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Systemic Anti-Cancer Therapy Regimen Library

Home > BR Metastatic - alpelisib and fulvestrant

BR Metastatic - alpelisib and fulvestrant

Treatment Overview

Cycle 1 - 28 days - fulvestrant loading dose

Cycle length:
28

Cycle 2 (and all further cycles) - 28 days

Cycle length:
28

Cycle details

Cycle 1 - 28 days - fulvestrant loading dose

Medication Dose Route Days Max Duration
loratadine 10 mg Once daily oral administration 0
alpelisib 300 mg Once daily oral administration 1 to 28
fulvestrant 500 mg intramuscular injection 1, 15
loperamide 2 mg oral administration 1

Cycle 2 (and all further cycles) - 28 days

Medication Dose Route Days Max Duration
alpelisib 300 mg Once daily oral administration 1 to 28
fulvestrant 500 mg intramuscular injection 1
loratadine 10 mg Once daily oral administration 1

Full details

Cycle 1 - 28 days - fulvestrant loading dose

Day: 0

Medication Dose Route Max duration Details
loratadine 10 mg Once daily oral administration
Instructions:

Commence taking the day before alpelisib and continue for 4 weeks or as per institutional policy.

If no rash develops after 4 weeks, consider taking only when required to manage symptoms of rash.

Day: 1

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.
fulvestrant 500 mg intramuscular injection
Instructions:
  • 500 mg dose should be administered as one 250 mg injection (slowly over 1–2 minutes) into each buttock (gluteal area).
  • Dorsogluteal injection site should be used with care due to proximity to underlying sciatic nerve (increased risk of sciatica, neuralgia and peripheral neuropathy).
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 3

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 4

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 5

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 6

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 7

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 8

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 9

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 10

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 11

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 12

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 13

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 14

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 15

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.
fulvestrant 500 mg intramuscular injection
Instructions:
  • 500 mg dose should be administered as one 250 mg injection (slowly over 1–2 minutes) into each buttock (gluteal area).
  • Dorsogluteal injection site should be used with care due to proximity to underlying sciatic nerve (increased risk of sciatica, neuralgia and peripheral neuropathy).

Day: 16

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 17

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 18

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 19

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 20

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 21

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 22

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 23

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 24

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 25

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 26

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 27

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 28

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Cycle 2 (and all further cycles) - 28 days

Day: 1

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.
fulvestrant 500 mg intramuscular injection
Instructions:
  • 500 mg dose should be administered as one 250 mg injection (slowly over 1–2 minutes) into each buttock (gluteal area).
  • Dorsogluteal injection site should be used with care due to proximity to underlying sciatic nerve (increased risk of sciatica, neuralgia and peripheral neuropathy).
loratadine 10 mg Once daily oral administration
Instructions:

When required to manage symptoms of rash, or as per institutional policy.

Day: 2

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 3

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 4

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 5

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 6

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 7

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 8

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 9

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 10

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 11

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 12

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 13

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 14

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 15

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 16

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 17

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 18

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 19

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 20

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 21

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 22

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 23

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 24

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 25

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 26

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 27

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Day: 28

Medication Dose Route Max duration Details
alpelisib 300 mg Once daily oral administration
Instructions:
  • Take immediately after food at approximately the same time each day. 
  • Swallow whole, do not crush or chew.

Supportive Care Factors

Factor Value
Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment
Emetogenicity: Minimal to low

Emetogenicity: Antiemetics may be required with continuous dosing of oral anti-cancer medicines with MINIMAL to LOW emetic risk; an individualised approach is appropriate.

References

André F, Ciruelos E, Rubovszky G, et al; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904. , PMID: 31091374

AstraZeneca Limited. Faslodex New Zealand Data Sheet 16 July 2020. https://www.medsafe.govt.nz/profs/datasheet/f/faslodexinj.pdf (Accessed 27 May 2025).

Novartis Pharmaceuticals Australia Pty Limited. Alpelisib Australian Data Sheet 20 March 2020. https://www.tga.gov.au/sites/default/files/auspar-alpelisib-200820-pi.pdf (Accessed 27 May 2025).

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.