Usual Adult Dose for Cervical Cancer

2 mg/kg (up to a maximum of 200 mg for patients 100 kg or greater) IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity

Premedication and Eye Care:

• Conduct an ophthalmic exam including visual acuity and slit lamp exam at baseline, prior to each dose, and as indicated.
• The initial prescription and all renewals of any corticosteroid medications should be made only after examination with a slit lamp.
• Administer the first drop in each eye prior to each infusion; continue to administer the drops in each eye 72 hours after each infusion.
• Administer topical ocular vasoconstrictor drops in each eye immediately prior to each infusion.
• Use cooling eye pads during the infusion.
• Administer topical lubricating eye drops for the duration of therapy and for 30 days after the last dose.
• Advise patients to avoid wearing contact lenses unless advised by their eye care provider for the entire duration of therapy.

Use: For the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended.
Moderate or severe hepatic impairment: Not recommended.

Dose Adjustments

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:

• Starting dose: 2 mg/kg
• First dose reduction: 1.3 mg/kg
• Second dose reduction: 0.9 mg/kg

NOTE: Permanently discontinue therapy in patients who cannot tolerate 0.9 mg/kg

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
KERATITIS:
Superficial Punctate Keratitis (SPK):

• Any: Monitor

Confluent Superficial Keratitis (CSK):

• First occurrence: Withhold dose until SPK or normal, then resume therapy at the next lower dose level
• Second occurrence: Permanently discontinue therapy

Ulcerative keratitis or perforation:

• Any: Permanently discontinue therapy

CONJUNCTIVAL ULCERATION:
Any Ulceration:

• First occurrence: Withhold dose until complete conjunctival re-epithelialization, then resume therapy at the next lower dose level
• Second occurrence: Permanently discontinue therapy

CONJUNCTIVAL OR CORNEAL SCARRING OR SYMBLEPHARON:
Any Scarring or Symblepharon:

• Any: Permanently discontinue therapy

CONJUNCTIVITIS AND OTHER OCULAR ADVERSE REACTIONS:
Grade 1:

• Any: Monitor

Grade 2:

• First occurrence: Withhold dose until Grade 1 or less then resume at the same dose
• Second occurrence: Withhold dose until Grade 1 or less then resume at the next lower dose level; if no resolution to Grade 1 or less, permanently discontinue therapy
• Third occurrence: Permanently discontinue therapy

Grade 3 or 4:

• Any: Permanently discontinue therapy

Grade 3 or 4:

• Any: Permanently discontinue therapy

PERIPHERAL NEUROPATHY:
Grade 2:

• Any (initial or worsening of pre-existing condition): Withhold dose until Grade 1 or less, then resume at the next lower dose

Grade 3 or 4:

• Any: Permanently discontinue therapy

HEMORRHAGE:
Any Grade Pulmonary or Central Nervous System (CNS):

• Any: Permanently discontinue therapy

Grade 2 in Any Other Location:

• Any: Withhold therapy until resolved then resume at the same dose

Grade 3 in Any Other Location:

• First occurrence: Withhold dose until resolved then resume at the same dose
• Second occurrence: Permanently discontinue therapy

Grade 4 in Any Other Location:

• Any: Permanently discontinue therapy

PNEUMONITIS:
Grade 2:

• Any: Withhold dose until Grade 1 or less for persistent or recurrent pneumonitis; consider resuming therapy at next lower dose level

Grade 3 or 4:

• Any: Permanently discontinue therapy

Precautions

US BOXED WARNINGS:
OCULAR TOXICITY:

• This drug causes changes in the corneal epithelium and conjunctiva resulting in changes in vision, including severe vision loss, and corneal ulceration.

Recommendations:

• Perform an ophthalmic exam at baseline, prior to each dose, and as indicated.
• Adhere to premedication and required eye care before, during, and after infusion.
• Withhold therapy until improvement and resume, reduce the dose, or permanently discontinue, based on severity.

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:

• This drug is available for IV administration; do not administer as IV push or bolus.

Storage requirements:

• Store vial refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light; do not freeze; do not shake.

Reconstitution/preparation techniques:

• Use aseptic technique for reconstitution and preparation of this drug.
• The manufacturer product information should be consulted.

IV compatibility:

• Dextrose 5% Injection
• Sodium Chloride 0.9% Injection
• Lactated Ringer's Injection

Monitoring:

• Renal
• Hepatic

Patient advice:

• This drug can harm a developing baby.
• Proper ocular care is essential when receiving this drug.