Imbruvica

What is Imbruvica?

Imbruvica can be used on its own or in conjunction with other medicines to treat adult patients with specific types of blood cancers.

Imbruvica can be used for treating patients suffering from:

• Mantle lymphoma (MCL which is a rapidly growing cancer that starts in the immune system's cells) that have had treatment with at minimum one other chemotherapy medication

• Chronic lymphocytic Leukemia (CLL is a form of cancer that develops with white blood cells) and small lymphocytic lymphoma (SLL is a form of cancer that starts within the lymph nodes),

• Waldenstrom's macroglobulinemia (WM - a cancer that grows slowly that starts in the white blood cells of the bone marrow),

• Marginal zone lymphoma (MZL marginal zone lymphoma (MZL) is a slow-growing cancer that develops in the form made up of white blood cells (which normally fight infections) who have received treatment with a particular type of chemotherapy medication and

• Chronic graft-vs-host disease (cGVHD is a complication of hematopoietic stem cell transplant [HSCT, a procedure that replaces the bone marrow of patients with bone marrow that is healthy that can begin a few days after the transplant and continue for a long period) after treatment failure with one or more drugs.

Your doctor will confirm that you are of the correct kind of tumor that can be treated by Imbruvica.

Imbruvica is a member of a class of drugs known as Kinase inhibitors. Ibrutinib is a drug that blocks the actions of an abnormal protein that allows cancer cells to grow. This stops the growth of cancerous cells.

Side effects of Imbruvica

Take immediate medical attention If you are experiencing symptoms that you are experiencing an allergic reaction Imbruvica: hives, difficulty breathing and swelling of your lips, face or tongue.

Imbruvica could result in the brain to develop an infection that could lead to disabilities or even death. Inform your doctor If you experience difficulties with speech, thinking or vision, or movement. The symptoms may get worse fast.

It is possible to contract infections more frequently, and even severe or fatal infections. Call your doctor immediately if you show symptoms of infection, such as:

• Fever the chills and sore throat;

• Mouth sores gums, which are red or swollen;

• Pale skin, easily bruising, unusual bleeding

• Chest pain, wheezing, dry cough or hack rapid reduction in weight.

Imbruvica could cause bleeding more easily. Contact your doctor or seek medical emergency attention when you suffer from:

• Easy bleeding, unusual, or bleeding that will not stop;

• Bleeding in your body - dizziness, weakness and vomiting brown or pink abnormal vaginal bleeding bloody or tarry stools vomiting blood or vomit that resembles coffee grounds.

• Bleeding within your brain A rapid weakness (especially on one side of your body) and extreme headache and problems with speech or vision.

Imbruvica may cause serious side effects. Contact your physician immediately If you suffer from:

• Chronic or persistent chronic or persistent diarrhea;

• Heart issues swelling rapidly gaining weight and feeling tired;

• Heart rhythm problems - chest pains, shortness of breath and irregular or fast pulse rate; feeling lightheaded;

• High blood pressure high blood pressure - severe headaches fuzzy vision and pounding inside your neck or ear;

• Low blood cells (fever, chills, tiredness, oral sores and skin sores easy bleeding and bleeding that is unusual and pale skin cold feet and hands feeling lightheaded or short of breath.

• Kidney issues - the kidneys are enlarged, you're not urinating as often and feeling tired or exhausted and

• Symptoms of a breakdown in tumor cells fatigue muscles cramps, weakness, nausea, vomiting and diarrhea. They can also be accompanied by a rapid and moderate heartbeat and tingling sensations in your feet and hands and around the mouth.

It is possible that your cancer treatment may be delayed or completely stopped in the event of certain adverse negative effects.

Common Imbruvica adverse effects could include:

• Diarrhea, 

• Nausea, 

• Stomach pain 

• Trouble breathing

• Mouth sores

• Fatigue 

• Low blood cell count

• Muscles spasms

• Bruising, rash; 

• Bone pain.

This is not a comprehensive list of possible side effects, and others could happen. Contact your physician for advice regarding medical adverse effects. You can report symptoms to the FDA at 1-800-FDA-1088.

Warnings

Imbruvica could make it more difficult to let you bleed. Consult your physician or seek urgent medical attention if you notice bruising that is easy to heal, unusual bleeding, or bleeding that isn't stopping. Contact your physician immediately If you are experiencing indications of bleeding within your body. For instance confusion, dizziness, speech issues, headache, bloody or black stool and brown or pink urine or coughing out blood or vomiting which looks like the coffee grinds. Imbruvica can also affect the immune system. It can cause you to contract infections more often, including severe or fatal infections. Inform your doctor in the event of an illness that causes chills, fever, mouth sores or cough or any other symptoms of an infection..

Before you take this drug

To ensure that Imbruvica is safe for you, ask your doctor if ever experienced:

• An infection;

• Bleeding issues;

• Take a blood thinner, like warfarin;

• A heart rhythm disorder

• Risk factors that increase the risk of heart risk factors for heart (such as smoking cigarettes, diabetes and being overweight, as well as having excessive blood pressure, or cholesterol);

• Low blood cell count;

• Recently had procedure or plans to undergo surgery surgical or tooth procedure or

• The liver condition.

