Description
Octreotide injection is used to treat severe diarrhea and other symptoms that occur with certain intestinal tumors (eg, vasoactive intestinal peptide tumors or VIPomas) or metastatic carcinoid tumors (tumors that has already spread in the body). It does not cure the tumor but it helps the patient feel more comfortable.
Octreotide injection is also used to treat a condition called acromegaly, which is caused by too much growth hormone in the body. Too much growth hormone produced in adults causes the hands, feet, and parts of the face to become large, thick, and bulky. Other problems, such as arthritis, can also develop. Octreotide works by reducing the amount of growth hormone that is produced by the body.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- Powder for Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of the short-acting form of octreotide injection or the long-acting form of octreotide injection in the pediatric population. Safety and efficacy have not been demonstrated.
Geriatric
Although appropriate studies on the relationship of age to the effects of octreotide injection have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of octreotide injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving octreotide injection.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Levoketoconazole
- Levomethadyl
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abemaciclib
- Acalabrutinib
- Acarbose
- Acecainide
- Acetophenazine
- Adagrasib
- Ajmaline
- Albiglutide
- Alfentanil
- Alogliptin
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apomorphine
- Aprindine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Axitinib
- Azimilide
- Azithromycin
- Bedaquiline
- Bosutinib
- Bretylium
- Brigatinib
- Buprenorphine
- Buserelin
- Canagliflozin
- Ceritinib
- Chloral Hydrate
- Chloroquine
- Chlorpromazine
- Chlorpropamide
- Ciprofloxacin
- Citalopram
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Lisinopril
- Pegvisomant
- Telotristat Ethyl
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cholangitis (inflammation or swelling of the bile duct) or
- Congestive heart failure or
- Gallbladder disease or
- Gallstones, or history of or
- Heart rhythm problems (eg, arrhythmia, QT prolongation, slow heartbeat) or
- Pancreatitis (inflammation or swelling of the pancreas) or
- Thyroid problems or
- Vitamin B12 deficiency—Use with caution. May make these conditions worse.
- Diabetes—Octreotide may cause high or low blood sugar. Your doctor may need to change the dose of your insulin or diabetes medicine.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional may give you this medicine. It is given as a shot under your skin or muscle, or as a needle placed into one of your veins. This medicine may also be given at home to patients who do not need to be in a medical facility. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.
This medicine usually comes with patient information or directions. Read them carefully and make sure you understand them before using this medicine. If you have any questions, ask your doctor.
You might not use all of the medicine in each ampul or vial (glass container) or prefilled pen. Do not save an opened ampul or vial or prefilled pen. If the medicine in the ampul or vial or prefilled pen has changed color, or if you see particles in it, do not use it.
Some patients may feel pain, stinging, tingling, or burning sensations at the place where they inject the medicine. Injecting the medicine after it has been warmed to room temperature rather than cold from the refrigerator may reduce the discomfort. However, do not use heat to warm it faster because heat can destroy the medicine.
Put used needles and syringes in a puncture-resistant disposable container or dispose of them as directed by your doctor. Do not reuse needles and syringes.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For long-acting injection dosage form:
- For treatment of acromegaly:
- Adults—At first, 20 milligrams (mg) injected into the buttocks once every 4 weeks for 3 months. Your doctor will adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For treatment of severe diarrhea and other symptoms that occur with certain types of intestinal tumors:
- Adults—At first, 20 milligrams (mg) injected into the muscles once every 4 weeks for 2 months. Your doctor will adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For treatment of acromegaly:
- For short-acting injection dosage form (solution):
- For treatment of acromegaly:
- Adults—At first, 50 micrograms (mcg) given as a shot under the skin 3 times a day. Your doctor will adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For treatment of carcinoid tumors:
- Adults—At first, 100 to 600 micrograms (mcg) per day, given in 2 to 4 divided doses, injected under the skin for the first 2 weeks. Your doctor will adjust your dose as needed. However, the dose is usually not more than 1500 mcg per day.
- Children—Use and dose must be determined by your doctor.
- For treatment of severe diarrhea that occurs with certain types of intestinal tumors:
- Adults—At first, 200 to 300 micrograms (mcg) per day, given in 2 to 4 divided doses, injected under the skin for the first 2 weeks. Your doctor will adjust your dose as needed. However, the dose is usually not more than 450 mcg per day.
- Children—Use and dose must be determined by your doctor.
- For treatment of acromegaly:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of the long-acting form of this medicine, contact your doctor.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
You may also keep the vials at room temperature, away from heat and direct light, for up to 14 days. Throw away any unused medicine after 14 days.
After first use of the prefilled pen, you can keep it at room temperature, away from heat and direct light, for up to 28 days. Throw away any unused medicine after 28 days.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Make sure your doctor knows if you are pregnant or planning to become pregnant. You must use an effective form of birth control to keep from getting pregnant. Talk to your doctor about effective birth control.
This medicine may increase your risk of having gallstones, which may lead to swelling of the gallbladder (cholecystitis), bile ducts (cholangitis), or pancreas (pancreatitis). Check with your doctor right away if you have severe stomach pain with nausea and vomiting, indigestion, fever, chills, pains in the stomach, side, or abdomen, possibly radiating to the back, fast heartbeat, dark urine, bloating, or yellow eyes or skin.
