Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Somatuline Autogel (Lanreotide). If you are concerned about side effects, discuss the risks and benefits of Somatuline Autogel (Lanreotide) with your doctor.

The following side effects have been reported by at least 1% of people taking Somatuline Autogel (Lanreotide). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• Constipation
• diarrhea
• dizziness
• fatigue
• fatty stools
• gas
• hair loss
• headache
• increased perspiration
• indigestion
• loss of appetite
• muscle pain
• nausea
• pain, redness, or swelling at the site of injection
• vomiting
• weight loss

Check with your doctor as soon as possible if any of the following side effects occur:

• confusion
• decreased heart rate
• increased blood pressure
• joint, bone or mouth pain
• persistent hard swelling at the site of injection
• ringing in the ears
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)signs of low blood sugar (e.g., tiredness, fatigue, shakiness, headache, difficulty concentrating, hunger, blurred vision)
• swelling of the arms or legs
• symptoms of gallstones (e.g., pain in back right shoulder blade, right sided chest pain below rib cage, nausea, vomiting, burping)
• weakness, numbness, tingling or pain in the hands or feet

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a Anaphylaxis (severe allergic reaction) (e.g., Hives; shortness of breath; difficulty breathing; or swelling of the face, lips, tongue, or throat)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, Fever, chills, rapid heartbeat, swollen abdomen)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Somatuline Autogel (Lanreotide).

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.