Deepika vegiraju at 08:13, 12 June 2023

2023-06-12T08:13:47Z

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== '''What is Trofinetide?''' ==

* Trofinetide ('''Daybue'''), is '''an analog of glycine-proline-glutamate (GPE)''', a protein that occurs naturally in the brain.

[[File:Trofinetide.svg|thumb|Trofinetide]]

[[File:Trofinetide structure.png|thumb|Trofinetide structure]]

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== '''What are the uses of this medicine?''' ==

* Trofinetide ('''Daybue''') is a prescription medicine used to treat [[Rett syndrome]] in adults and children 2 years of age and older.

== '''How does this medicine work?''' ==

* The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.

== '''Who Should Not Use this medicine ?''' ==

* This medicine have no usage limitations.

== '''What drug interactions can this medicine cause?''' ==

* Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
* Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Be sure to mention any of the following:
* [[laxatives]]
* Orally administered CYP3A4 sensitive substrates
* OATP1B1 and OATP1B3 substrates

== '''Is this medicine FDA approved?''' ==

* Trofinetide was approved for medical use in the United States in March 2023.

== '''How should this medicine be used?''' ==

'''Recommended dosage:'''
Administer Daybue orally twice daily, in the morning and evening, according to patient weight as shown:
* 9 kg to less than 12 kg: 5,000 mg twice daily(25 mL twice daily)
* 12 kg to less than 20 kg: 6,000 mg twice daily(30 mL twice daily)
* 20 kg to less than 35 kg: 8,000 mg twice daily(40 mL twice daily)
* 35 kg to less than 50 kg: 10,000 mg twice daily (50 mL twice daily)
* 50 kg or more: 12,000 mg twice daily (60 mL twice daily)

'''Administration:'''
* Take Daybue exactly as your healthcare provider tells you to take it.
* If you take laxatives, stop taking them before starting treatment with Daybue.
* Your healthcare provider may change your dose or stop treatment with Daybue if needed.
* Your pharmacist should provide an oral syringe or dosing cup that is needed to measure your prescribed dose. Do not use a household measuring cup.
* Daybue may be taken by mouth or given through a gastrostomy (G) tube. If Daybue is given through a gastrojejunal (GJ) tube, the G-port must be used.
* Daybue may be taken with or without food.
* Throw away any unused Daybue after 14 days of first opening the bottle.
* If you vomit after taking a dose of Daybue, do not take another dose to make up for that dose. Wait and take the next dose at your usual time.
* If you miss a dose of Daybue, skip that dose and take your next dose at your usual time. Do not take 2 doses to make up the missed dose.

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

This medicine is available in fallowing doasage form:
* '''As Oral solution:''' 200 mg/mL

This medicine is available in fallowing brand namesː
* '''Daybue'''

=='''What side effects can this medication cause?'''==

The most common side effects of this medicine include:
* [[Diarrhea]]
* Vomiting
* Fever
* [[Seizure]]
* [[Anxiety]]
* Decreased appetite
* [[Fatigue]]
* [[Nasopharyngitis]]

Less common, but serious side effects may include:
* [[Diarrhea]]
* Weight loss

==''' What special precautions should I follow?''' ==

* Most patients experience [[diarrhea]] during treatment with Daybue. Advise patients to stop [[laxatives]] before starting Daybue. If diarrhea occurs, patients should start [[antidiarrheal]] treatment, increase oral fluids, and notify their healthcare provider. Interrupt, reduce dose, or discontinue Daybue if severe diarrhea occurs or if [[dehydration]] is suspected.
* Weight loss may occur in patients treated with Daybue. Monitor weight and interrupt, reduce dose, or discontinue Daybue if significant weight loss occurs.
* Advise the caregiver or patient that Daybue can cause vomiting and if vomiting occurs after Daybue administration, do not take an additional dose, but continue with the next scheduled dose.
* Advise the caregiver or patient that Daybue may be given orally or via [[gastrostomy]] (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. Daybue may be taken with or without food.
* Instruct the caregiver or patient to obtain a calibrated measuring device, such as an oral syringe or oral dosing cup, from the pharmacy to measure and deliver the prescribed dose accurately. A household measuring cup is not an adequate measuring device.
* Instruct the caregiver or patient to discard any unused Daybue after 14 days of first opening the bottle.
* It is not known if Daybue passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Daybue.

== '''What to do in case of emergency/overdose?''' ==

* {{overdose}}

== '''Can this medicine be used in pregnancy?''' ==

* There are no adequate data on the developmental risks associated with the use of Daybue in pregnant women.
* It is not known if Daybue will harm your unborn baby.

=='''Can this medicine be used in children?'''==

* The safety and effectiveness of Daybue for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older.
* Safety and effectiveness in pediatric patients less than 2 years of age have not been established.

== '''What are the active and inactive ingredients in this medicine?''' ==

* '''Active ingredient:''' trofinetide
* '''Inactive ingredients:''' FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose.

== '''Who manufactures and distributes this medicine?''' ==

* Marketed by [[Acadia Pharmaceuticals Inc.]], San Diego, CA, USA
* Daybue is a trademark of Acadia Pharmaceuticals Inc.

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

* Store Daybue in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
* Keep Daybue in an upright position.
* Keep the child-resistant cap tightly closed.

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[[Category:Anti-inflammatory agents]]
[[Category:Tripeptides]]

Trofinetide - Revision history

Deepika vegiraju at 08:13, 12 June 2023