This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

Alpelisib is an anticancer medication which was approved for its medical use on 24th May 2019.

Mechanism of Action of undefined

Alpelisib is a targeted drug therapy for cancer that comes under the class of kinase inhibitors. It acts against the mutation of PI3K genes. PI3K genes are abundant in hormone receptor positive and human epidermal growth factor receptor 2 (HER2) breast cancers. Alpelisib works by stopping the cell signalling of PI3K genes and inhibits the growth and spread of cancer cells. It is often administered in combination with other chemotherapy agents like Fulvestrant.

Uses of undefined

Alpelisib Tablet has been developed to treat advanced and metastatic breast cancer in men and menopausal women who have stopped responding to other treatments. It is particularly effective against hormone receptor positive and human epidermal growth factor receptor 2 (HER2) breast cancers caused by mutation in the PIK3CA gene.

undefined Drug administaration and Dosage available

Alpelisib is available as a film-coated tablets in the doses 150mg, 200mg, 200+50mg. Swallow the tablet whole with a glass of water without crushing or chewing them.

Warnings, Precautions and Side Effects of undefined


Seek help from your healthcare provider if you experience diarrhoea, stomach pain, chest pain or breathing difficulty. Continuous diarrhoea can lead to severe dehydration and kidney injury. During the Alpelisib Tablet treatment, your doctor may periodically monitor your complete blood count and blood glucose levels to prevent serious complications. Report to your doctor if you have bleeding disorder, diabetes, heart problem, liver disease or kidney problem.


Alpelisib Tablet may cause fertility problems in men and women. Discuss with your healthcare provider before starting treatment with Alpelisib Tablet if this is a concern for you. This Tablet is not recommended for pregnant women due to its ability to cause fetal harm. Inform your healthcare provider before starting this treatment if you are pregnant or planning to have a baby. Pregnancy testing is recommended for women of reproductive potential within at least 7 days before starting Alpelisib treatment. Discuss effective contraceptive methods to use during and for one week after the last dose of Alpelisib.

There is no sufficient information regarding the impact of Alpelisib Tablet on breastfeeding. Hence, breastfeeding is not recommended during treatment with Alpelisib. Tell your healthcare provider if you are a breastfeeding mother or planning to breastfeed a baby.

Side Effects

The common side effects that are likely to occur while you are on the treatment with Alpelisib Tablet are rash, decreased appetite, mouth sores, nausea, tiredness, weakness, vomiting, weight loss, hair loss, changes in blood tests. Alpelisib Tablet may also cause Tablet site related nerve damage. Call your healthcare provider if you experience weakness, breathing difficulty, cough, chest pain or allergic reactions after taking this Tablet.

Word Of Advice

Alpelisib can cause diarrhoea. Reach out to your healthcare provider if the diarrhoea does not stop or if you experience severe stomach pain. Maintain a well-balanced diet. If you feel tired or weak, you should avoid driving or handling machines.

Frequently Asked Question


  1. Novartis Pharmaceuticals Corporation, US Food & Drug Administration, [Revised on May 2022] [8th Sep 2022],
  2. Chang et al., Role of Alpelisib in the Treatment of PIK3CA-Mutated Breast Cancer: Patient Selection and Clinical Perspectives, Therapeutics and Clinical Risk Management 2021:17 193–207,


The drug information on this page is not a substitute for medical advice, it is meant for educational purposes only. For further details consult your doctor about your medical condition to know if you are eligible to receive this treatment.