug will aid carcinoid tumor treatment.
• Drug may be kept at room temperature for 2 weeks. Refrigerate ampules.

Adverse reactions

CNS: dizziness, drowsiness, fatigue, headache, weakness

CV: edema, bradycardia, conduction abnormalities, arrhythmias

EENT: vision disturbances

GI: nausea, vomiting, diarrhea, abdominal pain, cholelithiasis, fat malabsorption

Skin: flushing

Metabolic: hypothyroidism, hyperglycemia, hypoglycemia

Other: injection site pain

Interactions

Drug-drug.Cyclosporine: reduced cyclosporine blood level

Insulin, oral hypoglycemics: altered requirements for these drugs

Orally administered drugs: altered absorption of these drugs

Drug-diagnostic tests.Glucose: increased or decreased level

Hepatic enzymes: slightly increased levels

Schilling's test: abnormal results

Thyroxine, vitamin B12: decreased levels

Drug-food.Fats: altered octreotide absorption

Patient monitoring

• Assess bowel sounds and stool frequency and consistency.
• Monitor vital signs and fluid intake and output. Stay alert for dehydration or edema.
• Evaluate diabetic patient for hypoglycemia or hyperglycemia.
• Know that in women with active acromegaly, normalization of growth hormone and insulin-like growth factor-1 may restore fertility.

Patient teaching

• Tell patient being treated for carcinoid tumor to keep track of number of daily stools or flushing episodes.
• Instruct patient to weigh himself daily and report significant changes.
• Advise female with childbearing potential to use adequate contraception while taking drug.
• If patient will use drug at home, teach correct methods for injection, storage, and needle disposal.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, vision, and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.

octreotide

(ok-tree-oh-tide) ,

SandoSTATIN

(trade name),

SandoSTATIN LAR

(trade name)

Classification

Therapeutic: antidiarrheals
Pregnancy Category: B

Indications

Treatment of severe diarrhea and flushing episodes in patients with GI endocrine tumors, including metastatic carcinoid tumors and vasoactive intestinal peptide tumors (VIPomas).Treatment of acromegaly.Management of diarrhea in AIDS patients, patients with fistulas, chemotherapy-induced diarrhea, and graft- vs. host–disease-induced diarrhea.Treatment of hyperinsulinemic hypoglycemia of infancy.Management of postoperative chylothorax.

Action

Suppresses secretion of serotonin and gastroenterohepatic peptides.
Increases absorption of fluid and electrolytes from the GI tract and increases transit time.
Decreases levels of serotonin metabolites.
Also suppresses growth hormone, insulin, and glucagon.

Therapeutic effects

Control of severe flushing and diarrhea associated with GI endocrine tumors.

Pharmacokinetics

Absorption: Well absorbed following subcut administration and IM administration of depot form.
Distribution: Unknown.
Protein Binding: 65%.
Metabolism and Excretion: Extensive hepatic metabolism; 32% excreted unchanged in urine.
Half-life: 1.5 hr.

Time/action profile (control of symptoms)

ROUTEONSETPEAKDURATION
Subcut, IVunknownunknownup to 12 hr
IM (LAR)unknown2 wkup to 4 wk

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Gallbladder disease (↑ risk of stone formation);Renal impairment (dose ↓ may be necessary);Hyperglycemia or hypoglycemia (changes in blood glucose may occur);Fat malabsorption (may be aggravated); Obstetric / Lactation: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • drowsiness
  • fatigue
  • headache
  • weakness

Ear, Eye, Nose, Throat

  • visual disturbances

Cardiovascular

  • bradycardia
  • edema
  • orthostatic hypotension
  • palpitations

Gastrointestinal

  • ileus (life-threatening)
  • abdominal pain
  • cholelithiasis
  • diarrhea
  • fat malabsorption
  • nausea
  • vomiting

Dermatologic

  • flushing

Endocrinologic

  • hyperglycemia
  • hypoglycemia
  • hypothyroidism

Local

  • injection-site pain

Interactions

Drug-Drug interaction

May alter requirements for insulin or oral hypoglycemic agents.May ↓ blood levels of cyclosporine.May ↑ levels of QTc-prolonging agents.

Route/Dosage

Carcinoid Tumors
Subcutaneous Intravenous (Adults) Sandostatin—100–600 mcg/day in 2–4 divided doses during first 2 wk of therapy (range 50–1500 mcg/day).
Intramuscular (Adults) Sandostatin LAR—20 mg q 4 wk for 2 mo; dose may be further adjusted.
VIPomas
Subcutaneous Intravenous (Adults) Sandostatin—200–300 mcg/day in 2–4 divided doses during first 2 wk of therapy (range 150–750 mcg/day).
Intramuscular (Adults) Sandostatin LAR—20 mg q 2 wk for 2 mo; dose may be further adjusted.
Suppression of Growth Hormone (Acromegaly)
Subcutaneous Intravenous (Adults) Sandostatin—50–100 mcg 3 times daily; titrate to achieve growth hormone levels <5 ng/mL or IGF-I levels <1.9 units/mL (males) or <2.2 units/mL (females) (usual effective dose = 100–200 mcg 3 times daily.
Intramuscular (Adults) Sandostatin LAR—20 mg q 4 wk for 3 mo, then adjusted on the basis of growth hormone levels.
Antidiarrheal
Subcutaneous Intravenous (Adults) AIDS-related—100–1800 mcg/day (unlabeled).
Subcutaneous Intravenous (Children) 1–10 mcg/kg q 12 hr or 1 mcg/kg IV bolus followed by a continuous infusion of 1 mcg/kg/hr.
Persistent Hyperinsulinemic Hypoglycemia of Infancy
Intravenous (Infants) Initially 2–10 mcg/kg/day divided q 12 hr up to 40 mcg/kg/day divided q 6–8 hr.
Chylothorax
Subcutaneous (Adults) 50–100 mcg q 8 hr.
Subcutaneous (Children) 40 mcg/kg/day.
Intravenous (Children) 0.3–10 mcg/kg/hr continuous infusion.

