Usual Adult Dose for Chemotherapy Toxicity

240 mg/m2 IV over 30-minute completed within 4 hours prior to the start of chemotherapy day

Comments:

• Interval between doses of this drug on sequential days should not be greater than 28 hours.
• For a is missed, discontinue chemotherapy that day and consider resuming both this drug and the chemotherapy on the next scheduled chemotherapy day.
• If this drug is discontinued, wait 96 hours from the last dose of this drug before resuming the chemotherapy regimen alone.

• To decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan containing regimen for extensive-stage small cell lung cancer

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild liver dysfunction (total bilirubin of at least the upper limit of normal [ULN] and AST up to the ULN, or total bilirubin less than 1.0 to 1.5 × ULN, irrespective of AST): No adjustment recommended.
Moderate or severe liver dysfunction (total bilirubin less than 1.5 × ULN, irrespective of AST): Not recommended.

Dose Adjustments

RECOMMENDED ACTIONS FOR ADVERSE REACTIONS:

INJECTION-SITE REACTIONS INCLUDING PHLEBITIS AND THROMBOPHLEBITIS:
Grade 1 tenderness with or without symptoms, e.g., warmth, erythema, itching:

• Interrupt or slow the drug infusion.
• For subsequent infusions, consider changing the diluent/flush to 5% Dextrose Injection, if using 0.9% Sodium Chloride Injection as appropriate.

• Interrupt the drug infusion.
• Follow instructions for Grade 1 if the pain is not severe.
• Stop the infusion for severe pain at the infusion site and switch to an alternate extremity.
• For subsequent infusions, consider changing the diluent/flush to 5% Dextrose Injection, if using 0.9% Sodium Chloride Injection as appropriate, or consider central access.

• Stop infusion and hold until recovery to Grade 1 or less or baseline, then consider resuming the infusion.
• If recurrence, permanently discontinue this drug.

• Permanently discontinue this drug.

• Permanently discontinue this drug.

• Permanently discontinue this drug.

• Permanently discontinue this drug.

• Hold infusion until recovery to Grade 1 or less or baseline, then consider resuming infusion.
• If recurrence, permanently discontinue this drug

• Permanently discontinue this drug.

Precautions

CONTRAINDICATIONS: History of serious hypersensitivity reactions, including anaphylaxis to the active ingredient or to any of the ingredients.

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:

• Administer the diluted solution as an IV infusion over 30-minute completed within 4 hours prior to the start of chemotherapy day.
• This drug should be reconstituted and further diluted prior to IV infusion.
• Use aseptic technique.
• The vial stopper of this product is NOT made with natural rubber latex
• Visually inspect the product for discoloration and particulate matter prior to the infusion.

• Store at 68F to 77F (20C to 25C)
• Excursion permitted to 59F to 86F (15C to 30C)

• If diluted in 5% Dextrose for Injection in any of these bag materials: Polyvinyl chloride (PVC), Ethylene vinyl acetate (EVA), Polyolefin (PO), or Polyolefin/polyamide (PO/PA): Store up to 12 hours at 68F to 77F (20C to 25C)
• If diluted in 0.9% Sodium Chloride Injection in any of these bag materials PVC, EVA, or PO: Store up to 8 hours at 68F to 77F (20C to 25C)
• If diluted in 0.9% Sodium Chloride Injection in a PO/PA bag material: Store up to 4 hours at 68F to 77F (20C to 25C)

• The manufacturer product information should be consulted.

• Monitor for signs and symptoms of injection-site reactions, phlebitis, and thrombophlebitis, including, infusion-site pain and erythema during infusion.
• Monitor for signs and symptoms of acute drug hypersensitivity reactions including facial, eye, and tongue edema, urticaria, pruritus, and anaphylactic reactions.
• Monitor for pulmonary symptoms indicative of ILD/pneumonitis such as cough, dyspnea, and hypoxia.
• Monitor closely for nephrotoxicity if this drug is given concurrently with cisplatin.
• Monitor for seizures if this drug is given concurrently with dalfampridine.
• Monitor for arrhythmias, including torsade de pointes, if this drug is given concurrently with dofetilide.

• Advise females of the potential risk to a fetus and inform their healthcare provider of a known or suspected pregnancy.
• Advise females of reproductive potential to use effective contraception during treatment and for at least 3 weeks after the last dose.
• Advise not to breastfeed during treatment and for at least 3 weeks after the last dose.
• Advise patients to inform their healthcare providers of all concomitant medications, including over-the-counter and herbal products.
• Advise patients to immediately report any signs and symptoms suggestive of injection-site reactions, including phlebitis and thrombophlebitis.
• Advise patients to immediately report any signs and symptoms suggestive of acute drug hypersensitivity reactions including facial, eye, and tongue edema, urticaria, pruritus, and anaphylactic reactions.
• Advise patients to immediately report any new or worsening respiratory symptoms.