Nitide
Generic Name
Nitisinone 100 mg suspension
Manufacturer
Hypothetical Pharmaceuticals Ltd.
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nitide 100 mg suspension | ৳ 35.11 | N/A |
Description
Overview of the medicine
Nitisinone is an oral medication used to treat hereditary tyrosinemia type 1 (HT-1) in combination with a restricted diet of tyrosine and phenylalanine. It works by preventing the buildup of toxic byproducts that can cause liver and kidney damage.
Uses & Indications
Dosage
Adults
Initially 0.5 mg/kg body weight once daily, adjusted based on plasma succinylacetone levels and clinical response. Maximum recommended dose is 2 mg/kg/day.
Elderly
No specific dosage adjustment recommended for elderly patients; however, monitor renal and hepatic function closely.
Renal_impairment
Use with caution. Dosage may need adjustment based on succinylacetone levels and clinical status. Monitor renal function.
How to Take
Administer orally once daily. Shake the suspension well before each use. Measure the dose accurately using an oral syringe. Can be taken with or without food.
Mechanism of Action
Nitisinone reversibly inhibits 4-hydroxyphenylpyruvate dioxygenase (HPPD), an enzyme involved in the catabolism of tyrosine. This prevents the formation of maleylacetoacetate and fumarylacetoacetate, which are then converted to the highly toxic succinylacetone that causes severe damage in HT-1.
Pharmacokinetics
Onset
Within days to weeks, as evidenced by reduction in succinylacetone levels.
Excretion
Mainly through renal excretion of unchanged drug and its metabolites.
Half life
Approximately 54 hours in children, 21-50 hours in adults.
Absorption
Well absorbed orally. Peak plasma concentrations are achieved in approximately 3 hours.
Metabolism
Primarily by CYP3A4, with minor contributions from CYP2C9 and CYP2D6.
Side Effects
Contraindications
- Hypersensitivity to nitisinone or any component of the formulation.
- Patients who cannot or will not adhere to a restricted diet of tyrosine and phenylalanine, due to the risk of severe ocular toxicity and developmental delay.
Drug Interactions
CYP3A4 Inducers
May decrease nitisinone plasma concentrations. Co-administration should be approached with caution and plasma levels monitored.
CYP3A4 Inhibitors
May increase nitisinone plasma concentrations. Monitor for increased adverse effects.
Other drugs that affect liver or kidney function
May require careful monitoring due to potential alterations in drug clearance.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Once opened, may be stored at room temperature below 25°C (77°F) for up to 60 days.
Overdose
In case of overdose, no specific antidote is available. Management should be symptomatic and supportive, including close monitoring and strict adherence to the restricted diet. Adjust nitisinone dose or temporarily discontinue if necessary.
Pregnancy & Lactation
Use in pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is not known whether nitisinone is excreted in human milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to nitisinone or any component of the formulation.
- Patients who cannot or will not adhere to a restricted diet of tyrosine and phenylalanine, due to the risk of severe ocular toxicity and developmental delay.
Drug Interactions
CYP3A4 Inducers
May decrease nitisinone plasma concentrations. Co-administration should be approached with caution and plasma levels monitored.
CYP3A4 Inhibitors
May increase nitisinone plasma concentrations. Monitor for increased adverse effects.
Other drugs that affect liver or kidney function
May require careful monitoring due to potential alterations in drug clearance.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Once opened, may be stored at room temperature below 25°C (77°F) for up to 60 days.
Overdose
In case of overdose, no specific antidote is available. Management should be symptomatic and supportive, including close monitoring and strict adherence to the restricted diet. Adjust nitisinone dose or temporarily discontinue if necessary.
Pregnancy & Lactation
Use in pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is not known whether nitisinone is excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months for unopened product; refer to product label for specific duration after opening (e.g., 60 days when stored below 25°C).
Availability
Specialized pharmacies, hospitals
Approval Status
FDA Approved
Patent Status
Patent expired for original brand, generics available
Clinical Trials
Approval was based on clinical trials demonstrating that nitisinone, combined with dietary management, significantly reduces succinylacetone levels and improves clinical outcomes, including survival, in HT-1 patients.
Lab Monitoring
- Plasma succinylacetone levels (to monitor treatment efficacy and adherence).
- Plasma amino acid levels (especially tyrosine and phenylalanine, to ensure dietary adherence and prevent toxicity).
- Liver function tests (LFTs) including ALT, AST, bilirubin.
- Renal function tests (e.g., serum creatinine, BUN, electrolytes).
- Complete blood count (CBC) to monitor for leukopenia and thrombocytopenia.
Doctor Notes
- Emphasize the absolute necessity of strict adherence to the low-tyrosine/low-phenylalanine diet for all patients on nitisinone.
- Regular and comprehensive monitoring of plasma succinylacetone, tyrosine, phenylalanine, liver function, and renal function is critical for optimal management.
- Educate patients/caregivers on the importance of ophthalmological examinations to detect and manage potential ocular toxicity early.
- Review drug interactions, especially with CYP3A4 modulators, and adjust therapy as needed.
Patient Guidelines
- Strictly adhere to the prescribed low-tyrosine and low-phenylalanine diet as directed by your doctor and dietitian.
- Do not discontinue Nitide-100 mg suspension without consulting your healthcare provider.
- Report any vision changes, eye irritation, skin rashes, or unusual bleeding/bruising immediately.
- Attend all scheduled clinic visits and laboratory tests for monitoring treatment effectiveness and safety.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double dose to make up for a missed one.
Driving Precautions
Nitisinone can cause ocular side effects such as photophobia (sensitivity to light) and keratitis, which may impair vision. Patients should exercise caution when driving or operating machinery, especially in bright conditions, until they know how the medication affects them.
Lifestyle Advice
- Maintain regular communication with your medical team, including your metabolic specialist and dietitian, to manage your condition effectively.
- Be vigilant for symptoms of high tyrosine levels, such as eye problems (photophobia, redness), skin lesions, or changes in neurological status.
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