Availability (generic available)

Injection: 50 mcg/mL, 100 mcg/mL, 200 mcg/mL, 500 mcg/mL, 1000 mcg/mL
Depot injection: 10 mg, 20 mg, 30 mg

Nursing implications

Nursing assessment

  • Assess frequency and consistency of stools and bowel sounds throughout therapy.
  • Monitor pulse and BP prior to and periodically during therapy.
  • Assess patient’s fluid and electrolyte balance and skin turgor for dehydration.
  • Monitor diabetic patients for signs of hypoglycemia. May require reduction in requirements for insulin and sulfonylureas and treatment with diazoxide.
  • Assess for gallbladder disease; assess for pain and monitor ultrasound examinations of gallbladder and bile ducts prior to and periodically during prolonged therapy.
  • Lab Test Considerations: Monitor 5-HIAA (urinary 5-hydroxyindoleacetic acid), plasma serotonin, and plasma substance P in patients with carcinoid; plasma vasoactive intestinal peptide (VIP) in patients with VIPoma; and free T4 and serum glucose concentrations prior to and periodically during therapy in all patients taking octreotide.
    • Monitor quantitative 72-hr fecal fat and serum carotene determinations periodically for possible drug-induced aggravations of fat malabsorption.
    • May cause a slight ↑ in liver enzymes.
    • May cause ↓ serum thyroxine (T4) concentrations.

Potential Nursing Diagnoses

Diarrhea (Indications)

Implementation

  • Do not confuse Sandostatin (octreotide) with Sandimmune (cyclosporine).
  • Do not use solution that is discolored or contains particulate matter. Ampules should be refrigerated but may be stored at room temperature for the days they will be used. Discard unused solution.
  • Subcutaneous: Administer the smallest volume needed to achieve required dose to prevent pain at injection site. Rotate injection sites; avoid multiple injections in same site within short periods of time. Preferred injection sites are the hip, thigh, or abdomen.
    • Administer injections between meals and at bedtime to avoid GI side effects.
    • Allow medication to reach room temperature prior to injection to minimize local reactions at injection site.
  • Intramuscular: Mix IM solution by adding diluent included in kit. Administer immediately after mixing into the gluteal muscle. Avoid using deltoid site due to pain of injection.
    • Patients with carcinoid tumors and VIPomas should continue to receive subcut dose for 2 wk following switch to IM depot form to maintain therapeutic level.
  • Intravenous Administration
  • Diluent: May be administered undiluted.
  • Rate: Administer over 3 min.
  • Intermittent Infusion: Diluent: Dilute in 50–200 mL of 0.9% NaCl or D5W.Concentration: 1.5–250 mcg/mL.
  • Rate: Infuse over 15–30 min.
  • Y-Site Compatibility: acyclovir, alfentanyl, allopurinol, amifostine, amikacin, aminocaproic acid, aminophylline, amiodarone, amphotericin B colloidal, amphotericin B lipid complex, amphotericin B liposome, ampicillin, ampicillin/sulbactam, anidulafungin, argatroban, atracurium, azithromycin, aztreoman, bivalirudin, bleomycin, bumetanide, buprenorphine, busulfan, butorphanol, calcium chloride, calcium gluconate, capreomycin, carboplatin, carmustine, caspofungin, cefazolin, cefepime, cefotaxime, cefotetan, cefoxitin, ceftazidime, ceftriaxone, cefuroxime, chloramphenicol, chlorpromazine, ciprofloxacin, cisatracurium, cisplatin, clindamycin, cyclosporine, cytarabine, dacarbazine, dactinomycin, dantrolene, daptomycin, daunorubicin hydrochloride, daunorubicin liposome, dexamethasone sodium phosphate, dexmedetomidine, dexrazoxane, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dolasetron, dopamine, doxorubicin hydrochloride, doxorubicin liposome, doxycycline, droperidol, enalaprilat, ephedrine, epinephrine, epirubicin, eptifibitide, ertapenem, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, fluconazole, fludarabine, fluorouracil, foscarnet, fosphenytoin, furosemide, ganciclovir, gemcitabine, gentamicin, glycopyrrolate, granisetron, haloperidol, heparin, hydralazine, hydrocortisone, hydromorphone, idarubicin, ifosfamide, imipenem/cilastatin, insulin, irinotecan, isoproterenol, ketorolac, labetalol, leucovorin calcium, levofloxacin, lidocaine, linezolid, lorazepam, magnesium hydroxide, mannitol, mechlorethamine, melphalan, meperidine, meropenem, mesna, methohexital, methotrexate, methylprednisolone, methyldopate, metoclopromide, metoprolol, metronidazole, midazolam, milrinone, minocycline, mitomycin, mitoxantrone, morphine, mycophenolate, nafcillin, nalbuphine, naloxone, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, ondansetron, oxaliplatin, paclitaxel, palonosetron, pamidronate, pancuronium, pemetrexed, pentamidine, pentazocine, pentobarbital, phenobarbital, phentolamine, phenylephrine, piperacillin/tazobactam, potassium acetate, potassium chloride, potassium phosphates, procainamide, prochlorperazine, promethazine, propranolol, quinapristin/dalfopristin, ranitidine, remifentanyl, rocuronium, sodium acetate, sodium bicarbonate, sodium phosphates, streptozocin, succinylcholine, sufentanil, tacrolimus, teniposide, thiopental, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, tobramycin, topotecan, trimethoprim/sulfamethoxazole, vancomycin, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, zidovudine, zoledronic acid
  • Y-Site Incompatibility: dantrolene, diazepam, micafungin, phenytoin

