ORMALVI™ (dichlorphenamide) tablets

What is ORMALVI?

At Cycle, we know that life-changing treatments need life-improving support to match. That’s why we created Cycle Vita, delivering individualized product support* every step of the way with ORMALVI.

ORMALVI is indicated for the treatment of hyperkalemic periodic paralysis, hypokalemic periodic paralysis and related variants.1

It can help you feel more confident by reducing the frequency and severity of attacks.2

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Support available to you with ORMALVI

Start your ORMALVI enrollment here

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

The first 24hrs

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

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

We will coordinate seamlessly between different parties, such as insurance companies, doctors, and pharmacists to help you with your prior authorization and document requirements.

Additional assistance, when required, throughout your journey

If you have commercial insurance, you may be eligible for the Cycle Vita Co-pay Assistance Program. Commercially insured eligible patients may pay as little as $0. Please contact our Access Specialists to find out more about this and other programs that may be available to you (such as the Bridge Program).

Important notice

A free supply of ORMALVI that, once you are diagnosed, will allow you to begin therapy immediately while Cycle Vita secures appropriate Benefit Verification and Prior Authorization. The Bridge Program may also be requested if you’re an existing patient who is temporarily experiencing disruption in therapy due to insurance coverage. Please contact our Access Specialists to find out more about this and other programs that may be available to you (such as Co-pay Assistance).

Important notice

In some cases, an appeal may be needed. Where this is the case, our experienced team will work with your insurer to understand the requirements and provide your doctor with information to help with the appeal.

If you agree, our proactive team will remind your doctor when your ORMALVI prescription needs to be renewed, in a timely manner, to ensure an uninterrupted supply of your therapy.

We will provide you with product support to help manage every aspect of the ORMALVI therapeutic routine, such as clinical education and onboarding onto dichlorphenamide.

Translation services are available on request.

We will provide you with on-going personal guidance and education through the duration of therapy. Monthly calls can be up to 30-minutes and are tailored to your type of Primary Periodic Paralysis and any known triggers, to reinforce your clinic’s nutrition plan.

Finally reaching a diagnosis can be a relieving experience, but it can be a challenging time too. We can introduce you to the Periodic Paralysis Association (PPA), a non-profit charitable corporation founded to foster awareness of the periodic paralyses, promote science-based information regarding this class of disorder, and champion the interests of the Periodic Paralysis Community.


What is Primary Periodic Paralysis (PPP)?


There are 4 main types of Primary Periodic Paralysis:

  • Hypokalemic (Hypo PP) – This is the most common type of Primary Periodic Paralysis. It is estimated to affect 1 in 100,000 people.3
  • Hyperkalemic (Hyper PP) – This occurs in around 1 in 200,000 people.3
  • Andersen-Tawil Syndrome (ATS) – Also known as cardiodysrhythmic periodic paralysis or potassium‐sensitive periodic paralysis. Anderson-Tawil only affects 1 in 1,000,000 people worldwide.4
  • Paramyotonia Congenita (PMC) – Also known as sodium channel myotonia, is estimated to affect 1 in 100,000 people worldwide.5


Patients with Primary Periodic Paralysis normally inherit a mutated gene from one of their parents, but this is not always the case. Each type of Primary Periodic Paralysis has different triggers:

  • Hypokalemic Periodic Paralysis (Hypo PP) – Patients have low potassium levels in their blood. Paralytic attacks can be worsened by low temperature, anxiety, excessive salt ingestion, lack of exercise, consumption of glucosteroids or alcohol, and anesthetic methods.6
  • Hyperkalemic Periodic Paralysis (Hyper PP)– Patients have high potassium levels in their blood. A paralytic attack can be triggered by potassium-rich food or post-exercise rest and be intensified by low temperature and emotional stress.6
  • Andersen-Tawil Syndrome (ATS) – Potassium doesn’t move in and out of the cells properly. Attacks can be triggered by both low and high potassium levels in patients’ blood. Low temperatures and exercise are also triggers.6
  • Paramyotonia Congenita (PMC) – The mutation of your muscles’ sodium channel causes higher-than-normal muscles excitation. Over excitation of muscles during brief exercise can trigger stiffness in your muscles.7 PMC patients benefit from low potassium diets.8 Patients should also avoid skipping meals and take carbohydrate rich snacks in between meals.9


Primary Periodic Paralysis causes patients to become temporarily paralyzed.

No two patients are the same, but typically symptoms begin in the first or second decade of life. Attacks of flaccid paralysis (weakness) usually occur on awakening in the night or in the early morning. Weakness may be focal or generalized, usually sparing facial and respiratory muscles, and lasting for hours (occasionally days) with gradual resolution. Frequency of individual attacks can vary from daily to a few episodes in a lifetime; attacks often decrease in frequency after age 40.10




The journey to a Primary Periodic Paralysis diagnosis can be a long one, often taking years and involving a multitude of diagnostic studies and misdiagnoses.11 Several symptoms, signs and test results can suggest alternative diagnoses.2 A significant number of these misdiagnoses are psychiatric conditions.11 There is an average of 26 years between age at onset and age at diagnosis.12 Most (82%) individuals who are diagnosed before the age of 20 are from families with a recognized history of periodic paralysis.12

The diagnosis of Primary Periodic Paralysis can be confirmed by genetic testing, which is recommended as the first diagnostic step when there is an intermediate-to-high clinical suspicion. Genetic testing identifies a heterozygous pathogenic mutation in 60% to 70% of patients meeting clinical criteria.2




Resources

 

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 +1 (888) 360-8482.

ORMALVITM is a trademark of Torrent Pharma Inc. in the United States.

