Overview: Signifor is used to treat conditions caused by too much stress hormone or growth hormone. Common side effects include diarrhea, gallbladder problems, and high blood sugar. Serious side effects are less common, but may include heart rate or rhythm problems, hormone level changes, or liver problems. Signifor comes in two forms, one that can be given at home (Signifor) and one that is given by a health care provider (Signifor LAR).
Uses
What is Signifor used for?
Signifor (pasireotide) is commonly used to treat certain people with the following conditions.
- Acromegaly: A condition where the body makes too much growth hormone
- Cushing’s disease: A condition where your body makes too much cortisol (the stress hormone)
These uses may vary depending on the specific Signifor product prescribed.
Signifor may also be used for other conditions as determined by your health care provider.
How does Signifor work (mechanism of action)?
Signifor acts like a natural hormone in your body called somatostatin. This helps regulate other hormones in your body, such as cortisol and growth hormone.
How is Signifor supplied (dosage forms)?
Signifor LAR is available as an intramuscular (IM) injection that is given by a health care provider. Signifor is available as a subcutaneous (under the skin) injection in the following forms that you or a caregiver may administer.
- 0.3 mg/mL, 0.6 mg/mL, 0.9 mg/mL injection
How should I store Signifor?
Signifor. Signifor should be stored at 77 F (25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Protect it from light.
Signifor LAR. Signifor LAR is usually given by a health care provider in a hospital or clinic. You will not store it at home.
Side Effects
What are the most common side effects of Signifor?
The most common side effects of Signifor are listed below. These side effects may vary depending on the condition that is being treated or the Signifor product you are using. Tell your health care provider if you have any of these side effects that bother you.
- Diarrhea
- Gallbladder problems (see below)
- High blood sugar or diabetes (see below)
- High blood pressure
- Nausea
- Headache
- Pain, itching, swelling, or redness near the injection site
- Stomach pain and decreased appetite
- Tiredness
- Hair loss
- Infection in the nose or throat, sore throat, or common cold symptoms
- Back pain
- Fluid retention, especially in your arms or legs
There may be other side effects of Signifor that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Signifor?
While less common, the most serious side effects of Signifor are described below, along with what to do if they happen.
Severe Allergic Reactions. Signifor may cause allergic reactions, which can be serious. Stop using Signifor and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Reduced Adrenal Function. Signifor can lower your blood levels of cortisol (the stress hormone). This is known as adrenal insufficiency. Tell your health care provider if you have any of the following symptoms of adrenal insufficiency.
- Nausea and vomiting
- Loss of appetite
- Weakness, tiredness, or lack of energy
- Low blood pressure
- Low sodium levels
- Low blood sugar
High Blood Sugar or Diabetes. Signifor may increase your blood sugar levels, which can lead to or worsen diabetes. Talk to your health care provider about how to maintain healthy blood sugar levels. Keep all appointments with your health care provider to check your blood work. Call your health care provider if you have the following symptoms of high blood sugar.
- Thirsty more than usual
- Peeing more than usual
- Increase in hunger
- Tiredness
- Feeling sick to your stomach
- Confusion
- Your breath smelling fruity
Diabetic Ketoacidosis (DKA). Signifor may cause diabetic ketoacidosis, a serious complication of diabetes. DKA can be life threatening. Stop using Signifor and get help right away if you have any of the following symptoms of diabetic ketoacidosis.
- Nausea or vomiting
- Stomach pain
- Feeling very tired, woozy, or confused
- Trouble breathing
- Your breath smells fruity or sweet
- Very high blood sugar levels (over 300 mg/dL)
Heart Rate Changes. Signifor can make your heart beat slower than normal (bradycardia). Call your health care provider right away if you have any of the following symptoms of bradycardia.
- Feeling lightheaded, dizziness, or fainting
- Confusion
- Feeling weak or easily tired
- Slow heartbeat or feeling of skipped heartbeats
- Chest pain
- Shortness of breath
Heart Rhythm Changes. Signifor may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.
Liver Problems. Using Signifor may cause your liver function tests to go up. Your health care provider will likely check your liver function levels before and during treatment. Keep all of your appointments, including lab appointments, before and while using Signifor.
Gallbladder Problems. Using Signifor can cause gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Call your health care provider right away if you have any of the following symptoms.
