Nitisinone: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag=<!--Overview--> | |authorTag=<!--Overview--> | ||
|genericName=Nitisinone | |||
|aOrAn=a | |aOrAn=a | ||
| | |drugClass= Gastrointestinal Agent | ||
|adverseReactions=<!--Black Box Warning--> | |indicationType=treatment | ||
|indication=hereditary tyrosinemia type 1 (HT-1) | |||
|adverseReactions= hepatic neoplasm, liver failure, thrombocytopenia, leucopenia, visual system complaints including conjunctivitis, corneal opacity, keratitis, and photophobia | |||
<!--Black Box Warning--> | |||
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | ||
<!--Adult Indications and Dosage--> | <!--Adult Indications and Dosage--> | ||
<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult===== | |fdaLIADAdult=====Indications==== | ||
* Orfadin(R) capsules (nitisinone) are indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 | |||
* | |||
* | ====Dosage==== | ||
* The recommended dose of Orfadin is 1 to 2 mg/kg divided into two daily doses. The initial dose is 1 mg/kg/day divided for morning and evening administration. Treatment with Orfadin should be initiated by a physician experienced in the treatment of HT-1. | |||
The dose of Orfadin may be adjusted in each patient. In patients whose erythrocyte PBG-synthase activity and urine 5-ALA and urine succinylacetone are not normalized within one month after the start of Orfadin treatment, the Orfadin dose may be increased to 1.5 mg/kg/day. In patients receiving 1.5 mg/kg/day, whose erythrocyte PBG-synthase activity and urine 5-ALA and urine succinylacetone remain elevated and whose plasma succinylacetone is not normalized after three months, the dose may be increased to up a maximum dose of 2 mg/kg/day. | |||
If plasma nitisinone concentration, plasma succinylacetone, urine 5-ALA and erythrocyte PBG-synthase activity are not available, clinical laboratory assessments should include urine succinyl acetone, liver function tests, alpha fetoprotein, and serum tyrosine and phenylalanine level. During initiation of therapy and during acute exacerbations, it may be necessary to follow more closely all available biochemical parameters | |||
3 DOSAGE FORMS AND STRENGTHS | |||
Orfadin capsules (nitisinone) are available as white capsules imprinted with ”NTBC” followed by "2 mg", "5 mg", or "10 mg", indicating the actual amount of nitisinone in each capsule. | |||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Non–Guideline-Supported Use (Adult)--> | <!--Non–Guideline-Supported Use (Adult)--> | ||
|offLabelAdultNoGuideSupport= | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | ||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Pediatric Indications and Dosage--> | <!--Pediatric Indications and Dosage--> | ||
<!--FDA-Labeled Indications and Dosage (Pediatric)--> | <!--FDA-Labeled Indications and Dosage (Pediatric)--> | ||
|fdaLIADPed====== | |fdaLIADPed=====Indications==== | ||
* Orfadin(R) capsules (nitisinone) are indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1) | |||
* | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
|offLabelPedGuideSupport= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Non–Guideline-Supported Use (Pediatric)--> | <!--Non–Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedNoGuideSupport= | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Contraindications--> | <!--Contraindications--> | ||
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<!--Administration and Monitoring--> | <!--Administration and Monitoring--> | ||
|administration= | |administration=Orfadin should be taken at least one hour before or at least two hours after a meal, since food effect is unknown. For young children, Orfadin capsules may be opened and the contents suspended in a small amount of water immediately before use. | ||
Physicians should counsel patients and their parents or caregivers of the need to maintain dietary restriction of tyrosine and phenylalanine when taking Orfadin to treat hereditary tyrosinemia type 1. | |||
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | ||
Revision as of 20:37, 17 February 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
Disclaimer
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Overview
Nitisinone is a Gastrointestinal Agent that is FDA approved for the treatment of hereditary tyrosinemia type 1 (HT-1). Common adverse reactions include hepatic neoplasm, liver failure, thrombocytopenia, leucopenia, visual system complaints including conjunctivitis, corneal opacity, keratitis, and photophobia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Orfadin(R) capsules (nitisinone) are indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1
Dosage
- The recommended dose of Orfadin is 1 to 2 mg/kg divided into two daily doses. The initial dose is 1 mg/kg/day divided for morning and evening administration. Treatment with Orfadin should be initiated by a physician experienced in the treatment of HT-1.
The dose of Orfadin may be adjusted in each patient. In patients whose erythrocyte PBG-synthase activity and urine 5-ALA and urine succinylacetone are not normalized within one month after the start of Orfadin treatment, the Orfadin dose may be increased to 1.5 mg/kg/day. In patients receiving 1.5 mg/kg/day, whose erythrocyte PBG-synthase activity and urine 5-ALA and urine succinylacetone remain elevated and whose plasma succinylacetone is not normalized after three months, the dose may be increased to up a maximum dose of 2 mg/kg/day.
If plasma nitisinone concentration, plasma succinylacetone, urine 5-ALA and erythrocyte PBG-synthase activity are not available, clinical laboratory assessments should include urine succinyl acetone, liver function tests, alpha fetoprotein, and serum tyrosine and phenylalanine level. During initiation of therapy and during acute exacerbations, it may be necessary to follow more closely all available biochemical parameters
3 DOSAGE FORMS AND STRENGTHS Orfadin capsules (nitisinone) are available as white capsules imprinted with ”NTBC” followed by "2 mg", "5 mg", or "10 mg", indicating the actual amount of nitisinone in each capsule.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nitisinone in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nitisinone in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
- Orfadin(R) capsules (nitisinone) are indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1)
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nitisinone in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nitisinone in pediatric patients.
Contraindications
- Condition1
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Nitisinone in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Nitisinone in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nitisinone in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Nitisinone during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Nitisinone with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Nitisinone with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Nitisinone with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Nitisinone with respect to specific gender populations.
Race
There is no FDA guidance on the use of Nitisinone with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Nitisinone in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Nitisinone in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Nitisinone in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Nitisinone in patients who are immunocompromised.
Administration and Monitoring
Administration
Orfadin should be taken at least one hour before or at least two hours after a meal, since food effect is unknown. For young children, Orfadin capsules may be opened and the contents suspended in a small amount of water immediately before use.
Physicians should counsel patients and their parents or caregivers of the need to maintain dietary restriction of tyrosine and phenylalanine when taking Orfadin to treat hereditary tyrosinemia type 1.
Monitoring
There is limited information regarding Monitoring of Nitisinone in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Nitisinone in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Nitisinone in the drug label.
Pharmacology
There is limited information regarding Nitisinone Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Nitisinone in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Nitisinone in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Nitisinone in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Nitisinone in the drug label.
How Supplied
Storage
There is limited information regarding Nitisinone Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Nitisinone |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Nitisinone |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Nitisinone in the drug label.
Precautions with Alcohol
- Alcohol-Nitisinone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
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