Signifor LAR

Signifor LAR is a prescription medication used to treat acromegaly, a condition caused by high growth hormone levels, when surgery has failed or is otherwise not an option for treatment. Signifor LAR belongs to a group of drugs called somatostatin analogues. These work to treat acromegaly by reducing growth hormone levels in the body.

The medication is available in an injectable form to be given directly into a muscle by a healthcare professional, typically once monthly.

Common side effects of Signifor LAR include diarrhea, nausea, and high blood sugar.

Signifor LAR can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Signifor LAR affects you.

Signifor LAR is a prescription medication used to treat acromegaly, a condition caused by high growth hormone levels, when surgery has failed or is otherwise not an option for treatment.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceutical Corporation

Serious side effects have been reported with Signifor LAR. See the “Signifor LAR Precautions” section.

Common side effects of Signifor LAR include the following:

• diarrhea
• gallstones
• elevated blood sugar
• diabetes 

This is not a complete list of Signifor LAR side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines to control your heart beat (anti-arrhythmics)
• medicines to control your blood pressure (such as beta-blockers or calcium channel blockers)
• medicines to control the potassium and magnesium (electrolytes) levels in your body
• medicines that may affect the way the electrical system of your heart works (QT prolongation)
• cyclosporine
• bromocriptine

This is not a complete list of Signifor LAR drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Signifor LAR including the following:

Slow heart rate (bradycardia). Signifor LAR can cause your heart to beat slower, which may cause you to feel weak, dizzy or even faint. People who have, or have had, heart problems are at higher risk for this. Consult with your physician about your risk.

Problems with the electrical conduction within your heart (QT interval prolongation). This can put you at risk for developing abnormal heart rhythms, dizziness, and fainting spells which can be dangerous. Call your physician right away if you experience unusual dizziness, feelings of faintness, or fainting.

Elevation of your liver tests. Your physician will monitor your liver function with blood tests while you take Signifor LAR.

Gallstones (cholelithiasis). Your physician will perform an ultrasound to check for gallstones before you start using Signifor LAR and again during treatment. Consult with your physician about your risk for developing gallstones during treatment.

Low levels of pituitary hormones (pituitary insufficiency). Signifor LAR may reduce the pituitary hormones in your body. Your healthcare provider should do a blood test to check your pituitary hormone levels before you start receiving Signifor LAR and while you receive it. Tell your healthcare provider if you get any of these symptoms: 

• nausea and vomiting
• tiredness
• dizziness
• diarrhea
• low blood glucose levels
• loss of appetite
• weight loss

Tell your physician right away if you develop any signs and symptoms of hypocortisolism. If you develop hypocortisolism while taking Signifor LAR, your physician may change your dose or ask you to stop taking Signifor LAR.

High blood sugar (hyperglycemia) and diabetes. Your physician will check your blood sugar level before you start taking Signifor LAR and again while you take it. Signs and symptoms of hyperglycemia may include:

• excessive thirst
• high urine output
• increased appetite with weight loss
• tiredness

If you develop high blood sugar while taking Signifor LAR, your physician may give you another medicine to take to lower your blood sugar. Your physician may also change your dose of Signifor LAR or ask you to stop taking Signifor LAR. It is possible that you could develop diabetes during treatment with Signifor LAR, as this was seen in some patients during clinical trials. Consult with your physician about your level of risk for developing diabetes during treatment with Signifor LAR.

Do not take Signifor LAR if you are allergic to Signifor LAR or to any of its ingredients.

Signifor LAR can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Signifor LAR affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Signifor LAR there are no specific foods that you must exclude from your diet. 

Before taking Signifor LAR, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Signifor LAR or to any of its ingredients
• have or have had high blood sugar (hyperglycemia)
• have diabetes
• have or have had heart problems
• have a history of low levels of potassium or magnesium in your blood
• have or have had liver problems
• have or have had gallstones
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Signifor LAR falls into category C. There are no well-controlled studies that have been done in pregnant women. Signifor LAR should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Signifor LAR crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Signifor LAR should not be used by a nursing mother. 

Receive Signifor LAR exactly as prescribed.

Signifor LAR comes in an injectable form to be given directly into the muscle of the buttock by a healthcare professional. It is typically administered once per month. 

Your healthcare provider will tell you how much Signifor LAR you will receive and when you will receive it.

Your healthcare provider may change your dose of Signifor LAR or the length of time between your injections.

Your healthcare provider will tell you how long you need to receive this medication.

Before you receive Signifor LAR for the first time, your healthcare provider should do a blood test to check your fasting blood sugar level, electrolyte levels, and your liver function.

Before you receive Signifor LAR for the first time and during your treatment, your healthcare provider should do a test to check your heart (electrocardiogram).

Because Signifor LAR must be injected by healthcare professional, it is critical that you keep up with all of your medical appointments each month. If you miss your dose, make a follow-up appointment as soon as possible. 

Receive this medication exactly as prescribed by your doctor.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• liver function
• other medications you are taking
• how you respond to this medication
• your weight
• your age

If Signifor LAR is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.