Sandostatin

Sandostatin

What is Sandostatin?

Sandostatin is used to treat acromegaly.

Sandostatin is also used to reduce hot flashes and watery diarrhea caused by cancerous tumors (carcinoid syndrome) or tumors called vasoactive intestinal peptide tumors (VIPomas).

Warnings

Use Sandostatin exactly as your doctor has told you. Follow all instructions on the label and packaging of your medicine. Tell each of your healthcare providers about all your medical conditions, allergies and any medications you take.

Before using Sandostatin, tell your doctor if you have diabetes, gallbladder disease, heart disease, high blood pressure, heart rhythm problems, thyroid problems, pancreatitis, kidney disease, or liver disease.

You may be shown how to use an infusion at home. Do not inject Sandostatin yourself if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the drug. Be sure to follow the instructions for the exact type of Sandostatin your doctor has prescribed for you.

To make sure Sandostatin is improving your condition and not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested frequently. Don't miss follow-up visits with your doctor for blood or urine tests. Call your doctor immediately if you experience serious side effects such as easy bruising or bleeding, a slow heart rate, or severe pain in the upper abdomen that spreads to the back.

Before you use this medicine

You should not use Sandostatin if you are allergic to octreotide.

To make sure Sandostatin is safe for you, tell your doctor if you have ever had:

• Diabetes;

• Gallbladder disease;

• heart disease, high blood pressure or cardiac arrhythmias;

• thyroid problems;

• pancreatitis;

• liver disease; or

• Kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

Using Sandostatin may affect certain hormones that may make it easier for you to get pregnant, even if you were previously unable to get pregnant. Talk to your doctor about using contraception to avoid an unwanted pregnancy.

Sandostatin is not approved for use in people under 18 years of age.

How should I use Sandostatin?

Use Sandostatin exactly as your doctor has told you. Follow all instructions on your prescription label and read any medication guides or instructions for use. Your doctor may occasionally change your dose.

Sandostatin injection is injected under the skin, into a muscle, or as an infusion into a vein. A doctor will give you the first dose and may teach you how to properly use the medication yourself.

Carefully read and follow all instructions for use that come with your medicine.

Do not prepare an injection until you are ready to give it. Do not use if the medicine has changed color or contains particles. Call your pharmacist for a new medicine.

Your doctor will show you where on your body Sandostatin should be injected. Use a different site for each injection. Do not inject in the same place twice in a row.

You need frequent medical examinations.

If you need radiation treatment, you may need to stop using Sandostatin for a short time. Follow your doctor's instructions very carefully.

Store Sandostatin unopened in the original carton in the refrigerator. Protect from light. Do not freeze.

Remove the ampoule from the refrigerator and allow it to reach room temperature before injecting your dose. Do not heat the ampoule. Each ampoule is for single use only. Throw it away after one use, even if it still contains medicine.

You can also keep it unopenedampouleStable at room temperature for up to 14 days. Discard the ampoule if not used within 14 days.

Use the needle and syringe only once and then place them in a puncture-proof sharps container. Follow state or local laws regarding disposal of this container. Keep it out of the reach of children and pets.

Dosage information

Usual Adult Dose for Carcinoid Tumors:

Initial dose: 100 to 600 mcg per day, intravenously or subcutaneously, divided into 2 to 4 doses

Comments:
-The mean daily dose was 450 mcg; The mean daily dose was 300 µg.
-Benefits were observed at doses of 50 mcg to 1500 mcg per day.
- There is limited experience with doses above 750 mcg per day.

Long-acting depot formulation (Establish tolerance with a short-acting product for at least 2 weeks before using this formulation):
Initial dose: 20 mg, IM (intragluteal), at 4 week intervals, for 2 months; Continue with the regular octreotide dose for at least 2 weeks (at the same dose the patient was taking before switching).
After 2 months:
-If symptoms are controlled, consider reducing the dose to 10 mg every 4 weeks
-If symptoms are not adequately controlled, increase the dose to 30 mg every 4 weeks
Maximum dose: 30 mg every 4 weeks

Comments:
-Failure to continue dosing of regular octreotide during a switch to the long-acting formulation may result in worsening of symptoms. Some patients require 3 to 4 weeks of adjunctive therapy.

Application: Symptomatic treatment of patients with metastatic carcinoid tumors, suppressing or inhibiting the severe diarrhea and hot flashes associated with the disease.

