Lanreotide

Lanreotide can make it harder for your body to absorb other medicines you take by mouth. Ask your doctor about the best schedule for taking all of your needed medicines.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• bromocriptine (Cycloset, Parlodel);
• cyclosporine; or
• beta-blocker heart or blood pressure medcine (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others).

This list is not complete. Other drugs may interact with lanreotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Dosage Forms And Strengths

Injection: 60 mg/0.2 mL, 90 mg/0.3 mL and 120 mg/0.5 mL sterile, single-use, prefilled syringes fitted with an automatic needle guard. The prefilled syringes contain a white to pale yellow, semi-solid formulation.

SOMATULINE DEPOT is supplied in strengths of 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL in a single, sterile, prefilled, ready-to-use, polypropylene syringe (fitted with an automatic needle guard) fitted with a 20 mm needle covered by a low density polythylene sheath.

Each prefilled syringe is sealed in a laminated pouch and packed in a carton.

NDC 15054-1060-3 60 mg/0.2 mL, sterile, prefilled syringe
NDC 15054-1090-3 90 mg/0.3 mL, sterile, prefilled syringe
NDC 15054-1120-3 120 mg/0.5 mL, sterile, prefilled syringe

Storage And Handling

SOMATULINE DEPOT must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) and protected from light in its original package. Thirty (30) minutes prior to injection, remove sealed pouch of SOMATULINE DEPOT from refrigerator and allow it to come to room temperature. Keep pouch sealed until injection.

Each syringe is intended for single use. Do not use beyond the expiration date on the packaging.

SOMATULINE DEPOT is manufactured by Ipsen Pharma Biotech, Parc d'Activities du Plateau de Signes, 83870 Signes, France for Ipsen Biopharmaceuticals, Inc., 106 Allen Road, Basking Ridge, NJ 07920 USA. Revised: December 2014.

Lanreotide is a prescription medicine used for the long-term treatment of adults with acromegaly when:

• surgery or radiotherapy have not worked well enough or
• they are not able to have surgery or radiotherapy

It is also approved for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The most common side effects include:

• diarrhea
• stomach area (abdominal) pain
• nausea
• pain, itching or a lump at the injection site

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of lanreotide. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Lanreotide falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

• Parlodel
• R-Gene 10
• Regonol
• Sandostatin

• Sandostatin LAR
• Signifor-LAR
• Somavert

© Somatuline Depot Patient Information is supplied by Cerner Multum, Inc. and Somatuline Depot Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

You should not use lanreotide if you are allergic to it.

To make sure lanreotide is safe for you, tell your doctor if you have:

• gallbladder disease;

• diabetes (your diabetes medicine may need to be adjusted);

• kidney disease;

• liver disease;

• heart disease; or

• thyroid disorder.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether lanreotide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Lanreotide is usually given every 4 weeks for 3 months at a time. Contact your doctor for instructions if you miss an appointment for your lanreotide injection.

• It is used to treat acromegaly.
• It is used to treat a certain type of cancer called neuroendocrine tumor from the gastrointestinal tract or the pancreas (GEP-NETs).
• It may be given to you for other reasons. Talk with the doctor.

Use lanreotide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Compared with healthy younger subjects, elderly subjects showed an 85% increase in half-life and a 65% increase in mean residence time.

US labeling:

Acromegaly: SubQ: Initial dose: 90 mg once every 4 weeks for 3 months; after initial 90 days of therapy, adjust dose based on clinical response of patient, growth hormone (GH) levels, and/or insulin-like growth factor 1 (IGF-1) levels as follows:

GH ≤1 ng/mL, IGF-1 normal, symptoms stable: 60 mg once every 4 weeks; once stabilized on 60 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing)

GH >1 to 2.5 ng/mL, IGF-1 normal, symptoms stable: 90 mg once every 4 weeks; once stabilized on 90 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing)

GH >2.5 ng/mL, IGF-1 elevated and/or uncontrolled symptoms: 120 mg once every 4 weeks

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs): SubQ: 120 mg once every 4 weeks until disease progression or unacceptable toxicity

Canadian labeling:

Acromegaly: SubQ: Initial dose: 90 mg once every 4 weeks for 3 months; after initial 90 days of therapy, adjust dose based on clinical response of patient, growth hormone (GH) levels, and/or insulin-like growth factor 1 (IGF-1) levels as follows:

GH ≤1 ng/mL, IGF-1 normal, symptoms stable: 60 mg once every 4 weeks; once stabilized on 60 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing)

GH >1 to 2.5 ng/mL, IGF-1 normal, symptoms stable: 90 mg once every 4 weeks; once stabilized on 90 mg once every 4 weeks, may consider regimen of 120 mg once every 6 or 8 weeks (extended-interval dosing)

GH >2.5 ng/mL, IGF-1 elevated and/or uncontrolled symptoms: 120 mg once every 4 weeks

Enteropancreatic neuroendocrine tumors (NETs): SubQ: 120 mg once every 4 weeks, continue until disease progression

Initial dose: 90 mg, by deep subcutaneous injection, every 4 weeks for 3 months

Comments:
-The goal of treatment is to reduce growth hormone (GH) and insulin-like growth factor (IGF-1) levels to normal.
-Adjust dose after initial 3 months.
-No dose adjustment is required for elderly patients.

Use: Long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.