Warnings and Precautions Gallbladder abnormalities may occur. There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications, including cholecystitis, cholangitis, ...
Sandostatin® LAR Depot (octreotide acetate) for injectable suspension for long-term maintenance of acromegaly.1
HIGHLIGHTS OF IMPORTANT SAFETY INFORMATION
Warnings and Precautions: Treatment with Sandostatin LAR Depot may affect gallbladder function, with postmarketing reports of cholelithiasis (gallstones) resulting in complications; glucose metabolism; thyroid and cardiac function; and nutritional absorption (periodic monitoring is recommended). Cardiac function: use with caution in at-risk patients.
Drug Interactions: The following drugs require monitoring and possible dose adjustment when used with Sandostatin LAR Depot: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.
- For lutetium Lu 177 dotatate injection: Discontinue Sandostatin LAR Depot at least 4 weeks prior to each lutetium Lu 177 dotatate dose
- The most common adverse reactions occurring in ≥20% of patients are diarrhea, cholelithiasis, abdominal pain, and flatulence
Please see additional Important Safety Information below.
In 2 clinical trials, patients were entered who had, in most cases, achieved a GH level <5 ng/mL on Sandostatin® (octreotide acetate) Immediate-Release Injection given in doses of 100 mcg or 200 mcg 3 times daily. Most patients were switched to 20 mg or 30 mg doses of Sandostatin LAR Depot given once every 4 weeks for up to 27 to 28 injections. A few patients received doses of 10 mg and a few required doses of 40 mg.
A third trial was a 12-month study in patients who had a GH level <10 ng/mL after treatment with Sandostatin Immediate-Release Injection (most had levels <5 ng/mL). The starting dose of Sandostatin LAR Depot was 20 mg every 4 weeks for 3 doses. Thereafter, patients received 10 mg, 20 mg, or 30 mg every 4 weeks, depending on the degree of GH suppression.1
GH, growth hormone; IGF-1, insulin-like growth factor 1; LAR, long-acting release.
*Includes Sandostatin® (octreotide acetate) Immediate-Release Injection and Sandostatin® LAR Depot (octreotide acetate) for injectable suspension for all approved indications.
†Safe GH levels considered <2.5 ng/mL.1,3,4
References: 1. Sandostatin LAR Depot [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 2. Center for Drug Evaluation and Research, Food and Drug Administration, US Department of Health and Human Services. CDER Approval Letter, Sandostatin LAR® (octreotide acetate for injectable suspension) Depot, 10, 20, 30 mg. Rockville, MD: Center for Drug Evaluation and Research: November 25, 1998. 3. Cozzi R, Attanasio R, Montini M, et al. Four-year treatment with octreotide-long-acting repeatable in 110 acromegalic patients: predictive value of short-term results? J Clin Endocrinol Metab. 2003;88(7):3090-3098. 4. Cozzi R, Montini M, Attanasio R, et al. Primary treatment of acromegaly with octreotide LAR: a long-term (up to nine years) prospective study of its efficacy in the control of disease activity and tumor shrinkage. J Clin Endocrinol Metab. 2006;91(4):1397-1403.
The right support at the right time
- The single source for patient and caregiver support
- Financial assistance option to help patients get access to the treatment(s) they need
- Personalized 1-on-1 support through unique programs designed to work with patients when they’re needed most
To learn more about what the Novartis Oncology Patient Support Program can offer your patients, call 1-800-282-7630 or visit www.HCP.Novartis.com/Access/.
Mobile Administration Program (MAP)
This program offers administration of Sandostatin® LAR Depot (octreotide acetate) for injectable suspension by a registered nurse at a time and place convenient for your eligible patients so they continue to receive the correct prescribed dose at the right time.‡
- Trained MAP nurses will prepare and administer the medication‡
- You will receive a report after each patient administration
- Administration is available on nights and weekends, and when patients are traveling within the continental United States
- Patients can receive their treatment at their home or workplace, or at another convenient location of their choice
Which patients are eligible?
The MAP is an additional benefit for all appropriate and eligible patients with acromegaly for whom Sandostatin LAR Depot has been prescribed.
