Generic Name: pasireotide (PAS-i-REE-oh-tide)
Brand Name: Signifor
Pasireotide is used for:
Treating Cushing disease. It may also be used for other conditions as determined by your doctor.
Pasireotide is somatostatin analogue. It works by reducing the levels of cortisol in the blood.
Do NOT use pasireotide if:
- you are allergic to any ingredient in pasireotide
- you have severe liver problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using pasireotide:
Some medical conditions may interact with pasireotide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have electrolyte problems (eg, low blood magnesium or potassium levels) or liver problems
- if you have or have had gallstones, heart problems (eg, heart failure; slow heartbeat; irregular heartbeat, such as prolonged QT interval), high blood sugar or diabetes, or pituitary gland problems
- if you have had a recent heart attack
- if you take any medicine that may increase the risk of a slow heartbeat or a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of these health problems
Some MEDICINES MAY INTERACT with pasireotide. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Beta-blockers (eg, propranolol), diltiazem, or verapamil because the risk of slow heartbeat may be increased
- Antiarrhythmic medicines (medicines to control your heartbeat, such as amiodarone) because the risk of irregular heartbeat may be increased
- Bromocriptine because the risk of its side effects may be increased by pasireotide
- Cyclosporine because its effectiveness may be decreased by pasireotide
This may not be a complete list of all interactions that may occur. Ask your health care provider if pasireotide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use pasireotide:
Use pasireotide as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Pasireotide comes with an extra patient information sheet called a Medication Guide. It also comes with detailed instructions for use. Read them carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about pasireotide.
- Pasireotide is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using pasireotide at home, a health care provider will teach you how to use it. Be sure you understand how to use pasireotide. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Pasireotide should be clear and colorless. Do not use pasireotide if it contains clumps or particles, is cloudy or discolored, or if the ampule is cracked or damaged.
- Inject pasireotide deep under the skin, NOT into muscle or a vein. Inject into the stomach area or the top of your thigh. Rotate injection sites with each dose of pasireotide.
- Do not inject pasireotide into an area that is red or irritated.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of pasireotide, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use pasireotide.
Important safety information:
- Pasireotide may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Pasireotide may lead to low levels of certain hormones in your body. Call your doctor right away if you have fainting; loss of appetite; symptoms of low blood sodium levels (eg, confusion, mental or mood changes, seizures, sluggishness); symptoms of low blood sugar levels (eg, increased sweating, weakness, tremors, fainting, drowsiness, headache, chills, fast heartbeat, vision changes, increased hunger); unusual diarrhea, dizziness, nausea, tiredness, or weakness; vomiting; or weight loss.
- You will need to have an ECG done before starting pasireotide. You may also need to have an ECG done while using pasireotide. Talk with your doctor.
- Lab tests may be performed while you use pasireotide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using pasireotide while you are pregnant. It is not known if pasireotide is found in breast milk. Do not breast-feed while taking pasireotide.
Possible side effects of pasireotide:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; flu-like signs; hair loss; headache; mild nausea, tiredness, or weakness; mild pain, redness, or swelling at the injection site; muscle pain; nose and throat irritation; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; muscle pain, weakness, or cramping; severe or persistent dizziness or headache; severe or persistent nausea; slow or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of gallstones (eg, sudden pain in the upper right stomach area, right shoulder area, or between the shoulder blades; yellowing of the skin or eyes; fever with chills); symptoms of liver problems (eg, dark urine, feeling tired, persistent loss of appetite, stomach pain, pale stools, unusual nausea or vomiting, yellow skin or eyes); unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Store pasireotide at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep pasireotide out of the reach of children and away from pets.
- If you have any questions about pasireotide, please talk with your doctor, pharmacist, or other health care provider.
- Pasireotide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take pasireotide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pasireotide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pasireotide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using pasireotide.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.