Imetelstat Dosage

Medically reviewed by Drugs.com. Last updated on Jul 25, 2024.

Usual Adult Dose for Myelodysplastic Syndrome

7.1 mg/kg IV every 4 weeks
Duration of therapy: Discontinue if patient does not experience a decreased RBC transfusion burden after 24 weeks of treatment (i.e., 6 doses), or if unacceptable toxicity occurs

Comments:

• Administer as an IV infusion over 2 hours; monitor patient for at least 1 hour after infusion completion.
• Pretreatment medications are recommended to reduce or prevent infusion-related reactions.
• Assess CBC and liver function tests prior to administration, and then as recommended.

Use: For the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Dosage Modifications For Elevated Liver Function Tests (LFTs):
Grade 3 or 4:

• First and second occurrence: Delay therapy until recovery of adverse reactions to grade 1 or baseline; restart at one dose level lower
• Third occurrence: Permanently discontinue therapy.

Dose Adjustments

Dose Reductions for Grade 3 or 4 Adverse Reactions:

• First dose reduction: 5.6 mg/kg IV every 4 weeks
• Second dose reduction: 4.4 mg/kg IV every 4 weeks
• Permanently discontinue therapy if patient cannot tolerate the lowest dose level (i.e., 4.4 mg/kg).

Dosage Modifications for Hematologic Adverse Reactions:
THROMBOCYTOPENIA: Delay the next cycle if platelets are less than 50 x 10(9)/L.
Grade 3:

• First occurrence: Delay therapy until recovery of platelets to 50 x 10(9)/L; restart at same dose level.
• Second and third occurrence: Delay therapy until recovery of platelets to 50 x 10(9)/L; restart at one dose level lower.
• Fourth occurrence: Discontinue therapy.

Grade 4:

• First and second occurrence: Delay therapy until recovery of platelets to 50 x 10(9)/L; restart at one dose level lower.
• Third occurrence: Discontinue therapy.

NEUTROPENIA: Delay the next cycle if absolute neutrophil count (ANC) is less than 1 x 10(9)/L.
Grade 3:

• First occurrence: Delay therapy until recovery of ANC to 1 x 10(9)/L; restart at same dose level.
• Second and third occurrence: Delay therapy until recovery of ANC to 1 x 10(9)/L; restart at one dose level lower.
• Fourth occurrence: Discontinue therapy.

Grade 4:

• First and second occurrence: Delay therapy until recovery of ANC to 1 x 10(9)/L; restart at one dose level lower.
• Third occurrence: Discontinue therapy.

Dosage Modifications for NON-Hematologic Adverse Reactions:
INFUSION-RELATED REACTIONS:
Grade 2 or 3:

• First or second occurrence: Interrupt infusion until reaction resolution or until reaction intensity decreases to grade 1; restart infusion at 50% of the infusion rate administered prior to the adverse reaction.
• Third occurrence: For grade 2: Stop infusion; may restart at next cycle; For grade 3: Permanently discontinue therapy.

Grade 4:

• First occurrence: Stop infusion, administer supportive care as appropriate, and permanently discontinue therapy.

OTHER ADVERSE REACTIONS:
Grade 3 or 4:

• First and second occurrence: Delay therapy until recovery of adverse reactions to grade 1 or baseline; restart at one dose level lower
• Third occurrence: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IV use
• Once reconstituted and diluted, infuse intravenously over 2 hours.
• Administer the following pretreatment medications at least 30 minutes prior to dosing:
• Diphenhydramine (or equivalent) 25 mg to 50 mg IV or orally
• Hydrocortisone (or equivalent) 100 mg to 200 mg IV or orally

Storage requirements:

• Vials: Store refrigerated at 2C to 8C (36F to 46F) in the original carton.
• Diluted solution: Store for 18 hours or less at room temperature from 20C to 25C (68F to 77F) OR for 48 hours or less under refrigeration from the time of reconstitution to completion of IV infusion.
• Do not freeze.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted prior to product reconstitution and dilution.
• Reconstituted solution: Do not use if discoloration or particulate matter is present.
• Infusion solution: Do not shake infusion bag prior to administration; gently invert to mix.

Monitoring:

• Hematologic: CBC (prior to treatment, weekly for the first 2 cycles, prior to each cycle thereafter, and as clinically indicated)
• Hepatic: LFTs (prior to administration, weekly for the first cycle, prior to each cycle thereafter, and as clinically indicated)
• Immunologic: For infusion-related reactions (for at least 1 hour after completion of infusion)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Understand that blood counts and liver function will be monitored before and during treatment.
• Infusion-related reactions may occur; you will be monitored for at least an hour after infusion completion.
• Notify a health care provider immediately if signs/symptoms such as fever, infection, or unusual bleeding/bruising occur.
• Females of reproductive potential: Use effective contraception during treatment and for 1 week after the last dose. Notify a health care provider of a known/suspected pregnancy; this drug may harm a developing fetus.
• Breastfeeding is not recommended during treatment and for 1 week after the last dose.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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