Octreotide Injection

Octreotide immediate-release injection is used to decrease the amount of growth hormone (a natural substance) produced by people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who cannot be treated with surgery, radiation, or another medication. Octreotide immediate-release injection is also used to control diarrhea and flushing caused by carcinoid tumors (slow-growing tumors that release natural substances that can cause symptoms) and vasoactive intestinal peptide secreting adenomas (VIP-omas; tumors that form in the pancreas and release natural substances that can cause symptoms). Octreotide long-acting injection is used to control acromegaly, carcinoid tumors, and VIP-omas in people who have been successfully treated with octreotide injection but prefer to receive injections less often. Octreotide injection is in a class of medications called octapeptides. It works by decreasing the amounts of certain natural substances produced by the body.

Octreotide comes as an immediate-release solution (liquid) for injection to be injected subcutaneously (under the skin) or intravenously (into a vein) Octreotide also comes as a long-acting injection to be injected into the muscles of the buttocks by a doctor or nurse. Octreotide immediate-release injection is usually injected 2 to 4 times a day. Octreotide long-acting injection is usually injected once every 4 weeks. Inject octreotide immediate-release injection at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Inject octreotide injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

If you are not already being treated with octreotide injection, you will begin your treatment with immediate-release octreotide injection. You will be treated with the immediate-release injection for 2 weeks, and your doctor may gradually increase your dose during that time. If the medication works for you and does not cause severe side effects, your doctor may give you the long-acting injection after 2 weeks. In order to control your condition, you may need to continue to receive the immediate-release injection for 2 weeks or longer after you receive your first dose of the long-acting injection. Your doctor may increase or decrease your dose of the long-acting injection 2 or 3 months after you first receive it.

If you are being treated for a carcinoid tumor or VIP-oma, you may experience worsening of your symptoms from time to time during your treatment. If this happens, your doctor may tell you to use the immediate-release injection for a few days until your symptoms are controlled.

If you have acromegaly and have been treated with radiation therapy, your doctor will probably tell you not to use octreotide immediate-release injection for 4 weeks every year or not to receive the octreotide long-acting injection for 8 weeks every year. This will allow your doctor to see how the radiation therapy has affected your condition and decide whether you should still be treated with octreotide.

Octreotide immediate-release injection comes in vials, ampules, and dosing pens that contain cartridges of medication. Be sure you know what type of container your octreotide comes in and what other supplies, such as needles, syringes, or pens, you will need to inject your medication.

If you are using the immediate-release injection from a vial, ampule or dosing pen, you may be able to inject the medication yourself at home or have a friend or relative perform the injections. Ask your doctor to show you or the person who will be performing the injections how to inject the medication. Also talk to your doctor about where on your body you should inject the medication and how you should rotate injection spots so that you do not inject in the same spot too often. Before you inject your medication, always look at the liquid. and do not use it if it is cloudy or contains particles. Check that the expiration date has not passed, that the solution for injection contains the correct amount of liquid, and that the liquid is clear and colorless. Do not use a vial, ampule, or dosing pen if it is expired, if it does not contain the correct amount of liquid, or if the liquid is cloudy or colored.

Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of octreotide injection. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication.

Dispose of used dosing pens, vials, ampules, or syringes in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Octreotide injection may control your symptoms, but it will not cure your condition. Continue to use octreotide injection even if you feel well. Do not stop using octreotide injection without talking to your doctor. If you stop using octreotide injection, your symptoms may return.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using octreotide injection,

• tell your doctor and pharmacist if you are allergic to octreotide injection, any other medications, or any of the ingredients in octreotide injection. Ask your pharmacist for a list of the ingredients. If you will be using the long-acting injection, also tell your doctor if you are allergic to latex.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using octreotide injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are being fed by total parenteral nutrition (TPN; feeding by giving a fluid containing nutrients directly into a vein) and if you have or have ever had diabetes or heart, liver, or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You may be able to become pregnant during your treatment with octreotide even if you were not able to become pregnant before your treatment because you have acromegaly. Talk to your doctor about methods of birth control that will work for you. If you become pregnant while receiving octreotide injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you forget to inject a dose of the immediate-release injection, inject the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

If you miss an appointment to receive a dose of the long-acting injection, call your doctor to reschedule the appointment.

This medication may cause changes in your blood sugar. You should know the symptoms of high and low blood sugar and what to do if you have these symptoms.

Octreotide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• pale, bulky, foul-smelling stools
• constantly feeling the need to empty the bowels
• gas
• stomach pain
• nausea
• heartburn
• headache
• dizziness
• tiredness
• back, muscle, or joint pain
• nosebleed
• hair loss
• pain in the area where the medication was injected
• vision changes

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• pain in the upper right part of the stomach, center of the stomach, back, or shoulder
• yellowing of the skin or eyes
• slowed or irregular heartbeat
• sluggishness
• sensitivity to cold
• pale, dry skin
• brittle fingernails and hair
• puffy face
• hoarse voice
• depression
• heavy menstrual periods
• swelling at the base of the neck
• tightness in the throat
• difficulty breathing and swallowing
• rash
• itching

Octreotide injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

If you are storing the long-acting injection in your home until it is time for it to be injected by your doctor or nurse, you should store it in original carton in the refrigerator and protect it from light. If you will be storing the immediate-release solution for injection in ampules, vials, or dosing pens, you should keep it in the original carton in the refrigerator to protect it from light; do not freeze. You may store the immediate-release injection multi-dose vials after first use at room temperature for up to 14 days. You may store the immediate-release dosing pen at room temperature after first use for up to 28 days with the pen cap always on. You may store the immediate-release injection single-dose vials and ampules at room temperature for up to 14 days, but discard any of the unused solution in the single dose ampules or vials after use.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• slowed or irregular heartbeat
• dizziness
• fainting
• flushing
• diarrhea
• weakness
• weight loss

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to octreotide injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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