Lanreotide (Subcutaneous Route)

This medicine works by reducing the amount of growth hormone that the body produces .

This medicine is available only with your doctor`s prescription .

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 lanreotide in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of lanreotide in the elderly. However, elderly patients are more likely to have age-related kidney problems or liver problems, which may require an adjustment in the dose for patients receiving lanreotide .

Pregnancy

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

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.

• Cyclosporine


• Quinidine


• Terfenadine

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


• Gallbladder disease or


• Gallstones, or history of, or


• Heart disease or


• High blood pressure or


• Thyroid problemsa€”May make these conditions worse .

• Diabetesa€”Use with caution. May cause changes in blood sugar levels .

• Kidney disease or


• Liver diseasea€”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 will give you this medicine. This medicine is given as a shot under your skin .

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

This medicine may cause your blood sugar levels to rise or fall . Also, 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 .

Tell your doctor if you are allergic to rubber or latex. The needle cover of the prefilled syringe contains natural dry rubber, which may cause an allergic reaction if you have a latex allergy .

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

• Abdominal fullness


• Blurred vision


• Chest pain or discomfort


• Dizziness


• Gaseous abdominal 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:

More common

• Bloated, 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 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.