# US 2013/0158362 A1 · Methods for treating hyperbilirubinemia with stannsoporfin > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158362 A1 - Document ID: US20130158362A1 - Status: Published application - Kind: A1 - Application number: 13/691,677 - Filed: 2012-11-30 - Published: 2013-06-20 - Earliest claimed: 2011-12-01 - Assignees: Infacare Pharmaceutical Corporation - Inventors: Simon J. TULLOCH; Warren W. WASIEWSKI - Web page: https://patentgrep.com/patent/US20130158362A1 ## CPC - A61K 31/555: containing heavy metals, e.g. hemin, hematin, melarsoprol - A61B 5/48: {Other medical applications} - A61B 5/4839: {combined with drug delivery} - A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent} - A61N 5/0621: {Hyperbilirubinemia, jaundice treatment} - A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics - A61P 7/00: Drugs for disorders of the blood or the extracellular fluid - A61P 7/06: Antianaemics - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Some embodiments relate to methods of treating hyperbilirubinemia comprising administrating a therapeutic amount of a metalloporphyrin to an infant. Administration may occur when the infant's measured total serum bilirubin levels are at or below about the level suggested by the AAP nomogram for initiating phototherapy, when the infant's measured total serum bilirubin levels are at about the level suggested for initiating phototherapy in an infant, or when the infant's measured total serum bilirubin levels are at about the level suggested for initiating phototherapy. Administration may occur without regard to the total serum bilirubin level of the infant. In some embodiments, administration of the metalloporphyrin does not cause QT prolongation. ## Claims ### Claim 1 A method of treating hyperbilirubinemia or the symptoms thereof in an infant, the method comprising: administering a therapeutic amount of a metalloporphyrin to the infant with hyperbilirubinemia where no exclusion factor is present and at least one of a baseline total bilirubin level is elevated above a predetermined threshold and at least one risk factor is present; wherein the hyperbilirubinemia or symptoms thereof is treated. ### Claim 2 (depends on 1) The method of claim 1, further comprising determining baseline total bilirubin levels in the infant. ### Claim 3 (depends on 1) The method of claim 1, wherein baseline total bilirubin levels comprises total serum bilirubin levels, total cutaneous bilirubin or a combination thereof. ### Claim 4 (depends on 1) The method of claim 1, wherein the infant is of a gestational age from about 35 to about 43 weeks. ### Claim 5 (depends on 1) The method of claim 1, wherein the infant has a minimum birth weight of about 2,500 g. ### Claim 6 (depends on 1) The method of claim 1, wherein the infant has a birth weight from about 1,700 g to about 4,000 g. ### Claim 7 (depends on 1) The method of claim 1, wherein the infant is Coombs positive. ### Claim 8 (depends on 1) The method of claim 1, wherein the infant is Coombs negative and at least one risk factor is present. ### Claim 9 (depends on 8) The method of claim 8, wherein the at least one risk factor is selected from hemolytic disease, ABO blood type incompatibility, anti-C Rh incompatibility, anti-c Rh incompatibility, anti-D Rh incompatibility, anti-E Rh incompatibility, anti-e Rh incompatibility, G6PD deficiency and combinations thereof. ### Claim 10 (depends on 1) The method of claim 1, wherein determining baseline total bilirubin levels is performed at a time selected from within 6 hours of birth, 12 hours of birth, within 24 hours of birth, and within 48 hours of birth. ### Claim 11 (depends on 1) The method of claim 1, further comprising identifying the presence of at least one risk factor. ### Claim 12 (depends on 11) The method of claim 11, wherein the at least one risk factor is selected from hemolytic disease, ABO blood type incompatibility, anti-C Rh incompatibility, anti-c Rh incompatibility, anti-D Rh incompatibility, anti-E Rh incompatibility, anti-e Rh incompatibility, and G6PD deficiency and combinations thereof. ### Claim 13 (depends on 1) The method of claim 1, further comprising identifying the absence of at least one exclusion factor. ### Claim 14 (depends on 16) 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. ### Claim 15 (depends on 1) The method of claim 1, wherein the predetermined threshold is the level determined by the AAP nomogram for initiating phototherapy for an infant of known age and known risk level. ### Claim 16 (depends on 1) The method of claim 1, wherein the predetermined threshold is selected from about 1-3 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 1 