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Treatment Name: Ribociclib (Kisqali®) + Fulvestrant (Faslodex®)

Ribociclib (Kisqali®) + Fulvestrant (Faslodex®) is a Treatment Regimen for Breast Cancer - metastatic

How does ribociclib + fulvestrant work?

Ribociclib is designed to inhibit a specific protein that is responsible for turning off tumor suppressor genes and allowing the cancer cell to grow and divide. In other words, by inhibiting this protein, ribociclib causes the cancer cell to stop actively growing and dividing.

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 the breast cancer cell to grow and divide. Fulvestrant blocks this signal and helps stop the breast cancer cell from growing.

Ribociclib + fulvestrant goals of therapy?

Ribociclib + fulvestrant are taken together to slow the growth of breast cancer and prevent it from spreading further and is not commonly given with the goal of cure.

Schedule

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How is ribociclib + fulvestrant for breast cancer given?

  • Usual ribociclib starting dose: 600 mg (three 200 mg tablets) by mouth daily for 21 consecutive days, followed by a 7-day no ribociclib rest period. This “21-Day on, 7-Day off” treatment period is known as one Cycle
  • Fulvestrant intramuscular (I.M.) injection every two weeks for three doses, then monthly thereafter

Ribociclib is usually taken at home and fulvestrant is usually given in an outpatient infusion center, allowing the person to go home afterwards. Treatment is continued until it no longer works or until unacceptable side effects are experienced. Each cycle is repeated every 28 days.

Click here for the common ribociclib + fulvestrant starting doses.

Side Effects

What are the most common side effects from ribociclib + fulvestrant for breast cancer?

In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported side effects of Ribociclib (Kisqali®) + fulvestrant (Faslodex®) are shown here.

  • Low white blood cells [neutropenia] (70%)
  • Nausea (45%)
  • Fatigue (32%)
  • Diarrhea (29%)
  • Vomiting (27%)
  • Constipation (25%)
  • Joint pain (24%)
  • Cough (22%)
  • Headache (22%)
  • Itching (20%)
  • Hair loss (19%)
  • Back pain (18%)
  • Skin rash (18%)
  • Anemia [low red blood cells] (17%)
  • Decreased appetite (16%)
  • Pain in arms or legs (14%)
  • Hot flash (13%)
  • Increase in blood liver enzymes (6-9%)
  • Increase in QTc interval (6%)

On average, 8% of patients discontinue treatment due to unacceptable side effects. Up to 33% of patient require a reduced dose of ribociclib due to adverse effects.

Watch videos on common side effects from ribociclib + fulvestrant therapy below

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingFatigue Fatigue DiarrheaDiarrheaConstipationConstipationPainPainHair LossHair LossAnemiaAnemia

Monitoring

How often is ribociclib + fulvestrant monitoring needed?

Labs (blood tests) may be checked before the start of treatment, then every 2 weeks for the first 2 cycles, then at the beginning of each cycle thereafter. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order.

How often is imaging needed with ribociclib + fulvestrant?

Imaging may be checked before treatment, then approximately every 2 months for the first 18 months, then every 3 months thereafter. Imaging may include: magnetic resonance imaging (MRI) or computerized tomography (CT) scans. Electrocardiograms (EKG) are typically done prior to starting treatment, approximately 2 weeks after starting treatment, before cycle 2, then at the discretion of your doctor thereafter. DEXA (dual energy x-ray absorptiometry) scans may be performed to monitor your bone mineral density (bone strength).

How might blood test results/imaging affect treatment with ribociclib + fulvestrant?

Depending upon the results, your doctor may advise to continue ribociclib + fulvestrant as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

What are the most important things to know about ribociclib + fulvestrant while receiving therapy?

  • Only a certain amount of fluid can be given by intramuscular (I.M.) injection at one time. Because of this, the total dose of fulvestrant must be given as two separate injections on the same day. Each injection will be given slowly over 1-2 minutes, one in each buttock
  • Electrocardiograms (EKG) are checked during therapy to check your heart QTc interval as ribociclib can affect this. Many other medications can also affect the QTc interval so check with your doctor or pharmacist if you are taking any of these medications
  • If you take the pain medication fentanyl, you may need your dose decreased as ribociclib may cause increased blood levels of fentanyl when taken together
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for breast cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Ribociclib (Kisqali®) + Fulvestrant (Faslodex®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Ribociclib (Kisqali®) + Fulvestrant (Faslodex®). Depending upon your income, they may be able to help cover the cost of:

