Usual Adult Dose for Chemotherapy Toxicity

To reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer:
910 mg/m2 IV over 15 minutes once daily starting 30 minutes prior to chemotherapy

The infusion should be interrupted if the systolic blood pressure decreases significantly from the baseline value:

• If baseline systolic blood pressure is less than 100 mm Hg and decreases by 20 mm Hg during the infusion.
• If baseline systolic blood pressure is 100 to 119 mm Hg and decreases by 25 mm Hg during the infusion.
• If baseline systolic blood pressure is 120 to 139 mm Hg and decreases by 30 mm Hg during the infusion.
• If baseline systolic blood pressure is 140 to 179 mm Hg and decreases by 40 mm Hg during the infusion
• If baseline systolic blood pressure is 180 mm Hg or greater and decreases by 50 mm Hg during infusion.

If the infusion is interrupted and blood pressure returns to normal within 5 minutes and the patient is asymptomatic, the infusion may be restarted so that the full dose may be administered. If the full dose cannot be administered, the dose for subsequent chemotherapy cycles should be 740 mg/m2.

Comments:

• It is recommended that antiemetic medication (dexamethasone 20 mg IV and a serotonin 5HT3 receptor antagonist) be administered prior to and in conjunction with this drug. Additional antiemetics may be required based on the chemotherapy drugs administered.
• The 15-minute infusion is better tolerated than more extended infusions (further reductions in infusion times for chemotherapy regimens have not been investigated).
• Patients should be adequately hydrated prior to receiving this drug and kept in a supine position during the infusion.
• Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as indicated.

Use: To reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer

Usual Adult Dose for Xerostomia

For reduction of moderate to severe xerostomia from radiation of the head and neck:
200 mg/m2 IV over 3 minutes once daily, starting 15 to 30 minutes prior to standard fraction radiation therapy (1.8 to 2 Gy)

Comments:

• Patients should be adequately hydrated prior to the infusion.
• Blood pressure should be monitored at least before and immediately after the infusion, and thereafter as indicated.
• It is recommended that antiemetic medication be administered prior to and in conjunction with this drug. Oral 5HT3 receptor antagonists, alone or in combination with other antiemetics, have been used effectively in the radiotherapy setting.

Use: For severe xerostomia in patients undergoing postoperative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Hypersensitivity to aminothiol compounds

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:

• Antiemetic medication should be administered prior to and in conjunction with this drug.

Storage requirements:

• Store the lyophilized dosage form at 20C to 25C (68F to 77F).

IV compatibility:

• The compatibility of this drug with solutions other than 0.9% Sodium Chloride for Injection or Sodium Chloride solutions with other additives is unknown. The use of other solutions is not recommended.

Monitoring:

• Serum calcium levels should be monitored in patients at risk of hypocalcemia, such as those with nephrotic syndrome or patients receiving multiple doses of this drug. If necessary, calcium supplements can be administered.