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Brand Name: Imbruvica

Generic Name: Ibrutinib

Drug Class: Antineoplastics, Tyrosine Kinase Inhibitor

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Description

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Buy Imbruvica Ibrutinib 140mg Online, as Imbruvica is a kinase inhibitor indicated for the treatment of adult patients with:

1. Mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

2. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).

3. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion

4. Waldenström’s macroglobulinemia (WM)

5. Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

6. Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy

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DOSAGE AND ADMINISTRATION

1.MCL and MZL: 560 mg taken orally once daily (four 140 mg capsules once daily)

2.CLL/SLL, WM, and cGVHD: 420 mg taken orally once daily (three 140 mg capsules once daily).

Capsules should be taken orally with a glass of water. Do not open, break, or chew the capsules

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Imbruvica Side Effects

1.Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time

2.Infections can happen during treatment with IMBRUVICA. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with Imbruvica

3.Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with Imbruvica, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts

4.Heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter). Serious heart rhythm problems and death have happened in people treated with IMBRUVICA, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint

5.High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure

6.Second primary cancers. New cancers have happened during treatment with IMBRUVICA, including cancers of the skin or other organs

7.Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

Imbruvica Cost & Price:

India’s Imbruvica price is only 10% of United States package.

For more Prescribing information,please check the → “FDA Prescribing Information”.

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WHAT IS IBRUTINIB AND HOW DOES IT WORK?

 

Ibrutinib is a prescription medication used as an inhibitor of Bruton’s tyrosine kinase (BTK) used to treat patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Ibrutinib is available under the following different brand names: Imbruvica.

Dosages of Ibrutinib:

Adult Dosages:

Capsule

Dosage Considerations – Should be Given as Follows:

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

  • Indicated for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) including patients who are treatment-naïve or have been previously treated; also indicated for patients who carry a deletion in chromosome 17 (del 17p CLL), which is associated with poor responses to standard treatment
  • 420 mg (three 140-mg capsules) orally once daily until unacceptable toxicity or disease progression
  • In combination with bendamustine and rituximab
    • Ibrutinib 420 mg orally each day plus bendamustine and rituximab administered every 28 days for up to 6 cycles until disease progression or unacceptable toxicity

Mantle Cell Lymphoma

  • Indicated for mantle cell lymphoma in patients who have received at least 1 previous therapy
  • 560 mg (four 140-mg capsules) orally once daily
  • Continue until disease progression or unacceptable toxicity

Waldenström Macroglobulinemia

  • Indicated for all lines of therapy for Waldenström macroglobulinemia (WM), a rare, indolent type of non-Hodgkin lymphoma (B-cell lymphoma)
  • 420 mg (three 140-mg capsules) orally once daily

Marginal Zone Lymphoma

  • Indicated for marginal zone lymphoma (MZL) in patients who require systemic therapy and have received at least 1 prior anti-CD20-based therapy
  • 560 mg (four 140-mg capsules) orally once daily
  • Continue until disease progression or unacceptable toxicity

Dosage Modifications

Interrupt or discontinue therapy

  • Interrupt therapy for any non-hematological toxicity Grade 3 or greater, neutropenia with infection or fever Grade 3 or greater, or Grade 4 hematological toxicities
  • Reinitiate ibrutinib at the starting dose (indicated specific) once toxicities have resolved to Grade 1 or baseline (recovery)
  • If the toxicity reoccurs, reduce dose by 1 capsule (140 mg/day)
  • A second reduction of dose by 140 mg may be considered as needed
  • Discontinue if these toxicities persist or recur following 2 dose reductions

