Uses

This medication is used to treat a certain type of cancer (chronic myeloid leukemia-CML). It works by slowing or stopping the growth of cancer cells.

How to use Omacetaxine Solution, Reconstituted (Recon Soln)

Read the Medication Guide and the Instructions for Use Leaflet provided by your pharmacist before you start using omacetaxine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin as directed by your doctor, usually twice a day (every 12 hours) for 7 to 14 days. This cycle should be repeated every 28 days as directed by your doctor. This medication is injected in your thigh or stomach area. It may also be injected in the back of the arm if somebody else is giving you the injection.

The dosage is based on your medical condition, body size, lab tests, and response to treatment. Do not increase your dose or use this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects will increase.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the Instructions for Use Leaflet. Learn how to store, transport, and discard the medication and medical supplies safely.

Wash your hands before and after using the medication. You should wear gloves and protective eyewear when handling and using this product. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject the medication in areas of the skin that are bruised, hard, red, tender, or have scars or stretch marks.

If this medication touches your skin, wash your skin right away and completely with soap and water. If this medication gets in your eyes, flush the eyes with water right away. Call your doctor afterwards for further instructions.

Side Effects

Diarrhea, nausea, vomiting, constipation, abdominal pain, weakness, headache, difficulty sleeping, nosebleed, tiredness, loss of appetite, and pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: swelling hands/ankles/feet, joint/back pain.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, rapid breathing, easy bruising/bleeding, signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

This drug may rarely cause serious (rarely fatal) bleeding in the brain or bleeding from the stomach or intestines. If you notice any of the following serious side effects, get medical help right away: stomach/abdominal pain that doesn't go away, black stools, vomit that looks like coffee grounds, dizziness/fainting, sudden vision changes, confusion, trouble speaking.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Omacetaxine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using omacetaxine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, bleeding problems, current/recent infections.

Omacetaxine can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using omacetaxine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you tired. Alcohol or marijuana (cannabis) can make you more tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially easy bruising/bleeding, bleeding from the stomach or intestines, unusual tiredness, signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using omacetaxine. Omacetaxine may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen or naproxen, "blood thinners" such as warfarin or dabigatran).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

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Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, blood glucose) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose Missed Dose

If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage Storage

Store in the refrigerator (or with ice packs and/or in a cooler when transporting the medication). When stored in the refrigerator, this medication expires 6 days from when it was first mixed by the health care professional. If stored at room temperature, this medication expires 12 hours from when it was first mixed by the health care professional. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Read the Medication Guide/Instructions for Use Leaflet for details. Consult your pharmacist or local waste disposal company.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.