SIGNIFOR LAR (Pasireotide)

What is this medication?

Signifor LAR is a man-made protein that is similar to a hormone in the body called somatostatin.

Signifor LAR is used to treat Cushing's disease or acromegaly (endocrine disorders). This medicine is usually given after surgery or other treatments did not work or have stopped working.

Signifor LAR may also be used for purposes not listed in this medication guide.

How should I use this medication?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Signifor LAR.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Signifor LAR is injected under the skin or into a muscle. A healthcare provider can teach you how to properly use the medication by yourself.

Signifor LAR is injected into a muscle once every 4 weeks. A healthcare provider will give you this type of pasireotide injection.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Your care provider will show you where on your body to inject Signifor LAR. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Avoid skin that is red or irritated.

Signifor LAR can raise your blood sugar, and you may develop diabetes or pre-diabetes. Your blood sugar will need to be tested before and during your treatment with this medicine. You may need to start using diabetes medication, or adjust the dose of medication you already use. Follow your doctor's instructions very carefully.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

If you store Signifor LAR at home, keep it in the original carton in the refrigerator. Do not freeze. Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not leave the medicine out for longer than 24 hours.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

If you miss a dose of Signifor LAR, you can receive your missed dose up to 14 days before your next dose.

How should I store this medication?

Store Signifor LAR at room temperature, away from moisture, heat, and light. Throw away an ampule after one use, even if there is still medicine left inside.

If you store Signifor LAR at home, keep it in the original carton in the refrigerator. Do not freeze. Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not leave the medicine out for longer than 24 hours.

What should I avoid while using Signifor LAR?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of using this medication?

Get emergency medical help if you have signs of an allergic reaction:

• hives;
• difficulty breathing;
• swelling of your face, lips, tongue, or throat.

Signifor LAR may cause serious side effects. Call your doctor at once if you have:

• fast or slow heartbeats;
• sudden dizziness (like you might pass out);
• high blood sugar--increased thirst, increased urination, fruity breath odor, tiredness, and weight loss even if you are more hungry than usual;
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
• low cortisol levels--nausea, vomiting, appetite changes, headache, irritability, confusion, slurred speech, or feeling weak, tired, unsteady, anxious, shaky, or light-headed; or
• gallbladder problems--chalky-colored stools, stomach pain just after eating a meal, heartburn, bloating, and upper stomach pain that may spread to your back.

Common side effects of Signifor LAR may include:

• high blood pressure;
• abnormal blood test results;
• feeling weak or tired;
• loss of appetite, nausea, stomach pain or bloating, diarrhea;
• headache;
• swelling, rapid weight gain;
• back pain;
• cold symptoms such as stuffy nose and sneezing;
• hair loss; or
• pain, redness, itching, bruising or bleeding where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Signifor LAR?

Signifor LAR can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your current medicines. Many drugs can affect Signifor LAR, especially:

• bromocriptine;
• cyclosporine;
• heart or blood pressure medication; or
• medicines to control blood levels of magnesium or potassium.

This list is not complete and many other drugs may affect Signifor LAR. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.