Usual Adult Dose for Mucositis

60 mcg/kg IV (as a bolus) once a day, administered for 3 consecutive days before and 3 consecutive days after myelotoxic therapy

Comments:

• Prior to myelotoxic therapy: The third dose should be administered 24 to 48 hours prior to beginning the myelotoxic agent.
• Following myelotoxic therapy: The first dose should be administered on the day of hematopoietic stem cell infusion after the infusion is complete, AND at least 7 days after the most recent dose of this drug.

• Decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support
• Supportive care for preparative regiments predicted to result in greater than or equal to WHO Grade 3 mucositis in the majority of patients

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be given as a IV bolus injection; the solution should not be filtered.
• If heparin is used, IV lines should be rinsed with saline prior to and after administration.
• Prior to administration, this drug should be allowed to reach room temperature for up to 1 hour (protected from light); however, this drug will need to be discarded in excursions exceeding 1 hour.

• Unopened vials: Store refrigerated (2 to 8C), and protect from light. Do not freeze.
• Reconstituted solution: The solution may be stored refrigerated (2 to 8C) and protected from light in its carton for up to 24 hours; the solution should be discarded after 24 hours if it is not used.
• Reconstituted solutions left at room temperature for longer than 1 hour should be discarded.

• Compatible: Sterile water for injection
• Other medications should not be added to solutions containing this drug.

• Safety and efficacy have not been established in patients with non-hematologic malignancies.
• This drug was not effective in decreasing severe mucositis in patients with hematologic malignancies who were receiving myelotoxic therapy with allogenic hematopoietic stem cell support.
• Once reconstituted, it is recommended that this drug is used immediately.
• Limitation of use: Treatment is not recommended for use with melphalan 200 mg/m2 as a conditioning regimen.

• HEMATOLOGIC: Platelet counts

• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.