Signifor

Generic name: Pasireotide
Drug class: Somatostatin and somatostatin analogs

Usage of Signifor

Signifor is a man-made protein that is similar to a hormone in the body called somatostatin. Pasireotide lowers certain hormone substances produced in the body.

Signifor is used to treat Cushing's disease or acromegaly (endocrine disorders).

Signifor is usually given after surgery or other treatments have been tried without success.

Signifor side effects

Get emergency medical help if you have signs of an allergic reaction to Signifor: 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);

high blood sugar - increased thirst, increased urination, fruity breath odor, tiredness, and weight loss even if you are more hungry than usual;

ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;

low cortisol levels - nausea, vomiting, appetite changes, headache, irritability, confusion, slurred speech, or feeling weak, tired, unsteady, anxious, shaky, or light-headed; or

gallbladder problems - chalky-colored stools, stomach pain just after eating a meal, heartburn, bloating, and upper stomach pain that may spread to your back.

Common Signifor side effects may include:

high blood pressure;

abnormal blood test results;

feeling weak or tired;

loss of appetite, nausea, stomach pain or bloating, diarrhea;

headache;

swelling, rapid weight gain;

back pain;

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.

Before taking Signifor

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

To make sure Signifor is safe for you, tell your doctor if you have:

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 Signifor.

Relate drugs

How to use Signifor

Usual Adult Dose for Cushing's Syndrome:

Intramuscular formulation: Initial dose: 10 mg intramuscularly every 4 weeks (28 days) Maximum dose: 40 mg intramuscularly every 4 weeks (28 days), after 4 months of treatment with 10 mg for patients without normalized 24-hour urinary free cortisol (UFC) levels after 4 months treatment who tolerated the 10 mg dose SuBCutaneous formulation: Initial dose: 0.6 mg or 0.9 mg subcutaneously twice daily. Maintenance dose: 0.3 to 0.9 mg subcutaneously twice daily. Maximum dose: 0.9 mg subcutaneously twice daily Duration of therapy: Treatment should be continued as long as benefit is derived. Comments: -Titrate dose based on response and tolerability. -Perform baseline evaluations of fasting plasma glucose, hemoglobin A1c, liver tests, electrocardiogram, serum potassium, and serum magnesium prior to initiating therapy. -Optimize glucose control in poorly controlled diabetics prior to initiating therapy. Use: The treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

Usual Adult Dose for Acromegaly:

Intramuscular formulation: Initial dose: 40 mg, IM, every 28 days Maximum dose: 60 mg, IM, every 28 days for patients without normalized growth hormone (GH) and/or age and sex adjusted insulin-like growth factor (IGF-1) levels after 3 months treatment who tolerated the 40 mg dose Comments: -Titrate dose based on response and tolerability. -Evaluate fasting plasma glucose, HbA1c, liver enzymes, electrocardiogram, and serum magnesium and potassium prior to therapy. -Optimize glucose control in poorly controlled diabetes prior to therapy. Use: Treatment of patients with acromegaly with an inadequate response to surgery and/or for whom surgery is not an option.

Warnings

Signifor 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.

Signifor 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 other drugs will affect Signifor

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

Disclaimer

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