Omacetaxine (Subcutaneous)

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

Omacetaxine is an antineoplastic (cancer) medicine. It disrupts the growth of cancer cells, which are eventually destroyed by the body. Since omacetaxine can also affect the growth of normal cells, other side effects may happen. Before starting treatment, talk to your doctor about the benefits of this medicine and the possible risks of using it.

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

It is very important that your doctor checks your progress at regular visits. This allows your doctor to see if the medicine is working properly and to decide if you should keep receiving 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 avoid getting pregnant during treatment and for 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 happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, 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 using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could happen.

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).

In deciding to use a medicine, your doctor will help you weigh the risks against the benefits of the medicine. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how omacetaxine injection affects children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of omacetaxine injection.

Breast Feeding

There are no sufficient studies in women to determine if there is a risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If an interaction might occur, your doctor may change the dose or take other precautions. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, 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 worsen these conditions.

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

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away 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 happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your healthcare professional may also provide ways to prevent or reduce some of these side effects. Check with your healthcare 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.

In the U.S.

• Synribo

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

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.