Thursday, August 15, 2019

VERZENIO: 45 FAQs ; Full Treatment Guide

What Is VERZENIO?

VERZENIO is a prescription medicine used to treat adults with HR Positive, HER-2 Negative advanced breast cancer or metastatic breast cancer whose disease has progressed after hormonal therapy and prior chemotherapy. Verzenio is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor.

(2) What is the most important information I should know about Verzenio?
VERZENIO may cause serious side effects including diarrhea, liver problems, blood clots, low white blood cells count or even death. Consult your doctor before taking VERZENIO medicine.

(3) Does VERZENIO cause Fertility problems?
VERZENIO may cause fertility problems in males. This may affect the ability to father a child.

(4) I am Pregnant or planning to become pregnant, what should I do?
If you become pregnant or you are planning to become pregnant during treatment, then tell your healthcare provider right away because VERZENIO can harm your unborn baby.

(5) Does VERZENIO pass into your breast milk? Can I breastfeed during treatment?
It is not known that VERZENIO passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of VERZENIO.
Verzenio

(6) What fruit I should avoid during treatment with VERZENIO?
Grapefruit may increase the amount of VERZENIO in your blood. Avoid grapefruit or products that contain grapefruit during the treatment with this medicine.

Artcle Covers:                Important Verzenio Guidance
Reading Time:                12 Useful Minutes

(7) Is Verzenio safe and effective in children?
It is not known that Verzenio is safe & effective in children. There is no such evidence.

(8) How to store VERZENIO?
Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep VERZENIO and all other medicines out of the reach of children.

(9) I have liver / kidney problems, can I take VERZENIO?
You must consult your healthcare provider as Abemaciclib (Verzenio) can cause serious liver problems.
(10) Can I drink Alcohol While having treatment with Verzenio?
Abemaciclib is an active agent in verzenio medicine. Alcohol-Abemaciclib interaction has not been established. You must consult your physician regarding the effects of drinking alcohol with this medication. In general, Alcohol causes damage to vital human organs. It also causes certain types of cancers.

(11) Is there any antidote for Verzenio?
There is no known antidote for abemaciclib. The treatment of overdose of abemaciclib should consist of general supportive measures.

(12) I am taking Vitamins or other supplements, what should I do?
If you are taking any kind of vitamins, herbal supplements, then tell your doctor. Especially tell your healthcare provider if you are taking a medicine that contains ketoconazole.

(13) What Are Serious Side Effects Associated With VERZENIO?

Serious Side Effects Of Verzenio:

Diarrhea is common with verzenio treatment. If you have any lose stool, then contact your physician right away. Your healthcare provider will guide you about antidiarrheal treatment. You must drink more fluids to cope up with diarrhea.

Neutropenia is a condition that means low white blood cells counts. You must tell your physician if you have low white blood cells count or infections such as fever and chills.

VERZENIO can cause serious liver problems. Your physician should do blood tests to check your liver before and during treatment with VERZENIO. If you feel very tired, appetite loss, bleeding / bruising or pain in the upper right side of your abdomen, then you must tell your doctor instantly about these symptoms.

VERZENIO can cause serious blood clots in your veins or the arteries of the lungs. If you feel rapid breathing, shortness of breath, chest pain or rapid heart rate, then tell your physician as these are the symptoms of Blood clots.

(14) Where to report side effects of VERZENIO?
You may report side effects to FDA at 1-800-FDA-1088.

(15) What are the most common side effects of VERZENIO?

COMMON SIDE EFFECTS OF VERZENIO:

  1. Abdominal pain
  2. Alopecia (Hair Loss)
  3. Anemia  (Low Red Blood Cells Count)
  4. Leukopenia (Low White Blood Cells Count)
  5. Thrombocytopenia (Low Platelet Count)
  6. Decreased Appetite
  7. Headache
  8. Infections
  9. Nausia
  10. Tiredness
  11. Vomiting
(16) Should I Test My White Blood Cells Counts Before Taking Verzenio?
If you develop low white blood cells count during treatment with VERZENIO, your healthcare provider may temporarily stop taking VERZENIO, decrease your dose, or wait before starting your next month of treatment.

(17) Should I Check My Liver During Or After VERZENIO Treatment?
Yes, you must check your liver before and during treatment with Verzenio. Because Abemaciclib can cause serious side effects if you have liver problems.

(18) If I Have Infections, Then Should I Take Verzenio?
If you have infections or low WBC count, then you must inform your physician before the start of verzenio treatment. As this drug can cause serious side effects even death. So you must tell your doctor right away.

