Sandostatin package insert pdf

Full prescribing information 1 indications and usage sandostatin lar depot 10 mg, 20 mg and 30 mg is indicated in patients in whom initial treatment with sandostatin injection has been shown to b e effective and tolerated. In most cases, the overproduction of growth hormone is caused by an enlargement in the pituitary gland a pituitary adenoma. The effects of octreotide include altering metabolic activities by decreasing hormone secretion. For more information on sandostatin lar depot, see the full prescribing information. Highlights of prescribing information procrit epoetin alfa. See full prescribing information for sandostatin lar. Lutathera lutetium lu 177 dotatate is indicated for the treatment of somatostatin receptorpositive gastroenteropancreatic neuroendocrine tumors gepnets, including foregut, midgut and hindgut neuroendocrine tumors in adults. Subcutaneous injection is the usual route of administration of sandostatin for control of symptoms. How to use sandostatin lar sandostatin lar must always be administered as an injection into the muscle of the buttocks. Sandostatin lar depot octreotide acetate for injectable suspension is indicated for patients in whom initial treatment with immediaterelease sandostatin octreotide acetate injection has been shown to be effective and tolerated for.

Sandostatin lar depot octreotide acetate for injectable. With repeated administration, the left and right buttock should be used alternately. J2353 sandostatin lar depot sandoz gmbh 10 mg, 20 mg, 30 mg injection. Discard product if it contains particulate matter, is cloudy, or discolored product is stable for up to 14 days at temperatures between 70 and 86 degrees f if protected from light protect from light refrigerate between 36 and 46 degrees f sandostatin lar. Sandostatin, it is recommended to start with the administration of s. Sandostatin should be continued at the previously effective dosage for 2 weeks after the first injection of sandostatin lar. The nccn drugs and biologics compendium nccn compendium. Dailymed sandostatin octreotide acetate injection, solution. Sandostatin lar octreotide acetate rationale for inclusion. Move the site where you give the shot with each shot. Preparing and mixing the updated formulation of sandostatin lar guaranteed administration by a healthcare professional. Sandostatin lar depot is indicated for long term maintenance therapy in acromegalic patients who have had an inadequate response to surgery andor radiotherapy, or for. A few patients received doses of 10 mg and a few required doses of 40 mg. The following drugs require monitoring and possible dose adjustment when used with sandostatin lar depot.

Highlightsof prescribing information kyprolis safely and. Longterm maintenance therapy in acromegalic patients who have had inadequate response to surgery and. Helps ensure control of patients therapy helps a patient receive the right dose at the right time, using the right technique preparation. Sandostatin 50 microgram1 ml, solution for injectioninfusion. Each vial contains 10 mg of pentostatin and 50 mg of mannitol, usp. Indicated for longterm maintenance therapy in acromegalic patients who have had an inadequate response to surgery andor radiotherapy, or for whom surgery andor. Protect from light reconstituted product should be used. A consensus on the medical treatment of acromegaly. Discard product if it contains particulate matter, is cloudy, or discolored product is stable for up to 14 days at temperatures between 70 and 86 degrees f if protected from light protect from. Sandostatin subcutaneous formulationis covered under the members pharmacy benefit. Each vial contains 10 mg of pentostatin and 50 mg of mannitol. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids.

Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Sandostatin lar depot given once every 4 weeks for up to 27 to 28 injections. Longterm treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. Sandostatin and associated names european medicines agency. Sandostatin sandostatin lar depot octreotide acetate policy.

Sandostatin octreotide acetate is indicated for the treatment of the profuse watery diarrhea associated with vipsecreting tumors. Save money on your sandostatin injection prescription by switching to tevas fdaapproved generic version, octreotide acetate injection. Apr 11, 2019 sandostatin octreotide acetate may be administered subcutaneously or intravenously. Acthar gel highlights of prescribing information these highlights do not include all the information needed to use acthar gel safely and effectively. Description sterile isotonic solution of sodium chloride 9gl in. Longterm treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid. Octreotide lowers many substances in the body such as insulin and glucagon. Tear open the pouch along the dotted line and take out the prefilled syringe. Due to the wide therapeutic window of octreotide, no dose adjustment of sandostatin. Sandostatin lar depot is covered under the members general benefits package medical benefit. Do not use if the solution is cloudy, leaking, or has particles. Sandostatin is authorised in the eu via national procedures. Remove the sandostatin lar injection kit from refrigerated storage.

