Somatuline Autogel

For the treatment of acromegaly, the recommended starting dose of Somatuline Autogel (Lanreotide) is 90 mg given by deep subcutaneous injection (under the skin) every 28 days. Depending on how well the medication works and whether you experience side effects, your doctor may change the dose or the time between your injections.

For the treatment of enteropancreatic neuroendocrine tumour or carcinoid syndrome, the recommended dose of Somatuline Autogel (Lanreotide) is 120 mg given by deep subcutaneous injection (under the skin) every 28 days.

Somatuline Autogel (Lanreotide) is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses) and can teach you how to give yourself the injection at home. Do not attempt to inject Somatuline Autogel (Lanreotide) on your own until you completely understand how to inject a dose. If you are unsure of how to prepare or administer a dose, ask a health care professional to clarify for you. If you are having difficulty giving yourself injections, ask a family member or other caregiver for help if they are willing to become involved with your treatment and are willing to learn how to give you your injections.

If you are injecting Somatuline Autogel (Lanreotide) yourself, it should be injected by deep subcutaneous injection into the upper outer part of your thigh. Avoid injecting Somatuline Autogel (Lanreotide) into an area of skin that is sore, red, infected, or otherwise damaged.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Somatuline Autogel (Lanreotide) exactly as prescribed by your doctor. If you miss an injection of Somatuline Autogel (Lanreotide), contact your doctor to determine when you should get your next injection. Do not take a double dose to make up for a missed one.

Store Somatuline Autogel (Lanreotide) in the refrigerator in its original package. Do not let it freeze. Keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

60 mg/0.5 mL
Each 0.5 mL prefilled syringe of extended release solution contains 60 mg of Somatuline Autogel (Lanreotide) as Somatuline Autogel (Lanreotide) acetate. Nonmedicinal ingredients: glacial acetic acid and water for injection.

90 mg/0.5 mL
Each 0.5 mL prefilled syringe of extended release solution contains 90 mg of Somatuline Autogel (Lanreotide) as Somatuline Autogel (Lanreotide) acetate. Nonmedicinal ingredients: glacial acetic acid and water for injection.

120 mg/0.5 mL
Each 0.5 mL prefilled syringe of extended release solution contains 120 mg of Somatuline Autogel (Lanreotide) as Somatuline Autogel (Lanreotide) acetate. Nonmedicinal ingredients: glacial acetic acid and water for injection.

Do not take Somatuline Autogel (Lanreotide) if you:

• are allergic to Somatuline Autogel (Lanreotide) or any ingredients of the medication
• are allergic to somatostatin
• have complicated, untreated gallstones

There may be an interaction between Somatuline Autogel (Lanreotide) and any of the following:

• Amiodarone
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Bromocriptine
• Ceritinib
• Clonidine
• Codeine
• Cyclosporine
• diabetes medications (e.g., chlorpropamide, glipizide, Glyburide, insulin, Metformin, Rosiglitazone, Acarbose, Canagliflozin)
• Digoxin
• Diltiazem
• Disopyramide
• Donepezil
• Dronedarone
• Fingolimod
• Galantamine
• Guanfacine
• hydroxychloroquine
• Lacosamide
• Linezolid
• methyldopa
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Octreotide
• Pasireotide
• Pegvisomant
• Propafenone
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Rivastigmine
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• somatostatin
• sulfamethoxazole
• testosterone
• Tizanidine
• Tofacitinib
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Somatuline Autogel (Lanreotide). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Somatuline Autogel (Lanreotide).

Blood sugar levels: Somatuline Autogel (Lanreotide) can cause high or low blood sugar. Your doctor will monitor your blood sugar levels closely while you are using Somatuline Autogel (Lanreotide), especially when you start treatment or when the dose is changed. If you experience symptoms of low blood sugar (e.g., tiredness, fatigue, shakiness, headache, difficulty concentrating, hunger, blurred vision) or high blood sugar (e.g., excessive thirst, excessive urination, weight loss) contact your doctor. People with Diabetes should monitor their blood sugar regularly while using Somatuline Autogel (Lanreotide) and report any changes in blood sugar control to their doctor.

Gallbladder problems: Somatuline Autogel (Lanreotide) may cause gallbladder problems including gallstones. Your doctor will periodically monitor for this with an ultrasound. If you have had gallstones, discuss with your doctor how Somatuline Autogel (Lanreotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Somatuline Autogel (Lanreotide), and whether any special monitoring is needed.

Heart rate: Somatuline Autogel (Lanreotide) may cause decreases in heart rate. If you experience a slow or irregular heartbeat, contact your doctor immediately. If you have any heart conditions, discuss with your doctor how Somatuline Autogel (Lanreotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Somatuline Autogel (Lanreotide), and whether any special monitoring is needed.

Kidney function: Kidney Disease or reduced kidney function may cause Somatuline Autogel (Lanreotide) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Somatuline Autogel (Lanreotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Somatuline Autogel (Lanreotide), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Somatuline Autogel (Lanreotide) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Somatuline Autogel (Lanreotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Somatuline Autogel (Lanreotide), and whether any special monitoring is needed.

Pancreatitis: Somatuline Autogel (Lanreotide) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Somatuline Autogel (Lanreotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Somatuline Autogel (Lanreotide), and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Thyroid problems: Somatuline Autogel (Lanreotide) may decrease thyroid function. Your doctor may monitor you for this with blood tests. If you experience symptoms of low thyroid (e.g., weight gain, tiredness, slow heart rate, feeling cold, or dry skin, swelling at the front of the neck), contact your doctor. If you have a thyroid condition, discuss with your doctor how Somatuline Autogel (Lanreotide) may affect your medical condition, and whether any special monitoring is needed.

Pregnancy: Somatuline Autogel (Lanreotide) should not be used during pregnancy unless the potential benefits outweigh the risks. Tell your doctor immediately if you become pregnant while using Somatuline Autogel (Lanreotide).

Breast-feeding: It is not known if Somatuline Autogel (Lanreotide) passes into breast milk. If you are a breast-feeding mother and are taking Somatuline Autogel (Lanreotide), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Somatuline Autogel (Lanreotide) have not been established for children under the age of 16 years.