1. Select a treatment
  2. HARLIKU™ (nitisinone) Tablets

HARLIKU™ (nitisinone) Tablets

What is HARLIKU?

HARLIKU is the first and only FDA-approved treatment for alkaptonuria (AKU), indicated for the reduction of urine homogentisic acid (HGA) in adult patients.1

Taking HARLIKU is simple, at once daily dosing, and offers the flexibility to be taken with or without food.1

Nitisinone, the active ingredient in HARLIKU, reduces HGA production by up to 97%, and may slow down the progression of AKU.1 It may help ease pain, reduce fatigue, and improve your physical functioning.2

At Cycle Pharma, we understand the importance of providing product support that complements treatment for patients living with a rare disease. That’s why we created Cycle Vita™, delivering individualized product support* at every step.

Placeholder Image

Find out more about HARLIKU

Support available to you with HARLIKU

Download and print the enrollment form, share it with your doctor and discuss why you think HARLIKU may be suited to your needs.

Enroll here

The first steps

Your Cycle Vita team will quickly get to work with your insurance provider to help you understand your coverage.

If prior authorization is needed, our experienced team will work with your insurance provider to understand the requirements and assist your healthcare provider to ensure they are met.

We will route your HARLIKU therapy to the appropriate specialty pharmacy and follow-up to ensure swift shipment of your medication.

Additional assistance, when required, throughout your journey

In some cases, an appeal for insurance coverage may be needed. Where this is the case, our experienced team will work with your insurance and healthcare providers to understand the requirements and help you with any HARLIKU reimbursement gaps.

If you are 18 years of age or older, and have commercial insurance, you may be eligible for the Cycle Vita Co-Pay Assistance Program.

Please contact us to find out more about this and other programs that may be available to you.

If you are 18 years of age or older and have commercial insurance, a free supply of HARLIKU is available to help you begin therapy immediately. Meanwhile, we will secure appropriate Benefit Verification and assist your healthcare provider with Prior Authorization, as necessary.

The Bridge Program may also be requested if you experience a temporary disruption in therapy due to insurance coverage. Bridge duration is driven by insurance coverage and the active collaboration of your clinic.

Important notice

We provide product support to help you manage every aspect of your HARLIKU therapeutic routine, such as onboarding onto therapy, clinical education and ongoing support with adherence.

Additional support with nutrition and educational resources to manage the physical aspects of AKU are available at request.

Translation services are available on request.

What is AKU?

Patients with AKU have trouble breaking down a chemical called homogentisic acid (HGA), an intermediate product in the breakdown of tyrosine (an amino acid commonly found in protein-rich food). Over time, HGA builds up around the bones and cartilage, leading to symptoms such as skin discoloration and joint pain.3

Common symptoms of AKU include black urine, black spots in the eyes, discoloration of the ears, and joint pain that is typically worse in knees, hips, shoulders and back. Other organs can be affected too, which can lead to kidney stones and heart complications.4

AKU is diagnosed by the appearance of characteristic symptoms, patient history and elevated levels of HGA in the urine.5

Resources

Resource IconFull Prescribing Information
Download
Resource IconPHI Form
Download
Resource IconEnrollment Form
Download
Resource IconPatient Initiation Brochure
Download

Footnote
*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482.

HARLIKU™ is a trademark of Cycle Pharmaceuticals Limited in the United States.

References

  1. HARLIKU™ (nitisinone) Tablets. Prescribing Information. Cycle Pharmaceuticals Ltd.
  2. Spears KR, Rossignol F, Perry MB, et al. 2024 Patient-reported outcomes and functional assessments of patients with Alkaptonuria in a 3-year Nitisinone treatment trial. Mol Genet Metab. 143(1-2),108562. doi:10.1016/j.ymgme.2024.108562
  3. Sharabi A, Goudar R. 2023. Alkaptonuria. Available at: https://www.ncbi.nlm.nih.gov/books/NBK560571/ [Accessed: April 29 2025].
  4. Introne WJ, Perry M, Chen M. 2003 (updated 2021). Alkaptonuria. Available at: https://www.ncbi.nlm.nih.gov/sites/books/NBK1454/ [Accessed: June 16 2025].
  5. AKU Society. Diagnosis. Available at: https://akusociety.org/diagnosis/ [Accessed: May 2 2025].

View

Indication and Important Safety Information: HARLIKU™ (nitisinone) Tablets

INDICATIONS

HARLIKU™ (nitisinone) Tablets is indicated for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU).

Important Safety Information

Do not take HARLIKU if you are allergic to nitisinone or any of the other ingredients. Tell your healthcare provider about any health problems, and if you are pregnant or planning to become pregnant and/or breastfeeding, before starting treatment.

Serious Adverse Reactions:

Eye Symptoms and Skin Changes Due To Elevated Plasma Tyrosine Levels:

Inadequate restriction of tyrosine and phenylalanine intake can result in elevated levels of plasma tyrosine, which may lead to keratitis (eye problems) and hyperkeratotic plaques (thickening of the skin on the soles and palms).

  • Your healthcare provider will obtain a slit-lamp examination prior to initiating HARLIKU treatment, regularly during treatment and may reexamine you if you develop symptoms or if you develop high plasma tyrosine levels.
  • Your HARLIKU treatment may be temporarily interrupted until symptoms have resolved.

Changes in Blood Profile:

  • You may develop leukopenia (reduction in the number of white blood cells, which form part of the immune system) and severe thrombocytopenia (abnormally low levels of platelets, which help the blood to clot).
  • Your healthcare provider will monitor platelet and white blood cell counts during HARLIKU therapy.

Common Adverse Reactions:

The most common adverse reactions (≥1%) reported in patients with AKU taking nitisinone in the clinical trials were elevated tyrosine levels, low platelets (thrombocytopenia) and inflammation of the cornea, eye irritation, eye pain and photophobia (keratitis).

Drug Interactions:

Nitisinone can interfere with the effect of other medicines. Tell your healthcare provider or pharmacist if you are taking, have recently taken or might take any other medicines.

Use in Specific Populations:

Pregnancy: The safety of this medicine has not been studied in pregnancy. Tell your healthcare provider immediately if you become pregnant or are planning to become pregnant.

Lactation: The safety of this medicine has not been studied in breastfeeding women. Tell your healthcare provider immediately if you plan to breastfeed.

Pediatric Use: The safety of this medicine have not been studied in pediatric patients with AKU.

Geriatric Use: Clinical studies of HARLIKU did not include a sufficient number of patients 65 years of age and older, to determine whether they respond differently from younger adult patients. Elderly patients should be cautious reflecting any decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

If you get any side effects, talk to your healthcare provider. This includes possible side effects not listed above.

For more detailed information, please refer to the full Prescribing Information at harliku.com/pi/

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.