Nipent pentostatin for injection is supplied as a sterile, apyrogenic, lyophilized powder in singledose vials for intravenous administration. Highlights of prescribing information procrit epoetin alfa. Dailymed sandostatin octreotide acetate injection, solution. 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. Sandostatin octreotide acetate injection rx only prescribing information description sandostatin octreotide acetate injection, a cyclic oc tapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffere d lactic acid solution for administration by deep subcutaneous intrafat or intravenous iv in jection. Apr 11, 2019 sandostatin injection is available as. How to use sandostatin lar sandostatin lar must always be administered as an. Sandostatin lar octreotide acetate rationale for inclusion. An instruction booklet for the preparation of drug suspension for injection is. 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. Protect from light reconstituted product should be used.
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. Description sterile isotonic solution of sodium chloride 9gl in. Sandostatin lar depot octreotide acetate for injectable suspension. Sandostatin is authorised in the eu via national procedures. Sandostatin is a medicine that contains the active substance octreotide. Sandostatin lar octreotide suspension updated 42019. Dailymed sandostatin lar depot octreotide acetate kit. 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. Follow how to use as you have been told by the doctor or read the package insert. It is an even more potent inhibitor of growth hormone, glucagon, and insulin. Octreotide lowers many substances in the body such as insulin and glucagon. Octreotide acetate is an octapeptide that mimicks the pharmacological action of the naturally occurring hormone somatostatin. Subcutaneous injection is the usual route of administration of sandostatin for control of symptoms.
Sandostatin lar depot drug product kit should remain at room temperature for 3060 minutes prior to preparation of the drug suspension. Sandostatin, it is recommended to start with the administration of s. A few patients received doses of 10 mg and a few required doses of 40 mg. Pain with subcutaneous administration may be reduced by using the smallest volume that will deliver the desired dose.
Us package insert or european spcs may differ in several respects, including but not limited to the characterisation of risks and benefits. Each vial contains 10 mg of pentostatin and 50 mg of mannitol, usp. Tear open the pouch along the dotted line and take out the prefilled syringe. The following drugs require monitoring and possible dose adjustment when used with sandostatin lar depot. Octreotide is a synthetic substance that mimics the activity of the natural hormone somatostatin. Octreotide lowers many substances in the body such as insulin and glucagon involved in regulating blood sugar, growth hormone, and chemicals that affect digestion. The effects of octreotide include altering metabolic activities by decreasing hormone secretion. How to use sandostatin lar sandostatin lar must always be administered as an injection into the muscle of the buttocks. Acthar gel highlights of prescribing information these highlights do not include all the information needed to use acthar gel safely and effectively. European spcs may differ in several respects, including.
Do not use if the solution is cloudy, leaking, or has particles. Sandostatin sandostatin lar depot octreotide acetate policy. Sandostatin octreotide acetate injection, a cyclic octapeptide prepared. Clinical pharmacy program guidelines for sandostatin. January 1, 2020 page 3 of 5 applicable procedure codes j2353 injection, octreotide, depot form for intramuscular injection, 1 mg. See full prescribing information for sandostatin lar. J2353 sandostatin lar depot sandoz gmbh 10 mg, 20 mg, 30 mg injection. 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. Highlights of prescribing information hypersensitivity. Sandostatin lar depot given once every 4 weeks for up to 27 to 28 injections. Sandostatin octreotide acetate studies were not designed to show an effect on the size, rate of growth or development of metastases. Us package insert or european spcs may differ in several respects, including but not limited to the characterisation of risks.
Twice weekly 2056mgm2 regimen by 30minute infusion kyprolis is administered intravenously as a 30minute infusion on two consecutive days, each week for threeweeks followed by a 12day rest period as shown in table2. J2353 injection, octreotide, depot form for intramuscular injection, 1 mg. 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. 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. A consensus on the medical treatment of acromegaly. Sandostatin should be continued at the previously effective dosage for 2 weeks after the first injection of sandostatin lar. Apr 11, 2019 sandostatin octreotide acetate may be administered subcutaneously or intravenously. Indicated for longterm maintenance therapy in acromegalic patients who have had an inadequate response to surgery andor radiotherapy, or for whom surgery andor. Sandostatin octreotide acetate is indicated for the treatment of the profuse watery diarrhea associated with vipsecreting tumors. With repeated administration, the left and right buttock should be used alternately. Package contents vial containing sandostatin lar depot vial adapter for drug product reconstitution pre. Sandostatin and associated names european medicines agency.
Preparing and mixing the updated formulation of sandostatin lar guaranteed administration by a healthcare professional. 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. The nccn drugs and biologics compendium nccn compendium. In most cases, the overproduction of growth hormone is caused by an enlargement in the pituitary gland a pituitary adenoma. Remove the sandostatin lar injection kit from refrigerated storage.
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. Vasoactive intestinal peptide tumors vipomas sandostatin octreotide acetate is indicated for the treatment of the profuse watery diarrhea associated with vipsecreting tumors. Jun 14, 2019 sandostatin octreotide is a manmade protein that is similar to a hormone in the body called somatostatin. In patients with renal impairment the elimination of octreotide from plasm. Longterm treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid. Refer to the dexamethasone prescribing information for other information on that product. Due to the wide therapeutic window of octreotide, no dose adjustment of sandostatin.
The ph of the final product is maintained between 7. 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. Sandostatin lar while maintaining optimal therapeutic outcomes. Longterm maintenance therapy in acromegalic patients who have had inadequate response to surgery and. The content of the prefilled syringe is a semisolid phase having a gellike appearance, with viscous characteristics and a. For patients who were not previously treated with s. 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. Highlights of prescribing information for intravenous.
Sandostatin lar depot is covered under the members general benefits package medical benefit. For more information on sandostatin lar depot, see the full prescribing information. Sandostatin lar depot octreotide acetate for acromegaly. Save money on your sandostatin injection prescription by switching to tevas fdaapproved generic version, octreotide acetate injection. Sandostatin octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide. Sandostatin lar octreotide acetate dose, indications. Octreotide acetate is an octapeptide that mimicks the pharmacological action. Drugs that may decrease the blood glucose lowering effect of myxredlin. Sandostatin sandostatin lar depot octreotide acetate. Highlights of prescribing information these highlights do not.
Move the site where you give the shot with each shot. Sandostatin lar depot octreotide acetate for injectable. Longterm treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. Dose adjustment and increased frequency of glucose monitoring may be required when myxredlin is coadministered with these drugs. Twice weekly 2056mgm2 regimen by 30minute infusion kyprolis is. Restricted access do not disseminate or copy without approval. Before giving the shot, let it come to room temperature. Highlightsof prescribing information kyprolis safely and. Helps ensure control of patients therapy helps a patient receive the right dose at the right time, using the right technique preparation. Sandostatin lar contains less than 1 mmol sodium 23 mg per dose, which means it is essentially sodiumfree. Advanced accelerator applications usa, inc july 2018. Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs.
172 1104 201 127 987 837 1100 1321 1142 1071 998 474 1455 1511 376 1437 1367 1113 290 1276 1408 495 794 901 801 764 249 355 1206 494 1488 622 674 974 1506 676 1191 345 584 1292 1261 5 1298 1008 1040 494 823 1050 1127