This medicine may cause your blood sugar levels to rise or fall. This medicine may cover up signs of hypoglycemia (low blood sugar), including a change in your pulse rate. If you notice a change in the results of your blood sugar test or urine sugar test, check with your doctor.
This medicine may increase your risk for heart and blood vessel problems, including hypertension and a slow heartbeat. This may cause chest pain or discomfort, headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high or if your heartbeat is too slow, call your doctor right away.
Check with your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, slow or irregular heartbeat, trouble breathing, or unusual tiredness. These may be symptoms of heart rhythm problems.
Make sure any doctor who treats you knows that you are receiving this medicine. This medicine may affect the results of certain medical tests.
This medicine may improve fertility in women and may cause unwanted pregnancies. Talk to your doctor if you have concerns.
You should not receive the long-acting form of octreotide injection for at least 4 weeks before receiving lutetium Lu 177 dotatate injection (Lutathera®).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine 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 immediately if any of the following side effects occur:
More common
- Constipation
- depressed mood
- diarrhea
- dizziness
- dry skin and hair
- fainting
- fast, slow, or irregular heartbeat
- feeling cold
- hair loss
- hoarseness or husky voice
- loss of appetite
- muscle cramps and stiffness
- nausea
- severe stomach pain with nausea and vomiting
- stomach pain
- unusual tiredness or weakness
- vomiting
- weight gain
Less common
- Anxiety
- bladder pain
- bloody or cloudy urine
- blurred vision
- chills
- cold sweats
- collection of blood under the skin
- confusion
- cool, pale skin
- deep, dark purple bruise
- difficult, burning, or painful urination
- dry mouth
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- itching, pain, redness, or swelling
- loss of consciousness
- lower back or side pain
- nervousness
- nightmares
- seizures
- shakiness
- slurred speech
- sweating
- swelling
- trouble breathing
- unexplained weight loss
Rare
- Black, tarry stools
- bleeding gums
- blood in vomit
- changes in skin color, pain, tenderness, swelling of the foot or leg
- chest pain or tightness
- cough
- coughing up blood
- dark urine
- decreased urine output
- difficulty in breathing or swallowing
- difficulty swallowing
- dilated neck veins
- extreme tiredness or weakness
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- hives, itching, skin rash
- increased menstrual flow or vaginal bleeding
- irregular breathing
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- light-colored stools
- nosebleeds
- pain in the groin or genitals
- pale skin
- paleness or cold feeling in the fingertips and toes
- paralysis
- pounding in the ears
- prolonged bleeding from cuts
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red or dark brown urine
- severe or continuing stomach pain
- sharp back pain just below the ribs
- sneezing
- sore throat
- swelling of the face, fingers, feet, or lower legs
- tingling or pain in the fingers or toes when exposed to cold temperatures
- tremor
- unusual bleeding or bruising
- upper right abdominal or stomach pain
- yellow eyes and skin
Incidence not known
- Blindness
- bloating
- clear or bloody discharge from nipple
- decreased vision
- delusions of persecution, mistrust, suspiciousness, and/or combativeness
- dimpling of the breast skin
- eye pain
- gaseous
- indigestion
- inverted nipple
- lump in the breast or under the arm
- pain or discomfort in the arms, jaw, back, or neck
- pains in the stomach, side, or abdomen, possibly radiating to the back
- persistent crusting or scaling of the nipple
- pinpoint red spots on the skin
- recurrent fever
- redness of swelling of the breast
- severe constipation
- severe cramping
- sore on the skin of the breast that does not heal
- sores, ulcers, or white spots on the lips or in the mouth
- stomach fullness
- swollen glands
- tearing
- weakness of the muscles in your face
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Anxiety
- blurred vision
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- depression
- dizziness
- fast heartbeat
- feeling of warmth
- headache
- increased hunger
- nausea
- nervousness
- nightmares
- redness of the face, neck, arms and occasionally, upper chest
- seizures
- shakiness
- slurred speech
- unusual tiredness or weakness
Some side effects 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:
More common
- Abnormal stool
- excess air or gas in the stomach or bowels
- full feeling
- pain, redness, stinging, swelling, tingling, or burning sensation at the injection site
- passing of gas
Less common
- Backache
- feeling of warmth
- hair loss
- joint pain
- redness of the face, neck, arms and occasionally, upper chest
Rare
- Absent, missed, or irregular menstrual periods
- change in vision
- difficulty in moving
- feeling of constant movement of self or surroundings
- hearing loss
- itching of the vagina or genital area
- joint swelling or redness
- loss of vision
- memory loss
- muscle pain
- numbness or tingling of the hands, feet, or face
- pain during sexual intercourse
- sensation of spinning
- stopping of menstrual bleeding
- swelling of the breasts or breast soreness in both females and males
- thick, white vaginal discharge with no odor or with a mild odor
- unexpected or excess milk flow from the breasts
Incidence not known
- Decreased interest in sexual intercourse
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- unexpected or excess milk flow from the breasts
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
