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Signifor-LAR

Last reviewed on RxList: 7/20/2020
Signifor-LAR Side Effects Center

What Is Signifor-LAR?

Signifor LAR (pasireotide) for Injectable Suspension is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

What Are Side Effects of Signifor-LAR?

Common side effects of Signifor LAR include:

Dosage for Signifor-LAR

The recommended initial dose of Signifor LAR is 40 mg administered by intramuscular injection once every 4 weeks (every 28 days) by a trained healthcare professional.

What Drugs, Substances, or Supplements Interact with Signifor-LAR?

Signifor LAR may interact with drugs that prolong the QT interval, cyclosporine, and bromocriptine. Tell your doctor all medications and supplements you use.

Signifor-LAR During Pregnancy and Breastfeeding

During pregnancy, Signifor LAR should be administered only if prescribed. It is unknown if this drug passes into breast milk. Because of the possible risk to the nursing infant, Signifor LAR is not recommended for use while breastfeeding.

Additional Information

Our Signifor LAR (pasireotide) for Injectable Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

About how much does an adult human brain weigh? See Answer
Signifor-LAR Consumer Information

Get emergency medical help if you have signs of an allergic reaction: 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 side effects may include:

  • abnormal blood test results;
  • feeling weak or tired;
  • nausea, stomach pain, diarrhea;
  • headache;
  • swelling, rapid weight gain;
  • 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.

Read the entire detailed patient monograph for Signifor-LAR (Pasireotide for Injectable Suspension, for Intramuscular Use)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Signifor-LAR Professional Information

SIDE EFFECTS

Clinically significant adverse reactions that appear in other sections of the labeling include:

  • Hyperglycemia and Diabetes [see WARNINGS AND PRECAUTIONS]
  • Bradycardia and QT Prolongation [see WARNINGS AND PRECAUTIONS]
  • Liver Test Elevations [see WARNINGS AND PRECAUTIONS]
  • Cholelithiasis [see WARNINGS AND PRECAUTIONS]
  • Pituitary Hormone Deficiency(ies) [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.

Drug-Naive Patients With Acromegaly

The data described in Table 1 are derived from an active-controlled trial in patients with acromegaly naive to previous drug therapy [see Clinical Studies]. The data reflect exposure of 178 patients with acromegaly to SIGNIFOR LAR for a mean duration of 43 weeks. In the overall study population, 52% were female and the average age of patients was 45 years. Additional information on design and demographics of this trial are described below [see Clinical Studies].

Table 1 presents common adverse reactions associated with SIGNIFOR LAR. These adverse reactions were not present at baseline or, if present, worsened from baseline and occurred in at least 5% of patients treated with SIGNIFOR LAR.

Table 1 : Adverse Reactions Occurring in ≥ 5% of Patients Exposed to SIGNIFOR LAR in Patients with Acromegaly Naive to Drug Therapy

Adverse Reaction Type SIGNIFOR LAR
(40-60 mg) % N=178
Active Comparator %
N=180
Hyperglycemia Related Adverse Reactions
Hyperglycemia 29 8
Diabetes mellitus* 26 4
Blood glucose increased 8 2
Glycosylated hemoglobin increased 6 2
Hypoglycemia 5 7
Gastrointestinal Related Adverse Reactions
Diarrhea 39 45
Abdominal pain 18 22
Nausea 14 22
Abdominal distension 12 12
Vomiting 8 7
Abdominal pain upper 6 8
Hepatobiliary Related Adverse Reactions
Cholelithiasis 26 36
Cardiac Related Adverse Reactions
Sinus bradycardia** 10 7
Hypertension 8 7
Nervous System Related Adverse Reactions
Headache 19 26
Dizziness 10 11
Skin Related Adverse Reactions
Alopecia 18 19
Infections Related Adverse Reactions
Nasopharyngitis 16 16
Influenza 8 4
Upper respiratory tract infection 7 3
Cough 5 8
Laboratory Related Adverse Reactions
Blood creatine phosphokinase increased 13 12
Alanine aminotransferase increased 8 4
Aspartate aminotransferase increased 6 4
Weight decreased 5 4
General and Injection Site Related Adverse Reactions
Fatigue 10 10
Injection site reaction*** 7 7
Musculoskeletal and Connective Tissue Related Adverse Reactions
Arthralgia 10 12
Back pain 8 11
Pain in extremity 7 4
Blood Related Adverse Reactions
Anemia 6 6
*Diabetes mellitus includes the following PTs: Diabetes mellitus and type 2 diabetes mellitus
**Sinus bradycardia includes the following PTs: Bradycardia and sinus bradycardia
***Injection site reaction related AEs includes the following PTs: Injection site pain, Injection site reaction, Injection site haematoma, Injection site pruritus, Injection site swelling, Injection site erythema

Other notable adverse reactions which occurred with a frequency of 5% or less for SIGNIFOR LAR were: adrenal insufficiency (3%); glucose tolerance impaired (1%); QT-prolongation (4%); blood amylase increased (2%).

