What Is Reampla (Palbociclib)? When Is It Used for Metastatic Breast Cancer?
In this article
What is Reampla (palbociclib)?
Reampla (active ingredient palbociclib), used in hormone receptor-positive advanced (stage 4) breast cancer, is a CDK4/6 inhibitor and a new-generation cancer drug.
Reampla is used together with an aromatase inhibitor (such as letrozole) or an estrogen receptor blocker (such as fulvestrant ). Reampla is a reversible small-molecule cyclin-dependent kinase (CDK) inhibitor. It blocks proteins called cyclin-dependent kinase (CDK) 4 and CDK 6 in the cell. Blocking these proteins in hormone-positive breast cancer cells helps stop the cells from undergoing mitosis to form new cells. It helps prevent cells from moving from the G1 to the S phase of the cell cycle during division. This slows cancer growth.
Palbociclib plus an aromatase inhibitor (such as Letrozole), or palbociclib plus an estrogen receptor blocker (such as Fulvestrant), is more effective than either agent alone.
Faslodex (fulvestrant) is designed to block estrogen receptors on the surface of breast cancer cells. In patients with estrogen receptor-positive (ER +) disease, estrogen binds to these receptors and tells breast cancer cells to grow and divide. Fulvestrant blocks this signal and helps stop breast cancer cell growth.
Femara (letrozole) is designed to block an enzyme (a type of protein) in your body called aromatase. Aromatase helps produce a female hormone known as estradiol (a type of estrogen). When letrozole inhibits aromatase, less estrogen is produced. When estrogen cannot bind to receptors on breast cancer cells, the cells cannot grow or divide.
Reampla Price
March 2026 current pharmacy retail prices for Reampla are as follows:
- Reampla 125 mg (21 Capsules): 30,267.80 TL
- Reampla 100 mg (21 Capsules): 30,267.80 TL
- Reampla 75 mg (21 Capsules): 30,267.80 TL
What is Reampla used for in breast cancer?
Reampla (palbociclib) and Faslodex, or Reampla and Femara, are used together to slow breast cancer growth and prevent further spread. It is generally not given with curative intent because it has so far been approved only to treat advanced hormone-positive breast cancer.
📜 Current SGK Reimbursement Criteria
Coverage is provided for patients with at least 10% estrogen receptor positivity and HER-2-negative, pre/peri/postmenopausal recurrent/metastatic breast cancer under the following criteria:
- a) With letrozole in those who have never received endocrine treatment or whose disease recurs 12 months after preventive treatment.
- b) With fulvestrant in those whose disease progresses after using a 1st-line aromatase inhibitor for more than 6 months in metastatic treatment. (Not reimbursed in those who previously received fulvestrant.)
- c) With fulvestrant in those who relapse while taking a preventive aromatase inhibitor (provided it has been taken for at least 12 months) or within 12 months after completing it.
- d) In pre/perimenopausal women, endocrine treatment must be combined with an LHRH agonist.
- e) The new report must state that there is no disease progression.
FDA Approval Dates:
- 2015: Palbociclib + letrozole as first-line treatment (see the related approval study).
- 2016: Palbociclib + fulvestrant as second-line treatment for patients whose cancer previously progressed on hormonal therapy.
- 2019: The indication for palbociclib + an aromatase inhibitor or fulvestrant was expanded to include men with breast cancer.
How is Reampla administered, and what is the dose?
- Reampla: 125 mg daily for 21 days, followed by a 7-day break.
- Faslodex: 500 mg intramuscularly (into the buttock). Initially on days 1, 14, and 28, then once a month.
- Femara: A 2.5 mg tablet once daily, continuously.
Side Effects
Reampla + Faslodex Side Effects
- Neutropenia: 79% | Fatigue: 38%
- Nausea: 29% | Anemia: 26%
- Headache: 21% | Low platelet count: 19%
- Diarrhea: 19% | Constipation: 17%
- Hair loss: 15% | Hot flashes: 15%
- Mouth sores: 12% | Shortness of breath: 11%
Reampla + Femara Side Effects
- Neutropenia: 75% | Fatigue: 41%
- Anemia: 35% | Nausea: 25%
- Joint pain: 23% | Mild hair loss: 22%
- Diarrhea: 21% | Hot flashes: 21%
- Embolism (Clot): 5% | Shortness of breath: 15%
- Numbness/Tingling: 10%
**Because of side effects, 7% of patients discontinued palbociclib and 2% discontinued letrozole. Most symptoms are mild (Grade 1-2).
How Are Patients Taking Reampla Monitored?
Blood Tests: Complete blood count and biochemistry are checked before each treatment, every 2 weeks during the first 2 cycles, and then at the start of each cycle.
Imaging: CT, MRI, or PET/CT is performed before treatment and periodically as advised by the doctor. ECG (QTc monitoring) for cardiac function and DEXA scans for bone density may be needed.
Precautions During Use
- Faslodex: The total dose should be given slowly over 1-2 minutes as two separate injections (one into each buttock).
- Diet: Grapefruit and grapefruit juice and St. John’s wort must not be consumed because they interact with the medication.
- Embolism Risk: Go to the emergency department if you experience shortness of breath, chest pain, or palpitations.
- Interactions: Ask your pharmacist whether your other medications affect the QTc interval.
Individual Drug Label Information
Faslodex (fulvestrant)
It is an intramuscular (I.M.) injection. Dose adjustment may be needed in those with reduced liver function. It may harm the fetus in pregnancy; those of childbearing potential should not become pregnant.
General Side Effects: Hot flashes, injection-site pain, headache, bone pain, weakness, nausea, vomiting, constipation/diarrhea, fatigue, and shortness of breath.
Reampla (palbociclib)
It is an oral capsule of 125, 100, or 75 mg. Take it with food at the same time every day; do not crush or open it. If vomiting occurs after a dose, do not take an extra dose that day.
General Side Effects: Reduced blood cell counts, infection risk, nosebleeds, nausea/vomiting, diarrhea, mouth sores, hair loss, and tingling/numbness.
Femara (letrozole)
It is an oral tablet, swallowed whole with or without food. Dose adjustment may be needed with liver impairment. Pregnancy should be avoided because of the risk of fetal harm.
General Side Effects: Hot flashes, joint pain, reduced bone strength, increased cholesterol, dizziness, high blood pressure, clot risk, mood changes, edema, and skin rash.
Sources
2. Finn RS, Crown JP, Lang I, et al. 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. Lancet Oncol. 2015.
Was this article helpful?
Your feedback helps us improve our content.
Reader comments
Share your comment
Your name and comment are published only after administrator approval. Your email address is never shown to visitors.
Be the first to comment.