Alpelisib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Uma Maveli[2]
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Uma Maveli[4]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
WARNING: SEVERE HYPERSENSITIVITY TO ALPELISIB
See full prescribing information for complete Boxed Warning.
Severe hypersensitivity: Anaphylaxis and Anaphylactic shock
The symptoms of these hypersensitivity reactions include dyspnea, flushing, rash, fever, and/or tachycardia About 7% of the patients showed signs of these symptoms. In cases of anaphylaxis or anaphylactic shock, patients showed Grade 3 or 4 hypersensitivity reactions Patients should be advised of the severe hypersensitivity reaction
|
Overview
Alpelisib is a kinase inhibitors that is FDA approved for the treatment of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include The most common adverse reactions for patients indicated for Alpelisib come in the form of laboratory abnormalities. The include increase in glucose, creatinine, GGT, ALT, or lipase, decrease in lymphocyte count, hemoglobin, appetite, calcium, weight, calcium, or glucose, the presence of diarrhea, rash, nausea, fatigue or alopecia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
ALPELISIB is indicated for:
Limitations of Use
Recommended Vaccination and Prophylaxis
Recommended Weight-Based Dosage Regimen
Recommended Weight-Based Dosage Regimen
Dosing Considerations
Preparation of ALPELISIB
Administration of ALPELISIB
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding ALPELISIB Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.
Non–Guideline-Supported Use
There is limited information regarding ALPELISIB Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding ALPELISIB FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding ALPELISIB Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.
Non–Guideline-Supported Use
There is limited information regarding ALPELISIB Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.
Contraindications
There is limited information regarding Alpelisib Contraindications in the drug label.
Warnings
|
WARNING: SEVERE HYPERSENSITIVITY TO ALPELISIB
See full prescribing information for complete Boxed Warning.
Severe hypersensitivity: Anaphylaxis and Anaphylactic shock
The symptoms of these hypersensitivity reactions include dyspnea, flushing, rash, fever, and/or tachycardia About 7% of the patients showed signs of these symptoms. In cases of anaphylaxis or anaphylactic shock, patients showed Grade 3 or 4 hypersensitivity reactions Patients should be advised of the severe hypersensitivity reaction
|
Serious Meningococcal Infections
Other Infections
Monitoring Disease Manifestations after ALPELISIB Discontinuation
Infusion Reactions
Adverse Reactions
Clinical Trials Experience
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Atypical Hemolytic Uremic Syndrome (aHUS)
Immunogenicity
Postmarketing Experience
There is limited information regarding Alpelisib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Alpelisib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There are no available data on ALPELISIB use in pregnant women to inform a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Alpelisib in women who are pregnant.
Labor and Delivery
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Nursing Mothers
There is no FDA guidance on the use of Alpelisib in women who are nursing.
Pediatric Use
The safety and efficacy of ALPELISIB for the treatment of PNH in pediatric patients have not been established.
Geriatic Use
Clinical studies of ALPELISIB did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Gender
There is no FDA guidance on the use of ALPELISIB with respect to specific gender populations.
Race
There is no FDA guidance on the use of ALPELISIB with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of ALPELISIB in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of ALPELISIB in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of ALPELISIB in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of ALPELISIB in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Alpelisib Administration in the drug label.
Monitoring
There is limited information regarding Alpelisib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Alpelisib and IV administrations.
Overdosage
If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
Alpelisib
| |
| Systematic (IUPAC) name | |
| ? | |
| Identifiers | |
| CAS number | |
| ATC code | ? |
| PubChem | ? |
| Chemical data | |
| Formula | ? |
| Mol. mass | 188303.705 Da |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
? |
| Legal status | |
| Routes | ? |
Mechanism of Action
- Ravulizumab-cwvz is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex [C5b-9]) and preventing the generation of the terminal complement complex C5b9.
Structure
There is limited information regarding ALPELISIB Structure in the drug label.
Pharmacodynamics
There is limited information regarding Alpelisib Pharmacodynamics in the drug label.
Pharmacokinetics
Distribution
Elimination
Specific Populations
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Clinical Studies
There is limited information regarding Alpelisib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Alpelisib How Supplied in the drug label.
Storage
There is limited information regarding Alpelisib Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Alpelisib |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Alpelisib |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
Meningococcal Infection
Other Infections
Discontinuation
Infusion reactions
- Advise patients that administration of ALPELISIB may result in infusion reactions.
Precautions with Alcohol
Alcohol-Alpelisib interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
Piqray
Look-Alike Drug Names
There is limited information regarding ALPELISIB Look-Alike Drug Names in the drug label.
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.