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NITYR® (nitisinone) Tablets / NITISINONE TABLETS

NITYR® (nitisinone) Tablets are a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase 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.

Cycles’ NlTYR® is the alternative option to treat patients living with hereditary Tyrosiemia Type 1 (HT-1). HT-1 is an ultra-rare genetic metabolic disease that can cause hepatic, renal and neurological complications. In most cases, if left untreated, the disease is fatal.

NITYR® (nitisinone) Tablets are approved and being prescribed in many countries* across the world

Further detail is available at nityr.us for medical professionals and HT-1 patients.

Important Safety Information

Do not prescribe NITYR to patients allergic to nitisinone or any other ingredients.

Warnings and Precautions:

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 ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms.

·        Do not adjust the NITYR dosage in order to lower the plasma tyrosine concentration.

·        Perform baseline ophthalmologic examination including slit-lamp examination prior to initiating treatment, and regularly during treatment. Reexamine patients if symptoms develop or tyrosine levels are > 500 micromol/L.

·        Perform a clinical laboratory assessment, including plasma tyrosine levels, in patients with an abrupt change in neurologic status.

Leukopenia and Severe Thrombocytopenia Patients can develop leukopenia and severe thrombocytopenia: monitor platelet and white blood cell counts.

Most Common Adverse Reactions: The most common adverse reactions (≥1%) reported in patients with HT-1 taking nitisinone in the clinical trials 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.

Drug Interactions:

  • Nitisinone is a moderate CYP2C9 inhibitor, a weak CYP2E1 inducer and an inhibitor of OAT1/OAT3.

  • Potential clinical impact of concomitant administration with CYP2C9 Substrates: Increased systemic exposure of co-administered drugs metabolized by CYP2C9. Intervention: reduce the dosage of the co-administered drugs metabolized by CYP2C9 by half. Additional dosage adjustments may be needed to maintain therapeutic drug concentrations for narrow therapeutic index drugs.

  • Potential clinical impact of concomitant administration with OAT1/OAT3 Substrates: Increased exposure of these co-administered drugs; monitor for potential adverse reactions.

Use in Specific Populations:

Pregnancy: Limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes.

Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NITYR and any potential adverse effects on the breastfed infant from NITYR or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of nitisinone have been established in pediatric patients for the treatment of HT-1 in combination with dietary restriction of tyrosine and phenylalanine. Use of NITYR in pediatric patients is supported by evidence from one open-label, uncontrolled clinical study conducted with another oral formulation of nitisinone in 207 patients with HT-1 ages 0 to 22 years (median age 9 months)

Geriatric Use: Clinical studies of nitisinone did not include any subjects aged 65 and over. No pharmacokinetic studies of nitisinone have been performed in geriatric patients. In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population.

For more detailed information, please refer to the full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS contact Cycle Pharmaceuticals at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

*NITYR® (nitisinone) Tablets is approved in the USA, Australia, New Zealand, the Kingdom of Saudi Arabia, the Kingdom of Morocco and Israel in 2, 5 and 10 mg strengths and in the EU, Egypt and Chile in 10 mg strength. Cycle Pharmaceuticals’ nitisinone products are also approved under a different name, NITISINONE TABLETS, in Canada in 2, 5, and 10 mg strengths. Registration conditions differ internationally.

SAJAZIR™ (icatibant) Injection

SAJAZIR is an FDA-approved injection indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults aged 18 years and older. 1

HAE is a rare and life-long, genetic condition that affects somewhere between 1 in 10,000–50,000 people.2,3,4 Patients may self-administers SAJAZIR upon recognition of symptoms of a HAE attack after training under the guidance of a health care professional.

For more information on SAJAZIR, please visit www.sajazir.com

Indications

SAJAZIRTM  (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Important Safety Information

Warnings and Precautions

Laryngeal Attacks. Given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately in addition to treatment with SAJAZIR.

Adverse Reactions

The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia (4%), transaminase increase (4%), dizziness (3%), and rash.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of icatibant: urticaria.

Drug Interactions:

ACE Inhibitors. Icatibant is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where icatibant may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.

Use in Specific Populations

Pregnancy: Available data from published literature and the pharmacovigilance database with icatibant use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for icatibant and any potential adverse effects on the breastfed child from icatibant or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Geriatric Use: Elderly patients are likely to have increased systemic exposure to icatibant injection compared to younger (18-45 years) patients. No dose adjustment is recommended.

For more detailed information, please refer to the full Prescribing Information

To report SUSPECTED ADVERSE REACTIONS contact Cycle Pharmaceuticals at 1-800-836-4380, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. SAJAZIR™ (icatibant) Injection. Prescribing Information. Cycle Pharmaceuticals Limited.
  2. Maurer M, et al. Allergy. 2018;73(8):1575–1596.
  3. Zuraw BL, et al. J Allergy Clin Immunol Pract. 2013;1(5):458–467.
  4. El-Shanawany T. Hereditary Angioedema. British Society for Immunology. https://www.immunology.org/public-information/bitesized-immunology/immune-dysfunction/hereditary-angioedema (accessed October 2021).
For NITYR® distribution information in the US market please contact +1-800-847-8714.
For NITYR® distribution information in Canada and all other markets please contact: sales-distribution@cyclepharma.com
For full Safety Information and Prescribing Information please visit:
Website for US Healthcare Professionals

 

Website for Canadian Healthcare Professionals
To report an Adverse Event please click here
STATE REGULATIONS INFORMATION
Information for U.S. Colorado Prescribers of Prescription Drugs Provided Pursuant to Colorado House Bill 19-1131
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