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pasireotide subcutaneous

COMMON BRAND NAME(S): Signifor

GENERIC NAME(S): PASIREOTIDE DIASPARTATE

Uses

Pasireotide is used to treat a certain condition (Cushing's disease) when surgery has not been fully successful or cannot be used to correct the condition. Cushing's disease occurs when the body makes too much of a certain hormone called cortisol. Having too much cortisol in the body may lead to high blood pressure, high blood sugar, and other problems. Pasireotide works by decreasing the amount of cortisol made in the body.

How to use pasireotide subcutaneous

Read the Medication Guide provided by your pharmacist before you start using pasireotide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the Patient Instructions for Use.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin as directed by your doctor, usually twice daily. Pasireotide may be injected into the top of the thigh or into the abdominal/stomach area.

Before injecting each dose, clean the injection site with rubbing alcohol. Avoid areas of the skin that are red or irritated. Change the injection site each time to lessen injury under the skin. Do not rub or massage the injection site after the injection.

Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition and response to treatment.

It may take up to 2 months before you get the full benefit of this drug.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Headache, hair loss, dizziness, diarrhea, constipation, nausea, vomiting, muscle/stomach/abdominal pain, swelling of arms/legs, and redness/pain/swelling/itching/bleeding at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: weakness, unusual tiredness, extreme drowsiness, mental/mood changes, seizures, fever, loss of appetite, persistent nausea, persistent vomiting, persistent stomach/abdominal pain, slow heartbeat.

This medication may infrequently cause changes in blood sugar, especially if you have diabetes. Symptoms of high blood sugar include increased thirst and urination. Symptoms of low blood sugar include nervousness, shakiness, sweating, fast heartbeat, and hunger. Follow your doctor's instructions to treat low blood sugar (e.g., eat a quick source of sugar such as glucose/gel tablets, table sugar, honey, or drink fruit juice or non-diet soda). Tell your doctor right away if you experience symptoms of high or low blood sugar while using this medication. Monitor your blood sugar levels as directed by your doctor. Your doctor may need to adjust your diabetes medications.

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using pasireotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart problems (such as irregular heartbeat), diabetes, gallbladder problems (such as gallstones).

Pasireotide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using pasireotide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using pasireotide safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as blood sugar tests, hemoglobin A1c, liver tests, hormone levels including cortisol and thyroid, EKG, gallbladder ultrasound) should be performed before you start treatment, and periodically to monitor your progress or to check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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