Usual adult dose for vasoactive intestinal peptide tumor:

Initial dose: 200 to 300 mcg per day, intravenously or subcutaneously, divided into 2 to 4 doses
Maintenance dose: 150 to 750 mcg per day
-Doses above 450 mcg per day are usually not required.

Long-acting depot formulation (Establish tolerance with a short-acting product for at least 2 weeks before using this formulation):
Initial dose: 20 mg, IM (intragluteal), at 4 week intervals, for 2 months; Continue with the regular octreotide dose for at least 2 weeks (at the same dose the patient was taking before switching).
After 2 months:
-If symptoms are controlled, consider reducing the dose to 10 mg every 4 weeks
-If symptoms are not adequately controlled, increase the dose to 30 mg every 4 weeks

Comments:
–Adjust dose based on therapeutic response.

Application: Long-term treatment of severe watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors.

Usual Adult Dose for Acromegaly:

Initial dose: 50 mcg, intravenously or subcutaneously, 3 times daily
Maintenance dose: Typically 100 mcg, three times daily
Maximum dose: 500 µg, 3 times daily

Comments:
– Starting at a low dose may help patients adjust to gastrointestinal side effects.
-Use IGF-1 (Somatomedin C) levels every two weeks to guide titration.
-Multiple levels of growth hormone, zero to 8 hours after dosing, may allow for more rapid dose titration.
-Doses above 300 mcg per day rarely provide additional biochemical benefit.

Long-acting depot formulation (Establish tolerance with a short-acting product for at least 2 weeks before using this formulation):
Initial dose: 20 mg, IM (intragluteal), at 4 week intervals for 3 months
After 3 months:
-If GH is 1 ng/mL or less, IGF-1 is normal, and clinical symptoms are controlled: 10 mg, IM, every 4 weeks
-If GH is 2.5 ng/mL or less and clinical symptoms are controlled: 20 mg, IM, every 4 weeks
-If GH is greater than 2.5 ng/mL and/or clinical symptoms are uncontrolled: 30 mg, IM, every 4 weeks
-If GH, IGF-1 or symptoms are not adequately controlled with 30 mg, the dose may be increased to 40 mg IM every 4 weeks. be increased
Maximum dose: 40 mg, every 4 weeks

Comments:
-The goal is growth hormone (GH) levels below 5 ng/ml or IGF-1 levels below 1.9 U/ml (male) or 2.2 U/ml (female).
-If increased doses do not provide additional benefit, reduce the dose.
-Check IGF-1 or growth hormone levels every 6 months.
-For patients who have received radiation: discontinue medication annually for approximately 4 weeks (8 weeks for long-acting formulation) to assess disease activity; If growth hormone or IGF-1 increases and symptoms recur, continue therapy.

Use: To reduce blood levels of growth hormone and IGF-1 (somatomedin C) in acromegaly patients who have had an inadequate response to surgical resection or radiation therapy or cannot be treated.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

Symptoms of overdose may include severe upper abdominal pain, diarrhea, weight loss, warmth or tingling, numbness or cold, unexplained muscle pain, weakness, weak pulse, fainting, or slow breathing (breathing may stop).

What should I avoid when using Sandostatin?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

Sandostatin side effects

If necessary, get emergency medical helpSigns of an allergic reaction to Sandostatin: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Call your doctor immediately if you have:

• severe constipation;

• slow or uneven heartbeat;

• Signs of gallstones- Fever, chills, nausea, vomiting, severe pain in the upper abdomen spreading to the back, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• high blood sugar– increased thirst, increased urination, dry mouth, fruity breath smell;

• low blood sugar- Headache, hunger, sweating, irritability, dizziness, fast heartbeat and feeling anxious or shaking; or

• Hypothyroidism– feeling extremely tired, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, increased sensitivity to cold, weight gain.

Common side effects of Sandostatin may include:

• gallstones;

• nausea, vomiting, diarrhea, stomach pain, flatulence;

• headache, back pain; or

• Dizziness, tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other drugs affect Sandostatin?

Tell your doctor about all other medicines you are taking, especially:

• Bromocriptine (Cycloset, Parlodel);

• cyclosporine;

• insulin or oral diabetes medications; or

• Heart or blood pressure medications.

This list is not complete. Other medications may interact with octreotide, including prescription and over-the-counter medications, vitamins, and herbal products. Not all possible drug interactions are listed here.