SOMATULINE DEPOT- lanreotide acetate injection
Ipsen Biopharmaceuticals, Inc.
1 INDICATIONS AND USAGE
1.1 Acromegaly
SOMATULINE DEPOT (lanreotide) Injection 60 mg, 90 mg, and 120 mg is indicated for the 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.
The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.
1.2 Gastroenteropancreatic neuroendocrine tumors
SOMATULINE DEPOT Injection 120 mg is indicated 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 [see Clinical Studies (14.2) ].
2 DOSAGE AND ADMINISTRATION
Somatuline Depot should be administered by healthcare professionals. Please see enclosed Instructions for Use Leaflet for administration of Somatuline Depot.
2.1 Acromegaly
Patients should begin treatment with SOMATULINE DEPOT 90 mg given via the deep subcutaneous route, at 4-week intervals for 3 months.
After 3 months, dosage may be adjusted as follows:
GH greater than 1ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain SOMATULINE DEPOT dose at 90 mg every 4 weeks
GH greater than 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: increase SOMATULINE DEPOT dose to 120 mg every 4 weeks.
GH less than or equal to 1 ng/mL, IGF-1 normal, and clinical symptoms controlled: reduce SOMATULINE DEPOT dose to 60 mg every 4 weeks.
Thereafter, the dose should be adjusted according to the response of the patient as judged by a reduction in serum GH and/or IGF-1 levels; and/or changes in symptoms of acromegaly.
Patients who are controlled on SOMATULINE DEPOT 60 mg or 90 mg may be considered for an extended dosing interval of SOMATULINE DEPOT 120 mg every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response.
Continued monitoring of patient response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.
The starting dose in patients with moderate or severe renal impairment or moderate or severe hepatic impairment should be 60 mg via the deep subcutaneous route at 4-week intervals for 3 months followed by dose adjustment as described above [see Clinical Pharmacology (12.3) ].
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.
4 CONTRAINDICATIONS
SOMATULINE DEPOT is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide [see Adverse Reactions (6.3)].
DESCRIPTION
SOMATULINE DEPOT (lanreotide) Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment).
SOMATULINE DEPOT is available as sterile, ready-to-use, single-use prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base.
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Lanreotide, the active component of SOMATULINE DEPOT is an octapeptide analog of natural somatostatin. The mechanism of action of lanreotide is believed to be similar to that of natural somatostatin
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms, or if any known symptom persists or worsens.
Advise patients with acromegaly that response to SOMATULINE DEPOT should be monitored by periodic measurements of GH and IGF-1 levels, with a goal of decreasing these levels to the normal range.
Advise patients experiencing dizziness not to drive or operate machinery.
Manufactured by:
Ipsen Pharma Biotech
83870 Signes, France
Distributed by:
Ipsen Biopharmaceuticals, Inc.
Basking Ridge, NJ 07920
USA
Patient Information
SOMATULINE� DEPOT (So-mah-tu-leen Dee-Poh)
(lanreotide)
Injection
Read this Patient Information before you receive your first SOMATULINE DEPOT injection and before each injection. There may be new information. This information does not take the place of talking with your healthcare professional about your medical condition or your treatment.
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 people 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
It is not known if SOMATULINE DEPOT is safe and effective in children.
Who should not take SOMATULINE DEPOT?
Do not take SOMATULINE DEPOT if you are allergic to lanreotide.
What should I tell my healthcare professional before receiving SOMATULINE DEPOT?
Before you receive SOMATULINE DEPOT, tell your healthcare professional if you:
have gallbladder problems
have diabetes
have thyroid problems
have heart problems
have kidney problems
have liver problems
are pregnant or plan to become pregnant. SOMATULINE DEPOT may harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if SOMATULINE DEPOT passes into your breast milk. You and your healthcare professional should decide if you will take SOMATULINE DEPOT or breastfeed. You should not do both.
Tell your healthcare professional 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 adjusted.
Especially tell your healthcare professional if you take:
insulin or other diabetes medicines
a cyclosporine (Gengraf, Neoral, or Sandimmune)
a medicine called bromocriptine (Parlodel, Cycloset)
medicines that lower your heart rate such as beta blockers
Know the medicines you take. Keep a list of them to show your healthcare professional when you get a new medicine.
How will I receive SOMATULINE DEPOT?
You will receive a SOMATULINE DEPOT injection every 4 weeks in your doctor's office.
Your prescriber may change your dose of SOMATULINE DEPOT or the length of time between your injections. Your healthcare professional 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 professional may do certain blood tests to see if SOMATULINE DEPOT is working.
What are the possible side effects of SOMATULINE DEPOT?
SOMATULINE DEPOT may cause serious side effects, including:
Gallstones. Tell your healthcare professional if you get any of these symptoms:
sudden pain in your upper right stomach area (abdomen)
sudden pain in your right shoulder or between your shoulder blades
yellowing of your skin and whites of your eyes
fever with chills
nausea
Changes in your blood sugar (high blood sugar or low blood sugar). If you have diabetes, test your blood sugar as your healthcare professional tells you to. Your healthcare professional may change your dose of diabetes medicine especially when you first start receiving SOMATULINE DEPOT or if your dose of SOMATULINE DEPOT changes.
Slow heart rate
High blood pressure
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-NETs include:
stomach area (abdominal) pain
muscle and joint aches
vomiting
headache
pain, itching, or a lump at the injection site
SOMATULINE DEPOT may cause dizziness. If this happens, do not drive a car or operate machinery.
Tell your healthcare professional if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SOMATULINE DEPOT. For more information ask your healthcare professional.
Call your healthcare professional 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 conditions other than those listed in the patient leaflet. This Patient Information leaflet summarizes the most important information about SOMATULINE DEPOT. If you would like more information about SOMATULINE DEPOT, talk with your healthcare professional. You can ask your healthcare professional for information about SOMATULINE DEPOT that is written for health professionals.