Orfadin (Nitisinone)

About Medicine

  • Brand Name: Orfadin
  • API: Nitisinone
  • Packaging: Capsules
  • Strength: 2 mg, 5 mg, 10 mg, 20 mg. 
  • Manufacturer Name: Swedish Orphan Biovitrum International AB
Get Price
Categories: ,


General Warning: This medication should not be used during pregnancy unless the clinical condition of the woman needs treatment with the nitisinone. Also, mothers taking this drug must avoid breast-feeding.

Orfadin – Nitisinone 2 mg, 5 mg, 10 mg is supplied for Tenders, Emergency imports, Orphan drug, Reference listed drugs, Comparator Drug, Name patient medicine and Innovator samples etc.

What is ORFADIN:

ORFADIN is a medicine that contains the active substance Nitisinone and is available as Capsules.

How Does Nitisinone(Orfadin) Work?

Nitisinone helps stop the build-up of the toxic substances which can be responsible for causing the severe liver and also kidney problems in patients with the HT-1. In order to do that, it is also helpful in preventing the porphyric crises associated with the HT-1.

In how many countries ORFADIN is approved for marketing?

ORFADIN is available/approved in USA and Europe. We can help you to access it in India.

What is ORFADIN used for?

It is used for the treatment of hereditary tyrosinemia type 1 (HT-1), in addition to limiting the amount of tyrosine and phenylalanine in the diet.

Nitisinone side effects: Patients with this drug may experience some most common side effects which are eye pain, elevated tyrosine levels, conjunctivitis, corneal opacity, keratitis, photophobia, leukopenia, blepharitis, granulocytopenia, epistaxis, exfoliative dermatitis, dry skin, alopecia, cataracts, pruritus, thrombocytopenia and maculopapular rash.

Nitisinone cost: Nitisinone 2 mg, 5 mg, 10 mg is available at a very promising rate.

Nitisinone FDA label should be taken twice a day. Nitisinone should be taken with or without meal however, it should always be taken at about the same way. Therefore, if you start taking this drug with food, you should always take it with food.


Orfadin is a hydroxy-phenylpyruvate dioxygenase inhibitor used for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) together with dietary restriction of tyrosine and phenylalanine.


The recommended starting dosage of nitisinone capsule is 0.5 mg/kg orally (by mouth) twice daily on an empty stomach, at least 1 hour prior to or 2 hours after a meal. In those aged 5 years and older, have undetectable serum and urine succinylacetone concentrations after at least 4 weeks on a stable nitisinone dosage, the total daily dose can be used once daily. Titrate the dosage depending on biochemical or clinical response. The maximum total daily dosage is 2 mg per kg orally. Treatment Reactions: The most commonly reported side effects with Nitisinone Capsules are
  • leukopenia
  • conjunctivitis
  • corneal opacity
  • keratitis
  • photophobia
  • eye pain
  • blepharitis
  • cataracts
  • granulocytopenia
  • epistaxis
  • pruritus
  • exfoliative dermatitis
  • dry skin
  • maculopapular rash
  • alopecia
  • thrombocytopenia
  • elevated tyrosine levels


  • Ocular signs/symptoms including eye pain, corneal opacities, corneal ulcers, keratitis, conjunctivitis, and photophobia may occur with orfadin capsules. Therefore, ophthalmologic examination including slit-lamp examination is required prior to initiating this treatment. 
  • In those with HT-1 treated with dietary restrictions and Nitisinone who develop elevated plasma tyrosine levels, evaluation of dietary tyrosine and phenylalanine intake is recommended. 
  • In clinical trials, patients treated with Nitisinone capsules and dietary restriction developed thrombocytopenia, transient leukopenia, or both. Monitor platelet and white blood cell (WBC) counts throughout the Nitisinone therapy. 
  • Caution is required in those with known history of any allergy, metabolic disorder, who are taking other medicinal products, during pregnancy and breastfeeding.
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). Alternatively, patients/caregivers may store the capsules at room temperature up to 25°C (77°F) for up to 45 days. If not used within 45 days, discard the capsules. Availability in India: The Indian Pharma helps connect buyers with suppliers who can ship ORFADIN at the global level as per the needs of buyer’s. The Indian Pharma (TIP) provides guarantee of quality and delivery for the ORFADIN Capsules. Buying Procedure: In order to buy ORFADIN, you can contact us at our TOLL-FREE Number: 1800 889 1064 or on WhatsApp Number: +919310090915 or an Email us at: info@theindianpharma.com along with your Proof of Identity, Valid Prescription Letter and Medical Reports.  Conclusion: In conclusion, Orfadin (Nitisinone) is a safe and effective adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1).


What does Orfadin contain as an active substance? The Orfadin specifically contains the active substance Nitisinone. Is Nitisinone available in the form of Tablets?  Yes. Nitisinone, also known as NTBC, is available in the form of tablets under the brand-nane Nityr.  Is Orfadin (nitisinone capsules) bioequivalent to Nityr (nitisinone tablets)? Yes, clinical trials have demonstrated Orfadin* capsules is bioequivalent to Nityr* tablets, which means that it has the identical safety, efficacy, and side effects, and may offer patients and their families greater convenience. How much does Nitisinone cost in India? The Cost of nitisinone capsule in India is reasonable and can vary. To buy/order/procure this HT-1 medication authentically, you can Call/WhatsApp +91-9310090915 or send mail to info@theindianpharma.com. Where can I get Orfadin at the best price in India? The Indian Pharma (TIP) helps patients in accessing or importing Orfadin, not approved in their home country against the legitimate prescription and in conformity with the all local laws and regulations of their home country. To get the best Orfadin capsules price in India, you can connect with us today. We’re an authorized (WHO-GDP & ISO 9001:2008) Pharmaceutical Wholesaler Company. Has a generic version of Orfadin been approved? Yes. A generic version of Orfadin has been approved by the Food and Drug Administration (FDA).  Is it safe to buy Orfadin (Nitisinone) online from India?  Yes, You can buy Orfadin (Nitisinone 2 mg, 5 mg, 10 mg) online in India authentically from The Indian Pharma (TIP) if Orfadin is not available or has not been approved in your home country.