Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Synribo

Descriptions


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.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

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.

Pediatric

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.

Geriatric

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

Pregnancy

Information about this omacetaxine-subcutaneous-route
Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

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.

Drug Interactions

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

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

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. If you think you 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.

Side Effects

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

  1. Black, tarry stools
  2. bleeding gums
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. blood in the urine or stools
  5. bloody nose
  6. chills
  7. cough
  8. fever
  9. lower back or side pain
  10. painful or difficult urination
  11. pale skin
  12. pinpoint red spots on the skin
  13. rapid weight gain
  14. shortness of breath
  15. sore throat
  16. tingling of the hands or feet
  17. troubled breathing with exertion
  18. ulcers, sores, or white spots in the mouth
  19. unusual bleeding or bruising
  20. unusual tiredness or weakness
  21. unusual weight gain or loss

Incidence not known

  1. Arm, back, or jaw pain
  2. blurred vision
  3. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  4. chest pain or discomfort
  5. confusion
  6. convulsions
  7. decreased urination
  8. deep, dark purple bruises
  9. difficulty with speaking
  10. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  11. double vision
  12. dry mouth
  13. fainting
  14. fast, shallow breathing
  15. fast, slow, pounding, or irregular heartbeat or pulse
  16. flushed, dry skin
  17. fruit-like breath odor
  18. headache
  19. hives, rash, or itching, pain, redness, or swelling of the skin
  20. hoarseness
  21. inability to move the arms, legs, or facial muscles
  22. inability to speak
  23. increased hunger
  24. increased thirst
  25. increased urination
  26. irritation
  27. joint pain, stiffness, or swelling
  28. loss of consciousness
  29. muscle cramps
  30. nausea
  31. nervousness
  32. pale, clammy skin
  33. pounding in the ears
  34. rapid breathing
  35. slow speech
  36. stomachache
  37. sunken eyes
  38. sweating
  39. swelling of the eyelids, face, lips, hands, or feet
  40. thirst
  41. troubled breathing or swallowing
  42. unexplained weight loss
  43. vomiting of blood or material that looks like coffee grounds
  44. 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

  1. Abdominal or stomach pain
  2. back pain
  3. 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
  4. diarrhea
  5. difficulty having a bowel movement (stool)
  6. difficulty with moving
  7. hair loss or thinning of the hair
  8. lack or loss of strength
  9. loss of appetite
  10. muscle pain or stiffness
  11. pain in the arms or legs
  12. trouble sleeping
  13. upper abdominal or stomach pain
  14. weight loss

Incidence not known

  1. Acid or sour stomach
  2. anxiety
  3. belching
  4. bleeding gums
  5. bloody eye
  6. bone pain
  7. burning, dry, or itching eyes
  8. continuous ringing or buzzing or other unexplained noise in the ears
  9. darkening of the skin
  10. decreased appetite
  11. depression
  12. double vision
  13. dry skin
  14. ear pain
  15. eye discharge or excessive tearing
  16. eye pain
  17. general feeling of discomfort or illness
  18. hearing loss
  19. heartburn
  20. increased sweating
  21. indigestion
  22. itching skin
  23. muscle spasm, stiffness, or weakness
  24. redness and swelling of the gums
  25. redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  26. stomach discomfort or upset
  27. 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.