Imbruvica can increase the risk of getting other types of cancer. Consult your physician about this possibility. It is possible that you will need to take an ultrasound test that is negative prior to beginning this treatment. Ibrutinib could cause harm to a baby who is not yet born when the mother or father uses Imbruvica.

• If you're female, you may need pregnancy tests to make sure you're not expecting. Make sure to use contraceptives when using Imbruvica, and at least one month following the last dose.

• If you're male, use birth control when your partner in sex is likely to become pregnant. Continue using contraceptives for at minimum one month following your last dose.

• Contact your doctor right away in the event of a pregnancy.

Don't breastfeed when you are taking Imbruvica and at least a week after the last dose.

How to take Imbruvica?

Consume Imbruvica exactly as directed by your physician. Follow all instructions on the prescription label and study all medication guides or instructions sheets. Doses are based on your body's areas (height as well as weight). Your dosage may alter when you gain or lose weight, or if you're still expanding. Drink the full glass of water at the same time every day. Drink plenty of fluids while you take Imbruvica. Take the tablet or capsule in its entirety and don't crush or chew on it, break it or even open it. Then shake up to mix the

oral suspension

(liquid). Take a dosage using the measuring device supplied (not an ordinary spoon). Inform your healthcare providers that you are planning a procedure. It is possible to become dehydrated in the course of long-term illness. Consult your doctor if you have a stomach ache or diarrhea. There is a chance that you will contract infections or have more bleeding. It is recommended to have regular blood tests and medical exams. Keep Imbruvica in its original container at ambient temperature, away from heat and moisture. Keep the oral suspension of Imbruvica (liquid) at room temperature, far from heat and moisture. Don't keep it in the freezer. Dispose within 60 days of the first opening.

Detail on dosage 

Usual Adult Dose for Lymphoma:

560 mg taken orally, once every day

Comments:

The treatment should continue until there is no longer a need for it or the patient experiences unacceptably toxic.

Uses:

For the treatment of patients in adulthood with mantle lymphoma (MCL) that have had minimum one treatment

For the treatment of adults suffering from marginal zone lymphoma (MZL) who require systemic treatment and have received at minimum one previous anti-CD20-based treatment

Usual Adult Dose of Imbruvica for Chronic Lymphocytic Leukemia:

420 mg taken orally, once a day

Comments:

The treatment should be continued until the disease progresses or there is unacceptably toxic.

This drug is available as a singular agent or when combined with rituximab, Obinutuzumab or with rituximab or bendamustine.

When administering it in conjunction with obinutuzumab or rituximab, think about administering this drug prior to the rituximab or obinutuzumab within the day.

Uses:

For the treatment of adults with chronic lymphocyticleukemia (CLL)/small lymphocytic tumor (SLL)

for the treatment of adults who suffer from chronic lymphocytic Leukemia (CLL)/small lymphocytic cancer (SLL) who have 17p deletion

Usual Adult Dose of Imbruvica for non-Hodgkin's Lymphoma:

420 mg taken orally, once a day

Comments:

The treatment of the disease called Waldenstrom's Macroglobulinemia (WM) is recommended to be maintained until the disease progresses or is unacceptably toxic.

When used to treat WM The drug is administered in a single dose or when combined with the rituximab.

The treatment for cGVHD is recommended to continue until progression of the disease or the recurrence of an existing malignancy, or a level of toxicity that is unacceptable.

Uses:

For the treatment of adults who suffer from anemia caused by Waldenstrom's macroglobulinemia (WM)

Treatment of adult patients suffering from chronic graft-versus-host diseases (cGVHD) following failure to respond to one or two regimens of systemic therapy

Usual Adult Dose of Imbruvica for Graft Versus Host Disease:

420 mg taken orally, once a day

Comments:

Treatment of the condition of Waldenstrom's Macroglobulinemia (WM) is recommended to be continued until progression of the disease or toxicity is unacceptable.

When used to treat WM the drug can be used as a standalone agent or as a combination with Rituximab.

The treatment for cGVHD is recommended to continue until progression of the disease or recurrence of an underlying malignancy or unacceptably toxic

Uses:

For the treatment of adults who suffer from anemia caused by Waldenstrom's macroglobulinemia (WM)

Treatment of adults suffering from chronic graft-versus-host diseases (cGVHD) following failure to respond to one or two regimens of systemic therapy

What happens If I overdose?

The missed dose should be taken on the day you remember it. The next dose should be taken at the same time, and continue to follow your once-a-day schedule. Do not take two doses in the same day.

What happens If I miss the dose?

Get medical attention in an emergency or contact toll-free the Poison Help line at 1-800-222-1222.

What should be avoided?

Grapefruit as well as Seville oranges can be in contact with ibrutinib, which can cause negative side consequences. Beware of grapefruit-based products and marmalades made of orange.

Interaction with other drugs 

It is sometimes not safe to use certain medications simultaneously. Certain drugs may affect the blood levels from other medications you take, which could create side effects or render the medications less effective.

Other medications can be incompatible with ibrutinib other medications, such as prescription and non-prescription medicine, vitamins, and herbal products. Discuss with your physician all other medicines you are taking.