Alkaptonuria Treatments
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Generic Name
Nitisinone
Brand Names
Harliku, NITYR, Orfadin
FDA approval date: June 01, 2016
Classification: 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Form: Tablet, Suspension, Capsule
What is Harliku (Nitisinone)?
HARLIKU TM is indicated for the reduction of urine homogentisic acid in adult patients with alkaptonuria . HARLIKU is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the reduction of urine homogentisic acid in adult patients with alkaptonuria .
Approved To Treat
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Brand Information
HARLIKU (nitisinone)
1INDICATIONS AND USAGE
HARLIKU
2DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg white to beige, round, flat tablets, which may display light yellow to brown speckles, debossed with “2” mg on one side and “L” on the other side.
3CONTRAINDICATIONS
None.
4DESCRIPTION
HARLIKU (nitisinone) is a hydroxyphenyl-pyruvate dioxygenase inhibitor.
Nitisinone occurs as a 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.
The chemical name of nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione. The molecular formula is C
Each HARLIKU (nitisinone) tablet contains 2 mg of nitisinone to be administered orally. The inactive ingredients are glyceryl dibehenate and lactose monohydrate.
5HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
HARLIKU (nitisinone) tablet is white to beige, round, flat which may display light yellow to brown speckles, debossed with the “strength” in mg on one side and “L” on the other side. Each tablet contains 2 mg nitisinone.
HARLIKU is supplied in a high-density polyethylene (HDPE) square bottle with a child-resistant tamper-evident polypropylene (PP) screw cap. Each bottle contains 60 tablets.
2 mg tablets: NDC 70709-112-60
Storage and Handling
Store HARLIKU tablets at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Pharmacist: Dispense in tight and light resistant container as defined in USP.
6PATIENT COUNSELING INFORMATION
Ocular Symptoms and Hyperkeratotic Plaques Due to Elevated Plasma Tyrosine Levels
Advise the patient or caregiver to report any unexplained ocular or other symptoms promptly to their healthcare provider
How Supplied/Storage and Handling
Advise the patient or caregiver to store HARLIKU in the container that it is dispensed in and keep the container tightly closed