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Signifor LAR Side Effects

Generic Name: pasireotide

Note: This document contains side effect information about pasireotide. Some of the dosage forms listed on this page may not apply to the brand name Signifor LAR.

In Summary

Common side effects of Signifor LAR include: asthenia, cholelithiasis, fatigue, hypoglycemia, increased serum alanine aminotransferase, nausea, and vomiting. Other side effects include: adrenocortical insufficiency, hypotension, and increased serum glucose. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pasireotide: powder for suspension, solution

Along with its needed effects, pasireotide (the active ingredient contained in Signifor LAR) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pasireotide:

More Common

  • Anxiety
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • darkening of the skin
  • decreased urine
  • depression
  • diarrhea
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fainting
  • flushed, dry skin
  • fruit-like breath odor
  • gaseous abdominal or stomach pain
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • irregular heartbeat
  • loss of appetite
  • loss of consciousness
  • muscle pain or cramps
  • nausea
  • nightmares
  • numbness or tingling in the hands, feet, or lips
  • pounding in the ears
  • rapid weight gain
  • recurrent fever
  • seizures
  • shakiness
  • skin rash
  • slow or fast heartbeat
  • slurred speech
  • stomach pain or fullness
  • sweating
  • tingling of the hands or feet
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
  • yellow eyes or skin

Incidence Not Known

  • Clay-colored stools
  • constipation
  • darkened urine
  • dry skin and hair
  • feeling cold
  • fever
  • hair loss
  • hoarseness or husky voice
  • indigestion
  • itching
  • loss of appetite
  • muscle stiffness
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • unpleasant breath odor
  • vomiting of blood
  • weight gain

Some side effects of pasireotide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Back pain
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • cough
  • decreased appetite
  • difficulty with moving
  • feeling of constant movement of self or surroundings
  • general feeling of discomfort or illness
  • joint pain
  • lack or loss of strength
  • pain in the arms or legs
  • pressure in the stomach
  • sensation of spinning
  • shivering
  • stuffy or runny nose
  • sweating
  • swelling of the abdominal or stomach area
  • swollen joints
  • trouble sleeping
  • upper abdominal or stomach pain

For Healthcare Professionals

Applies to pasireotide: intramuscular powder for injection extended release, subcutaneous solution

Cardiovascular

Very common (10% or more): Hypertension (10%)

Common (1% to 10%): Hypotension (7%), prolonged QT (6%), sinus bradycardia (6%)[Ref]

Dermatologic

Very common (10% or more): Alopecia (12%)

Common (1% to 10%): Pruritus (8%), dry skin (6%)[Ref]

Endocrine

Common (1% to 10%): Adrenal insufficiency (6%)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (58%), nausea (52%), abdominal pain (24%), upper abdominal pain (10%)

Common (1% to 10%): Constipation (7%), vomiting (7%), abdominal distention (6%)[Ref]

General

Very common (10% or more): Asthenia (11%), peripheral edema (10%), decreased appetite (10%)[Ref]

Hematologic

Very common (10% or more): Elevated PTT (47%), elevated PT (33%)

Common (1% to 10%): Anemia[Ref]

Hepatic

Very common (10% or more): Cholelithiasis (30%), alanine aminotransferase increased (10%), gamma-glutamyl transferase increased (10%)

Common (1% to 10%): Aspartate aminotransferase increased (6%)[Ref]

Local

Very common (10% or more): Injection site reactions (17%)[Ref]

Metabolic

Very common (10% or more): Hyperglycemia (40%), diabetes mellitus (18%), glycosylated hemoglobin increased (11%), hypercholesterolemia (10%)

Common (1% to 10%): Hypoglycemia (9%), Type 2 diabetes mellitus (9%), lipase increased (7%), hypokalemia (6%), blood glucose increased (6%), blood amylase increased (2%)[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia (9%), arthralgia (8%), back pain (6%), pain in extremity (6%)[Ref]

Nervous system

Very common (10% or more): Headache (28%), fatigue (19%)

Common (1% to 10%): Dizziness (9%), anxiety (9%), insomnia (9%), vertigo (6%)[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (13%)

Common (1% to 10%): Influenza (9%)[Ref]

References

1. "Product Information. Signifor (pasireotide)." Novartis Pharmaceuticals, East Hanover, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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