Omacetaxine mepesuccinate

What is Omacetaxine mepesuccinate?

• Omacetaxine mepesuccinate (Synribo; Ceflatonin) for Injection used to treat certain types of chronic myelogenous leukemia (CML) that have not gotten better after treatment with other anticancer drugs.

Omacetaxine mepesuccinate

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What are the uses of this medicine?

Omacetaxine mepesuccinate (Synribo; Ceflatonin) is a prescription medicine used to treat adults with a type of blood cancer called chronic myeloid leukemia (CML):

• that is in the chronic phase or accelerated phase, and
• who have not responded to (resistant) or cannot tolerate 2 or more medicines called tyrosine kinase inhibitors.

How does this medicine work?

• The mechanism of action of omacetaxine mepesuccinate has not been fully elucidated but includes inhibition of protein synthesis and is independent of direct Bcr-Abl binding.
• Omacetaxine mepesuccinate binds to the A-site cleft in the peptidyl-transferase center of the large ribosomal subunit from a strain of archaeabacteria. In vitro, omacetaxine mepesuccinate reduced protein levels of the Bcr-Abl oncoprotein and Mcl-1, an anti-apoptotic Bcl-2 family member.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Synribo.

Is this medicine FDA approved?

• It was approved by the US FDA in October 2012 for the treatment of adult patients with CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).

How should this medicine be used?

Recommended dosage:

• The recommended starting schedule for induction is 1.25 mg/m2 administered subcutaneously twice daily at approximately 12 hour intervals for 14 consecutive days every 28 days, over a 28-day cycle.
• Cycles should be repeated every 28 days until patients achieve a hematologic response.

Maintenance Dose:

• 1.25 mg/m2 administered by subcutaneous injection twice daily for 7 consecutive days of a 28-day cycle.

Administration:

• properly handle and inject Synribo
• dispose of used supplies for injecting Synribo
• clean up any spilled Synribo
• Your healthcare provider will tell you how much Synribo to inject and the timing of when to inject it. Inject Synribo exactly as prescribed.
• Do not change your dose or the timing of when you inject Synribo, unless your healthcare provider tells you to.
• Synribo is given as an injection under the skin (subcutaneous injection) of your thigh or stomach-area (abdomen). The injection can be given in the back of the arm if a caregiver is giving the injection.
• If your healthcare provider decides that you or a caregiver can inject Synribo, your healthcare provider will show you or your caregiver how to prepare for an injection and how to inject Synribo before you use it for the first time.
• Inject Synribo 2 times each day, about every 12 hours.
• Your healthcare provider may tell you to stop using Synribo for a period of time, or tell you to use Synribo less often if you get certain side effects.
• Your healthcare provider will arrange for you to receive syringes filled with Synribo that are ready to inject, along with the other supplies that you will need to inject Synribo. Each syringe contains 1 dose of Synribo as prescribed by your healthcare provider.
• Follow your healthcare provider’s instructions for how to carry (transport) Synribo using ice packs or a cooler.
• Do not eat or drink while handling Synribo.
• Inject Synribo in a place away from children and pregnant women.
• You or your caregiver should wear gloves and protective eyewear, for example protective eyeglasses (not regular eyeglasses) or face shield when handling Synribo and while giving your injection.
• If you or your caregiver get Synribo on your skin, wash the area with soap and water and call your healthcare provider right away.
• If you or your caregiver get Synribo in your eyes, flush your eyes with water and call your healthcare provider right away.
• If you miss a dose of Synribo, just skip the missed dose. Give your next injection of Synribo at your next scheduled time. Do not give 2 doses of Synribo at the same time to make up for a missed dose.
• If you inject too much Synribo, call your healthcare provider or go to the nearest emergency room right away. Follow your healthcare provider’s instructions for when you should inject your next dose of Synribo.
• If someone other than the patient is injected with Synribo, or if anyone accidentally swallows Synribo, call your healthcare provider or get emergency help right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: Single-dose vial containing 3.5 mg of omacetaxine mepesuccinate as a lyophilized powder

This medicine is available in fallowing brand namesː

• Synribo

What side effects can this medication cause?

The most common side effects of this medicine include:

• infections
• diarrhea
• nausea
• tiredness
• weakness
• redness, swelling, or pain at injection site
• fever

Synribo may cause serious side effects, including:

• Low blood counts
• Bleeding
• High blood sugar levels (hyperglycemia)

What special precautions should I follow?

• Severe and fatal thrombocytopenia, neutropenia and anemia may occur. Monitor hematologic parameters frequently.
• Synribo causes severe thrombocytopenia which increases the risk of hemorrhage. Fatal cerebral hemorrhage and severe, non-fatal gastrointestinal hemorrhage may occur.
• Synribo can induce glucose intolerance. Monitor blood glucose levels frequently, especially in patients with diabetes or risk factors for diabetes. Avoid Synribo in patients with poorly controlled diabetes mellitus until good glycemic control has been established.
• Based on findings from animal reproduction studies and the drug’s mechanism of action, Synribo can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• gastrointestinal disorders
• gingival hemorrhage
• alopecia
• Grade 4 thrombocytopenia
• neutropenia

Management of overdosage:

• No specific antidote for Synribo overdose is known.
• Management of overdosage should include general supportive measures, including monitoring of hematologic parameters.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings from animal studies, Synribo can cause fetal harm when administered to pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Synribo in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: omacetaxine mepesuccinate

• Inactive ingredients: hydrochloric acid, mannitol, sodium bicarbonate

Who manufactures and distributes this medicine?

• Distributed by: Teva Pharmaceuticals USA, Inc.

Parsippany, NJ

What should I know about storage and disposal of this medication?

• Carry (transport) Synribo as instructed by your healthcare provider. It is important to use ice packs or a cooler.
• When stored in a refrigerator 36°F to 46°F (2°C to 8°C), use Synribo within 6 days from when it was mixed.
• When stored at room temperature, 68°F to 77°F (20°C to 25°C), use Synribo within 12 hours from when it was mixed.
• When stored in a refrigerator, keep Synribo from coming into contact with food or drink.

• Dailymed label info on Omacetaxine mepesuccinate
• FDA Omacetaxine mepesuccinate

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