Pronunciation:

lan-REE-oh-tide

Brand Names:

• Somatuline Depot

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Somatostatin (class)

Uses of This Medicine:

Lanreotide injection is used for the long-term treatment of acromegaly (a growth hormone disorder) in patients who cannot be treated with surgery or radiation. This medicine works by reducing the amount of growth hormone that the body produces. This medicine is also used to treat neuroendocrine tumors from the stomach or bowels or pancreas (GEP-NET) that has spread or cannot be removed by surgery.

Lanreotide injection is also used to treat carcinoid syndrome. It reduces the need for the use of short-acting somatostatin medicine.

This medicine is to be given only by or under the direct supervision of your doctor.

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 lanreotide 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 lanreotide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving lanreotide injection.

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.

• Acarbose
• Albiglutide
• Alfentanil
• Alogliptin
• Canagliflozin
• Chlorpropamide
• Copper Cu 64 Dotatate
• Cyclosporine
• Dapagliflozin
• Dihydroergotamine
• Dofetilide
• Dulaglutide
• Empagliflozin
• Ergotamine
• Ertugliflozin
• Exenatide
• Fentanyl
• Flibanserin
• Gallium Ga 68 Dotatate
• Gallium Ga 68 Dotatoc
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Linagliptin
• Liraglutide
• Lixisenatide
• Lutetium Lu 177 Dotatate
• Metformin
• Miglitol
• Nateglinide
• Oxycodone
• Pimavanserin
• Pimozide
• Pioglitazone
• Pramlintide
• Quinidine
• Repaglinide
• Rosiglitazone
• Saxagliptin
• Sirolimus
• Sitagliptin
• Tacrolimus
• Temsirolimus
• Tolazamide
• Tolbutamide
• Vildagliptin

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:

• Bradycardia (slow heartbeat) or
• Diabetes or
• Gallbladder disease or
• Gallstones, or history of or
• Heart and blood vessel disease or
• Hypertension (high blood pressure) or
• Thyroid problems—Use with caution. May make these conditions worse.

• 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 of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under the skin of your upper buttocks every 4 weeks.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

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), such as 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.

This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

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 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 immediately if any of the following side effects occur:

More common

Blurred vision

chest pain or discomfort

dizziness

gaseous abdominal or stomach pain

headache

lightheadedness, dizziness, or fainting

nervousness

pale skin

pounding in the ears

recurrent fever

slow, fast, or irregular heartbeat

stomach fullness

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

Incidence not known

Bloating

chills

clay-colored stools

confusion

constipation

cough

dark urine

diarrhea

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fat in the stool

fever

hives, itching, skin rash

indigestion

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss of appetite

nausea

pains in the stomach, side, or abdomen, possibly radiating to the back

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

severe nausea or vomiting

stomach pain or cramps

sudden loss of weight

sweating

tightness in the chest

unusual drowsiness, dullness, or feeling of sluggishness

vomiting

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

Difficulty having a bowel movement

difficulty with moving

excess air or gas in the stomach or bowels

feeling of fullness

inflammation, itching, lumps, or pain at the injection site

muscle pain or stiffness

pain in the joints

passing gas

weight loss

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.