Pricing
Prices are indicative MRP and may vary by pharmacy. Trend compares against the last recorded price.
All price changes →Indications & Uses
Alpesib is indicated for:
Pharmacology
Alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K), and it works mainly against PI3Kα. Gain-of-function mutations in the gene that codes for the catalytic α-subunit of PI3K (PIK3CA) activate PI3Kα and Akt-signaling. This leads to cellular transformation and the formation of tumors in both in vitro and in vivo models.
Breast cancer cell lines gave similar findings. Alpelisib blocked the phosphorylation of PI3K downstream targets, including Akt, and it showed activity in cell lines carrying a PIK3CA mutation. Xenograft models, including breast cancer models, showed the same pattern: Alpelisib inhibited the PI3K/Akt signaling pathway and reduced tumor growth.
PI3K inhibition by Alpelisib has been shown to raise estrogen receptor (ER) transcription in breast cancer cells. When Alpelisib was combined with fulvestrant, antitumor activity was greater than with either treatment alone. This was seen in xenograft models derived from ER-positive, PIK3CA mutated breast cancer cell lines.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose of Alpelisib is 300 mg (two 150 mg film coated tablets) taken by mouth once daily with food. Treatment continues until the disease progresses or unacceptable toxicity occurs. Patients should take their dose at about the same time each day. Swallow the tablets whole, and don't chew, crush or split them. A tablet that is broken, cracked or otherwise not intact should not be taken. If a dose is missed, it can be taken with food within 9 hours after the usual time. After more than 9 hours, skip the dose for that day and take it at the usual time the next day. If the patient vomits after taking the dose, advise them not to take an additional dose that day, and to go back to the usual schedule the next day at the usual time. When fulvestrant is given with Alpelisib, the recommended dose of fulvestrant is 500 mg on Days 1, 15 and 29, and once monthly after that.
Side Effects
Alpelisib can cause severe allergic reactions, diarrhea, severe skin reactions, lung problems (pneumonitis) and high blood sugar levels (hyperglycemia).
Cautions & Contraindications
Warnings & Precautions
Severe hypersensitivity: Tell patients the signs and symptoms of severe hypersensitivity reactions. If a severe hypersensitivity reaction happens, stop Alpelisib permanently. Severe cutaneous reactions: Severe skin reactions, including Stevens-Johnson Syndrome (SJS) and Erythema Multiforme (EM), have been reported in patients treated with Alpelisib. Tell patients which signs and symptoms to watch for (e.g., a prodrome of fever, flu-like symptoms, mucosal lesions or a progressive skin rash). Hyperglycemia: Before treatment starts, test FPG and HbA1c, and get blood glucose as well controlled as possible. After starting, monitor blood glucose and/or FPG at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated. Monitor HbA1c every 3 months and as clinically indicated. Depending on how severe the hyperglycemia is, the medicine may need to be interrupted, reduced in dose or stopped. Pneumonitis: Stop the medicine permanently in all patients with confirmed pneumonitis. Tell patients to report any new or worsening respiratory symptoms immediately. Diarrhea: If diarrhea occurs while a patient is taking Alpelisib, they should start antidiarrheal treatment, increase oral fluids and tell their doctor. Embryo-fetal toxicity: Based on findings in animals and its mechanism of action, Alpelisib can cause fetal harm when given to a pregnant woman.
Contraindications
Alpelisib must not be given to anyone who has had a severe hypersensitivity reaction to alpelisib itself or to any of the other ingredients in the medicine.
Pregnancy & Breastfeeding
Pregnancy: Animal data and the way Alpelisib works suggest it can cause fetal harm when a pregnant woman takes it. Lactation: There is no data on whether Alpelisib passes into human milk, or on its effects on milk production or on the breastfed child. Because the breastfed child could have serious adverse reactions, women who are breastfeeding are advised not to breastfeed during treatment and for 1 week after the last dose. Infertility: Findings from animal studies suggest Alpelisib may impair fertility in males and females of reproductive potential.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Alpelisib's pharmacokinetics were not predicted to differ in any clinically significant way by age (21 to 87 years), sex, race/ethnicity (Japanese or Caucasian), body weight (37 to 181 kg), mild to moderate renal impairment (CrCl 30 to <90 mL/min, based on the Cockcroft-Gault formula), or mild to severe hepatic impairment (Child-Pugh Class A, B, and C). What severe renal impairment (CrCl <30 mL/min) does to the pharmacokinetics of Alpelisib is unknown.
Pediatric Use
The safety and efficacy of Alpelisib in pediatric patients have not been established.
Geriatric Use
On the whole, Alpelisib worked no differently in patients aged ≥65 years than in younger patients. Too few patients aged ≥75 years were studied to say whether safety or effectiveness differs in that group.
Renal Impairment
The effect of severe renal impairment (CLcr <30 mL/min) on Alpelisib pharmacokinetics is unknown. No dose adjustment is recommended for patients with mild to moderate renal impairment (CLcr 30 to <90 mL/min).
Storage
Keep Alpelisib below 30°C, in a cool and dry place. Protect it from light, and keep it out of the reach of children.
Drug Interactions
Common questions about Alpesib 150 mg
What is Alpesib 150 mg Tablet?
Alpesib 150 mg Tablet is a medicine that contains Alpelisib. It is made by Everest Pharmaceuticals Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Alpesib used for?
Alpesib is used for: Cancer.
What are the side effects of Alpesib?
Alpelisib can cause severe allergic reactions, diarrhea, severe skin reactions, lung problems (pneumonitis) and high blood sugar levels (hyperglycemia).
Can I take Alpesib during pregnancy or while breastfeeding?
Pregnancy: Animal data and the way Alpelisib works suggest it can cause fetal harm when a pregnant woman takes it. Lactation: There is no data on whether Alpelisib passes into human milk, or on its effects on milk production or on the breastfed child. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Alpesib?
Keep Alpelisib below 30°C, in a cool and dry place. Protect it from light, and keep it out of the reach of children.
Can I take other medicines with Alpesib?
Some medicines can interact with Alpelisib, for example: Warfarin Sodium. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Alpesib is already among the lowest-priced brands of Alpelisib at this strength.
Do I need a prescription for Alpesib?
Alpesib is a prescription (Rx) medicine. Take it as your doctor advises.