1 What is Synribo?

Brand: Synribo

Generic: Omacetaxine

Synribo injection is an antineoplastic drug used for the treatment of chronic or accelerated phase chronic myeloid leukemia. It is used in patients who have already received drugs for CML that did not work well.

Leukemia happens when there is an overproduction of abnormal white blood cells. This drug interferes with the growth of cancer cells, which are eventually destroyed by the body. The growth of normal cells may also be affected by this drug.

Discuss with your healthcare professional about the risks and benefits of this drug before starting treatment with it. This drug is to be given only by or under the direct supervision of a healthcare professional.

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2 What to Know Before Using

Before using Synribo, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in children regarding the correlation of age to the effects of omacetaxine injection have not been performed while safety and efficacy have not been established.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of omacetaxine injection. Risks to the fetus have been reported in studies of pregnant women but these may be outweighed by the benefits of therapy in a life threatening situation or a serious disease.

Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other prescription or nonprescription drugs. Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare professional if you have any other medical problems such as anemia, bleeding problems, diabetes, hyperglycemia, neutropenia, thrombocytopenia, or infection.

3 Proper Usage

Proper usage of Synribo requires strict adherence to your doctor’s orders. A trained healthcare professional will be the only one to give you this drug. This drug is injected under your skin, usually in the stomach or thigh.

You may be educated on how to give this drug properly at home. The body areas where this drug can be injected will be shown to you. It is recommended to use a different body area for each shot.

It is not recommended to inject into skin areas that are tender, red, bruised, hard, or have scars or stretch marks. Eating or drinking while handling this drug is not advised. Use it in an area away from food or food preparation.

It is recommended to wear disposable gloves and protective eyewear when handling this drug. Wash your hands before and after wearing the gloves. Recapping or clipping the used needle can cause a needle-stick injury.

Wash the area with soap and water if you get this drug on your skin. Flush the eyes with water and call your healthcare professional immediately if you get this drug in your eyes.

If you accidentally spill this drug, touching the area is not recommended unless you are wearing gloves and protective eyewear. An absorbent pad must be used to wipe the spill and the area must be washed with soap and water.

The supplies that were used to clean the spill must be placed in the biohazard container. The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug. The dose in adults with chronic myeloid leukemia is based on body surface area and must be determined by your healthcare professional.

1.25 milligrams per square meter of body surface area is initially injected under the skin every 12 hours for 14 days. The dose is repeated every 28 days. Your healthcare professional may adjust the schedule to one shot every 12 hours for 7 days during the 28-day cycle.

Use and dose in children must be determined by your healthcare professional. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Synribo, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened using blood tests.

This drug has teratogenic potential and it is recommended to use an effective form of birth control to keep from getting pregnant. Inform your healthcare professional if you think you have become pregnant while using this drug.

This drug can cause leukopenia and thrombocytopenia which can increase the risk of infection or bleeding. It is recommended to avoid people with infections. Check with your healthcare professional 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 healthcare professional 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 healthcare professional, dentist, or nurse may recommend other ways to clean your teeth and gums.

Check with your medical healthcare professional before having any dental work done. Touching your eyes or the inside of your nose is not recommended unless you have just washed your hands and have not touched anything else in the meantime.

Be careful in handling sharp objects such as a safety razor or fingernail or toenail cutters to prevent unnecessary cuts or wounds. Contact sports or other situations where bruising or injury could occur should be avoided. Tiredness has been associated with the use of this drug.

Driving or doing anything else that could be dangerous is not recommended until you know how this drug affects you. This drug may affect blood sugar levels.

Check with your healthcare professional if you are diabetic and notice a change in the results of your blood or urine sugar tests. Cancer drugs can cause stomach pain, constipation, diarrhea, nausea, or vomiting, even after receiving drugs to prevent it.

Consult with your healthcare professional about ways to control these side effects.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Synribo. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • 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
  • Shortness of breath
  • 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 gains or loss
  • 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. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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