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 2 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, at the threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 1-3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, is about 2 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, at the threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines and about 1 to about 3 mg/dL below the threshold for administration of phototherapy according to AAP nomogram corresponding to the infants age. ### Claim 17 (depends on 1) The method of claim 1, wherein administering a therapeutic amount of a metalloporphyrin is performed at a time selected from within about 6 hours of birth, within about 12 hours of birth, within about 24 hours of birth and within about 48 hours of birth. ### Claim 18 (depends on 1) The method of claim 1, wherein the metalloporphyrin is selected from tin mesoporphyrin, zinc mesoporphyrin, chromium mesoporphyrin, tin protoporphyrin, zinc protoporphyrin, chromium protoporphyrin, bisglycol protoporphyrin and ferroporphyrin. ### Claim 19 (depends on 1) The method of claim 1, wherein the metalloporphyrin is tin mesoporphyrin. ### Claim 20 (depends on 1) The method of claim 1, wherein the therapeutic amount of the metalloporphyrin is from about 0.75 mg/kg to about 5 mg/kg of the infant's weight. ### Claim 21 (depends on 1) The method of claim 1, wherein the therapeutic amount of the metalloporphyrin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg of the infant's weight. ### Claim 22 (depends on 1) The method of claim 1, wherein the therapeutic amount of the tin mesoporphyrin is from about 0.75 mg/kg to about 5 mg/kg of the infants weight. ### Claim 23 (depends on 1) The method of claim 1, wherein the therapeutic amount of the tin mesoporphyrin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg of the infants weight. ### Claim 24 (depends on 1) The method of claim 1, wherein the metalloporphyrin is administered by intramuscular injection. ### Claim 25 (depends on 1) The method of claim 1, wherein administering a therapeutic amount of a metalloporphyrin is performed when the infants age is less than 20 days of age. ### Claim 26 (depends on 1) The method of claim 1, wherein administering a therapeutic amount of a metalloporphyrin is performed when the infants age is less than 30 days of age. ### Claim 27 (depends on 1) The method of claim 1, further comprising administering phototherapy where total bilirubin levels following administration of the metalloporphyrin are above the baseline total bilirubin levels. ### Claim 28 (depends on 1) The method of claim 1, further comprising determining post treatment total bilirubin levels following administration of the metalloporphyrin. ### Claim 29 (depends on 28) The method of claim 28, wherein determining post treatment total bilirubin levels following administration of the metalloporphyrin is performed from about 6 and to about 72 hours after administering the metalloporphyrin to the infant. ### Claim 30 (depends on 28) The method of claim 28, wherein post treatment total bilirubin levels are at least 5% below the baseline total bilirubin levels 24 hours after administering a therapeutic amount of a metalloporphyrin to the infant. ### Claim 31 (depends on 28) The method of claim 28, wherein post treatment total bilirubin levels are at least 10% below the baseline total bilirubin levels 48 hours after administering a therapeutic amount of a metalloporphyrin to the infant. ### Claim 32 (depends on 28) The method of claim 28, wherein post treatment total bilirubin levels are at least 20% below the baseline total bilirubin levels 72 hours after administering a therapeutic amount of a metalloporphyrin to the infant. ### Claim 33 (depends on 28) The method of claim 28, wherein post treatment total bilirubin levels are less than 3 mg/dL above the baseline total bilirubin levels 48 hours after administering a therapeutic amount of a metalloporphyrin to the infant. ### Claim 34 (depends on 1) The method of claim 1, further comprising conducting on the infant an exam selected from a physical exam, a dermatologic exam, an audiology exam, an ophthalmological exam, a neurological exam, a laboratory test, an electrocardiogram and a combination thereof. ### Claim 35 A method of reducing the likelihood of hyperbilirubinemia and the symptoms thereof in an infant, the method comprising: administering a therapeutic amount of a metalloporphyrin to the infant where the infant's total bilirubin is determined to be increasing in at least one total bilirubin measurement compared with a baseline total bilirubin level wherein the likelihood of hyperbilirubinemia or the symptoms thereof is