(19) When Should I get worried during Verzenio treatment?
If you face the following signs or symptoms, then you must take it seriously and consult your doctor:

Precautions During Verzenio Treatment:

  1. Appetite loss,
  2. Bleeding or bruising,
  3. Chest pain,
  4. Feeling very tired,
  5. Pain in the upper right side of your stomach/abdomen,
  6. Pain or swelling in arms or legs,
  7. Rapid heart rate,
  8. Rapid breathing,
  9. Shortness of breath.
(20) I am taking certain medicines, What Should I do before the start of treatment with VERZENIO?
  • You must know all the vitamins, supplements or medicines that you are taking.
  • Make a complete list of them.
  • Show this list to your Physician.
  • Don’t hide anything even it is minor in your opinion.
  • Consult your doctor instantly if you feel certain changes or infections in your body.
(21) How should I take VERZENIO?
  1. Take VERZENIO as per your doctor’s prescription.
  2. Don’t stop taking VERZENIO without consulting your physician.
  3. Don’t miss a dose. If you miss a dose, do not take two doses at the same time.
  4. If you vomit, do not take extra dose of medicine.
  5. Do not take VERZENIO tablets, if they are broken, cracked, or damaged.
  6. Take your dose at the same regular time every day.
  7. VERZENIO can be taken with or without food.
  8. Do not change the dose of medicine without your doctor’s advice.
  9. Avoid concomitant use of ketoconazole.
(22) Can you give Verzenio to others if they have the same symptoms as you have?
Medicines are sometimes prescribed for purposes other than those listed in Patient information leaflet. Don’t use VERZENIO for a condition for which it was not prescribed. Don’t prescribe Verzenio to your friends or someone even if they have the same symptoms as you have. It may harm them seriously.

(23) What is the Class name of Abemaciclib (Verzenio)?
Verzenio belongs to Kinase Inhibitor class of drugs.

(24) Is VERZENIO Brand Name?
Verzenio is the brand name of the drug Abemaciclib.

(25) What is Abemaciclib?
Abemaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) that is used for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

(26) Is Verzenio approved by FDA?
Verzenio (Abemaciclib) is a FDA Approved drug for Certain Advanced Breast Cancers. In 2017, CDER (Food and Drug Administration) approved 46 new drugs, out of which 12 are anti-cancer drugs. Kinase inhibitors approved drugs include: acalabrutinib, abemaciclib, copanlisib dihydrochloride, neratinib, brigatinib and ribociclib.

(27) What is the Approved use/Indication of VERZENIO?
Abemaciclib (Verzenio) is used in the treatment of adult patients with HR (hormone receptor) positive, HER2 (human epidermal growth factor receptor) negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

(28) Is Verzenio a chemo drug?
Verzenio is a prescription medicine used as targeted treatment to deal with a certain type of breast cancer. It is not a chemotherapy.

(29) What are the adverse reactions of Abemaciclib?
Clinical trials experience shows that deaths during treatment or during the 30-day follow up, regardless of causality, were reported in 11 cases (3%) of abemaciclib plus an aromatase inhibitor treated patients versus 3 cases (2%) of placebo plus an aromatase inhibitor treated patients.

Adverse Reactions Of Abemaciclib:

Causes of death for patients receiving abemaciclib plus an aromatase inhibitor included:
  • 3 patient deaths due to underlying disease,
  • 3 due to VTE event,
  • 3 due to lung infection,
  • 1 due to cerebral infarction, and
  • 1 due to pneumonitis.
(30) What is the active ingredient in VERZENIO?
Abemaciclib is the active ingredient of the breast cancer fighting drug Verzenio.

(31) What are the inactive ingredients used in the composition of Verzenio?
Verzenio includes microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide.

(32) What are the color mixture ingredients of VERZENIO?
Verzenio consists of these ingredients s color mixture:  polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.

(33) What is the use of Abemaciclib in specific conditions?

Use of abemaciclib/verzenio in specific conditions:

Fruits
Grapefruit may interact with abemaciclib. Advise patients not to consume grapefruit products while on treatment with abemaciclib.

Infertility

Experimental use on animals shows that abemaciclib may impair fertility in males.

Contraception

Abemaciclib can cause fetal harm when administered to a pregnant woman.

Pregnancy Testing

Based on animal studies, abemaciclib can cause fetal harm when administered to a pregnant woman. Pregnancy testing is recommended for females of reproductive potential prior to the start of treatment with verzenio(abemaciclib).

Pregnancy

Advise pregnant women of the potential risk to a fetus. Findings in animals show that abemaciclib can cause fetal harm when administered to a pregnant woman. There are no available human data related to drug risk. In animal reproduction studies, administration of abemaciclib during organogenesis was teratogenic and caused decreased fetal weight.

Labor and Delivery

There is no FDA guidance on use of Abemaciclib during labor and delivery. 

