Lanreotide Side Effects

Some side effects of lanreotide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to lanreotide: subcutaneous solution

Stop using lanreotide and Get emergency medical help if you have any of these signs of an allergic reaction while taking lanreotide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• slow or uneven heartbeats;

• gallbladder problems (pain in your upper right stomach area with nausea and vomiting);

• thyroid problems (may be detected by blood tests);

• pale skin, weakness, easy bruising or bleeding;

• low blood sugar (headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, nausea); or

• high blood sugar (increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin).

Less serious side effects of lanreotide may include:

• nausea, vomiting;

• diarrhea, constipation;

• mild stomach pain or gas;

• headache;

• weight loss;

• joint pain; or

• pain, itching, or skin lump where injection was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to lanreotide: subcutaneous solution

Gastrointestinal

One percent of acromegalic patients treated with lanreotide in the pooled clinical studies discontinued treatment because of gastrointestinal reactions.

New cholelithiasis was reported in 12.0% of patients. Cholelithiasis may be related to dose or duration of exposure.

Gastrointestinal side effects including diarrhea (37%), cholelithiasis and gallbladder sludge (20%), abdominal pain (19%), nausea (11%), constipation (8%), flatulence (7%), vomiting (7%), and loose stools (6%) have been reported (percentages are from overall pooled data). A lethal case of acute necrotizing pancreatitis has also been reported.

Hepatic

Hepatic side effects including cholelithiasis (20%) have been reported. (Percentage is from overall pooled data.)

Local

Local side effects injection site pain (4.1%), injection site mass (1.7%), induration, nodule, and pruritus have been reported. (Percentage is from overall pooled data.)

Injection site adverse reactions were more commonly reported soon after the start of treatment and were less commonly reported as treatment continued. Such adverse reactions were usually mild or moderate but lead to withdrawal from clinical studies in two subjects.

Musculoskeletal

Musculoskeletal side effects including arthralgia (7%) have been reported. (Percentage is from overall pooled data.)

Nervous system

Nervous system side effects including headache (7%) have been reported. (Percentage is from overall pooled data.)

Cardiovascular

In patients without underlying cardiac disease, lanreotide may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to lanreotide treatment, sinus bradycardia may occur. Care should be taken when initiating treatment with lanreotide in patients with bradycardia.

Cardiovascular side effects including hypertension (5%) and sinus bradycardia (3%) have been reported. (Percentage is from overall pooled data.)

Hematologic

Hematologic side effects including anemia (3%) have been reported. (Percentage is from overall pooled data.)

Metabolic

Metabolic side effects including dysglycemia have been reported. In clinical studies of acromegalic patients treated with lanreotide, adverse reactions of dysglycemia (hypoglycemia, hyperglycemia, diabetes) were reported by 14% of patients and were considered related to study drug in 7% of patients.

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