decreased. ### Claim 36 (depends on 35) The method of claim 35, wherein the infant's total bilirubin is determined to be increasing in two consecutive total bilirubin measurements. ### Claim 37 (depends on 35) The method of claim 35, wherein the baseline total bilirubin measurement is performed from about 6 to about 96 hours of age. ### Claim 38 (depends on 35) The method of claim 35, wherein the baseline total bilirubin measurement is performed at about 6, 12, 24, 48, 72, or 96 hours of age. ### Claim 39 (depends on 35) The method of claim 35, wherein the at least one total bilirubin measurement is performed from about 6 to about 72 hours after the baseline total bilirubin measurement. ### Claim 40 (depends on 35) The method of claim 35, wherein administering a therapeutic amount of a metalloporphyrin is performed within about 1 to about 6 hours of when the infant's total bilirubin is determined to be increasing in at least one total bilirubin measurement. ### Claim 41 (depends on 35) The method of claim 35, wherein the infant has at least one risk factor selected from hemolytic disease, ABO blood type incompatibility, anti-C Rh incompatibility, anti-c Rh incompatibility, anti-D Rh incompatibility, anti-E Rh incompatibility, anti-e Rh incompatibility, G6PD deficiency and a combination thereof. ### Claim 42 (depends on 35) The method of claim 35, wherein the therapeutic amount of the metalloporphyrin is from about 0.75 mg/kg to about 5 mg/kg of the infant's weight. ### Claim 43 (depends on 35) The method of claim 35, wherein the therapeutic amount of the metalloporphyrin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg of the infant's weight. ### Claim 44 (depends on 35) The method of claim 35, wherein the therapeutic amount of the stannsoporfin is from about 0.75 mg/kg to about 5 mg/kg of the infant's weight. ### Claim 45 (depends on 35) The method of claim 35, wherein the therapeutic amount of the stannsoporfin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg of the infant's weight. ### Claim 46 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. ### Claim 47 (depends on 46) The method of claim 46, further comprising determining baseline total bilirubin levels. ### Claim 48 (depends on 47) The method of claim 47, wherein determining baseline total bilirubin levels is performed within 48 hours of birth. ### Claim 49 (depends on 46) The method of claim 46, further comprising identifying the presence of at least one risk factor prior to administering a therapeutic amount of the metalloporphyrin to the infant. ### Claim 50 (depends on 49) The method of claim 49, wherein the at least one risk factor is selected from hemolytic disease, ABO blood type incompatibility, anti-C Rh incompatibility, anti-c Rh incompatibility, anti-D Rh incompatibility, anti-E Rh incompatibility, anti-e Rh incompatibility, G6PD deficiency and a combination thereof. ### Claim 51 (depends on 46) The method of claim 46, further comprising identifying the presence of at least one exclusion factor prior to administering a therapeutic amount of the metalloporphyrin to the infant. ### Claim 52 (depends on 51) The method of claim 51, 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 hypematremia, 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. ### Claim 53 (depends on 46) The method of claim 46, wherein administering a therapeutic amount of a metalloporphyrin and administering a therapeutic amount of phototherapy is performed where no exclusion factor is present. ### Claim 54 (depends on 46) The method of claim 46, wherein administering a therapeutic amount of a metalloporphyrin and administering a therapeutic amount of phototherapy is performed where at least one of a baseline total bilirubin level elevated above a predetermined threshold and at least one risk factor, or a combination thereof is present. ### Claim 55 (depends on 54) The method of claim 54, wherein the predetermined threshold is selected from about 1-3 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 1 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 2 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, at the threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 1-3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 2 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, at the threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, and about 1 to about 3 mg/dL below the threshold for administration of phototherapy according to AAP nomogram corresponding to the infants age. ### Claim 56 (depends on 46) The method of claim 46, wherein the therapeutic amount of the metalloporphyrin is from about 0.75 mg/kg to about 5 mg/kg of the infant's weight. ### Claim 