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Lanreotide (Somatuline): Uses, Side Effects and Dosage

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60 mg/0.2 mL, 90 mg/0.3 mL, 120 mg/0.5 mL
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Lanreotide

What is Lanreotide injection?

Lanreotide injection is a prescription medicine used for:

  • the long-term treatment of people with acromegaly when:

⚬ surgery or radiotherapy have not worked well enough or

⚬ they are not able to have surgery or radiotherapy.

  • the treatment of adults with a type of cancer known as neuroendocrine tumors, from the gastrointestinal tract or the pancreas (GEP-NETs) that has spread or cannot be removed by surgery.
  • the treatment of adults with carcinoid syndrome to reduce the need for the use of short-acting somatostatin medicine

It is not known if Lanreotide injection is safe and effective in children.

Who should not receive Lanreotide injection?

Do not receive Lanreotide injection if you are allergic to lanreotide.

What should I tell my healthcare provider before receiving Lanreotide injection?

Before you receive Lanreotide injection , tell your healthcare provider about all of your medical conditions, including if you:

  • have gallbladder problems.
  • have diabetes.
  • have heart problems.
  • have thyroid problems.
  • have kidney problems.
  • have liver problems.

  • are pregnant or plan to become pregnant. It is not known if Lanreotide injection will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if Lanreotide injection passes into your breast milk. You should not breastfeed if you receive Lanreotide injection and for 6 months after your last dose of Lanreotide injection.
  • are a person who can become pregnant. Lanreotide injection may affect fertility and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider about all the medicines you take, including prescription and over the-counter medicines, vitamins, and herbal supplements. Lanreotide injection and other medicines may affect each other, causing side effects. Lanreotide injection may affect the way other medicines work, and other medicines may affect how Lanreotide injection works. Your dose of Lanreotide injection or your other medicines may need to be changed.

Especially tell your healthcare provider if you take:

  • insulin or other diabetes medicines.
  • cyclosporine (Gengraf, Neoral, or Sandimmune).
  • medicines that lower your heart rate such as beta blockers.

How will I receive Lanreotide injection ?

  • You will receive a Lanreotide injection dose every 4 weeks in your healthcare provider’s office.
  • Your healthcare provider may change your dose of Lanreotide injection or the length of time between your injections. Your healthcare provider will tell you how long you need to receive Lanreotide injection.
  • Lanreotide injection is injected deep under the skin of the upper outer area of your buttock. Your injection site should change (alternate) between your right and left buttock from one injection of Lanreotide injection to the next.
  • During your treatment with Lanreotide injection for acromegaly, your healthcare provider may do certain blood tests to see if Lanreotide injection is working.

What should I avoid while receiving Lanreotide injection ?

Lanreotide injection can cause dizziness. If you have dizziness, do not drive a car or operate machinery.

What are the possible side effects of Lanreotide injection ?

Lanreotide injection may cause serious side effects, including:

  • Gallstones (cholelithiasis) and complications that can happen if you have gallstones. Gallstones are a serious but common side effect in people who take Lanreotide injection and have acromegaly and GEP-NET. Your healthcare provider may check your gallbladder before and during treatment with Lanreotide injection. Possible complications of gallstones include inflammation and infection of the gallbladder and pancreatitis. Tell your healthcare provider if you get any symptoms of gallstones, including:

⚬ sudden pain in your upper right stomach area (abdomen)

⚬ yellowing of your skin and whites of your eyes

⚬ nausea

⚬ sudden pain in your right shoulder between your shoulder blades

⚬ fever with chills

  • Changes in your blood sugar (high blood sugar or low blood sugar). If you have diabetes, test your blood sugar as your healthcare provider tells you to. Your healthcare provider may change your dose of diabetes medicine especially when you first start receiving Lanreotide injection or if your dose of Lanreotide injection changes. High blood sugar is a common side effect in people with GEP-NET.

