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Ibrance (palbociclib)

Ibrance (palbociclib) is a medication used for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.

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Description

What is Ibrance (palbociclib) for?

Palbociclib is indicated for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease[1]. It is indicated in combination with an aromatase inhibitor (an hormonal therapy) as initial endocrine based therapy in postmenopausal women or fulvestrant in women with disease progression following endocrine therapy[1,8].

How does Ibrance (palbociclib) work?

Palbociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6.

Before a cell can divide, it has to go through four phases. The first phase is a growth phase (G1-phase), the second a synthesis phase (S-phase), the third another growth phase (G2-phase) and the last phase, where the cell divides (M-phase). Cancer cells divide exceedingly fast, passing through these 4 phases rapidly. Palbociclib blocks the progression from the first G1-phase, into the second S-phase. It does this by inhibiting the cyclin-dependent kinases 4 and 6 (CDK4 and CDK6)—two proteins that are involved in entering the S-phase[1].

Is Ibrance (palbociclib) approved?

Palbociclib was approved by:

  • Food and Drug Administration (FDA), USA:
    • February 3, 2015, for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease[2]
    • On March 31, 2017, the accelerated approval was converted into a regular approval for use in combination with an aromatase inhibitor (an hormonal therapy) as initial endocrine based therapy in postmenopausal women or fulvestrant in women with disease progression following endocrine therapy[1,8]
    • On April 4, 2019, the approval was expanded to include the indication for men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer when Ibrance (palbociclib) is used in combination with an aromatase inhibitor or fulvestrant[12,13] .
  • European Medical Agency (EMA), European Union,  November 11, 2016[4]

and

  • Therapeutic Goods Administration (TGA), Australia, May 3, 2017[11]
  • Health Canada, June 5, 2018[14]

for use in combination with an aromatase inhibitor (e.g. letrozole) or with fulvestrant for the treatment of women with HR+/HER2- locally advanced or metastatic breast cancer who have received prior endocrine therapy.

How do I take Ibrance (palbociclib)?

The standard dosage is:

  • 125 mg daily for 21 consecutive days, followed by 7 days of treatment with letrozole 2.5 mg daily continuously throughout the 28-day cycle[1,8].

Complete information about palbociclib dosage and administration can be found in the resources section.

Consult your treating doctor for personalised dosing.

Common adverse reactions or side effects of Ibrance (palbociclib)

Most common adverse reactions with palbociclib are[3,5]:

  • neutropenia
  • leukopenia
  • fatigue
  • anemia
  • infection
  • nausea

References

1. Summary of Product Characteristics [FDA]: Ibrance (palbociclib) [PDF]
Pfizer Inc., Mar 2017

2. FDA Approved Drugs. Palbociclib
FDA, cited Sept 2015

3. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA- 1/TRIO-18): a randomised phase 2 study
Finn R.S., et al. The Lancet Oncology, Jan 2015

4. Ibrance (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer
Pfizer, Nov 2016

5. Human Medicines: Ibrance (palbociclib)
EMA, cited Nov 2016

6. IQWiG finds no added benefit for breast cancer drug Ibrance
The pharma letter, March 2017

7. Palbociclib in advanced breast cancer: Disadvantages predominate in certain patients
IQWiG, March 2017

8. Summary of Product Characteristics [EMA]: Ibrance (palbociclib) [PDF]
Pfizer Ltd., May 2017

9. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial
Cristofanilli M., et al., The Lancet Oncology, April 2016

10. PALOMA-2: Primary Results From a Phase III Trial of Palbociclib Plus Letrozole Compared With Placebo Plus Letrozole in Postmenopausal Women With ER+/HER2- Advanced Breast Cancer.
Finn R.S., et.al. , ASCO University: Meeting Library. June 2016

11. Summary of Product Characteristics [TGA]: Ibrance (palbociclib) [PDF]
Pfizer Australia Ltd., May 2017

12. Summary of Product Characteristics [FDA]: Ibrance (palbociclib) [PDF]
Pfizer Inc., Mar 2017

13. US FDA approves Ibrance (palbociclib) for the treatment of men with HR+, HER2- metastatic breast cancer
Pfizer, Apr 2019

14. Summary of Product Characteristics [Health Canada]: Ibrance (palbociclib) [PDF]
Pfizer Inc., June 2018

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