Usual Adult Dose for Amyotrophic Lateral Sclerosis

• Initial Treatment Cycle: 60 mg once a day as IV infusion for 14 days followed by a 14-day drug-free period.

• Subsequent Treatment Cycles: 60 mg once a day as IV infusion for 10 days out of 14-day periods, followed by 14-day drug-free periods.

• Administer each 60 mg dose as 2 consecutive 30 mg IV infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 mL per minute]).
• Upon the first observation of any signs or symptoms of a hypersensitivity reaction, promptly discontinue the infusion.

Renal Dose Adjustments

Renal Impairment: No adjustment recommended.

Liver Dose Adjustments

• Mild to Moderate Hepatic Impairment: No adjustment recommended.
• Severe Hepatic Impairment: Dose adjustment may be required; however, no specific guidelines have been suggested. Caution is recommended.

Precautions

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:

• The oxygen indicator will turn blue or purple if the oxygen has exceeded acceptable levels; avoid use in such cases.
• Use within 24 hours once the overwrap package is opened.
• Inspect visually for particulate matter and discoloration prior to administration.

• Store at up to 25 degrees Celsius (77 degrees Fahrenheit); excursions permitted from 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).
• Protect from light, and keep in overwrapped package to protect from oxygen degradation until time of use.

• Do not inject other medications into the infusion bag or mixed with this drug.

• The efficacy of this drug was established in a 6-month clinical study of Japanese patients with ALS duration of 2 years or less who had normal respiratory function (forced vital capacity of 80% or more); 93% of these patients were living independently and retained most activities of daily living (2 points or better on each item of the ALS Functional Rating Scale - Revised).

• Hypersensitivity/allergic reactions, anaphylaxis, asthmatic episodes (throughout treatment)