Gedatolisib
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From MedlinePlus, U.S. National Library of Medicine
Kinase Inhibitor
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Recommended Dosage and Administration The recommended dosage of REVTORPYK is 180 mg as an intravenous infusion over 30 minutes once weekly on Days 1, 8, and 15 of every 28-day cycle, in combination with fulvestrant, with or without palbociclib, until disease progression or unacceptable toxicity. If a planned dose is delayed or missed, administer as soon as possible thereafter.
Do not wait until the next planned dose in the cycle. Adjust the timing of the subsequent dose to maintain the 3 weeks on followed by 1 week off schedule. Refer to the Prescribing Information for fulvestrant and palbociclib administered in combination with REVTORPYK for additional dosing information.
Preparation and Administration Reconstitute and further dilute REVTORPYK prior to intravenous infusion. Use appropriate aseptic technique. Reconstitution Add 20 mL of Sterile Water for Injection or 5% Dextrose Injection to the REVTORPYK vial. Swirl the vial until completely dissolved for up to 5 minutes. Minor foaming and opalescence may be observed.
If not used immediately, store the reconstituted solution in the vial for up to 4 hours at room temperature at 20°C to 25°C (68°F to 77°F). Do not freeze or refrigerate. REVTORPYK does not contain a preservative. Discard unused reconstituted REVTORPYK vial after 4 hours. DO NOT use common chloride-containing infusion solutions (for example: normal saline, Ringer’s solution, Lactated Ringer’s solution).
Dilution Withdraw the appropriate volume of the reconstituted solution from the REVTORPYK vial (See Table 3) using a sterile syringe. Inspect visually for particulate matter and discoloration prior to administration. The solution should be free of visible particulates, be clear (minor opalescence is acceptable) and colorless to pale yellow.
Discard the vial if particles or discoloration are observed. Table 3: Volume to Withdraw from Reconstituted Vial Based on [See table below.] Dilute the reconstituted REVTORPYK in an infusion bag containing 250 mL of 5% Dextrose Injection. Gently invert the infusion bag to thoroughly mix the solution. Do not shake. If not used immediately, store the diluted REVTORPYK infusion solution at room temperature at 20°C to 25°C (68°F to 77°F) for up to 24 hours.
Do not freeze or refrigerate. Discard any unused portion left in the vial. Administration Flush the intravenous line with 5% Dextrose Injection before REVTORPYK administration. Administer REVTORPYK by intravenous infusion over 30 minutes through a dedicated infusion line equipped with a sterile, non-pyrogenic, in-line or add-on polyether sulfone filter (0.2- or 0.22-micron pore size) and catheter.
DO NOT administer any chloride-containing solutions (e.g., Sodium Chloride for Injection, Ringer’s Injection, Lactated Ringer’s Injection) or other medications concomitantly via the same intravenous line. Upon completion of the infusion, flush the intravenous line with 5% Dextrose Injection. Discard any unused portions left in the infusion set.
| Dose | Volume of Reconstituted REVTORPYK |
| 180 mg | 20 mL |
| 150 mg | 17 mL |
| 130 mg | 14 mL |
Drug interactions
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- Gedatolisib
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for gedatolisib. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary REVTORPYK is used in combination with fulvestrant, with or without palbociclib. Refer to the Prescribing Information for fulvestrant and palbociclib for pregnancy information. When used in combination with REVTORPYK, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data in pregnant women to inform the drug-associated risk.
Animal reproductive toxicity studies have not been conducted with REVTORPYK. Inhibition of PI3K and mTOR pathways have been associated with adverse embryo-fetal growth and lethality in animals ( see Data ). 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 PIK3CA knockout mice experienced developmental delay at embryonic day 9.5 and mortality between embryonic day 9.5 and 10.5. mTOR knockout mice experienced early lethality by embryonic day 7.5.
In both animal models, early embryonic death was a result of impaired cell proliferation and structural development.
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.