Tell your healthcare provider right away if you have any signs or symptoms of high blood sugar or low blood sugar.

Signs and symptoms of high blood sugar may include:

⚬ increased thirst

⚬ increased appetite

⚬ nausea

⚬ weakness or tiredness

⚬ urinating more often than normal

⚬ your breath smells like fruit

Signs and symptoms of low blood sugar may include:

⚬ dizziness or lightheadedness

⚬ sweating

⚬ confusion

⚬ headache

⚬ blurred vision

⚬ slurred speech

⚬ shakiness

⚬ fast heartbeat

⚬ irritability or mood changes

⚬ hunger

  • Slow heart rate. Tell your healthcare provider right away if you have slowing of your heart rate or if you have symptoms of a slow heart rate, including:

⚬ dizziness or lightheadedness

⚬ fainting or near-fainting

⚬ chest pain

⚬ shortness of breath

⚬ confusion or memory

⚬ weakness, extreme tiredness

  • High blood pressure. High blood pressure can happen in people who receive Lanreotide injection and is a common side effect in people with GEP-NET.
  • Changes in thyroid function. Lanreotide injection can cause the thyroid gland to not make enough thyroid hormones that the body needs (hypothyroidism) in people who have acromegaly. Tell your healthcare provider if you have signs and symptoms of low thyroid hormones levels, including:

⚬ fatigue

⚬ weight gain

⚬ a puffy face

⚬ being cold all of the time

⚬ constipation

⚬ dry skin

⚬ thinning, dry hair

⚬ decreased sweating

⚬ depression

  • Fatty stool. Lanreotide injection may cause your body to have issues absorbing dietary fats. Tell your healthcare provider if you have any new or worsening symptoms including fatty or oily stools, changes in the color of your stools, loose stools, stomach (abdominal) bloating or weight loss.

The most common side effects of Lanreotide injection in people with acromegaly include:

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

The most common side effects of Lanreotide injection in people with GEP-NET include:

  • stomach area (abdominal) pain
  • muscle and joint aches
  • vomiting
  • headache
  • pain, itching, or a lump at the injection site

The most common side effects of Lanreotide Injection in people with carcinoid syndrome include:

  • headache • dizziness • muscle spasm

Tell your healthcare provider right away if you have signs of an allergic reaction after receiving Lanreotide injection, including:

  • swelling of your face, lips, mouth or tongue
  • breathing problems
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • itching
  • flushing or redness of your skin
  • rash
  • hives

These are not all the possible side effects of Lanreotide injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Lanreotide injection.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not receive Lanreotide injection for a condition for which it was not prescribed. You can ask your healthcare provider for information about Lanreotide injection that is written for health professionals.

What are the ingredients in Lanreotide injection?

Active ingredient: lanreotide acetate

Inactive ingredients: water for injection and acetic acid (for pH adjustment)

Manufactured by: Pharmathen International S.A., Rodopi, Greece

Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059

SAP Code: 99353071

For more information, go to www.ciplausa.com or call 1-886-604-3268.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 215395 · View the label on DailyMed

Revision date stated in the text: September 2024

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Lanreotide

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Somatostatin Analog
Active ingredient Lanreotide acetate
Dosage form Injection
Route Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) INVAGEN PHARMS
FDA approval NDA 215395New Drug Application (NDA) Approved December 17, 2021
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 3 labelers list this drug on DailyMed
Recalls
  • March 13, 2026: Class II recall: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
  • March 13, 2026: Class II recall: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
  • January 2, 2026: Class II recall: Presence of Particulate Matter.
Packages (NDC)
Package
60 mg/0.2 mL – 0.2 ml in 1 syringe / 1 in 1 carton NDC 69097-880-67
90 mg/0.3 mL – 0.3 ml in 1 syringe / 1 in 1 carton NDC 69097-890-67
120 mg/0.5 mL – 0.5 ml in 1 syringe / 1 in 1 carton NDC 69097-870-67

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.