- Patients must be recommended by their physician
- Residents of all states except Massachusetts, Michigan, Minnesota, and Rhode Island can participate
- The program is available to patients covered by most commercial plans (HMO, PPO, etc)
- Patients with government-provided medical insurance (eg, Medicare Part B and D, or Medicaid) are not eligible
Your office can confirm patient eligibility easily by calling 1-877-503-3377 and speaking with a representative. You can also print the enrollment form by clicking here.
Advantages of the MAP
Because the program provides specially trained registered nurses, you can feel confident about the following:
- No guesswork. You know that your patient will receive the right dose, at the right time, using the right technique
- Feedback from registered nurses. The nurse will submit a detailed report to you after each visit. You will know when the patient receives his/her treatment at the prescribed dose
- Your patients can receive injections when it is convenient for their schedule. Nurses are available outside traditional office hours, including weekends and evenings, even when patients are traveling within the continental United States
- Time saved for your patient. Your patient won't need to make long trips to the treatment center
- Nurse handles all needle disposals. The program nurse handles disposal of all equipment
The MAP program is not intended to replace the care provided by a patient's health care team
How MAP works
- As the prescribing physician, you evaluate your patients on a case-by-case basis and decide who is appropriate for the program
- Your office submits the patient's information to the company that administers the program, in 1 of 2 ways:
- By calling 1-877-503-3377 or
- By completing and sending in the enrollment form
- Patient eligibility is verified according to your patient's insurance plan
- Your patient receives a call to discuss his or her preferences and schedule the next injection.|| Patients must receive their first dose of Sandostatin LAR Depot in your office
- A specially trained treatment nurse visits your patient's home and:
- Administers the injection
- Schedules the next appointment and follows up with a reminder
- Sends a report to you, the prescribing physician, to update you on the patient’s status
‡The program does not replace your care or the authority of the prescribing physician. Patients still keep their regularly scheduled physician checkups. First dose must be administered by prescribing physician.
||Patient is responsible for acquiring his or her own medication.
Indication and Usage
Sandostatin® LAR Depot (octreotide acetate) for injectable suspension is indicated for patients in whom initial treatment with immediate-release Sandostatin® (octreotide acetate) Injection has been shown to be effective and tolerated for long-term maintenance therapy in patients with acromegaly who have had inadequate response to surgery and/or radiotherapy or for whom surgery and/or radiotherapy is not an option (the goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal).
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- Gallbladder abnormalities may occur. There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications, including cholecystitis, cholangitis, pancreatitis, and requiring cholecystectomy in patients taking Sandostatin LAR Depot. Patients should be monitored periodically. If complications of cholelithiasis are suspected, discontinue Sandostatin LAR Depot and treat appropriately
- Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Blood glucose levels should be monitored when Sandostatin LAR Depot treatment is initiated or when the dose is altered. Anti-diabetic treatment should be adjusted accordingly
- Thyroid Function: Hypothyroidism may occur. Baseline and periodic assessment of thyroid function (TSH, total and/or free T4) is recommended
- Cardiac Function: Bradycardia, arrhythmia, conduction abnormalities, and other electrocardiogram changes may occur. The relationship of these events to octreotide acetate is not established because many of these patients have underlying cardiac disease. Use with caution in at-risk patients
- Nutrition: Octreotide may alter absorption of dietary fats. Monitoring of vitamin B12 levels is recommended during therapy with Sandostatin LAR Depot. Patients on total parenteral nutrition and octreotide should have periodic monitoring of zinc levels
- The following drugs require monitoring and possible dose adjustment when used with Sandostatin LAR Depot: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Drugs mainly metabolized by CYP3A4 and which have a low therapeutic index should be used with caution
- Octreotide competitively binds to somatostatin receptors and may interfere with the efficacy of lutetium Lu 177 dotatate. Discontinue Sandostatin LAR Depot at least 4 weeks prior to each lutetium Lu 177 dotatate dose
- The most common adverse reactions occurring in patients receiving Sandostatin LAR Depot are biliary abnormalities (52%), diarrhea (36%-48%), cholelithiasis (13%-38%), abdominal pain or discomfort (11%-29%), flatulence (26%), influenza-like symptoms (20%), constipation (19%), headache (15%), anemia (15%), hyperglycemia (15%), injection-site pain (2%-14%), hypertension (13%), dizziness (12%), fatigue (11%), nausea (10%), vomiting (7%), hypothyroidism (2%), hypoglycemia (2%), and goiter (2%)
Please see full Prescribing Information.