References

    1. ORMALVI (dichlorphenamide). Prescribing Information. Cycle Pharmaceuticals Ltd.Statland, J., et al (2017). Review of the Diagnosis and Treatment of Periodic Paralysis. Muscle & Nerve, [online] 57(4), pp.522–530. Available at:: https://doi.org/10.1002/mus.26009 [Accessed 1 Nov. 2023].
    2. Statland, J., et al (2017). Review of the Diagnosis and Treatment of Periodic Paralysis. Muscle & Nerve, [online] 57(4), pp.522–530. Available at:: https://doi.org/10.1002/mus.26009 [Accessed 1 Nov. 2023].
    3. Finsterer, J. (2008). Primary periodic paralyses. Acta Neurologica Scandinavica, [online] 117(3), pp.145–158. Available at: https://doi.org/10.1111/j.1600-0404.2007.00963.x [Accessed 1 Nov. 2023].
    4. Medlineplus.gov. (2017). Andersen-Tawil syndrome: MedlinePlus Genetics. [online] Available at: https://medlineplus.gov/genetics/condition/andersen-tawil-syndrome [Accessed 1 Nov. 2023].
    5. Muscular Dystrophy Association. (2017). Paramyotonia Congenita (Eulenberg Disease) – Diseases | Muscular Dystrophy Association. [online] Available at: https://www.mda.org/disease/paramyotonia-congenita [Accessed 2 Jan. 2024].
    6. Umar Farooque et al  (2020). Primary Periodic Paralyses: A Review of Etiologies and Their Pathogeneses. Cureus. [online] Available at:  https://doi.org/10.7759/cureus.10112 [Accessed 1 Nov. 2023].
    7. National Organization for Rare Disorders. (2023). Paramyotonia Congenita. [online] Available at: https://rarediseases.org/rare-diseases/paramyotonia-congenita/#symptoms [Accessed 2 Jan. 2024].
    8. Channelopathy.nhs.uk. (2023). Dietary Advice For Channelopathies – Channelopathy Service. [online] Available at: https://channelopathy.nhs.uk/patients/living-channelopathies/dietary-advice/1178 [Accessed 2 Jan. 2024].‌
    9. National Organization for Rare Disorders. (2023). Paramyotonia Congenita. [online] Available at: https://rarediseases.org/rare-diseases/paramyotonia-congenita/#therapies [Accessed 2 Jan. 2024].
    10. Venance, S.L., et al. (2005). The primary periodic paralyses: diagnosis, pathogenesis and treatment. Brain, [online] 129(1), pp.8–17. Available at: https://doi.org/10.1093/brain/awh639 [Accessed 1 Nov. 2023].
    11. Charles, B., et al (2013). Characterization of hyperkalemic periodic paralysis: a survey of genetically diagnosed individuals. Journal of Neurology, [online] 260(10), pp.2606–2613. Available at: https://doi.org/10.1007/s00415-013-7025-9 [Accessed 1 Nov. 2023].
    12. Cavel-Greant, D., et al (2012). The impact of permanent muscle weakness on quality of life in periodic paralysis: a survey of 66 patients. Acta myologica: myopathies and cardiomyopathies: official journal of the Mediterranean Society of Myology, [online] 31(2), pp.126–33. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476862/ [Accessed 1 Nov. 2023].
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Indication and Important Safety Information: ORMALVI (dichlorphenamide) tablets

What is ORMALVI?

ORMALVI (pronounced or-MAL-vi) (dichlorphenamide), is a prescription drug used to treat primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and other similar diseases.

What should you tell your healthcare provider before taking ORMALVI?

Tell your doctor if you are allergic to dichlorphenamide or other sulfa drugs, if you take high doses of aspirin, or if you have lung or liver disease; if you are pregnant, plan to become pregnant or are breastfeeding or plan to breastfeed.

What should you know about ORMALVI?

    • Severe allergic and other reactions have happened with sulfonamides (drugs such as ORMALVI) and have sometimes been fatal. Stop taking ORMALVI at the first sign of skin rash, swelling, difficulty breathing, or any other unexpected side effect or reaction, and call 911 right away.

    • Tell your healthcare provider if you take aspirin or if another healthcare provider instructs you to begin taking aspirin. High doses of aspirin should not be taken with ORMALVI.

    • ORMALVI can cause your body to lose potassium, which can lead to heart problems. Your healthcare provider will measure the potassium levels in your blood before you start treatment and at certain times during treatment.

    • Tell your healthcare provider about all other prescription and over-the-counter medicines you take, including supplements, as some medicines can interact with ORMALVI.

    • While taking ORMALVI, your body may produce too much acid or may not be able to remove acid from the body. Your healthcare provider may run tests on a regular basis to check for signs of acid build up.

    • ORMALVI may increase your risk of falling. Tell your healthcare provider right away if you experience a fall while taking ORMALVI.

    • The risks of falls and acid buildup are greater in elderly patients.

    • It is not known whether ORMALVI is safe or effective for people younger than 18 years of age.

What are the most common side effects with ORMALVI?

The most common side effects are a feeling of numbness, tingling or burning (“pins and needles”) in the toes, feet, hands or fingers; trouble with memory or thinking; feeling confused; and unpleasant taste in the mouth.

These are not all of the possible side effects of ORMALVI. Call your healthcare provider for medical advice about side effects.

If you take too much ORMALVI immediately call your doctor or go to the nearest hospital emergency room.

You are encouraged to report negative side effects of prescription drugs. To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at +1-857-437-3969, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

For more detailed information, please refer to the full Prescribing Information at www.ORMALVI.com/PI