**Off Market Drug**
This medication is no longer available in the United States. Information provided here is for reference purposes only.
Pronunciation:
oh-ma-sat-axeen
Trade Name(s)
Ther. Class.
Pharm. Class.
protein synthesis inhibitors
Treatment of chronic or accelerated phase chronic myeloid leukemia (CML) that has become resistant or intolerant to at least 2 tyrosine kinase inhibitors.
Inhibits protein synthesis.
Therapeutic Effect(s):
Improved hematologic parameters and survival in CML.
Absorption: Absorbed following SUBQ administration.
Distribution: Widely distributed.
Metabolism and Excretion: Metabolized by enzymes in plasma; not metabolized by the liver; 37% excreted unchanged in urine.
Half-life: 6 hr.
TIME/ACTION PROFILE (response in Chronic Phase CML)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
SUBQ | 3.5 mo | unknown | 12.5 mo |
TIME/ACTION PROFILE (response in Accelerated Phase CML)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
SUBQ | 2.3 mo | unknown | 4.7 mo |
Contraindicated in:
Use Cautiously in:
CV: angina, arrhythmias, peripheral edema
Derm: alopecia, rash, hyperpigmentation, pruritus
EENT: epistaxis, ear pain, tinnitus
Endo: HYPERGLYCEMIA
GI: diarrhea, anorexia, mucositis, nausea, constipation, stomatitis, ↑ liver function tests, upper abdominal pain, vomiting
GU: ↓ fertility (males)
Hemat: ANEMIA, NEUTROPENIA, THROMBOCYTOPENIA, lymphopenia
Local: injection site reactions
MS: arthralgia, myalgia, musculoskeletal pain
Metabolic: INFECTION, fever
Neuro: fatigue, headache, insomnia, anxiety, depression, mental status changes
Resp: cough
Misc: hypersensitivity reactions, night sweats
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Drug-Drug
None noted.
SUBQ (Adults): Induction: 1.25 mg/m2 twice daily for 14 consecutive days of a 28-day cycle; maintenance: 1.25 mg/m2 twice daily for 7 consecutive days of a 28-day cycle. Modifications required for toxicity, treatment should be continued as long as benefit is noted.
Lyophilized powder for injection: 3.5 mg/vial
Monitor for bone marrow depression. Assess for bleeding (bleeding gums; bruising; petechiae; blood in stools, urine, and emesis; confusion, slurred speech, altered vision) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.
Lab Test Considerations:
Verify negative pregnancy test before starting therapy.
Monitor CBC and platelet count weekly during induction and maintenance cycles. After initial maintenance cycles, monitor CBC and platelet count every 2 wks or as clinically indicated. If Grade 4 neutropenia occurs (ANC <0.5 × 109 /L) or Grade 3 thrombocytopenia (platelet count <50 × 109 /L) during a cycle, delay starting next cycle until ANC is ≥1.0 × 109 /L and platelet count is ≥50 × 109 /L. For next cycle, also reduce number of days by 2 days (e.g. to 12 or 5 days).
Reconstitution: Reconstitute with 1 mL of 0.9% NaCl prior to use. Swirl gently until solution is clear; usually <1 minute. Concentration: 3.5 mg/mL.Solution is clear and colorless; do not administer solutions that are cloudy, discolored or contain particulate matter. Avoid contact with skin; immediately wash affected area with soap and water. Protect from light. Use solution within 12 hr at room temperature or 6 days if refrigerated. Discard unused solution.
Instruct patient to notify health care professional promptly if fever; chills; cough; hoarseness; sore throat; signs of infection; lower back or side pain; painful or difficult urination; bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; increased fatigue; dyspnea occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Caution patient not to drink alcoholic beverages or take medication containing aspirin or NSAIDs; may precipitate gastric bleeding.
Advise patients with diabetes to monitor blood glucose levels closely; may cause hyperglycemia.
Improved hematologic parameters in CML.