Pronunciation:

loo-TEE-shee-um loo 177 DOE-ta-tate

Brand Names:

• Lutathera

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lutetium Lu 177 dotatate injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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
• Rimexolone
• Triamcinolone

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
• Hypertension (high 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.

• Kidney disease, severe or end-stage or
• Liver disease, severe—Lutetium Lu 177 dotatate has not been studied in patients with these conditions.

Proper Use of This Medicine:

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.

Your doctor will give you this medicine in a hospital or cancer treatment center. It is given through a needle 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.

Precautions While Using This Medicine:

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. 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 are a woman who can get pregnant, you must have a negative pregnancy test before you will be allowed to receive this medicine. If you miss a period while you are receiving 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, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem. Drink plenty of fluids and urinate as often as possible during and after receiving this medicine.

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 is more likely if you have liver metastasis (cancer that has spread).

Side Effects of This Medicine:

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

difficulty in breathing

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

troubled breathing

troubled breathing with exertion

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

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.