Patients With Acromegaly Inadequately Controlled On Other Somatostatin Analogs At Baseline

The data described in Table 2 are derived from an active-controlled study in patients with acromegaly inadequately controlled at baseline on other somatostatin analogs [see Clinical Studies]. These data reflect exposure of 63 and 62 patients to SIGNIFOR LAR 40 mg and 60 mg, respectively, for a mean duration of 24 weeks.

In the overall study population, 56% were female and the average age of patients was 45 years. Additional information on design and demographics of this trial are described below [see Clinical Studies].

Table 2 presents common adverse reactions associated with SIGNIFOR LAR. These common adverse reactions were not present at baseline or, if present, worsened from baseline and occurred in at least 5% of patients treated with SIGNIFOR LAR.

Table 2 : Adverse Reactions Occurring in ≥ 5% of Patients Exposed to SIGNIFOR LAR in Patients with Acromegaly Previously Treated with Other Somatostatin Analogs

Adverse Drug Reactions SIGNIFOR LAR 40 mg %
N=63
SIGNIFOR LAR 60 mg %
N=62
Active Comparators %
N=66
Hyperglycemia Related Adverse Reactions
Hyperglycemia 33 30 14
Diabetes mellitus* 21 31 9
Blood glucose increased 5 7 0
Hypoglycemia 3 7 0
Gastrointestinal Related Adverse Reactions
Diarrhea 16 19 5
Abdominal pain 8 8 3
Nausea 3 7 3
Hepatobiliary Related Adverse Reactions
Cholelithiasis 10 13 14
Cardiac Related Adverse Reactions
Atrioventricular block first degree 6 0 0
Nervous System Related Adverse Reactions
Headache 14 3 5
Dizziness 8 2 3
Skin and Subcutaneous Tissue Related Adverse Reactions
Alopecia 2 7 0
Infections Related Adverse Reactions
Nasopharyngitis 6 11 3
Blood Related Adverse Reactions
Anemia 6 3 3
* Diabetes mellitus includes the following PTs: diabetes mellitus and type 2 diabetes mellitus

Other notable adverse reactions which occurred with a frequency of 5% or less in the SIGNIFOR LAR 40 mg, SIGNIFOR LAR 60 mg arm, respectively, were adrenal insufficiency (2% and 0%) and glucose tolerance impaired (3% and 5%).

Hyperglycemia

The average fasting plasma glucose levels in patients with acromegaly naive to drug therapy study [see Clinical Studies] across visits is shown in Figure 2.

Figure 2: Mean Fasting Plasma Glucose (mg/dL) by Visit in the Study of Patients with Acromegaly Naive to Drug Therapy*

Mean Fasting Plasma Glucose (mg/dL) by Visit
in the Study of Patients with Acromegaly Naive to Drug Therapy* - Illustration

*Numbers of patients with a glucose value at the given timepoint in the SIGNIFOR LAR/Active comparator arms are displayed as xxx/xxx on the x axis

Pancreatic Enzyme Elevation And Pancreatitis

Asymptomatic, elevations in lipase and alpha amylase were observed in 30% and 20% of patients receiving SIGNIFOR LAR in the drug naive study [see Clinical Studies] and in 1% and 3% of patients receiving SIGNIFOR LAR in the study of patients previously treated [see Clinical Studies]. In the drug-naive study, 2 patients receiving SIGNIFOR LAR developed pancreatitis. Pancreatitis is a potential adverse reaction associated with the use of SIGNIFOR LAR due to the association between cholelithiasis and acute pancreatitis.

Read the entire FDA prescribing information for Signifor-LAR (Pasireotide for Injectable Suspension, for Intramuscular Use)

Related Resources for Signifor-LAR

© Signifor-LAR Patient Information is supplied by Cerner Multum, Inc. and Signifor-LAR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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