Ibuprofen Lysine
Generic: IBUPROFEN LYSINE
Basic Information
Manufacturer
XGen Pharmaceuticals DJB, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
6cfdec66-9483-4abe-98d3-3a7d389cc952
Indications & Usage
1 INDICATIONS AND USAGE Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective.
The clinical trial was conducted among infants with an asymptomatic PDA.
However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.
Ibuprofen Lysine Injection is a nonsteroidal anti-inflammatory drug indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective.
The clinical trial was conducted among infants with an asymptomatic PDA.
However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.
(1)
The clinical trial was conducted among infants with an asymptomatic PDA.
However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.
Ibuprofen Lysine Injection is a nonsteroidal anti-inflammatory drug indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective.
The clinical trial was conducted among infants with an asymptomatic PDA.
However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.
(1)
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure.
(6) To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB Inc.
at 1-866-390-4411, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience The most frequently reported adverse events with Ibuprofen Lysine Injection were as shown in Table 1.
Table 1.
Adverse Events within 30 Days of Therapy in the Multicenter Study* % Incidence Adverse Event Ibuprofen Lysine Injection Placebo Sepsis 43 37 Anemia 32 25 Total Bleeding** 32 29 Intraventricular Hemorrhage, Grades 1/2 15 13 Intraventricular Hemorrhage, Grades 3/4 15 10 Other Bleeding 6 13 Intraventricular Hemorrhage, All Grades 29 24 Apnea 28 26 Gastrointestinal Disorders non-Necrotizing Enterocolitis 22 18 Total Renal Events** 21 15 Renal Failure 1 3 Renal Insufficiency, Impairment 6 4 Urine Output Reduced 3 1 Blood Creatinine Increased 3 1 Blood Urea Increased with Hematuria 1 1 Blood Urea Increased 7 4 Respiratory Infection 19 13 Skin Lesion/Irritation 16 6 Hypoglycemia 12 6 Hypocalcemia 12 9 Respiratory Failure 10 4 Urinary Tract Infection 9 4 Adrenal Insufficiency 7 1 Hypernatremia 7 4 Edema 4 0 Atelectasis 4 1 * Within 30 days of therapy, with an event rate greater on Ibuprofen Lysine Injection than on placebo, and greater than 2 events on Ibuprofen Lysine Injection.
** A given subject may have experienced more than one specific event within these adverse event categories.
Only the most severe grade of IVH counted for a given subject.
6.2 Renal Function Compared to placebo, there was a small decrease in urinary output in the ibuprofen group on days 2-6 of life, with a compensatory increase in urine output on day 9.
In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in ibuprofen treated infants.
6.3 Additional Adverse Events The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.
6.4 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, or establish a causal relationship to drug exposure.
The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation, necrotizing enterocolitis, drug reaction with eosinophilia and systemic symptoms (DRESS), and pulmonary hypertension.
(6) To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB Inc.
at 1-866-390-4411, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience The most frequently reported adverse events with Ibuprofen Lysine Injection were as shown in Table 1.
Table 1.
Adverse Events within 30 Days of Therapy in the Multicenter Study* % Incidence Adverse Event Ibuprofen Lysine Injection Placebo Sepsis 43 37 Anemia 32 25 Total Bleeding** 32 29 Intraventricular Hemorrhage, Grades 1/2 15 13 Intraventricular Hemorrhage, Grades 3/4 15 10 Other Bleeding 6 13 Intraventricular Hemorrhage, All Grades 29 24 Apnea 28 26 Gastrointestinal Disorders non-Necrotizing Enterocolitis 22 18 Total Renal Events** 21 15 Renal Failure 1 3 Renal Insufficiency, Impairment 6 4 Urine Output Reduced 3 1 Blood Creatinine Increased 3 1 Blood Urea Increased with Hematuria 1 1 Blood Urea Increased 7 4 Respiratory Infection 19 13 Skin Lesion/Irritation 16 6 Hypoglycemia 12 6 Hypocalcemia 12 9 Respiratory Failure 10 4 Urinary Tract Infection 9 4 Adrenal Insufficiency 7 1 Hypernatremia 7 4 Edema 4 0 Atelectasis 4 1 * Within 30 days of therapy, with an event rate greater on Ibuprofen Lysine Injection than on placebo, and greater than 2 events on Ibuprofen Lysine Injection.
** A given subject may have experienced more than one specific event within these adverse event categories.
Only the most severe grade of IVH counted for a given subject.
6.2 Renal Function Compared to placebo, there was a small decrease in urinary output in the ibuprofen group on days 2-6 of life, with a compensatory increase in urine output on day 9.
In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in ibuprofen treated infants.
6.3 Additional Adverse Events The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.
6.4 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, or establish a causal relationship to drug exposure.
The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation, necrotizing enterocolitis, drug reaction with eosinophilia and systemic symptoms (DRESS), and pulmonary hypertension.