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Omacetaxine (United States: Not available): Drug information

Omacetaxine (United States: Not available): Drug information
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For additional information see "Omacetaxine (United States: Not available): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Synribo [DSC]
Pharmacologic Category
  • Antineoplastic Agent, Cephalotaxine;
  • Antineoplastic Agent, Protein Synthesis Inhibitor
Dosing: Adult

Dosage guidance

Dosage form information: Synribo has been discontinued in the United States >1 year.

Chronic myeloid leukemia, chronic or accelerated phase

Chronic myeloid leukemia, chronic or accelerated phase (resistant or intolerant):

Induction: SUBQ: 1.25 mg/m2 twice daily for 14 consecutive days of a 28-day treatment cycle; continue until hematologic response is achieved (Ref).

Maintenance: SUBQ: 1.25 mg/m2 twice daily for 7 consecutive days of a 28-day treatment cycle; continue until disease progression or unacceptable toxicity (Ref).

Missed doses: If a dose is missed, skip that dose and resume with the next regularly scheduled dose. Do not administer 2 doses at the same time to make up for a missed dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). Based on the minimal amount of unchanged drug excreted in the urine, dosage adjustment is not likely necessary (Ref) and no need for dosage adjustment is expected (Ref).

Hemodialysis: No need for dosage adjustment is expected (Ref).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, no need for dosage adjustment is expected (Ref).

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

Hematologic toxicity: May delay treatment cycles and/or reduce the number of treatment days during a cycle for hematologic toxicities.

Neutropenia grade 4 (ANC <500/mm3) or thrombocytopenia ≥ grade 3 (platelets <50,000/mm3) during a cycle: Delay the start of the next cycle until ANC ≥1000/mm3 and platelets ≥50,000/mm3 AND reduce the number of treatment days by 2 days (eg, reduce from 14 days to 12 days or reduce from 7 days to 5 days).

Nonhematologic toxicity: Manage symptomatically; interrupt and/or delay treatment until toxicity resolves.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Peripheral edema (16%)

Central nervous system: Fatigue (29% to 31%), headache (13% to 20%), chills (13%), insomnia (12%)

Dermatologic: Alopecia (15%), skin rash (11%)

Endocrine & metabolic: Increased uric acid (grades 3/4: 56% to 57%), hyperglycemia (grades 3/4: 10% to 15%; hyperosmolar nonketotic hyperglycemia <1%)

Gastrointestinal: Diarrhea (35% to 41%), nausea (29% to 35%), abdominal pain (16% to 23%), vomiting (12% to 15%), constipation (14%), anorexia (10% to 13%)

Hematologic & oncologic: Thrombocytopenia (58% to 76%; grades 3/4: 49% to 88%), neutropenia (20% to 53%; grades 3/4: 18% to 81%), anemia (51% to 61%; grades 3/4: 36% to 80%), leukocyte disorder (decreased: grades 3/4: 61% to 72%), febrile neutropenia (10% to 20%; grades 3/4: 10% to 16%), lymphocytopenia (17%; grades 3/4: 16%)

Infection: Infection (46% to 56%; grades 3/4: 11% to 20%)

Local: Injection site reaction (22% to 35%; includes edema, erythema, hematoma, hemorrhage, hypersensitivity, induration, inflammation, infusion related reaction, irritation, mass, pruritus, rash)

Neuromuscular & skeletal: Weakness (23% to 24%), arthralgia (19%), limb pain (11% to 13%), back pain (12%), myalgia (11%)

Renal: Increased serum creatinine (grades 3/4: 9% to 16%)

Respiratory: Epistaxis (11% to 17%), cough (≤16%), dyspnea (11%)

Miscellaneous: Fever (25% to 29%)

1% to 10%:

Cardiovascular: Acute coronary syndrome, angina pectoris, bradycardia, cardiac arrhythmia, chest pain, edema, hypertension, hypotension, palpitations, tachycardia, ventricular premature contractions

Central nervous system: Agitation, anxiety, cerebral hemorrhage, confusion, depression, dizziness, hyperthermia, hypoesthesia, lethargy, malaise, mental status changes, mouth pain, myasthenia, pain, paresthesia, sciatica, seizure, voice disorder

Dermatologic: Burning sensation of skin, dermal ulcer, desquamation, erythema, hyperhidrosis, hyperpigmentation, night sweats, pruritus, skin lesion, xeroderma

Endocrine & metabolic: Decreased serum glucose (grades 3/4: 6% to 8%), dehydration, diabetes mellitus, gout, hot flash

Gastrointestinal: Abdominal distention, anal fissure, aphthous stomatitis, decreased appetite, dysgeusia, dyspepsia, dysphagia, gastritis, gastroesophageal reflux disease, gastrointestinal hemorrhage, gingival hemorrhage, gingival pain, gingivitis, hemorrhoids, melena, mucosal inflammation, oral mucosa ulcer, stomatitis, xerostomia

Genitourinary: Dysuria

Hematologic & oncologic: Bone marrow failure (10%; grades 3/4: 10%), bruise, hematoma, hemorrhage (ear), oral hemorrhage, petechia, purpura

Hepatic: Increased serum bilirubin (grades 3/4: 6% to 9%), increased serum ALT (grades 3/4: 2% to 6%)

Hypersensitivity: Hypersensitivity reaction, transfusion reaction

Neuromuscular & skeletal: Muscle spasm, musculoskeletal chest pain, musculoskeletal pain (or discomfort), ostealgia, stiffness, tremor

