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Daybue Stix
trofinetide
Adult Dosing .
Dosage forms: POWDER: 5000 mg per packet, 6000 mg per packet, 8000 per packet
Rett syndrome
- [20-34.9 kg]
- Dose: 8000 mg PO/GT/GJ bid; Info: interrupt tx, decr. dose, or D/C if severe diarrhea, vomiting, or significant weight loss
- [35-49.9 kg]
- Dose: 10,000 mg PO/GT/GJ bid; Info: interrupt tx, decr. dose, or D/C if severe diarrhea, vomiting, or significant weight loss
- [>50 kg]
- Dose: 12,000 mg PO/GT/GJ bid; Info: interrupt tx, decr. dose, or D/C if severe diarrhea, vomiting, or significant weight loss
renal dosing
- [see below]
- eGFR 30-59: decr. usual dose by 50%; eGFR <30: avoid use
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: POWDER: 5000 mg per packet, 6000 mg per packet, 8000 per packet
Rett syndrome
- [2 yo and older, 9-11.9 kg]
- Dose: 5000 mg PO/GT/GJ bid; Info: interrupt tx, decr. dose, or D/C if severe diarrhea, vomiting, or significant weight loss
- [2 yo and older, 12-19.9 kg]
- Dose: 6000 mg PO/GT/GJ bid; Info: interrupt tx, decr. dose, or D/C if severe diarrhea, vomiting, or significant weight loss
- [2 yo and older, 20-34.9 kg]
- Dose: 8000 mg PO/GT/GJ bid; Info: interrupt tx, decr. dose, or D/C if severe diarrhea, vomiting, or significant weight loss
- [2 yo and older, 35-49.9 kg]
- Dose: 10,000 mg PO/GT/GJ bid; Info: interrupt tx, decr. dose, or D/C if severe diarrhea, vomiting, or significant weight loss
- [2 yo and older, >50 kg]
- Dose: 12,000 mg PO/GT/GJ bid; Info: interrupt tx, decr. dose, or D/C if severe diarrhea, vomiting, or significant weight loss
renal dosing
- [see below]
- eGFR 30-59: decr. usual dose by 50%; eGFR <30: avoid use
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- eGFR <30
- caution: eGFR 30-59
Drug Interactions .
Overview
trofinetide
IGF-1 tripeptide
- CYP3A4 inhibitor, weak
- P-gp inhibitor, weak
Contraindicated
- cisapride
- colchicine
- eliglustat
Avoid/Use Alternative
- alprazolam
- apixaban
- codeine
- dabigatran
- ensartinib
- hydrocodone
- meperidine
- methadone
- neratinib
- oxycodone
- pimozide
- pralsetinib
- propafenone
- relugolix
- repotrectinib
- rivaroxaban
- simvastatin
- topotecan
- venetoclax
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- afatinib
- amiodarone
- atorvastatin
- avanafil
- avapritinib
- bisacodyl
- bisacodyl rectal
- brigatinib
- capivasertib
- carbamazepine
- castor oil
- clozapine
- cyclosporine
- digoxin
- disopyramide
- dofetilide
- domperidone
- edoxaban
- encorafenib
- entrectinib
- eplerenone
- erythromycin
- everolimus
- fedratinib
- felodipine
- finerenone
- flibanserin
- gepirone
- glycerin rectal
- ibrutinib
- ivabradine
- ivosidenib
- lactulose
- lemborexant
- levoketoconazole
- lomitapide
- lonafarnib
- loperamide
- lovastatin
- lumateperone
- lurasidone
- magnesium citrate
- magnesium hydroxide
- mavacamten
- mavorixafor
- methylcellulose
- midazolam
- mineral oil
- mineral oil rectal
- mobocertinib
- morphine
- nifedipine
- nimodipine
- nisoldipine
- pacritinib
- pemigatinib
- polycarbophil
- polyethylene glycol
- polyethylene glycol/electrolytes
- psyllium
- quinidine (antiarrhythmic)
- ranolazine
- red yeast rice
- ribociclib
- selpercatinib
- sennosides
- sirolimus
- sodium phosphate rectal
- sorbitol
- tacrolimus
- tadalafil
- talazoparib
- taletrectinib
- tenofovir alafenamide
- tenofovir disoproxil
- tolvaptan
- triazolam
- ubrogepant
- vardenafil
- warfarin
- zanubrutinib
Caution Advised
- cariprazine
- cobimetinib
- cyclophosphamide
- daridorexant
- darolutamide
- elinzanetant
- ergotamine
- fexinidazole
- glecaprevir
- methylergonovine
- naldemedine
- palovarotene
- pexidartinib
- pibrentasvir
- rilzabrutinib
- roflumilast
- verapamil
Adverse Reactions .
Serious Reactions
- diarrhea, severe
- vomiting, severe
- seizures
Common Reactions
- diarrhea
- vomiting
- weight loss
- fever
- seizures
- anxiety
- appetite decr.
- fatigue
- nasopharyngitis
Safety/Monitoring .
Monitoring Parameters
eGFR at baseline; weight
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of fetal harm based on animal data at less than MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for trofinetide: liver minimally; CYP450: minimal
Excretion: for trofinetide: urine 80% (primarily unchanged), feces 15.3%; Half-life: 1.5h
Subclass: Rett Syndrome
Mechanism of Action
for trofinetide: exact mechanism of action unknown; enhances neuronal synaptic function and morphology (IGF-1 amino-terminal tripeptide analog)
Formulary .
No Formulary Selected
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