Pyrukynd
Generic name: mitapivat
Dosage form: tablets, for oral use
Drug class: Miscellaneous metabolic agents
What is Pyrukynd?
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).
It is not known if Pyrukynd is safe and effective in children.
Before taking Pyrukynd
Before you start treatment, tell your healthcare provider about all your medical conditions, including if you:
- have liver problems.
- are pregnant or plan to become pregnant. It is not known if Pyrukynd will harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment.
- are breastfeeding or plan to breastfeed. It is not known if Pyrukynd passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.
What other drugs will affect Pyrukynd?
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
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.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
How should I take Pyrukynd?
- Take Pyrukynd exactly as your healthcare provider tells you to take it.
- Take the Pyrukynd tablets with or without food.
- Swallow the tablets whole. Do not split, chew, crush, or dissolve the tablets.
- Do not change your dose or stop treatment without talking to your healthcare provider. Your healthcare provider will give you instructions for stopping Pyrukynd. See Pyrukynd side effects.
- If you miss a dose 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.
Dosing information
Usual Adult Dose for Pyruvate Kinase Deficiency
- Starting dosage: 5 mg orally twice daily with or without food. See table below for dose titration and taper schedule.
- Use: treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
|
Duration
|
Dosage
|
| Week 1 through Week 4 | 5 mg twice daily |
| Week 5 through Week 8 |
If Hb is below normal range or patient has required a transfusion within the last 8 weeks:
If Hb is within normal range and patient has not required a transfusion within the last 8 weeks:
|
| Week 9 through Week 12 |
If Hb is below normal range or patient has required a transfusion within the last 8 weeks:
If Hb is within normal range and patient has not required a transfusion within the last 8 weeks:
|
| Maintenance | If Hb decreases, consider up-titration to the maximum of 50 mg twice daily as per the above schedule. |
Pyrukynd side effects
Pyrukynd may cause serious side effects, including:
- Rapid breakdown of red blood cells (acute hemolysis) has happened after suddenly interrupting or stopping treatment. You should not suddenly stop taking Pyrukynd. If you have to stop your treatment, your healthcare provider should monitor you closely. Tell your healthcare provider right away if you develop any signs or symptoms of breakdown of red blood cells including:
- yellowing of the skin or the whites of your eyes (jaundice)
- dark colored urine
- dizziness
- confusion
- feeling tired
- shortness of breath
The most common side effects include:
- decrease in reproductive hormone (estrone) in men
- increased salt from uric acid (urate) blood test
- decrease in reproductive hormone (estradiol) in men
- joint pain (arthralgia)
- back pain
These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Pyrukynd?
- 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.
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Pyrukynd.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.
What are the ingredients in Pyrukynd?
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.
More about Pyrukynd (mitapivat)
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- During pregnancy
- FDA approval history
- Drug class: miscellaneous metabolic agents
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