Ophthalmic: Blurred vision, cataract, conjunctival hemorrhage, conjunctivitis, diplopia, eyelid edema, eye pain, increased lacrimation, xerophthalmia

Otic: Otalgia, tinnitus

Respiratory: Flu-like symptoms, hemoptysis, nasal congestion, pharyngolaryngeal pain, rales, rhinorrhea, sinus congestion

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Grade 3/4 neutropenia, thrombocytopenia and anemia commonly occur; generally reversible, although may require treatment delay and/or a reduction in the number of treatment days with future cycles. Myelosuppression may rarely be fatal. Neutropenia may increase the risk for infection. Thrombocytopenia may increase the risk of bleeding; cerebrovascular hemorrhages have been reported (some fatal); gastrointestinal hemorrhages have occurred. Due to the increased risk of bleeding, avoid the use of anticoagulants, aspirin, and NSAIDs when the platelet count is <50,000/mm3.

• Glucose intolerance: Omacetaxine may induce glucose intolerance. Hyperglycemia (including grade 3 and 4 events) has been observed; hyperosmolar nonketotic hyperglycemia has been reported (case report). Avoid use in patients with poorly controlled diabetes; may initiate after glycemic control has been established.

Special populations:

• Older adult: Patients ≥65 years of age are more likely to experience toxicity, especially hematologic toxicity.

Product Availability

Synribo has been discontinued in the United States >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Subcutaneous, as mepesuccinate [preservative free]:

Synribo: 3.5 mg (1 ea [DSC])

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Synribo Subcutaneous)

3.5 mg (per each): $1,597.08

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

SUBQ: Administer SUBQ at approximately 12 hour intervals. If home administration is to occur, advise patient on proper handling, storage conditions, administration, disposal, and clean-up of accidental spillage; ensure that the patient or patient’s caregiver is an appropriate candidate for home administration. Avoid skin and eye contact; wear protective eyewear and gloves during handling and administration.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203585s007lbl.pdf#page=16, must be dispensed with this medication.

Use: Labeled Indications

Chronic myeloid leukemia, chronic or accelerated phase: Treatment of chronic or accelerated phase chronic myeloid leukemia (CML) in adults with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors.

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

Substrate of P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Anticoagulants: May increase adverse/toxic effects of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Management: Avoid concurrent use of anticoagulants with omacetaxine in patients with a platelet count of less than 50,000/uL. Risk X: Avoid

Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Aspirin: May increase adverse/toxic effects of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Management: Avoid concurrent use of aspirin with omacetaxine in patients with a platelet count of less than 50,000/uL. Risk X: Avoid

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nonsteroidal Anti-Inflammatory Agents: May increase adverse/toxic effects of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for 6 months after the last omacetaxine dose. Patients with partners who could become pregnant should use effective contraception during therapy and for 3 months after the last dose of omacetaxine.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, omacetaxine may cause fetal harm if administered during pregnancy.

Breastfeeding Considerations

It is not known if omacetaxine is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer does not recommend breastfeeding during therapy and for 2 weeks after the last dose of omacetaxine.

Monitoring Parameters

CBC with differential and platelets (weekly during induction and initial maintenance cycles, then every 2 weeks or as clinically indicated after initial maintenance cycles); blood glucose (frequently, especially in patients with diabetes or with risk factors for diabetes). Evaluate pregnancy status prior to use in patients who could become pregnant. Monitor for signs/symptoms of infection and signs of bleeding.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Omacetaxine is a reversible protein synthesis inhibitor which binds to the A-site cleft of the ribosomal subunit to interfere with chain elongation and inhibit protein synthesis. It acts independently of BCR-ABL1 kinase-binding activity, and has demonstrated activity against tyrosine kinase inhibitor-resistant BCR-ABL mutations.

Pharmacokinetics (Adult Data Unless Noted)

Onset:

Chronic phase CML: Mean time to major cytogenetic response: 3.5 months.

Accelerated phase CML: Mean time to response: 2.3 months.

Duration:

Chronic phase CML: Median duration of major cytogenetic response: 12.5 months.

Accelerated phase CML: Median duration of major hematologic response: 4.7 months.

Absorption: SUBQ: Rapid (Nemunaitis 2013).

Distribution: Vdss: 141 ± 93.4 L.

Protein binding: ≤50%.

Metabolism: Hydrolyzed by plasma esterases to 4’-DMHHT; minimal hepatic metabolism.

Half-life elimination: 14.6 hours.

Time to peak: SUBQ: ~30 minutes.

Excretion: Urine (~37); feces (~44%).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CN) China: Sai lan;
  • (PR) Puerto Rico: Synribo
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  2. Cortes JE, Kantarjian HM, Rea D, et al. Final analysis of the efficacy and safety of omacetaxine mepesuccinate in patients with chronic- or accelerated-phase chronic myeloid leukemia: Results with 24 months of follow-up. Cancer. 2015;121(10):1637-1644. [PubMed 25586015]
  3. Cortes J, Lipton JH, Rea D, et al, “Phase 2 Study of Subcutaneous Omacetaxine Mepesuccinate After TKI Failure in Patients With Chronic-Phase CML With T315I Mutation,” Blood, 2012, 120(13):2573-80. [PubMed 22896000]
  4. Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
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  6. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
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  9. Ovesen JL, Sammons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  10. Synribo (omacetaxine) [prescribing information]. Parsippany, NJ: Teva Pharmaceuticals USA Inc; September 2022.
  11. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
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