  • Fulvestrant
  • Riboci­clib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Ribociclib (Kisqali®) + Fulvestrant (Faslodex®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Ribociclib (Kisqali®) + Fulvestrant (Faslodex®)

Individual Drug Label Information

Fulvestrant (Faslodex®)

  • Fulvestrant is a intramuscular (I.M.) injection 
  • Dosage adjustments may be required for decreased liver function
  • Should only be given to post-menopausal women
  • Can cause fetal harm when given to pregnant women.  Women of childbearing age should be advised not to become pregnant
General Fulvestrant (Faslodex) Side Effects
  • One of the most common side effects reported are hot flashes. Talk to your doctor about ways to minimize and treat hot flashes. Do not take any medicines, herbs, or natural supplements without speaking with your doctor or pharmacist first
  • Injection site pain
  • Headache
  • Bone and join pain
  • Weakness
  • Nausea/Vomiting
  • Constipation or diarrhea
  • Fatigue
  • Shortness of breath
  • Click on the "See DailyMed package insert" below for complete reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPain

See DailyMed package insert.

Riboci­clib (Kisqali®)

  • Is an oral 200 mg tablet
  • Ribociclib may be taken with or without food. Swallow tablet whole and do not chew, crush, or break
  • If you miss a dose, do not take the dose later that day. Take the next dose the next day as scheduled
  • Store at room temperature (68°F to 77°F) in its original packaging. Do not remove tablets from blister packs until you are ready to take it
  • Dosage adjustments may be required if certain side effects are experienced
  • May interact with certain antifungal, antibiotic, and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions 
  • May interact with pomegranate or pomegranate juice, grapefruit or grapefruit juice, star fruit, or Seville oranges (found in marmalade) causing increased blood levels of ribociclib. This could increase your risk of experiencing side effects. Avoid eating pomegranate, grapefruit, marmalade, and star fruit or drinking anything containing grapefruit and pomegranate juice during treatment. Lemon, lime, and other oranges and their juices are acceptable.
  • Avoid therapy with St. Johns Wort as it will decrease blood levels of ribociclib. This could decrease the effectiveness of treatment.
  • May interact with medications known to interfere with heart rhythm. Ask your pharmacist to double-check if you are taking any of these types of interacting medicines
  • May cause fetal harm if taken while pregnant. Women of childbearing age should use effective contraception while taking ribociclib and for at least 3 weeks after the last dose. Do not breastfeed during treatment or for at least 3 weeks after the last dose
General side effects from ribociclib (Kisqali®):
  • Low white blood cells [neutropenia] and low red blood cells [anemia]
  • Liver injury
  • Nausea and vomiting
  • Infections
  • Diarrhea or constipation
  • Hair loss
  • Joint pain or back pain
  • Headache
  • Cough
  • Fatigue
  • Decreased appetite
  • Skin rash
  • Click on the Ribociclib (Kisqali®) package insert below for reported side effects, possible drug interactions, and other ribociclib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

1) Slamon DJ, Neven P, Chia S, et al. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018;36:2465-2472.

Created: February 16, 2019 Updated: February 16, 2019

What is Breast Cancer - metastatic?

What is Metastatic Breast Cancer?
A disease of the milk-producing glands known as lobules, milk ducts, or other cells found in the breast. Metastatic breast cancer is one that has moved from the breast to other areas of the body, which may include the brain, liver, or bone. Breast cancer is one of the most common types of cancers in women, but may rarely affect men as well. Known causes of breast cancer include genetic causes, such as the BRCA mutation, or obesity. The effectiveness of the treatment may depend upon the stage at diagnosis.

Types of metastatic breast cancer:
1. Hormone-receptor positive or negative (60 - 65% of patients)

  • Estrogen Receptor positive (ER)+ or negative (ER)-
  • Progestin Receptor positive (PR)+ or negative (PR)-

2. Hormone Epidermal growth factor Receptor-2 (HER-2) positive or negative (20 - 25% of patients)

  • HER-2 +
  • HER-2 -

3. Triple Negative (15 - 18% of patients)

  • ER- and PR- and (HER-2)-
NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common starting doses for Ribociclib (Kisqali®) + Fulvestrant (Faslodex®)

  • Ribociclib 600 mg (three 200 mg tablets) by mouth daily for 21 consecutive days, followed by a 7-day no ribociclib rest period
  • Fulvestrant 500 mg intramuscular (I.M.) injection every two weeks for three doses, then monthly thereafter

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium