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Pasireotide

(pass-ih-RE-uh-tide)

Trade/other name(s): Signifor, pasireotide diaspartate

Why would this drug be used?

Pasireotide is used to treat Cushing’s disease, a common problem of pituitary tumors. These tumors can make the adrenal glands put out too much cortisol, which causes symptoms of Cushing’s disease. Pituitary tumors are usually surgically removed, but pasireotide is used when the tumor can’t be taken out or when surgery doesn’t stop symptoms. The drug is also being studied in other diseases, such as to treat carcinoid tumors.

How does this drug work?

Pasireotide behaves like somatostatin, a naturally occurring hormone that helps control many functions in the body. In people with Cushing’s disease, it binds to receptors in the pituitary that stop it from releasing certain hormones, including the hormone that stimulates the adrenal glands to produce cortisol. This helps reduce the level of cortisol in the body.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have diabetes. This drug can make blood sugar go up and medicines to control it may need to be changed.
  • If you have a slow heartbeat, heart block, congestive heart failure, heart disease, or if you have long QT syndrome (which shows up on an EKG)
  • If you have low potassium or magnesium levels in the blood, or if you are taking medicines that can cause this
  • If you have had any liver diseases or liver damage. You may need a lower dose of this drug.
  • If you’ve ever had gallstones. This drug can cause gallstones or make them worse.
  • If you have any other medical conditions.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug might cause birth defects. Check with your doctor about what kinds of birth control can be used with this medicine.
  • If you are breastfeeding. It is not known whether this drug passes into breast milk. If it does, it could affect the baby. This drug should not be used while breastfeeding.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Drugs that prolong the QT interval or that slow down the heart (such as beta blockers, digoxin), certain blood pressure medicines (such as calcium channel blockers) and drugs that affect the heart rhythm (anti-arrhythmic drugs) can cause dangerously slow heartbeats.

Drugs that lower potassium or magnesium levels (such as diuretics) in the blood can worsen the effects on heartbeat.

Pasireotide may lower levels of cyclosporine (Gengraf, Neoral, Restasis, Sandimmune) in the blood and require the doctor to raise your cyclosporine dose.

Bromocriptine (Cycloset, Parlodel) doses may need to be reduced while taking pasireotide.

Check with your doctor, nurse, or pharmacist about other medicines, vitamins, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Pasireotide is injected under the skin (subcutaneously), usually twice a day, in the skin of the thigh or belly. Your doctor or nurse will show you how to do this. Don’t inject into areas that look red, swollen, or inflamed. Talk with your nurse about injecting your medicine in a different place with each dose.

The dose may need to be adjusted depending on its effects. Before taking this drug, be sure you understand exactly how to take it, and your dose. If you have any questions, check with your doctor or nurse.

Store this medicine and injection equipment out of the reach of children and pets. Talk with your doctor or nurse about how to dispose of used needles and syringes in closed, puncture-resistant containers.

Precautions

This drug lowers cortisol, a hormone made by the adrenal glands. If cortisol levels get too low, a person may notice weakness, fatigue, poor appetite, nausea, vomiting, faintness or dizziness due to low blood pressure, or symptoms of low blood sugar (such as shakiness, hunger, nervousness, sweating, unsteadiness, confusion, or even seizures). Very low cortisol levels can even cause you to faint (pass out) or go into a coma. If you notice such symptoms, contact your doctor right away. Your doctor might need to treat this problem, and possibly lower your dose of this drug.

Some people have a slow or irregular heartbeat while on the drug, which can make you feel weak, dizzy, or faint. Call your doctor right away if you notice these symptoms.

Your doctor will test your blood sugar, your heart, liver function, and gallbladder before starting this drug.

Your doctor will likely test your blood throughout your treatment, looking for its effects on blood sugar, electrolytes (blood chemistry), or on other body organs such as the liver. Based on the test results, you may be given medicines to help treat these effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it completely. Keep all your appointments for lab tests and doctor visits.

People with diabetes should have their blood glucose (sugar) levels under careful control before starting this drug. People without diabetes can also develop high blood sugars or even diabetes while on the drug, with symptoms like excessive thirst, feeling very hungry, losing weight, and feeling tired. Tell your doctor if you have these symptoms. You may need a dose change and treatment for high blood sugar or diabetes.

A few people develop gallstones while taking this drug. Report to your doctor if you have pain in the upper right side of the belly, just under your rib cage, even your back or right shoulder. If untreated, they can cause severe pain, fever, or yellow skin and eyes.

Avoid pregnancy and breastfeeding while taking this drug.

Possible side effects

Should you have any of the following side effects, talk to your doctor or nurse. They can help you understand these side effects and help you deal with them.

Common

  • Nausea*
  • Diarrhea
  • Abdominal (belly) pain*
  • High blood sugar levels* (pre-diabetes)
  • Diabetes*
  • Gallstones*
  • Headache

Less common

  • Low blood sugar*
  • Dizziness or fainting*
  • Fatigue (tiredness)
  • Weakness*
  • Diabetes
  • Hair loss
  • Injection site reactions (pain, redness, bruising, or itching where drug was injected)
  • Abnormal lab test results of liver function, the pancreas, thyroid, or certain electrolytes (like potassium). Your doctor will discuss the significance of these, if they occur.
  • Constipation
  • Vomiting*
  • Poor appetite
  • Itching
  • Muscle and/or joint aches
  • Slow heartbeat*
  • Prolonged QT interval, which can result in abnormal heartbeat*
  • High or low blood pressure
  • Swelling in the hands or feet (edema)
  • Anxiety
  • Trouble sleeping

Rare

  • Low red blood cell counts (anemia)

*See "Precautions" section for more detailed information.

Other side effects not listed above can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2012

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 12/27/2012
Last Revised: 01/15/2013