Interactions between Piqray and Trofinetide
1 drug interaction and 8 additional warnings found for the following 2 drugs:
- Piqray (alpelisib)
- trofinetide
Drug interactions
Moderate drug interactions
Moderate:
alpelisib trofinetide
Applies to: Piqray (alpelisib) and trofinetide
Monitor
Coadministration with trofinetide may increase the plasma concentrations of drugs that are substrates of CYP450 3A4 via inhibition of the isoenzyme. Based on pharmacokinetic modeling, concomitant use of trofinetide and oral midazolam, a sensitive CYP450 3A4 substrate, is predicted to increase midazolam systemic exposure (AUC) by approximately 1.33-fold. Clinical data are currently lacking.
Management
Caution is advised if trofinetide is coadministered with CYP450 3A4 substrates, particularly sensitive substrates or those with a narrow therapeutic range. If concomitant use is required, clinical and laboratory monitoring may be appropriate whenever trofinetide is added to or withdrawn from therapy. The prescribing information for concomitant medications should be consulted to assess the benefits versus risks of coadministration and for any dosage adjustments that may be required.
References (1)
- (2023) "Product Information. Daybue (trofinetide)." Acadia Pharmaceuticals
Food/lifestyle interactions
Moderate food/lifestyle interactions
Moderate:
alpelisib Food/Lifestyle
Applies to: Piqray (alpelisib)
Adjust dosing interval
Food significantly enhances the oral absorption and bioavailability of alpelisib. When administered with a high-fat high-calorie meal (985 calories with 58.1 g of fat) or a low-fat low-calorie meal (334 calories with 8.7 g of fat) the AUC and Cmax of a single dose of alpelisib was increased by 73% and 84% and 77% and 145%, respectively. There were no clinically significant differences in alpelisib AUC between the two types of meals. In addition, food appears to have a more pronounced effect on the solubility of alpelisib than gastric pH. When coadministered with a single 300 mg dose of alpelisib, ranitidine decreased the absorption and overall exposure of alpelisib. Following administration of ranitidine with a low-fat low-calorie meal, the mean AUC and Cmax of alpelisib was decreased by 21% and 36%, respectively. Administration of ranitidine under fasting conditions reduced the mean AUC and Cmax of alpelisib by 30% and 51%, respectively.
Management
To ensure maximal oral absorption, alpelisib should be administered with a meal.
References (1)
- (2019) "Product Information. Piqray (alpelisib)." Novartis Pharmaceuticals
Disease interactions
7 potential interactions Applies to: 7 conditions, including Diarrhea, Diabetes Mellitus, Interstitial Lung Disease, Renal Dysfunction, and Dermatitis, Drug-Induced.
Dermatitis, Drug-Induced
Moderate:
Piqray
The alpelisib in Piqray has a moderate potential interaction with Dermatitis, Drug-Induced.
Severe cutaneous reactions, including Stevens-Johnson Syndrome (SJS) and Erythema Multiforme (EM) were reported in patients treated with alpelisib. Do not initiate alpelisib treatment in patients with a history of SJS, EM, or Toxic Epidermal Necrolysis (TEN). If signs or symptoms of severe cutaneous reactions occur, interrupt treatment until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If SJS, TEN, or EM is confirmed, permanently discontinue alpelisib. Do not reintroduce alpelisib in patients who have experienced previous severe cutaneous reactions during treatment.
Diabetes Mellitus
Moderate:
Piqray
The alpelisib in Piqray has a moderate potential interaction with Diabetes Mellitus.
Severe hyperglycemia, including ketoacidosis, has been reported in patients treated with alpelisib. Before initiating treatment with alpelisib it is recommend to test, optimize and monitor blood glucose as clinically indicated. Care should be exercised when using this agent in diabetic patients. Patients with a history of diabetes mellitus may require intensified diabetic treatment. Based on the severity of the hyperglycemia, alpelisib may require dose interruption, reduction, or discontinuation. Advise patients of the signs and symptoms of hyperglycemia. Closely monitor patients with diabetes.
Diarrhea
Moderate:
Piqray
The alpelisib in Piqray has a moderate potential interaction with Diarrhea.
Severe diarrhea, including dehydration and acute kidney injury, occurred in patients treated with alpelisib. Based on the severity of the diarrhea, alpelisib may require dose interruption, reduction, or discontinuation. Care should be exercised when using this agent in patients with diarrhea. Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs while taking alpelisib.
Interstitial Lung Disease
Moderate:
Piqray
The alpelisib in Piqray has a moderate potential interaction with Interstitial Lung Disease.
Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, has been reported in patients treated with alpelisib. It is recommended to interrupt alpelisib immediately and evaluate the patient for pneumonitis in patients who have new or worsening respiratory symptoms or are suspected to have developed pneumonitis. Advise patients to immediately report new or worsening respiratory symptoms. Permanently discontinue alpelisib in all patients with confirmed pneumonitis.
Osteonecrosis of Jaw
Moderate:
Piqray
The alpelisib in Piqray has a moderate potential interaction with Osteonecrosis of Jaw.
Osteonecrosis of the jaw (ONJ) has been reported in patients using alpelisib. Caution is advised when this drug and bisphosphonates or denosumab are used either simultaneously or sequentially. Do not initiate treatment with alpelisib in patients with ongoing osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates or denosumab. Patients experiencing ONJ should be managed according to clinical practice.
Pleuropulmonary Infection
Moderate:
Piqray
The alpelisib in Piqray has a moderate potential interaction with Pleuropulmonary Infection.
Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, has been reported in patients treated with alpelisib. It is recommended to interrupt alpelisib immediately and evaluate the patient for pneumonitis in patients who have new or worsening respiratory symptoms or are suspected to have developed pneumonitis. Advise patients to immediately report new or worsening respiratory symptoms. Permanently discontinue alpelisib in all patients with confirmed pneumonitis.
Renal Dysfunction
Moderate:
Piqray
The alpelisib in Piqray has a moderate potential interaction with Renal Dysfunction.
No dose adjustment is recommended for patients with mild to moderate renal impairment (CrCl 30 to < 90 mL/min). Close monitoring is recommended when using alpelisib in patients with severe renal impairment (CrCl < 30 mL/min) as its effect on the pharmacokinetics is unknown.
Report options
More resources
Piqray
A total of 356 drugs are known to interact with Piqray.
- Piqray is in the drug class PI3K inhibitors.
- Piqray is used to treat the following conditions:
trofinetide
A total of 407 drugs are known to interact with trofinetide.
- Trofinetide is in the drug class miscellaneous central nervous system agents.
- Trofinetide is used to treat Rett Syndrome.
Drug Interaction Classification
| Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
| Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
| Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. | |
| No interaction information available. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.