Methods for treating hyperbilirubinemia with stannsoporfin

The method of claim 16, wherein the at least one exclusion factor is selected from a clinical suggestion of neonatal thyroid disease, current uncontrolled thyroid disease in the mother excluding maternal Hashimoto's, treatment or need for treatment in the infant with medications that may prolong the QT interval excluding eythromycin ointment for eye prophylaxis, a family history of Long QT syndrome, a family history of sudden infant death syndrome, known porphyrias, risk factors for porphyrias, a family history of porphyrias, a maternal history of systemic lupus erythematosus, maternal use of phenobarbital 30 days before, or after delivery, if breastfeeding, maternal current drug or alcohol abuse, maternal history of drug or alcohol abuse, an Apgar score less than or equal to 6 at age 5 minutes, congenital anomalies or infections, acidosis, sepsis, hepatitis;

• an excess risk of requiring surgery or exposure to operating room lights in the foreseeable future, cardiorespiratory distress defined as a respiratory rate >60 breaths per minute, a diagnosis of transient tachypnea of the newborn, abnormal auditory or ophthalmologic findings, clinically significant abnormalities on a screening laboratory evaluation, elevated direct or conjugated bilirubin (>1.0 mg/dL if the TSB is <5.0 mg/dL or >20% of the TSB if the TSB is ≧5.0 mg/dL), persistent hypoglycemia (blood glucose <40 mg/dL) despite standard-of-care treatment, liver diseases defined as ALT and/or AST greater than 2 times the upper limit of normal [ULN], abnormal renal function defined as creatinine and/or blood urea nitrogen greater than 2 times the ULN, any blood smear finding of structural red cell abnormalities, such as spherocytosis, not caused by isoimmune hemolysis, temperature instability defined as temperature consistently (3 consecutive times) greater than 36° C. and/or greater than 37.5° C. axillary, use of photosensitizing drugs or agents;
• dehydration, defined by hypernatremia, serum sodium greater than ULN, use of intravenous immunoglobulin (IVIG) or albumins, post-delivery treatment with medications that are known or suspected to displace bilirubin from albumin (e.g., ceftriaxone or sulfa-based antibiotics), serious morbid conditions including but not limited to pulmonary disease, cardiovascular disease), exposure to any investigational medications or devices after delivery, participation in a clinical trial and combinations thereof.

A method of treating hyperbilirubinemia and the symptoms thereof in an infant, the method comprising:

• administering a therapeutic amount of a metalloporphyrin to the infant;
• and
• administering a therapeutic amount of phototherapy to the infant
• wherein the hyperbilirubinemia or symptoms thereof is treated.

A method of stabilizing bilirubin levels in an infant, the method comprising:

• obtaining a baseline total bilirubin level measurement;
• and
• administering a therapeutic amount of a metalloporphyrin to the infant wherein the infant has at least one of hyperbilirubinemia, bilirubin levels above a pre-determined threshold, rising bilirubin levels, and a combination thereof
• wherein bilirubin levels in the infant are stabilized.