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omacetaxine (Rx)Brand and Other Names:Synribo

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for injection

  • 3.5mg/vial (3.5mg/mL following reconstitution)
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Chronic Myeloid Leukemia

Indicated for treatment of chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to ≥2 tyrosine kinase inhibitors

Induction: 1.25 mg/m² SC BID for 14 consecutive days q28 days; repeat q28 days until hematologic response achieved

Maintenance: 1.25 mg/m² SC BID for 7 consecutive days q28 days; continue as long as clinically beneficial

Dosing Modifications

Nonhematologic toxicities: Manage symptomatically; may interrupt and/or delay treatment until toxicity resolved

Neutropenia or thrombocytopenia

  • Dosage cycles may be delayed and/or the number of days during the cycle reduced for hematologic toxicities (eg, neutropenia, thrombocytopenia)
  • Grade 4 neutropenia (AND < 0.5 x 10^9/L) or grade 3 thrombocytopenia (platelets < 50 x 10^9/L): Delay starting next cycle until ANC ≥1 X 10^9/L and platelets ≥50 x 10^9/L
  • For next cycle, reduce number of dosing days by 2 days (eg, to 12 or 5 days)

Safety and efficacy not established

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Adverse Effects

>10% (Chronic Phase CML)

Thrombocytopenia (74%)

Anemia (61%)

Neutropenia (50%)

Infections and infestations (46%)

Diarrhea (42%)

Injection site reactions (34%)

Nausea (32%)

Fatigue (26%)

Pyrexia (24%)

Asthenia (23%)

Arthralgia (19%)

Headache (19%)

Lymphopenia (17%)

Cough (16%)

Alopecia (15%)

Constipation (15%)

Epistaxis (15%)

Abdominal pain, upper (14%)

Pain in extremities (13%)

Peripheral edema (13%)

Vomiting (12%)

Back pain (11%)

Hyperglycemia, grade 4 (11%)

Bone marrow failure (10%)

Febrile neutropenia (10%)

Insomnia (10%)

Rash (10%)

>10% (Accelerated Phase CML)

Thrombocytopenia (56%)

Infections and infestations (56%)

Anemia (51%)

Diarrhea (35%)

Fatigue (31%)

Pyrexia (29%)

Nausea (27%)

Asthenia (24%)

Injection site reactions (22%)

Febrile neutropenia (20%)

Neutropenia (20%)

Cough (15%)

Vomiting (15%)

Abdominal pain (13%)

Anorexia (13%)

Chills (13%)

Headache (13%)

Dyspnea (11%)

Epistaxis (11%)

Pain in extremities (11%)

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Warnings

Contraindications

None

Cautions

Monitor CBC panel for myelosuppression

Grade 3/4 neutropenia, thrombocytopenia and anemia commonly occur; avoid use of anticoagulants, aspirin, and NSAIDs when platelet count is <50,000/ mm³

Therapy may induce glucose intolerance; monitor glucose levels frequently, especially in patients with diabetes or with risk factors for diabetes; avoid use in patients with poorly controlled diabetes; may initiate after glycemic control established

Avoid pregnancy

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Pregnancy & Lactation

Pregnancy Category: D

May cause serious embryo-fetal toxicity and death; women should avoid becoming pregnant

Lactation: Unknown whether distributed in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Inhibition of protein synthesis and is independent of direct Bcr-Abl binding; binds to the A-site cleft in the peptidyl-transferase center of the large ribosomal subunit from a strain of archaeabacteria

Absorption

Peak Plasma Time: 30 minutes

Distribution

Protein Bound: 50%

Vd: 141 ±93.4 L

Metabolism

Hydrolyzed to 4′-DMHHT via plasma esterases; little evidence of hepatic microsomal oxidative and/or esterase-mediated metabolism in vitro

Elimination

Half-life: 6 hr

Excretion: ≤15% unchanged in urine

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Administration

Administration

Inject subcutaneously

Follow institutional guidelines for preparing, administering, and disposal of chemotherapy

Preparation

  • Reconstitute with 1 mL of 0.9% NaCl
  • After addition of the diluent, gently swirl until a clear solution obtained
  • Lyophilized powder should be completely dissolved in <1 minute
  • Resulting solution concentration is 3.5 mg/mL
  • Does not contain antimicrobial preservatives

Home administration

Provide training on proper handling, storage conditions, administration, disposal, and clean-up of accidental spillage of the product

Ensure that patients receive the necessary supplies for home administration. at minimum these should include:

  • Reconstituted omacetaxine with patient-specific dose in syringe with a capped needle for SC injection
  • Protective eyewear
  • Gloves
  • An appropriate biohazard container
  • Absorbent pad(s) for placement of administration materials and for accidental spillage
  • Alcohol swabs
  • Gauze pads
  • Ice packs or cooler for transportation of reconstituted syringes

Storage

Reconstituted solution: Use within 12 hr when stored at room temperature and within 6 days if refrigerated between 2- 8 °C (36-46°F)

Protect reconstituted solution from light

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Images

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Formulary

FormularyPatient Discounts

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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