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Fever or chills
- Pain in your upper stomach area or near your shoulder blades
- Stool (poop) that is clay-colored
Inflammation of the Pancreas (Pancreatitis). Signifor may cause inflammation of the pancreas, which is called pancreatitis. Stop using Signifor and call your health care provider right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.
Pituitary Problems. Signifor can affect your pituitary gland, leading to low levels of certain hormones. You may be at higher risk for pituitary problems if you had surgery or radiation to your pituitary gland. Your health care provider will likely check hormone levels before and during treatment. Keep all of your appointments, including lab appointments, before and while using Signifor. Tell your health care provider if you have any of the following symptoms of pituitary problems.
- Nausea or vomiting
- Diarrhea
- Feeling tired or dizzy
- Low blood sugar levels
- Decreased appetite or losing weight
Fatty Poop. Signifor may make it hard for your body to absorb fats from food. This can cause you to have too much fat in your poop (stool), also called fatty stool. Tell your health care provider right away if you start to have any of the following symptoms, or if your symptoms get worse.
- Changes in the color or consistency of your poop, such as loose or greasy poop
- Stomach bloating
- Unexplained weight loss
Warnings & Precautions
Who should not use Signifor?
Allergies to Ingredients. People who are allergic to any of the following should not use Signifor.
- Pasireotide
- Signifor
- Signifor LAR
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Signifor.
What should I know about Signifor before using it?
Do not use Signifor unless it has been prescribed to you by a health care provider. Use it as prescribed.
Do not share Signifor with other people, even if they have the same condition as you. It may harm them.
Keep Signifor out of the reach of children.
Keep all appointments to have your blood checked. Your health care provider will likely check your labs before and during your treatment. This is to monitor for side effects, make sure Signifor is working, and make sure you are getting the right dose.
There is more than one form of Signifor available. Signifor LAR is injected by a health care provider into a muscle. Signifor can be used at home. It is injected under the skin. Make sure that you or a caregiver understands how to properly prepare and use Signifor. Avoid using the same exact spot for each injection. Do not inject Signifor into skin that is irritated or inflamed. If you have any questions about injecting Signifor, talk to your health care provider.
If you are able to get pregnant, Signifor may make it easier for this to happen. To avoid an unplanned pregnancy, talk to your health care provider about your birth control options.
What should I tell my health care provider before using Signifor?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Signifor is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- High blood sugar or diabetes
- Heart problems
- Heart rate or rhythm problems
- Low potassium or magnesium levels
- Liver problems
- Gallbladder problems or gallstones (cholelithiasis)
Other Medicines and Supplements. Signifor may interact with other medicines and supplements. Before using Signifor, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. It is not known if or how Signifor could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant.
Breastfeeding (Signifor). It is not known if Signifor passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Signifor while breastfeeding.
How can I get more information about Signifor?
For more information about Signifor, you can visit the drugmaker’s website at www.signifor.com (Signifor) or www.signiforlar.com (Signifor LAR) or call them at 888-575-8344.
Interactions
Does Signifor interact with foods or drinks?
There are no known interactions between Signifor and foods or drinks.
It is unknown if drinking alcohol will affect Signifor. The risk of tiredness may be increased if you drink alcohol while using Signifor.
Does Signifor interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before using Signifor.
- Bromocriptine (Cycloset, Parlodel), which is a medicine commonly used to treat symptoms of high prolactin hormone levels
- Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
- A medicine used to control your heart rate or rhythm (antiarrhythmic)
- Medicines that can cause QT prolongation, which is a potentially dangerous heart rhythm problem
- A beta-blocker, such as metoprolol (Lopressor, Toprol XL, and others), atenolol (Tenormin), or propranolol (Inderal LA, Innopran XL), which is a medicine that may be used for certain heart conditions or to lower blood pressure
- A calcium channel blocker, such as diltiazem (Cardizem CD and others) or verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or other conditions
Signifor may alter the blood levels of some other medicines. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Signifor. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Signifor?
If you or someone else has used too much Signifor, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Signifor?
Signifor. If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not use double or extra doses.
Signifor LAR. Signifor LAR is usually given by a health care provider in a hospital or clinic. Your health care provider will make sure you are receiving Signifor LAR as scheduled. If you miss an appointment to get your Signifor LAR dose, call to make another appointment as soon as possible.