Pronunciation:

oh-ma-se-TAX-een

Brand Names:

• Synribo

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Omacetaxine injection is used to treat chronic or accelerated phase chronic myeloid leukemia (CML). It is used in patients who have already received medicines for CML that did not work well. Leukemia is a type of cancer where the body makes abnormal white blood cells.

Omacetaxine is an antineoplastic (cancer) medicine. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by omacetaxine, other side effects can occur. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of using it.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of omacetaxine injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omacetaxine injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia (low red blood cells) or
• Bleeding problems or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Neutropenia (low white blood cells) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually in the stomach (abdomen) or thigh.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Call your doctor if you have any questions.

You may also be taught how to give this medicine at home. Read and follow the directions in the Instructions for Use sheet before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to. Call your doctor if you have any questions.

To use at home:

• You will be shown the body areas where this shot can be given. Use a different body area for each shot.
• Do not inject into skin areas that are tender, red, bruised, hard, or have scars or stretch marks.
• Do not eat or drink while handling this medicine. Use it in an area away from food or food preparation.
• Wear disposable gloves and protective eyewear when handling this medicine.
• Wash your hands before and after wearing the gloves.
• Do not recap or clip the used needle. This could cause a needle-stick injury.
• If you get this medicine on your skin, wash the area with soap and water.
• If you get this medicine in your eyes, flush the eyes with water and call your doctor right away.
• If you accidentally spill this medicine, do not touch the area unless you are wearing gloves and protective eyewear. Use an adsorbent pad to wipe the spill and wash the area with soap and water. Put all the supplies that were used to clean the spill in the biohazard container and call your healthcare provider right away to report the spill.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For chronic myeloid leukemia:
    • Adults—Dose is based on body surface area and must be determined by your doctor. At first, 1.25 milligrams (mg) per square meter (m(2)) of body surface area injected under the skin every 12 hours for 14 days. The dose is repeated every 28 days. Your doctor may adjust the schedule to one shot every 12 hours for 7 days during the 28-day cycle.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

To store syringes at home:

• Use an ice pack or cooler to carry the syringes from your doctor's office.
• If placed in a refrigerator, use the syringes within 6 days after you receive them. Do not allow food or drinks to touch the syringes.
• If placed at room temperature, use the syringes within 12 hours after you receive them.

Do not throw the used syringes, needles, or other supplies in a household trash or recycle container. Put all of the used supplies in the biohazard container and return it to your doctor for disposal.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and at least 6 months after the last dose. Men should not father a child for at least 3 months after treatment ends. If you think you or your partner have become pregnant while using this medicine, tell your doctor right away.

Omacetaxine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• 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.
• 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.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may make you feel tired. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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.

Cancer medicines can cause stomach pain, constipation, diarrhea, nausea, or vomiting, even after receiving medicines to prevent it. Ask your doctor or nurse about ways to control these side effects.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

bloody nose

chills

cough

fever

lower back or side pain

painful or difficult urination

pale skin

pinpoint red spots on the skin

rapid weight gain

sore throat

tingling of the hands or feet

troubled breathing with exertion

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Arm, back, or jaw pain

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

confusion

convulsions

decreased urination

deep, dark purple bruises

difficulty with speaking

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

double vision

dry mouth

fainting

fast, shallow breathing

fast, slow, pounding, or irregular heartbeat or pulse

flushed, dry skin

fruit-like breath odor

headache

hives, rash, or itching, pain, redness, or swelling of the skin

hoarseness

inability to move the arms, legs, or facial muscles

inability to speak

increased hunger

increased thirst

increased urination

irritation

joint pain, stiffness, or swelling

loss of consciousness

muscle cramps

nausea

nervousness

pale, clammy skin

pounding in the ears

rapid breathing

slow speech

stomachache

sunken eyes

sweating

swelling of the eyelids, face, lips, hands, or feet

thirst

troubled breathing or swallowing

unexplained weight loss

vomiting of blood or material that looks like coffee grounds

wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain

back pain

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

diarrhea

difficulty having a bowel movement (stool)

difficulty with moving

hair loss or thinning of the hair

lack or loss of strength

loss of appetite

muscle pain or stiffness

pain in the arms or legs

trouble sleeping

upper abdominal or stomach pain

weight loss

Incidence not known

Acid or sour stomach

anxiety

belching

bleeding gums

bloody eye

bone pain

burning, dry, or itching eyes

continuous ringing or buzzing or other unexplained noise in the ears

darkening of the skin

decreased appetite

depression

double vision

dry skin

ear pain

eye discharge or excessive tearing

eye pain

general feeling of discomfort or illness

hearing loss

heartburn

increased sweating

indigestion

itching skin

muscle spasm, stiffness, or weakness

redness and swelling of the gums

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

stomach discomfort or upset

stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.