What is Synribo?
Synribo is an anti-cancer medicine that inhibits the growth and spreading of cancerous cells. The Synribo injection treats chronic leukemia (CML). Synribo should only be given if at least two cancer treatments have failed or stopped working. In 2012, it was approved for adults with CML who are in the chronic phase or have accelerated disease and have tried at least 2 tkis but failed. Synribo targets the proteins that are responsible for leukemia cell proliferation and survival and inhibits their synthesis.
Synribo works even for patients with BCR-ABL mutation T315I; this mutation confers resistance to many TKI inhibitors, such as dasatinib, imatinib, and nilotinib. Around three-quarters of patients who are prescribed Synribo experience hematologic side effects (such as thrombocytopenia, anemia, and neutropenia). Other side effects include diarrhea, fatigue, nausea, fever, infection, and tiredness.
Warnings
Synribo lowers blood cells, which help the body fight infection and clot your blood. You could get an infection more easily or bleed. You should call your doctor if there are any unusual symptoms, such as unusual bleeding or bruising, blood in the urine or stools, or confusion.
Before you take this drug
Synribo should not be used if you have an allergy to omacetaxine.
Tell your doctor about any of the following to ensure that Synribo will be safe for you:
- Diabetes (in yourself or in a member of your family);
- Bleeding problems
If either the mother or father uses this medicine, it can cause birth defects or harm to an unborn child.
- Do not use Synribo while pregnant if you're a woman. Before starting the treatment, you may need a negative pregnancy result. Use birth control to avoid pregnancy during the time you use this medication and for 6 months following your last dose.
- Men should use effective birth control if their partner could become pregnant. Continue to use birth control for at least three months after your last dose.
- Inform your doctor immediately if you become pregnant while using Synribo.
This medication may interfere with men's fertility (the ability of a man to have children). It is still important to use birth control to avoid pregnancy, as omacetaxine may harm an unborn child. Do not breastfeed for 2 weeks after taking this medication.
How to take Synribo?
Follow the instructions on your prescription label and read all medication guides or instruction sheets. Read all the instructions on the prescription label. Synribo can be injected into the skin. Your healthcare provider may instruct you on the correct use of medication. Synribo should be taken every 12 hours. Do not stop taking this medication or change your dosage schedule unless you are told to by your doctor.
Your healthcare provider can show you the best place to inject Synribo. Each time you inject, use a new place. Don't inject in the same spot twice. Prefilled syringes will be provided to you by the pharmacy. Do not freeze these syringes. Store them in the fridge. Place the syringes with ice packs in a cooler if you have to transport medicine.
This medicine should not be allowed to contact food or beverages in your refrigerator. The Synribo mix does not contain any preservatives. Prefilled syringes must be used within six days after they are mixed in the pharmacy. A prefilled syringe must be used within 12 hours of mixing. Each vial is only for one-time use. After one use, throw it out, even if the medicine is still inside.
If you accidentally get this medicine on your skin, thoroughly wash it with warm, soapy water. Wear safety glasses and gloves when handling or injecting this medicine. Only use a needle or syringe once, and then store them in a "sharps container" that is puncture-proof. Be sure to follow local or state regulations regarding how best to dispose of the container. Keep the container out of the reach of pets and children.
Tell the dentist or surgeon that you use Synribo before you undergo any dental or surgical work. It may be necessary to temporarily stop taking the medication. Omacetaxine lowers blood cells, which help the body fight infection and clot your blood. You will have to test your blood frequently. The results may delay your cancer treatment.
Details on dosage
Adult dose for Chronic Myelogenous Lymphoma:
Induction dose: 1,25 mg/m2 twice daily subcutaneously for 14 days in a row of a 28-day cycle.
Maintenance dose: 1,25 mg/m2 twice daily subcutaneously for 7 consecutive days in a 28-day cycle.
Use: CML in chronic or accelerated phases with resistance or intolerance to at least two tyrosine kinase inhibitors. Synribo has not been proven to improve the symptoms of disease or increase survival.
What happens if I miss the dose?
Do not take the missed dose. Use your next dose as usual. Do not take two doses at the same time. If you missed your Synribo appointment at a cancer center or clinic, you should call your doctor to get instructions.
What happens if I overdose?
Call 1-800-222-1222 for poison help or seek immediate medical attention.
What should be avoided?
If you get this medication in your eyes, call your doctor immediately and rinse your eyes with water.
Avoid being around people who are ill or infected. If you notice any signs of an infection, contact your doctor immediately. Avoid any activity that could increase your chances of injury or bleeding. Take extra precautions to avoid bleeding when shaving or brushing your teeth. Do not drive or engage in hazardous activities until you have determined how the medicine will affect you. You may be unable to react properly.
Side effects of Synribo
If you experience any of the following symptoms of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, or tongue, or difficulty breathing, seek emergency medical attention.
If you experience:
- Continued diarrhea, nausea, or stomach pain
- Easy bruising and unusual bleeding (nose or mouth, vaginal or rectum)
- Confuse speech, confusion, and visual changes
- Blood in urine, bloody or tarry stool, vomiting blood, or vomit looking like coffee grounds
- Itching or severe skin rash;
- Anemia (low red blood cells): pale skin and unusual fatigue; light-headedness or feeling short-of-breath; cold hands, feet, and fingers;
- High blood sugar: increased thirst, increased urination, and dry mouth;
- Signs and symptoms of an infection: fever, chills, or body aches.
Synribo may cause side effects such as:
- Fever and low blood cell count
- Feeling tired or weak
- Diarrhea;
- Nausea;
- Pain, swelling, or redness at the injection site.
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Interaction with other drug
Omacetaxine may interact with other drugs, such as vitamins and herbal supplements. Inform your doctor of all the medicines you are taking and those that you stop or start using.
