ALPELISIB TAB,ORAL
Clinical Criteria Summary
Document 455
Indication & Patient Population
- • Advanced or metastatic, HR+, HER2- PIK3CA-mutated breast cancer
- • Postmenopausal women and men who are HR+, HER2-, PIK3CA-mutation+
- • Patients who have progressed on AI-based therapy (with or without CDK4/6i)
- • Excluded populations: inflammatory br ca, DM type 1 or uncontrolled type 2, pneumonitis
Administration & Dosage
- • Oral tablets to be taken with food
- • Administered in combination with fulvestrant 500mg IM injection
Monitoring & Precautions
- • Close monitoring essential for potential cutaneous reactions, severe diarrhea/colitis, pneumonitis and hyperglycemia
- • Caution and close monitoring required in patients with diabetes
- • Severe diarrhea may result in dehydration, AKI
- • Monitor for adverse reactions > 20%: ↑glucose, ↑SCr, diarrhea, rash, ↑GGT, ↑ALT, ↑lipase, ↓lymphocytes, nausea, fatigue, ↓hgb, ↓appetite, stomatitis, vomiting, ↓calcium, ↓glucose, aPTT prolonged
Contraindications & Warnings
- • Severe hypersensitivity to alpelisib or any component of the formulation
- • Warnings/Precautions include: Dermatologic, GI and pulmonary toxicity, hyperglycemia, hypersensitivity
- • No boxed warnings
Drug Interactions
- • Avoid CYP3A4 inducers, BRCP inhibitors
- • Closely monitor with CYP2C9 substrates
Formulary & Restrictions
- • PA-F for Alpelisib + fulvestrant and Fulvestrant alone
- • Restrict to H/O for Fulvestrant alone
Document 457
Exclusion Criteria
- Hypersensitivity to alpelisib or any of its components
Inclusion Criteria
- Men or postmenopausal women with advanced or metastatic breast cancer
- Hormone receptor (HR)-positive, HER2-negative breast cancer
- Activating PIK3CA-mutation positive as detected by an approved test
- Progressive disease on or after an endocrine-based regimen
Additional Inclusion Criteria
- Care is provided by a VA/VA Community Care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0 – 1
- Goals of care and role of Palliative Care consult have been discussed and documented
Additional Inclusion Criteria (Select if applicable)
- For patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 1 week after end