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Care During Chemotherapy and Beyond

Omacetaxine

(oh ma se TAX een)

Trade name: Synribo™

Omacetaxine is the generic name for the trade name chemotherapy drug Synribo™. In some cases, health care professionals may use the trade name Synribo™ when referring to the generic drug name omacetaxine.

Drug type: Omacetaxine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Omacetaxine is classified as a plant alkaloid - (For more detail, see "How this drug works," below.)

What Omacetaxine Is Used For:

  • For the treatment of adult patients with chronic- or accelerated-phase Chronic Myelogenous Leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Omacetaxine Is Given:

  • Omacetaxine is given by injection, under the skin (subcutaneous, SubQ).
  • There is no pill form of omacetaxine.
  • Omacetaxine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
  • The amount of omacetaxine that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of omacetaxine:

  • Most people do not experience all of the side effects listed.
  • Side effects are often predictable in terms of their onset and duration.
  • Side effects are almost always reversible and will go away after treatment is complete.
  • There are many options to help minimize or prevent side effects.
  • There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking omacetaxine :

These side effects are less common side effects (occurring in about 10-29%) of patients receiving omacetaxine :

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Fever of 100.4° F (38° or higher, chills)
  • Signs of a very bad reaction (wheezing, chest tightness, fever, itching, bad cough, blue or grey skin color, seizures, or swelling or the face, lips, tongue or throat).

Always inform your health care provider if you experience any unusual symptoms.

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Diarrhea (4-6 episodes in a 24-hour period).
  • Nausea (interferes with ability to eat and unrelieved with prescribed medication).
  • Vomiting (vomiting more than 4-5 times in a 24 hour period).
  • Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.
  • Skin or the whites of your eyes turn yellow
  • Urine turns dark or brown (tea color)
  • Decreased appetite
  • Pain on the right side of your stomach
  • Bleed or bruise more easily than normal
  • Skin changes (rash, acne, itching, blisters, peeling, redness or swelling)
  • Feeling very tired or weak (unable to carry on self-care activities)
  • Big weight gain or loss
  • Black or tarry stools, or blood in your stools
  • Blood in the urine
  • Signs of infection (very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal or anal itching or pain).

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

  • Before starting omacetaxine treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take anything new without discussing with your provider first. This is very important as other medications, etc. may interact with omacetaxine.
  • Do not receive any kind of immunization or vaccination without your doctor's approval while taking omacetaxine.
  • Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (omacetaxine may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
  • For both men and women: Do not conceive a child (get pregnant) while taking omacetaxine. Barrier methods of contraception, such as condoms, are recommended during therapy and for at least 2 months following treatment. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
  • Do not breast feed while taking this medication.
  • You should not drink grapefruit juice or eat grapefruit during your treatment with omacetaxine. It may make the amount of omacetaxine in your blood increase to a harmful level.
  • If you are taking a blood thinner, have your blood levels checked as prescribed.
  • This medicine may affect blood sugar levels. Check with your doctor if you are diabetic and notice a change in the results of your blood or urine sugar tests.

Self-Care Tips:

  • Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
  • You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your healthcare provider.
  • Wash your hands often. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Ask your doctor or nurse before scheduling dental appointments or procedures.
  • Use an electric razor to minimize bleeding.
  • Avoid contact sports or activities that could cause injury.
  • If you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
  • Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.
  • In general, drinking alcoholic beverages should be avoided completely. You should discuss this with your doctor.
  • Get plenty of rest.
  • Maintain good nutrition.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • If you experience symptoms or side effects, be sure to discuss them with your healthcare team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking omacetaxine. Testing may include: electrolytes and complete blood counts to monitor side effects and check your response to therapy. If you are on warfarin (Coumadin) your blood INR may be monitored more frequently.

How Omacetaxine Works:

Cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. "Normal" cells stop dividing when they come into contact with like cells, a mechanism known as contact inhibition. Cancerous cells lose this ability. Cancer cells no longer have the normal checks and balances in place that control and limit cell division. The process of cell division, whether normal or cancerous cells, is through the cell cycle. The cell cycle goes from the resting phase, through active growing phases, and then to mitosis (division).

The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis).

Chemotherapy drugs that affect cells only when they are dividing are called cell-cycle specific. Chemotherapy drugs that affect cells when they are at rest are called cell-cycle non-specific. The scheduling of chemotherapy is set based on the type of cells, rate at which they divide, and the time at which a given drug is likely to be effective. This is why chemotherapy is typically given in cycles.

Chemotherapy is most effective at killing cells that are rapidly dividing. Unfortunately, chemotherapy does not know the difference between the cancerous cells and the normal cells. The "normal" cells will grow back and be healthy but in the meantime, side effects occur. The "normal" cells most commonly affected by chemotherapy are the blood cells, the cells in the mouth, stomach and bowel, and the hair follicles; resulting in low blood counts, mouth sores, nausea, diarrhea, and/or hair loss. Different drugs may affect different parts of the body.

Omacetaxine belongs to a class of chemotherapy drugs called plant alkaloids. Plant alkaloids are made from plants. The plant alkaloids are cell-cycle specific. This means they attack the cells during various phases of division. Omacetaxine (Cephalotaxus harringtonia) comes from the Japanese Plum Yew plant and is also known as an antimicrotubule agent. Antimicrotubule agents inhibit the microtubule structures within the cell. Microtubules are part of the cell's apparatus for dividing and replicating itself. Inhibition of these structures ultimately results in cell death.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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