Somatuline Depot

What is Somatuline Depot?

Somatuline Depot 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 Somatuline Depot is safe and effective in children.

Who should not use Somatuline Depot?

Do not receive Somatuline Depot if you are allergic to lanreotide.

What should I tell my healthcare provider before using Somatuline Depot?

Before you receive Somatuline Depot, 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 Somatuline Depot will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if Somatuline Depot passes into your breast milk. You should not breastfeed if you receive Somatuline Depot and for 6 months after your last dose of Somatuline Depot
• are a female who can become pregnant. Somatuline Depot may affect fertility in females 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. Somatuline Depot and other medicines may affect each other, causing side effects. Somatuline Depot may affect the way other medicines work, and other medicines may affect how Somatuline Depot works. Your dose of Somatuline Depot 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 should I use Somatuline Depot?

• You will receive a Somatuline Depot injection every 4 weeks in your healthcare provider's office
• Your healthcare provider may change your dose of Somatuline Depot or the length of time between your injections. Your healthcare provider will tell you how long you need to receive Somatuline Depot
• Somatuline Depot 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 Somatuline Depot to the next
• During your treatment with Somatuline Depot for acromegaly, your healthcare provider may do certain blood tests to see if Somatuline Depot is working

What should I avoid while using Somatuline Depot?

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

What are the possible side effects of Somatuline Depot?

Somatuline Depot 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 Somatuline Depot and have acromegaly and GEP-NET. Your healthcare provider may check your gallbladder before and during treatment with Somatuline Depot. Possible complications of gallstones include inflammation and infection of the gall bladder, 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 or 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 Somatuline Depot or if your dose of Somatuline Depot 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 problems
  • weakness, extreme tiredness
• High blood pressure. High blood pressure can happen in people who receive Somatuline Depot and is a common side effect in people with GEP-NET.
• Changes in thyroid function. Somatuline Depot 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

The most common side effects of Somatuline Depot 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 Somatuline Depot 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 Somatuline Depot 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 Somatuline Depot, 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 Somatuline Depot. 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 Somatuline Depot

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

What are the ingredients in Somatuline Depot?

Active ingredient: lanreotide acetate

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

For more information, go to www.somatulinedepot.com or call Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127.

Instructions for use for Somatuline Depot

Somatuline Depot
(lanreotide) Injection

Important

If you have any questions about this medication or procedure, call 855-463-5127

Before You Begin Injection

1. Please follow both sides of these Instructions for Use before using the device. Follow this procedure exactly, as it may differ from your past experience.

2. Somatuline Depot should be administered by a Healthcare Professional.

3. If this device is dropped or damaged in any way, please call 855-463-5127

A. Storage of Somatuline Depot

When you receive the medication, follow these steps for storing Somatuline Depot.

Important: Somatuline Depot must be refrigerated. Do not allow it to reach room temperature until ready to use.

A1. Remove box from cold pack. Do not open box.

A2. Check the following:

Note: Call 855-463-5127 if you have any questions.

A3. Place unopened box in your refrigerator.

a. Do not place in freezer.

B.Prepare to Inject

B1. Confirm that date of this injection is as prescribed.

B2. Remove box from refrigerator. Open box and remove contents.

B3. Confirm that pouch is sealed and not damaged.

B4. Check that the dose is as prescribed and the expiration date has not passed.

B5. Let pouch sit for 30 minutes to reach room temperature. Do not open the pouch until ready to inject.

• Injection of cold medication may be painful.

Note: Product left in its sealed pouch at room temperature (not to exceed 104° F or 40 °C) for up to 24 hours may be returned to the refrigerator for continued storage and use at a later time.

B6. Find a clean, comfortable area for the patient to relax during procedure.

• It's important that the patient remains as still as possible during the injection.

OR

B7. The person administering the injection must wash his/her hands with soap and water.
Follow the doctor or institution's policy on the use of surgical gloves during this procedure.

B8. Tear open pouch along dotted line starting at the notch.

B9. Do the following:

a. Prior to administration, inspect the Somatuline depot syringe visually for particulate matter and discoloration. Do not administer if particulate matter or discoloration is observed. The content of the prefilled syringe is a semi-solid phase having a gel-like appearance, with viscous characteristics and a color varying from white to pale yellow. The supersaturated solution can also contain micro bubbles that can clear up during injection. These differences are normal and do not interfere with the quality of the product.

b. Confirm that expiration date on the device has not passed.

c. Make sure it is the right dosage:

• 60 mg, or
• 90 mg, or
• 120 mg

d. Set device aside on the empty pouch.

Note: Call 855-463-5127 if you have any questions.

B10. Choose which side of the buttocks to inject.

a. Switch sides with each injection.

b. Avoid areas with moles, scare tissue, reddened skin, or skin that feels bumpy.

c. Only inject in the areas market with OK in the picture.

Important: It is very important that you only inject in one of the areas marked OK in the picture (upper outer quadrants of the right or left buttocks).

B11. Clean area to be injected.

C. Inject

Important: This is a single-use pre-filled syringe with a retractable needle.

• All the medication must be injected during this use.
• If you drop or damage this device in any way, please call 855-463-5127.

Follow these injection instructions exactly! This procedure may be different from your past experience.

C1. Before injecting,

• Remove the pre-filled syringe from its tray.
• Discard tray.

C2. Remove needle cap

• Hold pre-filled syringe by the syringe body and pull off the needle cap to remove it.
• Do not hold the pre-filled syringe by the plunger
• Discard needle cap.

C3. Hold pre-filled syringe by the syringe body. The pre-filled syringe is now ready for injection.

C4. Flatten injection area using the thumb and index finger of your other hand to stretch the skin.

• Do not pinch skin.

C5. Insert needle perpendicular to the skin (90 degree angle).

• Use a strong, straight, dart-like motion to quickly insert the needle all the way into the skin.
• It is very important that you insert the needle completely. You should not see any needle once it is fully inserted.
• Do not aspirate (do not draw back).

1. Do not insert needle at an acute angle.

2. Make sure needle is fully inserted.

C6. When needle is completely inserted, release injection site that has been flattened by your hand.

C7. Push plunger with steady, very firm pressure.

• The medication is thicker and harder to push than you might expect.
• While depressing plunger, slowly count to 20 and continue steady pressure on the plunger. You may find it helpful to say:
  
  a. "1 one-thousand"
  b. "2 one-thousand"
  c. "3 one-thousand"

Note: Pushing the plunger too fast may cause discomfort to the patient or may break device.

C8. Give plunger a final push to make sure you cannot depress the plunger further.
Continue steady pressure with your thumb.

C9.While continuing to hold down the plunger, remove the needle from the injection site (1), then allow the needle to retract by removing your thumb from the plunger (2) (3).

• If needle does not retract, push plunger again to engage safety mechanism. The needle will then retract.

C10. If needed, gently apply gauze pad to injection area.

• Important: Never rub or massage the injection site.

D. Dispose of Device

D1. Discard used device into a hard plastic container with a screw top (such as a detergent bottle) or sharps container as per your institutional policy.

D2. Wash your hands.

Instructions for use 09/2019.