Synribo subcutaneous

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 Synribo Vial

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, laboratory 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.

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 persist or worsen, 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, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside 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 fever, chills, persistent sore throat, 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: black stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain, dizziness/fainting, sudden vision changes, confusion, slurred speech.

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. Therefore, 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.

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 worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. 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 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.

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 fever, chills, persistent sore throat, cough).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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 at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

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

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, blood glucose) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all regular medical and laboratory appointments.

Missed Dose

If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

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.Information last revised July 2017. Copyright(c) 2017 First Databank, Inc.