Trofinetide
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Dosage Recommendations in Patients with Renal Impairment No dosage adjustment is recommended for patients with mild renal impairment (estimated glomerular filtration rate [eGFR] 60 to 89 mL/min for adult patients or 60 to 89 mL/min/1.73 m 2 for pediatric patients). The recommended dosage of DAYBUE or DAYBUE STIX for patients with moderate renal impairment (eGFR 30 to 59 mL/min for adult patients or 30 to 59 mL/min/1.73 m 2 for pediatric patients) is described in Table 4 [see Use in Specific Populations , Clinical Pharmacology ].
DAYBUE and DAYBUE STIX are not recommended for patients with severe renal impairment (eGFR less than 30 mL/min for adult patients or less than 30 mL/min/1.73 m 2 for pediatric patients). For patients with moderate renal impairment who require a dose less than 5,000 mg, DAYBUE oral solution is recommended. Do not attempt to use partial packets of DAYBUE STIX to prepare a dose. [See table below.]
| Dosage | DAYBUE Oral Solution Volume |
|---|---|
| 2,500 mg twice dailyDosage for patients with moderate renal impairment [see Dosage and Administration (2.6)] | 12.5 mL twice daily |
| 3,000 mg twice daily | 15 mL twice daily |
| 4,000 mg twice daily | 20 mL twice daily |
| 5,000 mg twice daily | 25 mL twice daily |
| 6,000 mg twice daily | 30 mL twice daily |
| 8,000 mg twice daily | 40 mL twice daily |
| 10,000 mg twice daily | 50 mL twice daily |
| 12,000 mg twice daily | 60 mL twice daily |
| Patient Weight | Recommended Dosage |
|---|---|
| 9 kg to less than 12 kg | 2,500 mg twice dailyUse DAYBUE oral solution to administer this dosage. |
| 12 kg to less than 20 kg | 3,000 mg twice daily |
| 20 kg to less than 35 kg | 4,000 mg twice daily |
| 35 kg to less than 50 kg | 5,000 mg twice daily |
| 50 kg or more | 6,000 mg twice daily |
Preparation and administration
DAYBUE Oral Solution Preparation Table 2 includes the volume of DAYBUE oral solution to administer for the corresponding recommended dosage [see Dosage and Administration (2.1 , 2.6) ] . A calibrated measuring device, such as an oral syringe or oral dosing cup, should be obtained from the pharmacy to measure and deliver the prescribed dose accurately.
A household measuring cup, teaspoon, or tablespoon is not an adequate measuring device. [See table below.] Discard any unused DAYBUE oral solution after 14 days of first opening the bottle [see How Supplied/Storage and Handling ] .
DAYBUE STIX for Oral Solution Preparation Prior to administration, DAYBUE STIX for oral solution powder must be dissolved in a cold to room temperature water or water-based beverage (juice, tea, lemonade, limeade, or liquid hydration). Preparation of DAYBUE STIX Determine the correct dosage as shown in Table 1 or Table 4 (for patients with moderate renal impairment).
Select the appropriate packet strength and number of packets required for each dose, as shown in Table 3 . Determine the appropriate volume of liquid within the recommended volume range as shown in Table 3 , based on individual patient factors (e.g., age, palatability). Measure the volume of liquid determined in Step 3 by using a calibrated measuring device obtained from the pharmacy.
Empty the entire contents of the DAYBUE STIX packet(s) into the measured liquid. Do not attempt to use partial packets to prepare a dose. Stir until the powder is completely dissolved. Administer the prepared oral solution immediately; do not store for future use. Discard any prepared oral solution that is not immediately administered. [See table below.] 12,000 mg Two 6,000 mg packets 30 mL to 120 mL (each packet requires 15 mL to 60 mL)
Dose Modification for Vomiting After Administration If vomiting occurs after DAYBUE or DAYBUE STIX administration, an additional dose should not be taken. Instead, continue with the next scheduled dose. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management [see Warnings and Precautions ] .
| Dosage | DAYBUE Oral Solution Volume |
|---|---|
| 2,500 mg twice dailyDosage for patients with moderate renal impairment [see Dosage and Administration (2.6)] | 12.5 mL twice daily |
| 3,000 mg twice daily | 15 mL twice daily |
| 4,000 mg twice daily | 20 mL twice daily |
| 5,000 mg twice daily | 25 mL twice daily |
| 6,000 mg twice daily | 30 mL twice daily |
| 8,000 mg twice daily | 40 mL twice daily |
| 10,000 mg twice daily | 50 mL twice daily |
| 12,000 mg twice daily | 60 mL twice daily |
| Dose | DAYBUE STIX Packet(s) Needed to Prepare Each Dose | Volume of Liquid Required to Dissolve Entire DoseLiquid types include water or water-based beverage., Volume should be selected within the recommended range based on individual patient factors. |
|---|---|---|
| 5,000 mg | One 5,000 mg packet | 15 mL to 60 mL |
| 6,000 mg | One 6,000 mg packet | 15 mL to 60 mL |
| 8,000 mg | One 8,000 mg packet | 25 mL to 120 mL |
| 10,000 mg | Two 5,000 mg packets | 30 mL to 120 mL (each packet requires 15 mL to 60 mL) |
| 12,000 mg | Two 6,000 mg packets | 30 mL to 120 mL (each packet requires 15 mL to 60 mL) |
Drug interactions
Check trofinetide against a medication listLabel text (2 paragraphs)
Orally administered CYP3A and/or P-gp sensitive substrates for which a small change in substrate plasma concentration may lead to serious adverse reactions: closely monitor for adverse reactions with concomitant use. ( 7.1 )
7.1 Effect of DAYBUE and DAYBUE STIX on Other Drugs CYP3A and/or P-gp Substrates Closely monitor patients when DAYBUE or DAYBUE STIX is administered concomitantly with sensitive CYP3A and/or P-gp substrates where minimal increases in the plasma concentration of these substrates may lead to serious adverse reactions. Trofinetide, a weak inhibitor of CYP3A and an inhibitor of P-gp, increased the plasma concentrations of CYP3A and/or P-gp substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions associated with these substrates.
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of DAYBUE or DAYBUE STIX in pregnant women. No adverse developmental effects were observed following oral administration of trofinetide to pregnant animals at doses associated with plasma exposures below those used clinically [see Animal Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Oral administration of trofinetide (0, 150, 450, or 1000 mg/kg twice daily; 0, 300, 900, or 2000 mg/kg/day) to pregnant rats during the period of organogenesis resulted in no adverse effects on embryofetal development. At the highest dose tested, plasma exposure (AUC) was less than that in humans at the maximum recommended human dose (MRHD) of 12,000 mg twice daily (24,000 mg/day). Oral administration of trofinetide (0, 75, 150, or 300 mg/kg twice daily; 0, 150, 300, or 600 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in no adverse effects on embryofetal development.
At the highest dose tested, plasma exposure (AUC) was less than that in humans at the MRHD. Oral administration of trofinetide (0, 150, 450, or 1000 mg/kg twice daily; 0, 300, 900, or 2000 mg/kg/day) to rats throughout pregnancy and lactation resulted in no adverse effects on pre- and postnatal development. At the highest dose tested, plasma exposure (AUC) was less than that in humans at the MRHD.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.