ALPELISIB
Background and Date of Approval
Alpelisib is an anticancer medication approved for medical use on 24 May 2019.
Uses
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.
How is it administered?
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.
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.
Warnings
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.
Precautions
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.
Word of Advice
Alpelisib may cause diarrhoea. Contact your healthcare provider if diarrhoea persists or if you develop severe abdominal pain. Ensure adequate nutritional intake through a balanced diet. If you experience fatigue or weakness, refrain from driving or operating machinery.
References
Novartis Pharmaceuticals Corporation, US Food & Drug Administration, [Revised on May 2022] [8th Sep 2022], https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212526s006lbl.pdf 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 193â207, https://www.dovepress.com/getfile.php?fileID=67389
Frequently Asked Questions
Is Alpelisib Tablet used as a monotherapy to treat cancer?
Alpelisib Tablet is prescribed in combination with fulvestrant to treat breast cancer that is hormone receptor-positive and human epidermal growth factor receptor 2 (HER 2)-negative.
Is it safe to use Alpelisib Tablet during pregnancy?
Alpelisib 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.
Is Alpelisib Tablet safe to use during breastfeeding?
There is no sufficient information regarding the impact of Alpelisib Tablet on breastfeeding. Tell your healthcare provider if you are a breastfeeding mother or planning to breastfeed your child.
Who should not take Alpelisib Tablet?
Patients who are allergic to Alpelisib or its ingredients should not take Alpelisib Tablet.
How to identify signs of high blood sugar during Alpelisib treatment?
Hyperglycemia is a common side effect of Alpelisib treatment and some of its prominent symptoms include frequent thirst, frequent urination, dry mouth, increased appetite with weight loss, confusion, nausea, vomiting, fruity odour in breath, dry skin.
How would you know if you are allergic to Alpelisib Tablet?
Flushing, rash, fever, rapid heartbeat, swelling of face, lips, tongue, throat and breathing trouble indicate that you are allergic to Alpelisib Tablet. Report to your Healthcare provider right away if you experience any of these symptoms.
What can you expect from MrMed PAP?
PAP or the Patient Assistance Program enables you to receive financial assistance about accessing medications at a minimal cost. MrMed coordinates with pharmaceutical manufacturers and companies to provide up to date information regarding the eligibility and document requirements.