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Iwilfin Dosage

Generic name: EFLORNITHINE HYDROCHLORIDE 250mg
Dosage form: tablet
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Dec 21, 2023.

Recommended Testing Before Initiating IWILFIN

Prior to initiating IWILFIN, perform complete blood count, liver function tests, and baseline audiogram [see Warnings and Precautions (5.1-5.3)].

Recommended Dosage of IWILFIN

The recommended IWILFIN dosage, based on body surface area (BSA), is provided in Table 1.

Recalculate the BSA dosage every 3 months during treatment with IWILFIN.

Table 1: Recommended Dose
Body Surface Area (m2) Dosage
>1.5 768 mg (four tablets) orally twice a day
0.75 to 1.5 576 mg (three tablets) orally twice a day
0.5 to < 0.75 384 mg (two tablets) orally twice a day
0.25 to < 0.5 192 mg (one tablet) orally twice a day

Dosage Modifications for Adverse Reactions

The recommended dose reductions for adverse reactions are provided in Table 2.

Table 2: Recommended IWILFIN Dose Reductions for Toxicity Management
Current Dose Reduced Dose
768 mg (four tablets) orally twice a day 576 mg (three tablets) orally twice a day
576 mg (three tablets) orally twice a day 384 mg (two tablets) orally twice a day
384 mg (two tablets) orally twice a day 192 mg (one tablet) orally twice a day
192 mg (one tablet) orally twice a day 192 mg (one tablet) orally once daily

If subsequent adverse reactions occur, continue dose reduction until reaching the minimum dose of one 192 mg tablet once per day. Permanently discontinue IWILFIN if the patient is unable to tolerate the minimum dose of 192 mg once daily.

The recommended dosage modifications of IWILFIN for the management of adverse reactions are provided in Table 3.

Table 3: Recommended IWILFIN Dosage Modifications for Adverse Reactions
Adverse Reaction Severity* Dosage Modification
*
Severity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Myelosuppression [see Warnings and Precautions (5.1)]
Neutrophil count decreased <500/mm3 Withhold IWILFIN until recovery to ≥500/mm3.
  • If recovered within 7 days, resume IWILFIN at the same dose.
  • If recovered after 7 days, resume IWILFIN at the next reduced dose level.
Platelet count decreased <25,000/mm3 Withhold IWILFIN until recovery to ≥25,000/mm3.
  • If recovered within 7 days, resume IWILFIN at the same dose.
  • If recovered between 7 and 14 days, resume IWILFIN at the next reduced dose level.
If not recovered within 14 days, permanently discontinue IWILFIN.
Anemia <8g/dL Withhold IWILFIN until recovery to ≥8g/dL.
  • Resume IWILFIN at the same dose.
If anemia recurs (<8g/dL)
  • Withhold IWILFIN until recovery to ≥8g/dL.
  • Resume IWILFIN at the next reduced dose level.
Hepatotoxicity [see Warnings and Precautions (5.2)]
Aspartate aminotransferase increased
or
Alanine aminotransferase increased		 AST or ALT ≥10 × ULN Withhold IWILFIN until recovery to <10 × ULN.
  • If recovered within 7 days, resume IWILFIN at the same dose.
  • If recovered after 7 days, resume IWILFIN at the next reduced dose level.
Hearing Loss [see Warnings and Precautions (5.3)]
Hearing loss Clinically concerning new or worsening hearing loss compared to IWILFIN baseline audiogram Continue dosing with IWILFIN and repeat audiogram in 3 weeks.
  • If improved, continue IWILFIN at the same dose.
  • If clinically concerning changes persist, hold IWILFIN for up to 30 days and repeat audiogram.
If stable or improved, resume IWILFIN at the next reduced dose level.
Other Adverse Reactions [see Adverse Reactions (6.1)]
Nausea, vomiting, or diarrhea Grade 3 If symptoms respond to supportive treatment (e.g., anti-emetic, anti-diarrheal), continue dosing with IWILFIN at the same dose.
If symptoms do not respond to treatment,
  • Withhold IWILFIN until recovery to ≤ Grade 2.
  • Resume IWILFIN at the next reduced dose level.
Other adverse reactions Grade 3 or 4 Withhold IWILFIN until recovery to ≤ Grade 2.
  • Resume IWILFIN at the next reduced dose level.
Recurrent Grade 4 Permanently discontinue IWILFIN.

Administration, Crushed Preparation, and Missed Dose Instructions

Administration

  • Administer IWILFIN orally twice daily, with or without food, for two years or until recurrence of disease or unacceptable toxicity [see Clinical Pharmacology (12.3)].
  • IWILFIN tablets can be swallowed whole, chewed, or crushed.

Crushed Preparation

  • For patients who have difficulty swallowing tablets, IWILFIN can be chewed, or crushed then mixed with two tablespoons of soft food or liquid.
  • Visually confirm the entire contents are consumed. If any crushed tablet particles remain in the container, mix with an additional small volume (e.g., no more than one ounce, 30 mL) of soft food or liquid.
  • Discard crushed tablet preparation after one hour.

Missed Dose

  • A missed dose of IWILFIN should be administered as soon as possible. If the next dose is due within 7 hours, the missed dose should be skipped.
  • If vomiting occurs after taking IWILFIN, an additional dose should not be administered. Continue with the next scheduled dose.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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