Patient/Family Teaching

  • May cause dizziness, drowsiness, or visual disturbances. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient to change positions slowly to minimize orthostatic hypotension.
  • Home Care Issues: Instruct patients administering octreotide at home on correct technique for injection, storage, and disposal of equipment.
    • Instruct patient to administer octreotide exactly as directed. If a dose is missed, administer as soon as possible, then return to regular schedule. Do not double doses.

Evaluation/Desired Outcomes

  • Decrease in severity of diarrhea and improvement of electrolyte imbalances in patients with carcinoid or VIP-secreting tumors.
  • Relief of symptoms and suppressed tumor growth in patients with pituitary tumors associated with acromegaly.
  • Management of diarrhea in patients with AIDS.

Sandostatin LAR®

Octreotide, see there.
References in periodicals archive ?
Swiss drugmaker Novartis AG said late-stage data showed its Sandostatin LAR drug helped fight tumors of the mid-gut, while other drugs showed benefits for treating advanced melanoma.
The dosage for Sandostatin LAR is one 20-40 mg intramuscular injection every 30 days, starting at 20 mg and adjusted per GH levels.
Novartis, Basel, Switzerland, has announced that the Japanese health authority has approved Sandostatin LAR (octreotide acetate for injectable suspension) for the treatment of acromegaly and pituitary gigantism which is unresponsive to or unsuitable for surgery or other drug therapies, and for symptoms associated with gastrointestinal hormone secreting tumors (also known as gastroenteropancreatic (GEP) neuroendocrine tumors (NET), including carcinoid tumors, gastrinomas, and VIPomas (Vasoactive Intestinal Peptide- secreting tumors).
The company's latest report " OpportunityAnalyzer: Acromegaly and Gigantism - Opportunity Analysis and Forecast to 2018" states that across six major markets (the US, UK, France, Spain, Germany and Italy), Novartis' Sandostatin LAR Depot, which is the current standard of care, will remain the dominant treatment throughout the forecast period.
Tenders are invited for Inj Sandostatin Lar 20Mg Prefilled Syringes
Other data, also presented at the ASCO meeting, showed Novartis's Sandostatin LAR was effective in controlling tumor growth in patients with rare gastrointestinal tumors.
Sandostatin LAR Table 3: Select late- & mid-stage pipeline: Plaque Psoriasis Table 4: PhIII Clinical data on Plaque Psoriasis of marketed products 8.
In the combination treatment group, 45 patients whose tumours progressed during treatment with Sandostatin LAR continued treatment with the addition of RAD001.
Outside the US, octreotide LAR is available as Sandostatin LAR for the treatment of patients with acromegaly who are adequately controlled on subcutaneous treatment with Sandostatin or in whom surgery or radiotherapy is inappropriate or ineffective; in the interim period until radiotherapy becomes fully effective.
dera (BiogenIdec) is extraordinary -- SERELAXIN (RLX-030) in Acute Heart Failure - Unmet need would allow an approval-FDA breakthrough designation granted - LCZ696 in chronic heart failure -- Secukinumab in Plaque Psoriasis - Trying To Be Different in a Crowded Space -- Competitive Scenario in Plaque Psoriasis -- PASPORT-Cushings Head to Head Study positive: Sandostatin LAR Replacement ready in active acromegaly -- Signifor/ Pasireotide will penetrate in patients inadequately controlled on Sandostatin.
Follow-up analysis from the PROMID trial evaluating overall survival in patients with metastatic midgut neuroendocrine tumors (NET) taking Sandostatin LAR Depot (octreotide acetate for injectable suspension) vs.
The trial examined the efficacy and safety of everolimus plus Sandostatin LAR Depot (octreotide acetate for injectable suspension) versus placebo plus octreotide LAR in 429 patients with advanced carcinoid tumors.