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VIJOICE (alpelisib)
- PIK3CA-related overgrowth spectrum
125 mg tablet
- 1 tablet (125 mg) by oral route once daily
250 mg/day(200 mg x 1 and 50 mg x 1) tablet
- by oral route once daily per package directions
50 mg tablet
- 1 tablet (50 mg) by oral route once daily
Default screening record
- by oral route once daily per package directions
- 1 tablet (50 mg) by oral route once daily
- 1 tablet (125 mg) by oral route once daily
- 2 tablets (250 mg) by oral route once daily
- None
Contraindicated
- None
Severe
Moderate
- None
- Lactation
Contraindicated
- Dehydration
- Hyperglycemia
- Interstitial lung disease
- Interstitial pneumonitis
- Pregnancy
- Severe diarrhea
Severe
Moderate
- Diabetes mellitus
VIJOICE (alpelisib)
- PIK3CA-related overgrowth spectrum
- Anemia
- Dehydration
- Hyperglycemia
- Hypocalcemia
- Hypoglycemic disorder
- Increased alanine transaminase
- Lymphopenia
- Alopecia
- Anorexia
- Diarrhea
- Elevated serum lipase
- Fatigue
- Prolonged activated partial thromboplastin time
- Skin rash
- Stomatitis
- Vomiting
- Weight loss
More Frequent
Severe
Less Severe
- Abnormal hepatic function tests
- Kidney disease with reduction in GFR
- Acute abdominal pain
- Dry skin
- Dysgeusia
- Headache disorder
- Peripheral edema
- Pruritus of skin
- Urinary tract infection
- Vulvovaginal dryness
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Anaphylaxis
- Angioedema
- Colitis
- DRESS syndrome
- Erythema multiforme
- Hyperosmolar hyperglycemic state
- Hypersensitivity drug reaction
- Interstitial pneumonitis
- Ketoacidosis
- Stevens-johnson syndrome
- Toxic epidermal necrolysis
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Alpelisib
Safety and efficacy not established age < 18 years.
- 1 Day – 18 Years
- Safety and efficacy not established age < 18 years.
Alpelisib
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible
Contraindicated
Alpelisib
Avoid breastfeeding during treatment and for 1 week after last dose.
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Avoid breastfeeding during treatment and for 1 week after last dose. |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Alpelisib
Endocrine-Incidence and severity of hyperglycemia is higher in the patients >75 years. Monitor blood glucose monitoring and increase monitoring frequency in diabetic patients.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | N | N | N | Y |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
| PIk3Ca-related overgrowth spectrum | |
| Q87.3 | Congenital malformation syndromes involving early overgrowth |
| 0-9 | A-Z |
|---|---|
| Q87.3 | Congenital malformation syndromes involving early overgrowth |
Formulary Reference Tool