Breastfeeding Moms

There are no data on the presence of abemaciclib in human milk, or its effects on the breastfed child or on milk production. Advise  women not to breastfeed during abemaciclib treatment and for at least 3 weeks after the last dose.

Pediatric Use

The safety and effectiveness of abemaciclib have not been established in pediatric patients.

Gender

There is no FDA guidance on the use of Abemaciclib with respect to specific gender populations. 

Race

There is no FDA guidance on the use of Abemaciclib with respect to specific racial populations. 

Immunocompromised Patients

There is no FDA guidance one the use of Abemaciclib in patients who are immuno-compromiseds.

(34) How much does Verzenio cost?
Verzenio is available as a brand name drug only, a generic version is not yet available. The cost for Verzenio oral tablet 50 mg is around $3,071 for a supply of 14 tablets, depending on the pharmacy you visit. These prices are for cash paying customers only and are not valid with insurance plans.
 
(35) How much does Abemaciclib cost?
Abemaciclib, sold under the brand name Verzenio, will carry a list price before any discounts or rebates of about $10,948 per month, Lilly had said it.

(36) What is Verzenio used to treat?
Active ingredient in Verzenio is used to treat certain types of breast cancer. This cancer fighting medicine  stops or slows down the growth of cancer cells.

(37) What is metastatic breast cancer?
Metastatic breast cancer (also called stage IV or advanced breast cancer) is breast cancer that has spread beyond the breast and nearby lymph nodes to other organs in the body.

(38) How long can you live with breast cancer that has metastasized?
This means that people with metastatic breast cancer are 22 percent as likely as people without the condition to live at least 5 years following diagnosis. Anyhow, many factors can affect how long a person with metastatic breast cancer can live. Survival rates also depend upon the type of breast cancer.

(39) What is the difference between Ibrance and Verzenio?
Verzenio  is a CDK4/6 inhibitor, like Ibrance and Kisqali. Verzenio works against advanced-stage or metastatic, HR-positive, HER2-negative breast cancer.

(40) Is Verzenio drug approved in Canada?
Breast cancer is the most common form of cancer among women worldwide. Verzenio is used alone or in combination with endocrine therapies that are already approved in Canada. Canadian government has been working continuously to improve the drug regulatory system to make it more efficient and accurate.

(41) What causes her2 positive breast cancer?
In about 25% of breast cancers, the cancer cells have an excess of the HER2 protein. This is caused by a mutation in the HER2 (human epidermal growth factor receptor 2) gene. When the HER2 gene mutates, it causes cells in the breast to grow and divide in unchecked way. This condition leads to tumour growth.

(42) What is the first CDK inhibitor drug approved by FDA?
In Feb 2015, US FDA approved palbociclib (Ibrance), a CDK4/6 inhibitor. 

Currently, there are 11 inhibitors -Palbociclib, Pfizer (Onyx Pharmaceuticals); Abemaciclib(verzenio), Eli Lilly; Ribociclib, Novartis/Astex; Alvocidib, Sanofi (Tolero); Milciclib, Nerviano; MM-D37K, MetaMax; G1T28-1, G-1 Therapeutics; TG-02, Tragara Pharmaceuticals; Seliciclib, Cyclacel; AT-7519, Astex; Roniciclib, Bayer- under clinical evaluation.
(43) What are CDK inhibitors & what is their role as anti-cancer drugs?
The cell reproduces itself via replication. The cyclical replication processes from the resting state (G1 phase) to cell division (M Phase) called cell cycle. Cell cycle requires complicated steps are composed of G1, S, G2, and M. These step transitions from one to another. The monitoring proteins that manage these transitions are CDKs. These are the central players in the process of cell cycle. The expression and inhibition of CDKS are deregulated in cancer. So the successful inhibition of CDKs is focused for cancer therapy.

(44) What Is the Mechanism of Action of Abemaciclib (Verzenio)?
Active agent in Verzenio medicine is an inhibitor of cyclin-dependent kinases 4 and 6. These kinases are activated upon binding to D-cyclins. In ER+breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein, cell cycle progression, and cell proliferation. In vitro, continuous exposure to abemaciclib inhibited Rb phosphorylation and blocked progression from G1 into S phase of the cell cycle. This resulted in apoptosis. In breast cancer xenograft models, abemaciclib dosed daily without interruption as a single agent or in combination with antiestrogens resulted in reduction of tumor size.


Disclaimer:
The content on this page is based upon the FDA package insert, National Library of Medicine content and internet research on topics. We have created this article with good intention. Anyhow we neither are a professional health care provider, nor suitable replacement for a licensed doctor. You must consult your nearby physician or breast cancer treatment centre before the start of VERZENIO Treatment.

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