Anthropometric Measurements as Predictors of Low Birth Weight Among Tanzanian Neonates: A Hospital-Based Study
November 7, 2025
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Brand Name :
Orfadin, nityr
Synonyms :
Nitisinone, nitisinona
Class :
Enzyme inhibitors, therapeutic agents
Brand Name :
Orfadin, nityr
Synonyms :
Nitisinone, nitisinona
Class :
Enzyme inhibitors, therapeutic agents
Dosage Forms & StrengthsÂ
CapsuleÂ
2mgÂ
5mgÂ
10mgÂ
20mgÂ
Oral suspensionÂ
4mg/mlÂ
TabletÂ
2mgÂ
5mgÂ
10mgÂ
Type 1 Hereditary TyrosinemiaÂ
Initial dose
:
0.5
mg/kg
Tablet
Orally 
every 12 hours twice a day
If succinylcholine is present in urine, increase the dose to 0.75mg/kg orally twice a day
Alternate maintenance regimen-Undetectable concentration of succinyl acetone:
Maintenance dose: 1-2mg/day
Maximum dose: 2mg/day
Dosage Forms & StrengthsÂ
CapsuleÂ
2mgÂ
5mgÂ
10mgÂ
20mgÂ
Oral suspensionÂ
4mg/mlÂ
TabletÂ
2mgÂ
5mgÂ
10mgÂ
Type 1 Hereditary TyrosinemiaÂ
Initial dose
:
0.5
mg/kg
Tablet
Orally 
every 12 hours twice a day
If succinylcholine is present in urine, increase the dose to 0.75mg/kg orally twice a day
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
may enhance the serum concentration of CYP2C9 inhibitors
It may enhance the risk of adverse effects when combined with Metabolic agents
It may enhance the risk of adverse effects when combined with Metabolic agents
may increase serum concentration of OAT1/3 substrates
may increase serum concentration of OAT1/3 substrates
may increase the serum concentration of oat1/3 substrates
it enhances by affecting the hepatic enzyme CYP2C9 metabolism
may increase the level by affecting hepatic enzyme CYP2C9 metabolism
may enhance the serum concentration of OAT1/3 Substrates
Nitisinone treats hereditary tyrosinemia type 1 (HT-1), which is a genetic disorder that leads to accumulation of toxic metabolites due to the deficiency of enzyme fumarylacetoacetate hydrolase (FAH).
Frequency defined:
>10%
Increased tyrosine levels
Liver transplantation
1-10%
Malignant hepatic neoplasm
Thrombocytopenia
Corneal opacity
Photophobia
Blepharitis
Dry skin
Exfoliative dermatitis
Granulocytopenia
Porphyria
Liver failure
Leukopenia
Conjunctivitis
Keratitis
Alopecia
Cataracts
Epistaxis
Eye pain
Maculopapular rash
Pruritis
<1%
Hyperkinesia
Abdominal pain
Enanthema
Melena
Hypoglycemia
Bronchitis
Seizure
Encephalopathy
Cyanosis
Diarrhea
Hemorrhage
Elevated hepatic enzymes
Septicemia
None
Hypersensitivity
Pregnancy consideration:
US FDA Pregnancy category: C
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Nitisinone inhibits 4-hydroxyphenylpyruvate dioxygenase (HPPD) and prevents the conversion of 4-hydroxyphenylpyruvate to homogentisic acid by reducing the formation of toxic metabolites such as maleylacetoacetate and fumarylacetoacetate.
Pharmacokinetics:
Absorption:
It is well absorbed orally with a bioavailability of 80-90%.
Distribution:
It is highly protein-bound in plasma (over 90%), particularly to albumin.
It has a relatively large volume of distribution which widely distributes in the body.
Metabolism:
Nitisinone undergoes minimal hepatic metabolism as it is metabolized by oxidation, but the exact pathways of metabolism are not fully characterized.
Excretion:
Nitisinone is primarily excreted unchanged in urine.
It is administered orally through capsule form
Generic Name: Â nitisinone
Pronounced: [Â nye-TIS-i-none]
Why do we use nitisinone?
It is used to treat type 1 hereditary tyrosinemia (excessive tyrosine in the blood)
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