Octreotide-injection

Yes

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Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain or tenderness, severe constipation;

• slow or uneven heartbeats;

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or

• underactive thyroid--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain.

Common side effects may include:

• diarrhea, constipation;

• vomiting, upset stomach;

• bloating, gas;

• headache, dizziness; or

• pain when injecting the medicine.

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

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with octreotide, especially:

• bromocriptine (Cycloset, Parlodel);

• cyclosporine (Neoral, Sandimmune, Gengraf);

• insulin or oral diabetes medicine;

• a diuretic or "water pill"; or

• medicine for heart disease or high blood pressure.

This list is not complete. Other drugs may interact with octreotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

• It is used to treat loose stools (diarrhea) and flushing caused by cancer.
• It is used to treat acromegaly.
• It may be given to you for other reasons. Talk with the doctor.

Applies to octreotide: powder for solution, powder for suspension, solution

Along with its needed effects, octreotide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking octreotide:

• Abdominal or stomach pain
• blurred vision
• constipation
• depressed mood
• dizziness
• dry mouth
• dry skin and hair
• fainting
• fast, slow, or irregular heartbeat
• feeling cold
• flushed, dry skin
• fruit-like breath odor
• hair loss
• hoarseness or husky voice
• increased hunger
• increased thirst
• increased urination
• muscle cramps and stiffness
• nausea
• severe stomach pain with nausea and vomiting
• sweating
• troubled breathing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• weight gain

• Abdominal or stomach bloating
• anxious feeling
• behavior change similar to drunkenness
• changes in menstrual periods
• cold sweats
• confusion
• convulsions (seizures)
• cool, pale skin
• decreased sexual ability in males
• difficulty with concentrating
• drowsiness
• headache
• loss of appetite
• muscle cramps and stiffness
• nightmares
• restless sleep
• shakiness
• slurred speech
• swelling of the front part of the neck
• tiredness
• troubled breathing (rapid and deep)
• unconsciousness
• unusual thirst

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chills
• darkened urine
• fever
• indigestion
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• severe constipation
• unusual bleeding or bruising
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking octreotide:

• Abdominal or stomach discomfort
• decreased appetite
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, shallow breathing
• feeling of warmth
• general feeling of discomfort
• light-colored stools
• muscle pain or cramping
• no blood pressure or pulse
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• sleepiness
• stopping of heart
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• upper right abdominal or stomach pain
• weakness
• weight loss

Some side effects of octreotide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Pain, redness, stinging, swelling, tingling, or burning sensation at the injection site
• passing of gas

• Backache
• bladder pain
• cloudy urine
• cough
• difficult, burning, or painful urination
• disturbed color perception
• double vision
• frequent urge to urinate
• frequent urination usually with very small amounts of urine
• general feeling of discomfort or illness
• halos around lights
• itching skin
• joint pain
• lack of appetite
• loss of vision
• lower back or side pain
• muscle aches and pains
• night blindness
• overbright appearance of lights
• runny nose
• shivering
• sore throat
• stools that float, are foul smelling, and fatty in appearance
• trouble concentrating
• trouble sleeping
• tunnel vision

No adjustment recommended.

Administration advice:
-Standard formulation may be given IV or subcutaneously.
-Subcutaneous route is usually used for control of symptoms.
-To minimize pain with subcutaneous administration, use smallest volume that will deliver the dose.
-Avoid multiple subcutaneous injections at the same site within a short period of time.
-Rotate sites systematically.
-Infuse IV over 15 to 30 minutes
-Administer IV push over 3 minutes
-Rapid bolus may be given for emergency situations

Storage requirements:
-Refrigerate; protect from light
-Stable for 14 days at room temperature (70 to 86F) if protected from light

Reconstitution/preparation techniques:
-Dilute in 50 to 200 mL for IV infusion

IV compatibility:
-Stable in sterile isotonic saline solutions or dextrose 5% in water (D5W) for 24 hours.
-NOT compatible with TPN (total parenteral nutrition).

Monitoring:
-Monitor IGF-1 (somatomedin C) or growth hormone levels every 6 months.

Use is not recommended unless clearly needed. AU TGA pregnancy category: C US FDA pregnancy category: B Comments: -Use of this product could potentially restore fertility in women with acromegaly. -Advise females of childbearing potential to use adequate contraception.

Animal studies at doses up to 16 times the recommended human dose have shown no fetal harm, although fetal and post-natal growth retardation was seen. There are no controlled data in human pregnancy. A limited number of pregnancy exposures resulted in mostly normal newborns, and no cases of congenital anomalies or malformations, however there were several spontaneous abortions during the first trimester. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.