Synribo (omacetaxine) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Synribo is used to treat chronic myeloid leukemia (CML).
Synribo is usually given after other cancer medications have been tried without success.
Important information
Synribo can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, swollen glands, cold or flu symptoms).
Before taking this medicine
You should not use Synribo if you are allergic to omacetaxine.
To make sure Synribo is safe for you, tell your doctor if you have:
FDA pregnancy category D. Do not use Synribo if you are pregnant. It could harm the unborn baby. Use effective birth control to avoid pregnancy during your treatment with Synribo. Follow your doctor"s instructions about how long to prevent pregnancy after your treatment ends.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether omacetaxine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Synribo.
How is Synribo given?
Synribo is injected under the skin. A healthcare provider will give you this injection.
You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.
Synribo is usually given every 12 hours. Your care provider will show you the best places on your body to inject the medicine. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not change your doses without your doctor"s advice.
Your Synribo injection will be prepared at the pharmacy and you will receive the medicine in prefilled syringes. Store these syringes in the refrigerator, do not freeze. If you need to transport the medicine, place the syringes in a cooler with ice packs.
Do not allow this medicine to come into contact with food or drinks inside your refrigerator.
The Synribo mixture does not contain a preservative. You must use a prefilled syringe within 6 days of when it was mixed at the pharmacy.
If a prefilled syringe reaches room temperature, you must use it within 12 hours after it was mixed.
Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
If Synribo accidentally gets on your skin, wash it thoroughly with soap and warm water. Anyone handling this medicine or giving you an injection should wear protective gloves and safety glasses.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
If you need surgery or dental work, tell the surgeon ahead of time that you are using Synribo. You may need to stop using the medicine for a short time.
Synribo can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.
Synribo dosing information
Usual Adult Dose of Synribo for Chronic Myelogenous Leukemia:
Induction dose: 1.25 mg/m2 subcutaneously twice daily for 14 consecutive days of a 28 day cycle.
Maintenance dose: 1.25 mg/m2 subcutaneously twice daily for 7 consecutive days of a 28 day cycle.
Use: Chronic or accelerated phase CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors.
Comments: There are no trials verifying an improvement in disease-related symptoms or increased survival with Synribo.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
If you are receiving this medicine in a clinic or cancer center, call your doctor for instructions if you miss an appointment for your Synribo injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Synribo?
If Synribo gets in your eyes, rinse with water and call your doctor right away.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
Synribo may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.
Synribo side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Synribo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
-
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), confusion, vision changes, slurred speech;
-
blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
-
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
-
fever, chills, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
-
high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
-
severe skin rash.
Common Synribo side effects may include:
-
nausea, diarrhea;
-
bruising or bleeding;
-
weakness, tired feeling; or
-
pain, swelling, or irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Synribo?
Other drugs may interact with omacetaxine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
