Synribo
Synribo (omacetaxine) is a type of chemotherapy used to treat people with chronic myeloid leukemia (CML) who have tried at least two other treatments. It’s given as an injection under the skin by a healthcare provider, but there’s a chance you may be able to do it at home yourself. Synribo (omacetaxine) is only available as a brand medication, so it can be expensive.
What is Synribo (omacetaxine)?
What is Synribo (omacetaxine) used for?
Chronic myeloid leukemia (CML) in adults who have tried at least two tyrosine kinase inhibitors
How Synribo (omacetaxine) works
Synribo (omacetaxine) is an anticancer medication that blocks the production of proteins in the body. This lowers the amount of certain proteins in the body, including BCR-ABL1 and Mcl-1. These proteins specifically help cancer cells grow, survive, and divide. By lowering the amount of these proteins with Synribo (omacetaxine), cancer cells are unable to grow and then die.
Drug Facts
What are the side effects of Synribo (omacetaxine)?
Common Side Effects
- Low platelet count (up to 76%)
- Low red blood cell count (anemia; up to 61%)
- Infection (up to 56%)
- Low white blood cell count (up to 53%)
- Diarrhea (up to 41%)
- Nausea (up to 35%)
- Injection-site reaction (up to 35%)
- Lack of energy (up to 31%)
- Fever (up to 29%)
- Stomach pain (up to 23%)
- Fever with low white blood cell count (febrile neutropenia; up to 20%)
- Headache (up to 20%)
Other Side Effects
- Vomiting
- Constipation
- Loss of appetite
- Nose bleeds
- Cough
- Difficulty breathing
- Hair loss
- Trouble sleeping
- Chills
- Rash
- Swelling in arms and legs
- Pain in arms, legs, back, joints, or muscles
Serious Side Effects
- Serious infections: repeated fevers, chills, sweating, trouble breathing
- Serious bleeding: unusual bleeding, easy bruising, blood in urine or stool, confusion, vision changes
Source: DailyMed
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately 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
lower back or side pain
painful or difficult urination
pale skin
pinpoint red spots on the skin
rapid weight gain
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
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
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 occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care 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
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
Incidence not known
Acid or sour stomach
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
double vision
ear pain
eye discharge or excessive tearing
general feeling of discomfort or illness
hearing loss
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
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.
Pros and cons of Synribo (omacetaxine)
Pros
Can administer at home if your provider decides it’s right for you
A treatment option for people with certain mutations in their CML who have already tried other anticancer medications
No known drug interactions
Cons
Injection that’s given twice a day
Can raise uric acid levels in your body, which can cause kidney problems or inflammation of your joints
May affect a male’s ability to father a child (fertility)
Pharmacist tips for Synribo (omacetaxine)
Make sure to get your lab work done on time so your provider can monitor your blood counts during treatment. You’ll need to do blood work every week during your first few cycles and then possibly every 2 weeks during later cycles.
Synribo (omacetaxine) can cause tiredness. See how this medication affects you before driving or operating any machinery.
Let your care team know if you have any dental or surgical procedures planned, and tell your surgeon you’re taking Synribo (omacetaxine). This medication can raise your risk of bleeding.
Tell your provider and pharmacist about all the medications you take, including supplements and over-the-counter medications. Before starting any new medications, make sure your provider knows you're taking Synribo (omacetaxine). In addition to Synribo (omacetaxine), other medications — like non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin — can also cause bleeding. Taking these medications with Synribo (omacetaxine) can raise your risk of bleeding even more.
If you miss a dose of Synribo (omacetaxine), skip the missed dose, and take your next dose at your next regularly scheduled time. Don't give two injections at the same time to make up for the missed dose.
Regardless of sex, if you or your partner is able to become pregnant, use birth control during treatment to help prevent pregnancy. Continue to use birth control for at least 3 months (males) or 6 months (females) after your last dose. Synribo (omacetaxine) might cause harm to an unborn baby.