CYP3A inhibitors

  • Avoid coadministration with strong or moderate CYP3A inhibitors and consider alternative agents with less CYP3A inhibition
  • Concomitant use of strong CYP3A inhibitors which would be taken chronically (ritonavir, indinavir, nelfinavir, saquinavir, boceprevir, telaprevir, nefazodone) is not recommended
  • Short-term use (7 days or less) of strong CYP3A inhibitors: Consider interrupting ibrutinib until CYP3A inhibitor is no longer needed
  • Coadministration with moderate CYP3A inhibitors (fluconazole, darunavir, erythromycin, diltiazem, atazanavir, aprepitant, amprenavir, fosamprenavir, crizotinib, imatinib, verapamilgrapefruit products and ciprofloxacin): Reduce dose to 140 mg daily

CYP3A inducers

  • Strong CYP3A inducers decrease ibrutinib plasma concentrations by approximately 10-fold
  • Avoid concomitant use of strong CYP3A inducers (carbamazepinerifampinphenytoin, St. John’s Wort)
  • Consider alternative agents with less CYP3A induction

Hepatic impairment

  • Mild (Child Pugh class A): 140 mg orally once daily
  • Moderate-to-severe (Child Pugh Classes B and C): Avoid use

Pediatric Use

  • Not indicated.

Dosage Considerations

  • Indications for mantle cell lymphoma and marginal cell lymphoma is based on overall response rate (both received accelerated approval from the FDA); an improvement in survival or disease-related symptoms has not been established
  • Available via a limited distributed system from specialty pharmacies

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How to use Imbruvica

Read the Patient Information Leaflet if available from your pharmacist before you start taking ibrutinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a full glass of water (8 ounces or 240 milliliters) as directed by your doctor, usually once daily. Swallow the capsules and tablets whole. Do not open, break, or chew the capsules. Do not cut, crush, or chew the tablets. Drink plenty of fluids while taking ibrutinib unless otherwise directed by your doctor.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Also avoid eating Seville oranges (often found in marmalade). Grapefruit and Seville oranges can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Side Effects

Upset stomachdiarrheanauseavomiting, decreased appetite, headachejoint/muscle pain, swelling of ankles/legs/feet, numbness/tingling of arms/legs, anxietyconstipationdizziness, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, dark/tarry/bloody stools, fast/irregular/pounding heartbeat, signs of low red blood cell count (such as rapid breathing, pale skin, shortness of breath).

Ibrutinib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throatcough).

Very rarely, people taking this medication have developed other cancers (including skin cancer). Consult your doctor for more details.

Get medical help right away if you have any very serious side effects, including: chest pain, signs of bleeding in the brain or a stroke (such as fainting, sudden vision changes, severe nausea, seizures, confusion, weakness on one side of the body, trouble speaking).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rashitching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Precautions

Before taking ibrutinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding problems, heart problems (such as fast/irregular heartbeat, previous heart attack), high blood pressurekidney problems, liver problems, high levels of uric acid in the blood.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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Ibrutinib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpoxmeaslesflu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

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Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may tell you to temporarily stop treatment with this medication before certain medical, surgical, or dental procedures.

Older adults may be at greater risk for low red blood cell count, bleeding, fast/irregular heartbeat, and high blood pressure while using this drug.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

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Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking ibrutinib. Ibrutinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women should ask about reliable forms of birth control while taking this medication and for 1 month after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 1 week after stopping treatment. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

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Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug are: other drugs that can cause bleeding/bruising (such as antiplatelet drugs like clopidogrelNSAIDs like ibuprofen/naproxen, “blood thinners” like warfarin/dabigatran).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of ibrutinib from your body, which may affect how ibrutinib works. Examples include azole antifungals (such as itraconazoleketoconazole), boceprevirnefazodone, St. John’s wort, telaprevirHIV protease inhibitors (such as ritonavirsaquinavir), macrolide antibiotics (such as erythromycinclarithromycin), rifamycins (such as rifampinrifabutin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

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Imbruvica 140 mg capsule
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Imbruvica 140 mg capsule

Color: white

Shape: oblong

Imprint: ibr 140 mg

This medicine is a white, oblong, capsule imprinted with “ibr 140 mg”.

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