Mitapivat

What is Mitapivat?

• Mitapivat (Pyrukynd) is a pyruvate kinase activator used to treat hemolytic anemia in pyruvate kinase deficiency.

Mitapivat skeletal

What are the uses of this medicine?

• Mitapivat (Pyrukynd) is a prescription medicine used to treat low red blood cell counts caused by the early breakdown of red blood cells (hemolytic anemia) in adults with pyruvate kinase deficiency (PK Deficiency).

How does this medicine work?

• Mitapivat is a pyruvate kinase activator that acts by allosterically binding to the pyruvate kinase tetramer and increasing pyruvate kinase (PK) activity.
• The red blood cell (RBC) form of pyruvate kinase (PK-R) is mutated in PK deficiency, which leads to reduced adenosine triphosphate (ATP), shortened RBC lifespan, and chronic hemolysis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Pyrukynd and certain other medicines may affect each other causing side effects. Pyrukynd may affect the way other medicines work, and other medicines may affect how Pyrukynd works.
• Co-administration of Pyrukynd with strong CYP3A inhibitors increased mitapivat plasma concentrations. Avoid co-administration of strong CYP3A inhibitors with Pyrukynd.
• Co-administration of Pyrukynd with moderate CYP3A inhibitors will increase mitapivat plasma concentrations. Do not titrate Pyrukynd beyond 20 mg twice daily.
• Co-administration of Pyrukynd with strong CYP3A inducers decreased mitapivat plasma concentrations. Avoid co-administration of strong CYP3A inducers with Pyrukynd.
• Co-administration of Pyrukynd with moderate CYP3A inducers will decrease mitapivat plasma concentrations. Consider alternative therapies that are not moderate CYP3A inducers during treatment with Pyrukynd. If there are no alternative therapies, monitor Hb and titrate beyond 50 mg twice daily, if necessary, but do not exceed a maximum recommended dose of 100 mg twice daily.
• Avoid concomitant use with sensitive CYP3A, CYP2B6, CYP2C substrates including hormonal contraceptives that have narrow therapeutic index.
• Avoid concomitant use with UGT1A1 Substrates that have narrow therapeutic index.
• Avoid concomitant use with P-gp Substrates that have narrow therapeutic index.

Is this medicine FDA approved?

• Mitapivat was approved for medical use in the United States in February 2022.

How should this medicine be used?

Recommended dosage:

• The starting dosage for Pyrukynd is 5 mg orally twice daily.
• To gradually increase hemoglobin (Hb), titrate Pyrukynd from 5 mg twice daily to 20 mg twice daily, and then to the maximum recommended dose of 50 mg twice daily, with these dose increases occurring every 4 weeks.
• Assess Hb and transfusion requirement before increasing to the next dose level, as some patients may reach and maintain normal Hb at 5 mg twice daily or 20 mg twice daily.

Administration:

• Take Pyrukynd with or without food.
• Swallow Pyrukynd tablets whole. Do not split, chew, crush, or dissolve the tablets.
• Do not change your dose or stop taking Pyrukynd without talking to your healthcare provider. Your healthcare provider will give you instructions for stopping Pyrukynd.
• If you miss a dose of Pyrukynd by 4 hours or less, take your dose as soon as possible. If more than 4 hours have passed since your regularly scheduled dose, wait for the next dose. Return to your normal schedule at the next dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg, 20 mg, and 50 mg.

This medicine is available in fallowing brand namesː

• Pyrukynd

What side effects can this medication cause?

The most common side effects of this medicine include:

• decrease in reproductive hormone (estrone) in men
• increased salt from uric acid (urate) blood test
• back pain
• decrease in reproductive hormone (estradiol) in men
• joint pain (arthralgia)

Pyrukynd may cause serious side effects, including:

• Rapid breakdown of red blood cells (acute hemolysis)

What special precautions should I follow?

• Acute hemolysis with subsequent anemia has been observed following abrupt interruption or discontinuation of Pyrukynd in a dose-ranging study. Avoid abruptly discontinuing Pyrukynd. Gradually taper the dose of Pyrukynd to discontinue treatment if possible.
• Upon discontinuing Pyrukynd, tell patients to immediately report any symptoms suggestive of acute hemolysis including jaundice, scleral icterus, dark urine, dizziness, confusion, fatigue, or shortness of breath to their healthcare provider for further evaluation.
• Advise patients to inform their healthcare providers of all concomitant medications, including over-the-counter medications, vitamins, and herbal products.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Pyrukynd will harm your unborn baby.
• Available data from clinical trials of Pyrukynd are insufficient to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: mitapivat
• Inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate.
• The tablet film coating contains: FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin.
• The tablets printed with black ink contains: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze.

Who manufactures and distributes this medicine?

Manufactured for and Distributed by:

• Agios Pharmaceuticals, Inc.
• Cambridge, MA
• Pyrukynd® is a trademark of Agios Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store Pyrukynd at room temperature between 68°F to 77°F (20°C to 25°C).
• Store the blister wallets in the original carton until use.

• Dailymed label info on Mitapivat
• FDA Mitapivat

Mitapivat Resources
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Mitapivat Resources
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