How to inject Synribo (omacetaxine) at home
If your provider says it’s okay for you to inject Synribo (omacetaxine) yourself at home, carefully review the instructions to store and use the medication safely. If you have any questions on how to take the medication, ask your provider.
Inject Synribo (omacetaxine) at around the same times on each treatment day. Inject Synribo (omacetaxine) into the fatty tissue under the skin of your thigh or stomach. It can also be given in the back of your upper arm if someone is helping you inject the medication.
Rotate your injection sites each time you use the medication. Don’t inject into any areas on your body that are tender, red, bruised, hard, or have scars. This will help prevent more skin irritation.
If you accidentally inject more Synribo (omacetaxine) than prescribed, go to the emergency room right away. The emergency room will check if anything needs to be done. Your provider will tell you when you should take your next dose.
Ask your provider or pharmacist about the best way to handle and throw away Synribo (omacetaxine) safely. Anticancer medications can be very harmful to people who handle or come into contact with them.
Frequently asked questions about Synribo (omacetaxine)
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What are the risks and warnings for Synribo (omacetaxine)?
Synribo (omacetaxine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Low blood cell counts
Synribo (omacetaxine) can cause your red blood cells, white blood cells, and platelets to drop. When these cells are lower than usual, you’re at risk for developing anemia, infections, and bleeding or bruising. Your provider will closely monitor your blood counts through lab work while you’re receiving Synribo (omacetaxine). If your blood counts are too low, you might have to skip your injection. Let your provider know as soon as possible if you experience any symptoms of infection (like fever, chills, or body aches), shortness of breath, or bleeding and bruising that doesn’t stop or go away. Your provider will decide if you should continue your Synribo (omacetaxine) treatment as scheduled.
Bleeding
Risk factors: Dangerously low platelet counts | Taking other medications that can raise bleeding risk
Synribo (omacetaxine) can cause your platelets to drop. When this happens, your risk of bleeding goes up. Your provider will periodically monitor your blood counts through lab work while you’re receiving treatment. Let your provider know right away if you experience any easy bruising, blood in your urine or stool, confusion, or vision changes. These can be symptoms of serious bleeding, and your provider will decide how to best treat your bleeding.
High blood sugar levels
Risk factors: Uncontrolled diabetes | People who identify as overweight | Over the age of 45 | Family history of diabetes
Some people taking Synribo (omacetaxine) experienced higher levels of blood sugar. Your provider will monitor your blood sugar levels while you’re taking this medication, especially if you have diabetes or certain risk factors for diabetes. Let your provider know if you develop any symptoms of high blood sugar levels like needing to urinate more often or becoming thirstier. Your provider will decide how to best manage these symptoms.
Harm to unborn baby
Based on animal studies, Synribo (omacetaxine) might cause harm to an unborn baby. Females taking Synribo (omacetaxine) who are able to become pregnant should use birth control during treatment and for at least 6 months after the last dose. Males taking Synribo (omacetaxine) who have female partners of childbearing age should also use birth control during treatment and for at least 3 months after the last dose. Let your provider know if you or your partner becomes pregnant during this time.
Synribo (omacetaxine) dosage forms
Typical dosing for Synribo (omacetaxine)
Your provider will calculate your dose of Synribo (omacetaxine) using your body surface area (BSA, in units of m2), which takes into account your body weight and height.
The typical dose is 1.25 mg/m2 injected subcutaneously (into the fatty tissue under the skin of your thigh or stomach). It’s given twice a day (about 12 hours apart).
Follow the Synribo (omacetaxine) dosing schedule for your injections. When you start treatment, Synribo (omacetaxine) injections are given for the first 14 days of a 28-day cycle. You’ll repeat this cycle until your provider has determined that you’ve responded well to this starting dose. After that, you’ll only need Synribo (omacetaxine) injections on the first 7 days of each 28-day cycle.
Interactions between Synribo (omacetaxine) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
What are alternatives to Synribo (omacetaxine)?
Chronic myeloid leukemia (CML) in adults who have tried at least two tyrosine kinase inhibitors
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