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NITYR

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Overview

What is NITYR?

NITYR contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1).

Nitisinone occurs as white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.

Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione, and the structural formula is:

Figure 1. The molecular formula is CHNOF and with a relative mass of 329.23

Each NITYR (nitisinone) tablet contains 2, 5 or 10 mg of nitisinone. Inactive ingredients are: glyceryl dibehenate, and lactose monohydrate. NITYR tablets are intended for oral administration.



What does NITYR look like?



What are the available doses of NITYR?

Tablets: 2 mg, 5 mg, 10 mg.

What should I talk to my health care provider before I take NITYR?

How should I use NITYR?

NITYR™ is indicated for the treatment of patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

Starting Dosage

[see Dosage Forms and Strengths ()]

Titrate the dosage for individual patients, as needed based on biochemical and/or clinical response.

Dosage Titration


What interacts with NITYR?

Sorry No Records found


What are the warnings of NITYR?

Sorry No Records found


What are the precautions of NITYR?

Sorry No Records found


What are the side effects of NITYR?

Sorry No records found


What should I look out for while using NITYR?

None.


What might happen if I take too much NITYR?

Accidental ingestion of nitisinone by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels. In healthy subjects given a single 1 mg/kg dose of nitisinone, the plasma tyrosine level reached a maximum of 1200 micromol/L from 48 to 120 hours after dosing. After a washout period of 14 days, the mean value of plasma tyrosine was still 808 micromol/L. Fasted follow-up samples obtained from subjects several weeks later showed tyrosine values back to normal. There were no reports of changes in vital signs or laboratory data of any clinical significance. One patient reported sensitivity to sunlight. Hyper-tyrosinemia has been reported with nitisinone treatment 


How should I store and handle NITYR?

