Imbruvica (Ibrutinib)

Imbruvica (Ibrutinib)

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Imbruvica (Ibrutinib) Dosage and Side Effects

IMBRUVICA is used in adults to treat certain types of blood cancer.

Warnings and Precautions

Tests and check-ups before and during treatment:

Laboratory tests may show that your blood count contains more white blood cells (called “lymphocytes”) in the first few weeks of treatment. This is expected and may last for a few weeks or months. This does not necessarily mean that your blood cancer is getting worse. Your doctor will check your blood counts before and during the treatment. In rare cases your doctor may need to give you another medicine. Talk to your doctor about what your test results mean.

Your doctor will check your blood pressure during treatment and may need to give you another medicine to control your blood pressure.

Children and adolescents:

IMBRUVICA is not recommended for use in patients under 18 years of age.

IMBRUVICA with food:

Do not take IMBRUVICA with grapefruit or Seville oranges; this includes eating them, drinking the juice, or taking supplements that might contain them. These products may increase the amount of IMBRUVICA in your blood.

Pregnancy, breast-feeding and fertility:

IMBRUVICA can harm your unborn baby.

Do not get pregnant while you are taking IMBRUVICA. Women of childbearing age must use two forms of effective birth control methods together during treatment with IMBRUVICA and for at least 3 months after the last dose of IMBRUVICA.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your healthcare professional for advice before taking IMBRUVICA.

Tell your healthcare professional immediately if you become pregnant.

Do not breast-feed while you are taking IMBRUVICA.

Do not father a child while taking IMBRUVICA and for 3 months after stopping treatment. Use condoms and do not donate sperm during treatment and for 3 months after your treatment has finished. If you plan to father a child, talk to your healthcare professional before taking IMBRUVICA.

Men who are sexually active with a pregnant woman must use a condom during and for 3 months after treatment with IMBRUVICA.

Driving and using machines:

You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability to drive and use tools or machines. Ask your healthcare professional about your ability to drive and use tools or machines while taking IMBRUVICA.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Side Effects

These are not all the possible side effects you may feel when taking IMBRUVICA. If you experience any side effects not listed here, contact your healthcare professional.

Lymphocytosis: An increase in the number of white blood cells, specifically lymphocytes may be reported in your blood test results. This increase in white blood cells is expected in the first few weeks of treatment and may last for 3 or more months. Uncommonly, this increase may be severe, causing cells to clump together (leukostasis). Your doctor will monitor your blood counts. Talk to your doctor about what your blood test results mean.

  • Diarrhea: You may experience an increase in frequency of loose or watery stools. If you have diarrhea that lasts for more than a week, your doctor may need to give you treatment to manage your diarrhea such as a fluid and salt replacement or another medicine. Contact your doctor if your diarrhea persists.
  • Viral, bacterial, or fungal infections: Infections can be serious and may lead to death. Contact your doctor if you have fever, chills, weakness, confusion, body aches, cold or flu symptoms, feel tired or feel short of breath, or have any other signs or symptoms of a possible infection.
  • Fatigue, lack of energy
  • Common cold
  • Muscle aches, muscle spasm, joint aches
  • Headache, dizziness, weakness
  • Rash, skin infection
  • Nausea, sore mouth, constipation, vomiting, loss of appetite, stomach pain, indigestion
  • Types of skin cancers that are not melanoma, most frequently squamous cell or basal cell skin cancers, have happened in people taking IMBRUVICA. Other cancers that are not skin cancer have happened in people taking IMBRUVICA. Talk to your doctor about monitoring for new cancer symptoms.

Interactions with this medication

The following may interact with IMBRUVICA:

  • medicines called antibiotics used to treat bacterial infections (clarithromycin, ciprofloxacin, erythromycin, rifampin).
  • medicines for fungal infections (ketoconazole, itraconazole, fluconazole, voriconazole).
  • medicines for HIV infection (indinavir, nelfinavir, ritonavir, saquinavir, atazanavir, darunavir/ritonavir, cobicistat, fosamprenavir).
  • medicine to prevent nausea and vomiting (aprepitant).
  • medicines called kinase inhibitors for treatment of other cancers (crizotinib, imatinib).
  • medicines called calcium channel blockers for high blood pressure, chest pain, irregular heart beat and other heart problems (diltiazem, verapamil).
  • medicines called statins to treat high cholesterol (rosuvastatin).
  • heart medicines/anti-arrhythmics (amiodarone, dronedarone).
  • medicines that may increase your risk of bleeding, including:
    • aspirin and anti-inflammatories such as ibuprofen or naproxen.
    • blood thinners such as warfarin, heparin or other medicines for blood clots such as dabigatran, rivaroxaban, apixaban.
    • supplements such as fish oil, vitamin E and flaxseed.
  • medicines used to prevent seizures or to treat epilepsy or medicines used to treat a painful condition of the face called trigeminal neuralgia (carbamazepine and phenytoin).

Proper Use of this medication

  • Chronic Lymphocytic Leukemia (CLL): 3 capsules once daily
  • Waldenström’s Macroglobulinemia (WM): 3 capsules once daily
  • Mantle Cell Lymphoma (MCL): 4 capsules once daily

IMBRUVICA is given as a continuous daily therapy, which means you need to take it every day until your disease no longer responds to treatment or you experience unacceptable side effects. Do not change your dose or stop taking IMBRUVICA unless your doctor tells you to.

Overdose:

If you think you have taken too much IMBRUVICA, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

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