Signifor LAR

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 Signifor LAR (Pasireotide).

Abnormal heart rhythms: Signifor LAR (Pasireotide) can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation and should not be used in combination with Signifor LAR (Pasireotide). You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have diabetes
• have had a Stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Signifor LAR (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor LAR (Pasireotide), and whether any special monitoring is needed.

Diabetes: Signifor LAR (Pasireotide) often causes increased blood sugar levels, causing the loss of blood glucose control. Glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Signifor LAR (Pasireotide). Your doctor should monitor your blood glucose levels regularly when you first start using Signifor LAR (Pasireotide), even if you do not have diabetes.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Signifor LAR (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor LAR (Pasireotide), and whether any special monitoring is needed.

Drowsiness/dizziness: Signifor LAR (Pasireotide) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by Signifor LAR (Pasireotide).

Fluid and electrolyte balance: Signifor LAR (Pasireotide) may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking Signifor LAR (Pasireotide). If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; Dry Mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking Signifor LAR (Pasireotide).

Liver function: People taking Signifor LAR (Pasireotide) may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking Signifor LAR (Pasireotide). Liver disease or reduced liver function may cause Signifor LAR (Pasireotide) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Signifor LAR (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor LAR (Pasireotide), and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pancreatitis: Signifor LAR (Pasireotide) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Signifor LAR (Pasireotide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Signifor LAR (Pasireotide), 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.

Pregnancy: The potential risks of using Signifor LAR (Pasireotide) during pregnancy, for the mother or developing baby, are not known. Women who may become pregnant should not use Signifor LAR (Pasireotide) unless they are using reliable birth control. Birth control should be used while using Signifor LAR (Pasireotide) and for at least 2 months after stopping the medication. If you become pregnant while taking Signifor LAR (Pasireotide), contact your doctor immediately.

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

Children: The safety and effectiveness of using Signifor LAR (Pasireotide) have not been established for children.