57 (depends on 46) The method of claim 46, wherein the therapeutic amount of the metalloporphyrin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg of the infant's weight. ### Claim 58 (depends on 46) The method of claim 46, wherein the therapeutic amount of the stannsoporfin is from about 0.75 mg/kg to about 5 mg/kg of the infant's weight. ### Claim 59 (depends on 46) The method of claim 46, wherein the therapeutic amount of the stannsoporfin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg of the infant's weight. ### Claim 60 (depends on 46) The method of claim 46, wherein administering a therapeutic amount of a metalloporphyrin is performed in the infant is performed when the infants age is less than about 48 hours. ### Claim 61 (depends on 46) The method of claim 46, wherein administering a therapeutic amount of a metalloporphyrin is performed in the infant is performed when the infants age is less than about 20 days of age. ### Claim 62 (depends on 46) The method of claim 46, wherein administering a therapeutic amount of a metalloporphyrin is performed in the infant is performed when the infants age is less than about 30 days of age. ### Claim 63 (depends on 46) The method of claim 46, wherein administering a therapeutic amount of a metalloporphyrin and phototherapy is performed simultaneously. ### Claim 64 (depends on 46) The method of claim 46, wherein phototherapy is performed at a time selected from within about 12 hours of administration of therapeutic amount of a metalloporphyrin and within about 24 hours of administration of therapeutic amount of a metalloporphyrin. ### Claim 65 (depends on 46) The method of claim 46, further comprising conducting on the infant, a physical exam selected from, a dermatologic exam, an audiology exam, an ophthalmological exam, a neurological exam, a laboratory test, an electrocardiogram and a combination thereof. ### Claim 66 A method of reducing the risk of hyperbilirubinemia and the symptoms thereof in an infant, the method comprising administering a therapeutic amount of a metalloporphyrin to the infant wherein the infant has at least one risk factor associated with hyperbilirubinemia. ### Claim 67 (depends on 66) The method of claim 66, wherein the infant has a total bilirubin level of less than about 3 mg/dL below the threshold for administration of phototherapy according to AAP nomogram corresponding to the infants age. ### Claim 68 (depends on 66) The method of claim 66, wherein administering a therapeutic amount of a metalloporphyrin to the infant comprises administering a single dose of a metalloporphyrin. ### Claim 69 (depends on 66) The method of claim 66, wherein the least one risk factor is selected from hemolytic disease, ABO blood type incompatibility, anti-C Rh incompatibility, anti-c Rh incompatibility, anti-D Rh incompatibility, anti-E Rh incompatibility, anti-e Rh incompatibility, G6PD deficiency and a combination thereof. ### Claim 70 (depends on 66) The method of claim 66, wherein the risk factor is a total bilirubin level at or above a pre-determined threshold. ### Claim 71 (depends on 70) The method of claim 70, wherein the predetermined threshold is selected from about 1-3 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 1 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 2 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, is at the threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 1-3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 1-3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 2 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, at the threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 1 to about 3 mg/dL below the threshold for administration of phototherapy according to AAP nomogram corresponding to the infants age and at the threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines. ### Claim 72 (depends on 66) The method of claim 66, wherein administering a therapeutic amount of the metalloporphyrin to the infant results in at least one of a decrease in total bilirubin levels compared with total bilirubin levels prior to administering the metalloporphyrin and no detectable increase in total bilirubin levels compared with total bilirubin levels prior to administering the metalloporphyrin. ### Claim 73 (depends on 66) The method of claim 66, wherein the therapeutic amount of the metalloporphyrin is from about 0.75 mg/kg to about 5 mg/kg of infant's weight. ### Claim 74 (depends on 66) The method of claim 66, wherein the therapeutic amount of the metalloporphyrin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg of infant's weight. ### Claim 75 (depends on 66) The method of claim 66, wherein