Mitapivat

Generic Name:Mitapivat

Brand Name: Pyrukynd

Dosage Formula tablets, intended for oral use

Medically reviewed by S Shah MD. Updated on March 18, 2022.

What is Mitapivat?

Mitapivat is a prescription medication that is used to treat the low count of red blood cells due to the premature break-up of the red blood cell (hemolytic anemia) for adults suffering from pyruvate insufficient kinase (PK Deficiency).

It isn’t known whether Mitapivat is safe and effective for children.

Mitapivat is an active pyruvate kinase, which is present as mitapivat Sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). Mitapivat’s chemical formula for is:

Mitapivat

Its molecular formula can be described as (C24H26N4SO3)2 H2SO4 3H2O. it has a molecular weight of 1053.23 for mitapivat Sulfate. Mitapivat sulfur is a white or off-white solid, and it is liquid with water.

This medicine is available in five milligrams, 20 grams, or 50 mg tablets that can be taken orally. Each tablet has five mg, twenty mg, or 50 mg mitapivat-free base, which is provided in the form of 5.85 mg, 23.4 mg, or 58.5 mg, respectively of the salt sulfate hydrate as well as the following active ingredients: croscarmellose salt, microcrystalline cellulose, mannitol, and sodium Stearyl fumarate. 

The film coating of the tablet includes inactive ingredients such as FD&C Blue No. 2, hypromellose and lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted using black ink that is based on ammonium hydroxide, an inactive ingredient, ferrosoferric oxide alcohol, n-butyl alcohol propylene glycol, and shellac glaze.

Mechanism of Action

Mitapivat is a pyruvate kinase activator that increases pyruvate kinase (PK) activity by allosterically attaching to the pyruvate kinase tetramer. In PK deficiency, the RBC form of pyruvate kinase (PK-R) is altered, resulting in lower adenosine triphosphate (ATP), shorter RBC lifespan, and persistent hemolysis.

Prior to taking Mitapivat 

Before starting treatment, inform your physician about any medical issues you have for example if you

What other drugs can interact with Mitapivat?

Inform your doctor about the medications you take, which include prescription and over-the-counter medications as well as vitamins and herbal supplements.
Mitapivat along with other medicines can interact, and cause side consequences. Mitapivat could affect how other medicines function and other medications may influence how Mitapivat operates.

Take note of the medications you take. Keep a list to show your healthcare professional or pharmacist when you are prescribed an upcoming medication.

How do I use Mitapivat?

Dosing information

Usual Adult Dose for Pyruvate Kinase Deficiency

Start dose: 5 mg taken orally twice daily either with food or no. Check out the below table for dose titration as well as a taper plan.

– Treatment for hemolytic anemia among adults with pyruvate-kinase (PK) deficiency

Duration Dosage of medication
Week 1 to Week 4 5 mg twice a day
Week 5 to Week 8 If Hb is lower than normal levels or if the patient has needed a transfusion in the past 8 weeks:

  • Increase to 20 mg every day and continue for 4 weeks.

If Hb is in the normal range and the patient hasn’t needed a transfusion during the past 8 weeks:

  • Take 5 mg once a day.
Week 9 to Week 12 If Hb is not within normal levels or the patient needed a transfusion within the past 8 weeks:

  • Increase to 50 mg two times every day and continue to do so.

If Hb is in the normal range and patient hasn’t required a transfusion during the past 8 weeks:

  • Keep current dosage (5 mg twice a day or 20 mg daily).
Maintenance If Hb levels decrease, think about increasing the dosage to 50 mg twice daily , as according to the schedule above.

 For Missed Dose

If you miss a dosage of Mitapivat by 4 hours or less, take it as soon as possible. Do not provide a replacement dose if a Mitapivat dose is missed by more than 4 hours; instead, wait until the next regular dose. Return to your regular dosing schedule after that.

 

Interruption or Discontinuation

When feasible, avoid sudden termination or withdrawal of Mitapivat to lessen the risk of acute hemolysis. To gradually stop using the drug, reduce the dose (see TABLE). Keep an eye on patients for signs of acute hemolysis and anemia worsening.

Table: Dose Taper Schedule
Current Dose Dose Taper Schedule
Day 1-7 Day 8-14 Day 15
Abbreviations: N/A = not applicable.
5 mg twice daily 5 mg once daily Discontinue N/A
20 mg twice daily 20 mg once daily 5 mg once daily Discontinue
50 mg twice daily 50 mg once daily 20 mg once daily Discontinue

Mitapivat side effects

Mitapivat could be a cause of serious adverse reactions, including:

The most commonly reported adverse effects are:

This is not the only list of the possible adverse negative effects. Consult your physician for advice from a medical professional regarding adverse effects. You can report adverse reactions to the FDA at 1-800-FDA-1088.

How do I store it?

Make sure that all medications are away from the reach of pets and children.

General information regarding the safety

Sometimes, medicines are used for reasons other than those described in the Patient Information leaflet. Use this medication only to treat a problem that was not recommended. Don’t give it to others even if they suffer from the same symptoms as you do. It could harm them. You may seek advice from your doctor or pharmacist for advice designed for health professionals.

How Supplied

Mitapivat 28-Day Packs
Tablet Strength Description Imprint NDC
5 mg Round, blue, film-coated tablets “M5” printed on one side 71334-205-05
20 mg Round, blue, film-coated tablets “M20” printed on one side 71334-210-20
50 mg Oblong, blue, film-coated tablets “M50” printed on one side 71334-215-50

 

Mitapivat Taper Packs
Tablet strength(s) Blister Wallet Configuration Tablet Description Imprint NDC
5 mg
  • 5 mg blister wallet containing 7 tablets
round, blue, film-coated tablets “M5” printed on one side 71334-220-11
20 mg and 5 mg
  • 20 mg blister wallet containing 7 tablets
round, blue, film-coated tablets “M20” printed on one side 71334-225-12
  • 5 mg blister wallet containing 7 tablets
round, blue, film-coated tablets “M5” printed on one side
50 mg and 20 mg
  • 50 mg blister wallet containing 7 tablets
oblong, blue, film-coated tablets “M50” printed on one side 71334-230-13
  • 20 mg blister wallet containing 7 tablets
round, blue, film-coated tablets “M20” printed on one side

Label

5 mg Tab

  • Mitapivat tablets
    5 mg per tablet
  • 56 tablets
  • Contains 4-week supply of Mitapivat
    (Four 7-day blister wallets with 14 tablets per wallet)
    Swallow the tablets whole. Do Not split, crush, chew, or dissolve the tablets.
Mitapivat

20 mg Tab

  • Mitapivat tablets
    20 mg per tablet
  • 56 tablets
  • Contains a 4-week supply of Mitapivat
    (Four 7-day blister wallets with 14 tablets per wallet)
    Swallow the tablets whole. Do Not split, crush, chew, or dissolve the tablets.
Pyrukynd

 

50 mg Tab

  • Mitapivat tablets
    50 mg per tablet
  • 56 tablets
  • Contains 4-week supply of Mitapivat
    (Four 7-day blister wallets with 14 tablets per wallet)
    Swallow tablets whole. Do Not split, crush, chew, or dissolve the tablets.
Principal Display Panel - 50 mg Tablet Blister Pack Carton

More details

Always consult your physician to make sure the information presented on this site is appropriate to your specific situation.

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