Lanreotide Subcutaneous

In the U.S.

• Somatuline Depot

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somatostatin (class)

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 lanreotide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lanreotide 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 lanreotide injection in the pediatric population. 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 lanreotide in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving lanreotide injection.

Pregnancy

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.

Interactions with 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 lanreotide, 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 lanreotide 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
• Alogliptin
• Canagliflozin
• Chlorpropamide
• Cyclosporine
• Dapagliflozin
• Dulaglutide
• Empagliflozin
• Exenatide
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Linagliptin
• Liraglutide
• Lixisenatide
• Metformin
• Miglitol
• Nateglinide
• Pioglitazone
• Pramlintide
• Quinidine
• Repaglinide
• Rosiglitazone
• Saxagliptin
• Sitagliptin
• Terfenadine
• Tolazamide
• Tolbutamide
• Vildagliptin

Interactions with Food/Tobacco/Alcohol

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 lanreotide. 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 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.

A nurse or other trained health professional will give you lanreotide. lanreotide is given as a shot under the skin of your upper buttocks every 4 weeks.

lanreotide comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

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:

• Abdominal or stomach fullness
• 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
• shortness of breath
• slow, fast, or irregular heartbeat
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

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:

• Bloated or full feeling
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• excess air or gas in stomach or intestines
• inflammation, itching, lumps, or pain at the injection site
• muscle pain or stiffness
• nausea
• pain in the joints
• passing gas
• stomach pain
• vomiting
• 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.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (e.g., growth hormone levels, blood glucose tests, thyroid function tests, blood pressure, heart rate) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic and will not be stored at home.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.