Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Treatment of patients with acromegaly in whom surgery is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective (see section 4.2).
Treatment of patients with symptoms associated with functional gastro-entero-pancreatic endocrine tumours e.g. carcinoid tumours with features of the carcinoid syndrome (see section 5.1).
Treatment of patients with advanced neuroendocrine tumours of the midgut or of unknown primary origin where non-midgut sites of origin have been excluded.
Treatment of TSH-secreting pituitary adenomas:
It is recommended to start treatment with the administration of 20 mg Sandostatin LAR at 4-week intervals for 3 months. Patients on treatment with s.c. Sandostatin can start treatment with Sandostatin LAR the day after the last dose of s.c. Sandostatin. Subsequent dosage adjustment should be based on serum growth hormone (GH) and insulin-like growth factor 1/somatomedin C (IGF-1) concentrations and clinical symptoms.
For patients in whom, within this 3-month period, clinical symptoms and biochemical parameters (GH; IGF-1) are not fully controlled (GH concentrations still above 2.5 microgram/L), the dose may be increased to 30 mg every 4 weeks. If after 3 months, GH, IGF-1, and/or symptoms are not adequately controlled at a dose of 30 mg, the dose may be increased to 40 mg every 4 weeks.
For patients whose GH concentrations are consistently below 1 microgram/L, whose IGF-1 serum concentrations normalised, and in whom most reversible signs/symptoms of acromegaly have disappeared after 3 months of treatment with 20 mg, 10 mg Sandostatin LAR may be administered every 4 weeks. However, particularly in this group of patients, it is recommended to closely monitor adequate control of serum GH and IGF-1 concentrations, and clinical signs/symptoms at this low dose of Sandostatin LAR.
For patients on a stable dose of Sandostatin LAR, assessment of GH and IGF-1 should be made every 6 months.
It is recommended to start treatment with the administration of 20 mg Sandostatin LAR at 4-week intervals. Patients on treatment with s.c. Sandostatin should continue at the previously effective dosage for 2 weeks after the first injection of Sandostatin LAR.
For patients in whom symptoms and biological markers are well controlled after 3 months of treatment, the dose may be reduced to 10 mg Sandostatin LAR every 4 weeks.
For patients in whom symptoms are only partially controlled after 3 months of treatment, the dose may be increased to 30 mg Sandostatin LAR every 4 weeks.
For days when symptoms associated with gastro-entero-pancreatic tumours may increase during treatment with Sandostatin LAR, additional administration of s.c. Sandostatin is recommended at the dose used prior to the Sandostatin LAR treatment. This may occur mainly in the first 2 months of treatment until therapeutic concentrations of octreotide are reached.
The recommended dose of Sandostatin LAR is 30 mg administered every 4 weeks (see section 5.1). Treatment with Sandostatin LAR for tumour control should be continued in the absence of tumour progression.
Treatment with Sandostatin LAR should be started at a dose of 20 mg at 4-weekly intervals for 3 months before considering dose adjustment. The dose is then adjusted on the basis of the TSH and thyroid hormone response.
Impaired renal function did not affect the total exposure (AUC) to octreotide when administered s.c. as Sandostatin. Therefore, no dose adjustment of Sandostatin LAR is necessary.
In a study with Sandostatin administered s.c. and i.v. it was shown that the elimination capacity may be reduced in patients with liver cirrhosis, but not in patients with fatty liver disease. In certain cases patients with impaired hepatic function may require dose adjustment.
In a study with Sandostatin administered s.c., no dose adjustment was necessary in subjects ≥ 65 years of age. Therefore, no dose adjustment is necessary in this group of patients with Sandostatin LAR.
There is limited experience with the use of Sandostatin LAR in children.
Sandostatin LAR may only be administered by deep intramuscular injection. The site of repeat intramuscular injections should be alternated between the left and right gluteal muscle (see section 6.6).
A limited number of accidental overdoses of Sandostatin LAR have been reported. The doses ranged from 100 mg to 163 mg/month of Sandostatin LAR. The only adverse event reported was hot flushes.
Cancer patients receiving doses of Sandostatin LAR up to 60 mg/month and up to 90 mg/2 weeks have been reported. These doses were in general well tolerated; however, the following adverse events have been reported: frequent urination, fatigue, depression, anxiety, and lack of concentration.
The management of overdosage is symptomatic.
3 years.
The product must not be stored after reconstitution (must be used immediately).
Store in the original package in order to protect from light.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Sandostatin LAR may be stored below 25°C on the day of the injection.
For storage conditions after reconstitution, refer to section 6.3.
Unit packs containing one 6 mL glass vial with rubber stopper (bromobutyl rubber), sealed with an aluminium flip-off seal, containing powder for suspension for injection and one 3 mL colourless pre-filled glass syringe with front and plunger stopper (chlorobutyl rubber) with 2 mL solvent, co-packaged in a sealed blister tray with one vial adapter and one safety injection needle.
Multipacks of three unit packs, each unit pack containing: one 6 mL glass vial with rubber stopper (bromobutyl rubber), sealed with an aluminium flip-off seal, containing powder for suspension for injection and one 3 mL colourless pre-filled glass syringe with front and plunger stopper (chlorobutyl rubber) with 2 mL solvent, co-packaged in a sealed blister tray with one vial adapter and one safety injection needle.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
FOR DEEP INTRAMUSCULAR INJECTION ONLY
Included in the injection kit:
a. One vial containing Sandostatin LAR powder,
b. One prefilled syringe containing the vehicle solution for reconstitution,
c. One vial adapter for drug product reconstitution,
d. One safety injection needle.
Follow the instructions below carefully to ensure proper reconstitution of Sandostatin LAR before deep intramuscular injection.
There are 3 critical actions in the reconstitution of Sandostatin LAR. Not following them could result in failure to deliver the drug appropriately.
Sandostatin LAR should only be administered by a trained healthcare professional.
ATTENTION: It is essential to start the reconstitution process only after the injection kit reaches room temperature. Let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
Note: The injection kit can be re-refrigerated if needed.
ATTENTION: It is essential to let the vial stand for 5 minutes to ensure that the diluent has fully saturated the powder.
Note: It is normal if the plunger rod moves up as there might be a slight overpressure in the vial.
ATTENTION: Keep the plunger pressed and shake the vial moderately in a horizontal direction for a minimum of 30 seconds so that the powder is completely suspended (milky uniform suspension). Repeat moderate shaking for another 30 seconds if the powder is not completely suspended.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
