Alpelisib is an anticancer drug indicated for the treatment of advanced or metastatic breast cancer in men and postmenopausal women.
Alpelisib is an anticancer drug that is indicated for the treatment of advanced or metastatic breast cancer in postmenopausal women and men.
3.Hypersensitivity to Alpelisib
The recommended dose of Alpelisib is 300mg- two 150mg tablets taken once daily orally with food.
Available tablet strength of Alpelisib- 50mg, 150mg, 200mg In case of adverse effects consider dose interruption, reduction, or discontinuation
Dose of Alpelisib should be taken with food and at the same time every day.
The tablets of Alpelisib should be swallowed whole. Do not crush, chew or spilt the tablet. Do not take the tablet if it is broken, cracked, or otherwise not intact.
The recommended dose of Fulvestrant is 500 mg with Alpelisib on days 1, 15, and 29, and once monthly thereafter.
If a dose of Alpelisib is missed then take the missed dose within 9 hours with food.
Skip the dose for that day if the time passed is more than 9 hours, take Alpelisib at the usual time the next day.
If the patient vomits a dose of Alpelisib, then advise the patient not to take an additional dose on that day and the next dose should be taken according to the schedule at the usual time.
1.Gastrointestinal symptoms- Diarrhea, Nausea, Vomiting, Abdominal pain, indigestion, painful swelling and sores inside the mouth (stomatitis), weight loss
2. Administration site and General disorders- Fatigue, Fever, mucosal inflammation, swelling, mucosal dryness
3. Infections- Urinary Tract Infection (UTI)
4. Nutrition and Metabolism Disorder- Reduced appetite
5.Skin and Subcutaneous tissue disorder- rash, dry skin, sudden hair loss, itching
6.Nervous disorder- headache, impaired sense of taste (dysgeusia)
1.In case of severe hypersensitivity reactions- shortness of breath, skin rash, fever, itching then permanently discontinue Alpelisib and start appropriate treatment.
2.Severe skin reactions- In case of severe skin reactions like Stevens-Johnson syndrome (severe skin rash) and Erythema Multiforme (skin rash) discontinue Alpelisib and consult a dermatologist. Do not start treatment in patients with a history of Stevens-Johnson syndrome (SJS), Erythema Multiforme (EM) or Toxic Epidermal Necrolysis (TEN).
3.Before starting treatment with Alpelisib, test blood sugar parameters like fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After starting treatment with Alpelisib, monitor blood sugar levels and initiate appropriate medications. In case of severely high blood sugar levels, interrupt, stop or reduce the dose.
4.Alpelisib can cause severe pneumonitis (inflammation of lung tissue) and lung diseases. Monitor patients for the same and discontinue or interrupt the drug if severe pneumonitis occurs.
5.During treatment with Alpelisib, most patients experience diarrhea, start antidiarrheal treatment, increase oral fluid intake, and inform healthcare providers if diarrhea continues. If severe diarrhea occurs then interrupt, discontinue or reduce the dose of Alpelisib.
6.Embryo-fetal toxicity- Alpelisib can cause harm to the fetus. Males and females should use appropriate contraception during treatment and 1 week after treatment.
7.The patient should inform the healthcare provider about all the medicines they take including, OTCs, vitamins, herbal supplements, and prescription medicines.
1.Phenobarbital, phenytoin, rifampicin, glucocorticoids
2.Nelfinavir, ritonavir, gefitinib, imatinib
3.Amiodarone, fluorouracil, metronidazole, miconazole, warfarin, etc.
Store at room temperature between 68°F to 77°F (20°C to 25°C).