Alert

pasireotide

Pronunciation: PAS i REE oh tide

Brand: Signifor, Signifor LAR

What is the most important information I should know about pasireotide?

Pasireotide may lower your cortisol levels. Tell your doctor if you have symptoms such as nausea, vomiting, appetite changes, headache, irritability, confusion, slurred speech, or feeling weak, tired, unsteady, anxious, shaky, or light-headed.

Pasireotide can raise your blood sugar and may cause diabetes. Your blood sugar may need to be tested before and during treatment with this medicine. Call your doctor if you have increased thirst or urination, tiredness, and weight loss even if you are more hungry than usual.

What is pasireotide?

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

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

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

What should I discuss with my healthcare provider before using pasireotide?

You should not use pasireotide if you are allergic to it.

Tell your doctor if you have ever had:

  • diabetes, or high blood sugar;
  • liver disease;
  • heart problems;
  • gallstones; or
  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

It is not known whether pasireotide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Pasireotide may alter hormone levels in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breast-feed while using pasireotide.

How is pasireotide given?

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

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.

Pasireotide 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 pasireotide. 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.

Pasireotide can raise your blood sugar, and may cause diabetes. Your blood sugar may need to be tested regularly while you are using this medicine. You will also need frequent medical tests, including an occasional ultrasound or electrocardiograph or ECG (sometimes called an EKG).

Store Signifor 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.

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 happens 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using pasireotide?

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

What are the possible side effects of pasireotide?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fast or slow heartbeats;
  • sudden dizziness (like you might pass out);
  • low cortisol levels --nausea, vomiting, appetite changes, headache, irritability, confusion, slurred speech, or feeling weak, tired, unsteady, anxious, shaky, or light-headed;
  • high blood sugar --increased thirst, increased urination, fruity breath odor, tiredness, and weight loss even if you are more hungry than usual; or
  • gallbladder problem --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 may include:

  • abnormal blood test results;
  • feeling weak or tired;
  • nausea, stomach pain, diarrhea;
  • headache;
  • swelling, rapid weight gain;
  • 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 pasireotide?

Pasireotide 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 pasireotide, 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 pasireotide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about pasireotide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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