Nitisinone — Membership Pricing

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About Nitisinone

Nitisinone is a crucial medication prescribed for individuals with Hereditary Tyrosinemia Type 1 (HT-1), a rare genetic disorder. This life-saving treatment helps manage the severe symptoms of the condition. At TheDrugClub, we recognize the significant financial burden specialty medications like nitisinone can impose and are dedicated to helping our members access potential savings.

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Nitisinone is approved for (FDA label)

Nitisinone capsules are indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Nitisinone is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. (1)

Source: Read the full FDA label on DailyMed. Label effective date: August 6, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Nitisinone (FDA label)

Nitisinone Capsules are available as: 2 mg: White Opaque Hard gelatin capsule shell Size #3, imprinted with black ink as "008" on cap and "Novitium 2 mg" on body, filled with white to off white powder blend. 5 mg: White Opaque Hard gelatin capsule shell Size #3, imprinted with black ink as "009" on cap and "Novitium 5 mg" on body, filled with white to off white powder blend. 10 mg: White Opaque Hard gelatin capsule shell Size #3, imprinted with black ink as "010" on cap and "Novitium 10 mg" on body, filled with white to off white powder blend. Capsules: 2 mg, 5 mg, 10 mg. (3)

Source: FDA prescribing information (DailyMed). Set ID: 437868f5-1c9e-4b0f-8a03-77df8ac0900d. SPL document ID: 403b3d85-e7be-4cc8-b286-bd0a099dae77. Label effective date: August 6, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Nitisinone (FDA label)

Most common adverse reactions (>1%) are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Source: FDA prescribing information (DailyMed). Set ID: 437868f5-1c9e-4b0f-8a03-77df8ac0900d. SPL document ID: 403b3d85-e7be-4cc8-b286-bd0a099dae77. Label effective date: August 6, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Nitisinone (FDA label)

Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust nitisinone dosage in order to lower the plasma tyrosine concentration.

Source: FDA prescribing information (DailyMed). Set ID: 437868f5-1c9e-4b0f-8a03-77df8ac0900d. SPL document ID: 403b3d85-e7be-4cc8-b286-bd0a099dae77. Label effective date: August 6, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Nitisinone (FDA label)

Nitisinone is a moderate CYP2C9 inhibitor, a weak CYP2E1 inducer and an inhibitor of OAT1/OAT3. Table 2 includes drugs with clinically important drug interactions when administered concomitantly with nitisinone and instructions for preventing or managing them. Table 2: Clinically Relevant Interactions Affecting Co-Administered Drugs Sensitive CYP2C9 Substrates (e.g., celecoxib, tolbutamide) or CYP2C9 Substrates with a Narrow Therapeutic Index (e.g., phenytoin, warfarin) Clinical Impact Increased exposure of the co-administered drugs metabolized by CYP2C9. [see Clinical Pharmacology (12.3)] Intervention Reduce the dosage of the co-administered drugs metabolized by CYP2C9 drug by half. Additional dosage adjustments may be needed to maintain therapeutic drug concentrations for narrow therapeutic index drugs. See prescribing information for those drugs. OAT1/OAT3 Substrates (e.g., adefovir, ganciclovir, methotrexate) Clinical Impact Increased exposure of the interacting drug [see Clinical Pharmacology (12.3)] Intervention Monitor for potential adverse reactions related to the co-administered drug.

Source: FDA prescribing information (DailyMed). Set ID: 437868f5-1c9e-4b0f-8a03-77df8ac0900d. SPL document ID: 403b3d85-e7be-4cc8-b286-bd0a099dae77. Label effective date: August 6, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.