OCTREOTIDE ACETATE

2 DOSAGE AND ADMINISTRATION • Octreotide acetate for injectable suspension should be administered by a trained healthcare provider. It is important to closely follow the mixing instructions included in the packaging. Octreotide acetate for injectable suspension must be administered immediately after mixing. Discard unused portion. • Do not directly inject diluent without preparing suspension. • The recommended needle size for administration of octreotide acetate for injectable suspension is the 1½” 19 gauge safety injection needle (supplied in the drug product kit). For patients with a greater skin to muscle depth, a size 2” 19 gauge needle (not supplied) may be used. • Octreotide acetate for injectable suspension should be administered intramuscularly (IM) in the gluteal region at 4-week intervals. Administration of octreotide acetate for injectable suspension at intervals greater than 4 weeks is not recommended. • Injection sites should be rotated in a systematic manner to avoid irritation. Deltoid injections should be avoided due to significant discomfort at the injection site when given in that area. • Octreotide acetate for injectable suspension should never be administered intravenously or subcutaneously. The following dosage regimens are recommended. Patients Not Currently Receiving Octreotide Acetate Injection Subcutaneously: • Acromegaly: 50 mcg three times daily octreotide acetate injection subcutaneously for 2 weeks followed by octreotide acetate for injectable suspension 20 mg intragluteally every 4 weeks for 3 months ( 2.1 ) • Carcinoid Tumors and VIPomas: Octreotide acetate injection subcutaneously 100 mcg/day to 600 mcg/day in 2 to 4 divided doses for 2 weeks followed by octreotide acetate for injectable suspension 20 mg every 4 weeks for 2 months ( 2.2 ) Patients Currently Receiving Octreotide Acetate Injection Subcutaneously: • Acromegaly: 20 mg every 4 weeks for 3 months ( 2.1 ) • Carcinoid Tumors and VIPomas: 20 mg every 4 weeks for 2 months ( 2.2 ) Renal Impairment, Patients on Dialysis: 10 mg every 4 weeks ( 2.3 ) Hepatic Impairment, Patients With Cirrhosis: 10 mg every 4 weeks ( 2.4 ) 2.1 Acromegaly Patients Not Currently Receiving Octreotide Acetate Patients not currently receiving octreotide acetate should begin therapy with octreotide acetate injection given subcutaneously in an initial dose of 50 mcg three times daily which may be titrated. Most patients require doses of 100 mcg to 200 mcg three times daily for maximum effect but some patients require up to 500 mcg three times daily. Patients should be maintained on octreotide acetate injection subcutaneous for at least 2 weeks to determine tolerance to octreotide acetate. Patients who are considered to be “responders” to the drug, based on GH and IGF-1 levels and who tolerate the drug, can then be switched to octreotide acetate for injectable suspension in the dosage scheme described below (Patients Currently Receiving Octreotide Acetate Injection). Patients Currently Receiving Octreotide Acetate Injection Patients currently receiving octreotide acetate injection can be switched directly to octreotide acetate for injectable suspension in a dose of 20 mg given IM intragluteally at 4-week intervals for 3 months. After 3 months, dosage may be adjusted as follows: • GH ≤ 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain octreotide acetate for injectable suspension dosage at 20 mg every 4 weeks • GH > 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled, increase octreotide acetate for injectable suspension dosage to 30 mg every 4 weeks • GH ≤ 1 ng/mL, IGF-1 normal, and clinical symptoms controlled, reduce octreotide acetate for injectable suspension dosage to 10 mg every 4 weeks • If GH, IGF-1, or symptoms are not adequately controlled at a dose of 30 mg, the dose may be increased to 40 mg every 4 weeks. Doses higher than 40 mg are not recommended. In patients who have received pituitary irradiation, octreotide acetate for injectable suspension should be withdrawn yearly for approximately 8 weeks to assess disease activity. If GH or IGF-1 levels increase and signs and symptoms recur, octreotide acetate for injectable suspension therapy may be resumed. 2.2 Carcinoid Tumors and VIPomas Patients Not Currently Receiving Octreotide Acetate Patients not currently receiving octreotide acetate should begin therapy with octreotide acetate injection given subcutaneously. The suggested daily dosage for carcinoid tumors during the first 2 weeks of therapy ranges from 100 mcg/day to 600 mcg/day in 2 to 4 divided doses (mean daily dosage is 300 mcg). Some patients may require doses up to 1,500 mcg/day. The suggested daily dosage for VIPomas is 200 mcg to 300 mcg in 2 to 4 divided doses (range, 150 mcg to 750 mcg); dosage may be adjusted on an individual basis to control symptoms but usually doses above 450 mcg/day are not required. Octreotide acetate injection should be continued for at least 2 weeks. Thereafter, patients who are considered “responders” to octreotide acetate, and who tolerate the drug, may be switched to octreotide acetate for injectable suspension in the dosage regimen as described below (Patients Currently Receiving Octreotide Acetate Injection). Patients Currently Receiving Octreotide Acetate Injection Patients currently receiving octreotide acetate injection can be switched to octreotide acetate for injectable suspension in a dosage of 20 mg given IM intragluteally at 4-week intervals for 2 months. Because of the need for serum octreotide to reach therapeutically effective levels following initial injection of octreotide acetate for injectable suspension, carcinoid tumor and VIPoma patients should continue to receive octreotide acetate injection subcutaneously for at least 2 weeks in the same dosage they were taking before the switch. Failure to continue subcutaneous injections for this period may result in exacerbation of symptoms (some patients may require 3 or 4 weeks of such therapy). After 2 months, dosage may be adjusted as follows: • If symptoms are adequately controlled, consider a dose reduction to 10 mg for a trial period. If symptoms recur, dosage should then be increased to 20 mg every 4 weeks. Many patients can, however, be satisfactorily maintained at a 10 mg dose every 4 weeks. • If symptoms are not adequately controlled, increase octreotide acetate for injectable suspension to 30 mg every 4 weeks. Patients who achieve good control on a 20 mg dose may have their dose lowered to 10 mg for a trial period. If symptoms recur, dosage should then be increased to 20 mg every 4 weeks. • Dosages higher than 30 mg are not recommended. Despite good overall control of symptoms, patients with carcinoid tumors and VIPomas often experience periodic exacerbation of symptoms (regardless of whether they are being maintained on octreotide acetate injection or octreotide acetate for injectable suspension). During these periods, they may be given octreotide acetate injection subcutaneously for a few days at the dosage they were receiving prior to switching to octreotide acetate for injectable suspension. When symptoms are again controlled, the octreotide acetate injection subcutaneous can be discontinued. 2.3 Special Populations: Renal Impairment In patients with renal failure requiring dialysis, the starting dose should be 10 mg every 4 weeks. In other patients with renal impairment, the starting dose should be similar to a nonrenal patient (i.e., 20 mg every 4 weeks) [see Clinical Pharmacology (12) ] . 2.4 Special Populations: Hepatic Impairment – Cirrhotic Patients In patients with established cirrhosis of the liver, the starting dose should be 10 mg every 4 weeks [see Clinical Pharmacology (12.3) ] .

See official label

1 INDICATIONS AND USAGE Octreotide acetate for injectable suspension 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated.