Description
Lutetium Lu 177 dotatate injection is used to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including tumors of the different parts of the gut.
Lutetium Lu 177 dotatate injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.
This medicine is to be given only by or under the direct supervision of a doctor with a specialized training in nuclear medicine.
This product is available in the following dosage forms:
- Solution
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 lutetium Lu 177 dotatate injection in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lutetium Lu 177 dotatate injection in the elderly.
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 receiving 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 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.
- Alclometasone
- Amcinonide
- Beclomethasone
- Betamethasone
- Budesonide
- Ciclesonide
- Clobetasol
- Clobetasone
- Clocortolone
- Cortisone
- Deflazacort
- Desonide
- Desoximetasone
- Dexamethasone
- Diflorasone
- Diflucortolone
- Difluprednate
- Flucloronide
- Flumethasone
- Flunisolide
- Fluocinonide
- Fluocortin
- Fluocortolone
- Fluorometholone
- Flurandrenolide
- Fluticasone
- Halcinonide
- Halobetasol
- Hydrocortisone
- Lanreotide
- Loteprednol
- Medrysone
- Methylprednisolone
- Mometasone
- Octreotide
- Paramethasone
- Pasireotide
- Prednicarbate
- Prednisolone
- Prednisone
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:
- Diabetes or
- Diarrhea or
- Flushing or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Liver tumor that has spread—Use with caution. May cause side effects to become worse.
- Kidney disease, mild to moderate—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A doctor or other trained health professional will give you this medicine. This medicine is given through an IV catheter placed into one of your veins.
You will receive medicines to prevent nausea and vomiting 30 minutes before receiving the amino acid solution. You will also receive the amino acid solution 30 minutes before, during, and for at least 3 hours after receiving this medicine.
Do not use long-acting somatostatin products for at least 4 weeks before receiving this medicine.
Do not use short-acting octreotide for at least 24 hours before receiving this medicine.
Drink extra fluids so you will pass more urine while you are using this medicine. This may help prevent kidney problems.
You will need to urinate right away and as often as possible before and after you receive this medicine. This will help remove this radioactive medicine from your body.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use effective birth control during treatment with this medicine and for at least 7 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).
This medicine may increase your risk of having cancer (eg, secondary myelodysplastic syndrome, leukemia). Talk to your doctor if you have concerns.
You will be exposed to radiation when you receive this medicine and can be detected in your urine for up to 30 days. Talk with your doctor about the ways to lessen the exposure of radiation in your household and if you have concerns.
Lutetium Lu 177 dotatate may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
Check with your doctor right away if you have blurred vision, chest tightness, confusion, cough, diarrhea, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, feeling of warmth, redness of the face, neck, arms and occasionally, upper chest, sweating, trouble breathing, unusual tiredness or weakness. These may be symptoms of neuroendocrine hormonal crisis.
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 or nurse immediately if any of the following side effects occur:
More common
- Agitation
- anxiety
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- chills
- cold sweats
- confusion
- cool, pale skin
- cough
- decreased urine output
- diarrhea
- dizziness
- dry mouth
- feeling of warmth
- fever
- flushed, dry skin
- fruit-like breath odor
- headache
- hoarseness
- hostility
- increased hunger
- increased thirst
- increased urination
- irritability
- joint pain, stiffness, or swelling
- loss of appetite
- loss of consciousness
- lower back, side, arm, leg, or stomach pain
- mood changes
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- muscle pain or twitching
- nausea
- nervousness
- nightmares
- numbness and tingling around the mouth, lips, hands, fingertips, or feet
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- rapid weight gain
- redness of the face, neck, arms, and occasionally, upper chest
- restlessness
- seizures
- shakiness
- slow, fast, or irregular heartbeat
- slurred speech
- sore throat
- sweating
- swelling of the face, feet, lower legs, ankles, or hands
- tremor
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unexplained weight loss
- unusual bleeding or bruising
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- vomiting
- weakness or heaviness of the legs
Less common
- Bone pain
- chest pain or discomfort
- dilated neck veins
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extreme tiredness or weakness
- irregular breathing
- pain or discomfort in the arms, jaw, back, or neck
- swollen glands
Incidence not known
- Chest tightness
- confusion
- difficulty swallowing
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
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
- Constipation
- decreased appetite
- hair loss or thinning of the hair
- loss or change in taste
Less common
- Difficulty in moving
- neck pain
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.
DRG-20444486