Store refrigerated between 2°C and 8°C (36°F and 46°F). Handle and dispose of topotecan injection consistent with recommendations for the handling and disposal of hazardous drugs. Protect from light.Sterile, Nonpyrogenic, Preservative-free.Store refrigerated between 2°C and 8°C (36°F and 46°F). Handle and dispose of topotecan injection consistent with recommendations for the handling and disposal of hazardous drugs. Protect from light.Sterile, Nonpyrogenic, Preservative-free.Store refrigerated between 2°C and 8°C (36°F and 46°F). Handle and dispose of topotecan injection consistent with recommendations for the handling and disposal of hazardous drugs. Protect from light.Sterile, Nonpyrogenic, Preservative-free.Tablets:  White to off white, round, flat tablets debossed with the “strength” in mg on one side and “L” on the other side. Each tablet contains 2, 5 or 10 mg nitisinone. NITYR tablets are packed in high-density polyethylene (HDPE) square bottles with a child-resistant tamper-evident polypropylene (PP) screw cap. Each bottle contains 60 tablets.2 mg tablets: From white to off white, round, flat tablets debossed “2” on one side and “L” on the other side, NDC 70709-002-605 mg tablets: From white to off white, round, flat tablets debossed “5” on one side and “L” on the other side, NDC 70709-005-6010 mg tablets: From white to off white, round, flat tablets debossed “10” on one side and “L” on the other side, NDC 70709-000-60Store NITYR tablets at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight and light resistant container as defined in USP.Tablets:  White to off white, round, flat tablets debossed with the “strength” in mg on one side and “L” on the other side. Each tablet contains 2, 5 or 10 mg nitisinone. NITYR tablets are packed in high-density polyethylene (HDPE) square bottles with a child-resistant tamper-evident polypropylene (PP) screw cap. Each bottle contains 60 tablets.2 mg tablets: From white to off white, round, flat tablets debossed “2” on one side and “L” on the other side, NDC 70709-002-605 mg tablets: From white to off white, round, flat tablets debossed “5” on one side and “L” on the other side, NDC 70709-005-6010 mg tablets: From white to off white, round, flat tablets debossed “10” on one side and “L” on the other side, NDC 70709-000-60Store NITYR tablets at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight and light resistant container as defined in USP.Tablets:  White to off white, round, flat tablets debossed with the “strength” in mg on one side and “L” on the other side. Each tablet contains 2, 5 or 10 mg nitisinone. NITYR tablets are packed in high-density polyethylene (HDPE) square bottles with a child-resistant tamper-evident polypropylene (PP) screw cap. Each bottle contains 60 tablets.2 mg tablets: From white to off white, round, flat tablets debossed “2” on one side and “L” on the other side, NDC 70709-002-605 mg tablets: From white to off white, round, flat tablets debossed “5” on one side and “L” on the other side, NDC 70709-005-6010 mg tablets: From white to off white, round, flat tablets debossed “10” on one side and “L” on the other side, NDC 70709-000-60Store NITYR tablets at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight and light resistant container as defined in USP.Tablets:  White to off white, round, flat tablets debossed with the “strength” in mg on one side and “L” on the other side. Each tablet contains 2, 5 or 10 mg nitisinone. NITYR tablets are packed in high-density polyethylene (HDPE) square bottles with a child-resistant tamper-evident polypropylene (PP) screw cap. Each bottle contains 60 tablets.2 mg tablets: From white to off white, round, flat tablets debossed “2” on one side and “L” on the other side, NDC 70709-002-605 mg tablets: From white to off white, round, flat tablets debossed “5” on one side and “L” on the other side, NDC 70709-005-6010 mg tablets: From white to off white, round, flat tablets debossed “10” on one side and “L” on the other side, NDC 70709-000-60Store NITYR tablets at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight and light resistant container as defined in USP.Tablets:  White to off white, round, flat tablets debossed with the “strength” in mg on one side and “L” on the other side. Each tablet contains 2, 5 or 10 mg nitisinone. NITYR tablets are packed in high-density polyethylene (HDPE) square bottles with a child-resistant tamper-evident polypropylene (PP) screw cap. Each bottle contains 60 tablets.2 mg tablets: From white to off white, round, flat tablets debossed “2” on one side and “L” on the other side, NDC 70709-002-605 mg tablets: From white to off white, round, flat tablets debossed “5” on one side and “L” on the other side, NDC 70709-005-6010 mg tablets: From white to off white, round, flat tablets debossed “10” on one side and “L” on the other side, NDC 70709-000-60Store NITYR tablets at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight and light resistant container as defined in USP.Tablets:  White to off white, round, flat tablets debossed with the “strength” in mg on one side and “L” on the other side. Each tablet contains 2, 5 or 10 mg nitisinone. NITYR tablets are packed in high-density polyethylene (HDPE) square bottles with a child-resistant tamper-evident polypropylene (PP) screw cap. Each bottle contains 60 tablets.2 mg tablets: From white to off white, round, flat tablets debossed “2” on one side and “L” on the other side, NDC 70709-002-605 mg tablets: From white to off white, round, flat tablets debossed “5” on one side and “L” on the other side, NDC 70709-005-6010 mg tablets: From white to off white, round, flat tablets debossed “10” on one side and “L” on the other side, NDC 70709-000-60Store NITYR tablets at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight and light resistant container as defined in USP.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Nitisinone is a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme upstream of fumarylacetoacetate hydrolase (FAH) in the tyrosine catabolic pathway. By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the catabolic intermediates maleylacetoacetate and fumarylacetoacetate. In patients with HT-1, these catabolic intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate, which are responsible for the observed liver and kidney toxicity. Succinylacetone can also inhibit the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate, a neurotoxin responsible for the porphyric crises characteristic of HT-1.

Nitisinone inhibits catabolism of the amino acid tyrosine and can result in elevated plasma levels of tyrosine. Therefore, treatment with nitisinone requires restriction of the dietary intake of tyrosine and phenylalanine to prevent the toxicity associated with elevated plasma levels of tyrosine

Non-Clinical Toxicology
None.

The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.

Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index.

Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin chloride was administered with ketoconazole, a potent CYP3A4 inhibitor.

Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are coadministered.

Nitisinone is an inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme in the tyrosine metabolic pathway . Therefore, treatment with NITYR may cause an increase in plasma tyrosine levels in patients with HT-1. Maintain concomitant reduction in dietary tyrosine and phenylalanine while on NITYR. Do not adjust the dosage of NITYR in order to lower the plasma tyrosine concentration. Maintain plasma tyrosine levels below 500 micromol/L. Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine levels and levels greater than 500 micromol/L may lead to the following:

In patients with HT-1 treated with dietary restrictions and NITYR who develop elevated plasma tyrosine levels, assess dietary tyrosine and phenylalanine intake.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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