the therapeutic amount of the stannsoporfin is from about 0.75 mg/kg to about 5 mg/kg of infant's weight. ### Claim 76 (depends on 66) The method of claim 66, wherein the therapeutic amount of the stannsoporfin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg of infant's weight. ### Claim 77 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. ### Claim 78 (depends on 77) The method of claim 77, wherein administering a therapeutic amount of a metalloporphyrin to the infant comprises administering a single dose of a metalloporphyrin. ### Claim 79 (depends on 77) The method of claim 77, wherein the infant has at least one risk factor selected from hemolytic disease, ABO blood type incompatibility, anti-C Rh incompatibility, anti-c Rh incompatibility, anti-D Rh incompatibility, anti-E Rh incompatibility, anti-e Rh incompatibility, G6PD deficiency and a combination thereof. ### Claim 80 (depends on 77) The method of claim 77, wherein the infant is of a gestational age from about 35 to about 43 weeks. ### Claim 81 (depends on 77) The method of claim 77, wherein the infant has a minimum birth weight of about 2500 g. ### Claim 82 (depends on 77) The method of claim 77, wherein the infant has a birth weight from about 1,700 g to about 4,000 g. ### Claim 83 (depends on 77) The method of claim 77, wherein stabilization of total bilirubin levels is achieved when at least two total bilirubin level measurements taken at pre-determined time points after administration of a single therapeutic amount of a metalloporphyrin indicate a total bilirubin level at or below the baseline total bilirubin level. ### Claim 84 (depends on 77) The method of claim 77, wherein the predetermined threshold is about 1-3 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 1 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 2 mg/dL below a threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, is at the threshold for administration of phototherapy to an infant up to about 12 hours of age per the AAP guidelines, about 1-3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 1-3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 2 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 3 mg/dL below a threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, at the threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines, about 1 to about 3 mg/dL below the threshold for administration of phototherapy according to AAP nomogram corresponding to the infants age and at the threshold for administration of phototherapy to an infant from about 12 to 48 hours of age per the AAP guidelines. ### Claim 85 (depends on 77) The method of claim 77, wherein the therapeutic amount of the metalloporphyrin is from about 0.75 mg/kg to about 5 mg/kg. ### Claim 86 (depends on 77) The method of claim 77, wherein the therapeutic amount of the metalloporphyrin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg. ### Claim 87 (depends on 77) The method of claim 77, wherein the therapeutic amount of the stannsoporfin is from about 0.75 mg/kg to about 5 mg/kg. ### Claim 88 (depends on 77) The method of claim 77, wherein the therapeutic amount of the stannsoporfin is selected from 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg. ### Claim 89 A method for treating rising bilirubin levels comprising: establishing a baseline bilirubin level in a patient at risk for hyperbilirubinemia at a predetermined age; administering to the patient a therapeutic amount of stannsoporfin after the baseline is established. ### Claim 90 (depends on 89) The method of claim 89, wherein the predetermined age is about 6 hours, about 12 hours, or about 24 hours from birth. ### Claim 91 (depends on 89) The method of claim 89, wherein a baseline reading at the AAP nomogram threshold for administering phototherapy or up to 3.0 mg/dL below the AAP nomogram threshold for administering phototherapy indicates treatment is required. ### Claim 92 A method of treating hyperbilirubinemia comprising: administering a therapeutic amount of stannsoporfin to a patient in need thereof to achieve a Cmax of at least 5000 ng/mL. ### Claim 93 (depends on 92) The method of claim 92, wherein the therapeutic amount of stannsoporfin is 1.5 mg/kg and achieves a Cmax of about 6450 ng/mL. ### Claim 94 (depends on 92) The method of claim 92, wherein the therapeutic amount of stannsoporfin is 3.0 mg/kg and achieves a Cmax of about 11500 ng/mL. ### Claim 95 (depends on 92) The method of claim 92, wherein the therapeutic amount of stannsoporfin is 4.5 mg/kg and achieves a Cmax of about 20400 ng/mL. ### Claim 96 (depends on 92) The method of claim 92, wherein Cmax is achieved at a Tmax of about 1.5 hours to about 2.5 hours.