Highlights of prescribing information hypersensitivity. European spcs may differ in several respects, including. Sandostatin lar depot is indicated in patients in whom initial treatment with sandostatin injection has been shown to be effective and tolerated. Follow how to use as you have been told by the doctor or read the package insert. J2353 injection, octreotide, depot form for intramuscular injection, 1 mg. Octreotide lowers many substances in the body such as insulin and glucagon involved in regulating blood sugar, growth hormone, and chemicals that affect digestion. Sandostatin lar while maintaining optimal therapeutic outcomes.

An instruction booklet for the preparation of drug suspension for injection is. Pain with subcutaneous administration may be reduced by using the smallest volume that will deliver the desired dose. Refer to the dexamethasone prescribing information for other information on that product. Octreotide acetate is an octapeptide that mimicks the pharmacological action of the naturally occurring hormone somatostatin. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab. For patients who were not previously treated with s. Sandostatin octreotide acetate studies were not designed to show an effect on the size, rate of growth or development of metastases. Sandostatin octreotide acetate injection, a cyclic octapeptide prepared. Apr 11, 2019 sandostatin injection is available as.

Sandostatin sandostatin lar depot octreotide acetate. Dose adjustment and increased frequency of glucose monitoring may be required when myxredlin is coadministered with these drugs. Advanced accelerator applications usa, inc july 2018. Twice weekly 2056mgm2 regimen by 30minute infusion kyprolis is. Restricted access do not disseminate or copy without approval. Highlights of prescribing information for intravenous. Dailymed sandostatin lar depot octreotide acetate kit. Sandostatin octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide. Drugs that may decrease the blood glucose lowering effect of myxredlin. Growth hormone and igf1 levels were at least as well controlled with sandostatin lar depot as they had been on sandostatin injection and this level of control remained for the entire. Nipent pentostatin for injection is supplied as a sterile, apyrogenic, lyophilized powder in singledose vials for intravenous administration. Sandostatin lar depot is available in singleuse kits for injectable suspension containing a 6ml vial of 10 mg, 20 mg, or 30 mg strength, a syringe containing 2 ml of diluent, one vial adapter, and one sterile 1.

In patients with renal impairment the elimination of octreotide from plasm. It is an even more potent inhibitor of growth hormone, glucagon, and insulin. Octreotide acetate is an octapeptide that mimicks the pharmacological action. The content of the prefilled syringe is a semisolid phase having a gellike appearance, with viscous characteristics and a. Sandostatin octreotide is a manmade protein that is similar to a hormone in the body called somatostatin. Sandostatin lar octreotide acetate dose, indications. Package contents vial containing sandostatin lar depot vial adapter for drug product reconstitution pre. Sandostatin lar depot octreotide acetate for acromegaly. Sandostatin lar octreotide suspension updated 42019. Sandostatin lar depot drug product kit should remain at room temperature for 3060 minutes prior to preparation of the drug suspension. The ph of the final product is maintained between 7. Clinical pharmacy program guidelines for sandostatin.

Sandostatin is a medicine that contains the active substance octreotide. This policy provides information about sandostatin and sandostatin lar depot octreotide acetate and its recommended use. Before giving the shot, let it come to room temperature. Octreotide is a synthetic substance that mimics the activity of the natural hormone somatostatin. Us package insert or european spcs may differ in several respects, including but not limited to the characterisation of risks. Apr 11, 2019 for prolonged storage, sandostatin lar depot should be stored at refrigerated temperatures between 2c to 8c 36f to 46f and protected from light until the time of use. Sandostatin lar depot is available in singleuse kits for injectable suspension containing a 6ml vial of 10 mg, 20 mg, or 30 mg strength, a syringe containing 2 ml of diluent, one vial adapter, and one. How to use sandostatin lar sandostatin lar must always be administered as an. Like somatostatin, octreotide blocks the release of hormones found in the body, particularly growth hormone which consequently reduces the release of insulinlike growth factor 1, igf1 but also others such as thyroid. Sandostatin lar contains less than 1 mmol sodium 23 mg per dose, which means it is essentially sodiumfree. Us package insert or european spcs may differ in several respects, including but not limited to the characterisation of risks and benefits. Jun 14, 2019 sandostatin octreotide is a manmade protein that is similar to a hormone in the body called somatostatin. Vasoactive intestinal peptide tumors vipomas sandostatin octreotide acetate is indicated for the treatment of the profuse watery diarrhea associated with vipsecreting tumors. Highlights of prescribing information these highlights do not.

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