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Folotyn Dosage

Medically reviewed by Drugs.com. Last updated on Sep 28, 2020.

Generic name: PRALATREXATE 20mg in 1mL
Dosage form: injection

Important Dosing Information

Pretreatment Vitamin Supplementation

Folic Acid
Instruct patients to take folic acid 1 to 1.25 mg orally once daily beginning 10 days before the first dose of FOLOTYN. Continue folic acid during treatment with FOLOTYN and for 30 days after the last dose [see Warnings and Precautions (5.1, 5.2)].

Vitamin B12
Administer vitamin B12 1 mg intramuscularly within 10 weeks prior to the first dose of FOLOTYN and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with FOLOTYN [see Warnings and Precautions (5.1, 5.2)].

Recommended Dosage

The recommended dosage of FOLOTYN is 30 mg/m2 intravenously over 3-5 minutes once weekly for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity.

Dosage Modifications for Renal Impairment and End Stage Renal Disease

Monitoring and Dosage Modifications for Adverse Reactions

Monitoring
Monitor complete blood cell counts and severity of mucositis at baseline and weekly. Perform serum chemistry tests, including renal and hepatic function, prior to the start of the first and fourth dose of each cycle.

Recommended Dosage Modifications
Do not administer FOLOTYN until:

  • Mucositis Grade 1 or less.
  • Platelet of 100,000/mcL or greater for first dose and 50,000/mcL or greater for all subsequent doses.
  • Absolute neutrophil count (ANC) of 1,000/mcL or greater.

Dosage modifications for adverse reactions are provided in Tables 1, 2, and 3.

Table 1 FOLOTYN Dose Modifications for Mucositis


Mucositis Gradea on Day of Treatment


Action


Recommended Dose upon Recovery to Grade 0 or 1

Patients Without Severe Renal Impairment

Patients with Severe Renal Impairment
Grade 2 Omit dose
Continue prior dose
Continue prior dose
Grade 2 recurrence Omit dose
20 mg/m2
10 mg/m2
Grade 3 Omit dose
20 mg/m2
10 mg/m2
Grade 4 Stop therapy

a Based National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0)


Table 2 FOLOTYN Dosage Modifications for Myelosuppression

Blood Count on Day of Treatment

Duration of Toxicity

Action

Recommended Dose Upon Recovery

Patients Without Severe Renal Impairment

Patients with Severe Renal Impairment
Platelet less than
50,000/mcL
1 week
Omit dose
Continue prior dose
Continue prior dose
2 weeks
Omit dose
20 mg/m2
10 mg/m2
3 weeks
Stop therapy
ANC 500 to 1,000/mcL
and no fever
1 week
Omit dose
Continue prior dose
Continue prior dose
ANC 500 to 1,000/mcL
with fever or ANC
less than 500/mcL
1 week
Omit dose, give G‑CSF or GM‑CSF
Continue prior dose with G-CSF or GM‑CSF
Continue prior dose with G-CSF or GM‑CSF support
2 weeks or recurrence
Omit dose, give G‑CSF or GM‑CSF
20 mg/m2 with G-CSF or GM-CSF
10 mg/m2 with G-CSF or GM-CSF
3 weeks or 2nd recurrence
Stop therapy

G-CSF=granulocyte colony-stimulating factor; GM-CSF=granulocyte macrophage colony-stimulating factor


Table 3 FOLOTYN Dosage Modifications for All Other Adverse Reactions

Toxicity Grade a on Day of Treatment

Action

Recommended Dose upon Recovery to Grade 2 or Lower

Patients Without Severe Renal Impairment

Patients with Severe Renal Impairment
Grade 3 Omit dose
20 mg/m2
10 mg/m2
Grade 4 Stop therapy

a Based on NCI CTCAE version 3.0

Preparation and Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use any vials exhibiting particulate matter or discoloration.

FOLOTYN is a hazardous drug. Follow applicable special handling and disposal procedures.1 If FOLOTYN comes in contact with the skin, immediately and thoroughly wash with soap and water. If FOLOTYN
comes in contact with mucous membranes, flush thoroughly with water.

Aseptically withdraw the calculated dose from the appropriate number of vial(s) into a syringe for immediate use. Do not dilute FOLOTYN.

Administer undiluted FOLOTYN intravenously over 3-5 minutes via the side port of a free-flowing 0.9% Sodium Chloride Injection.

After withdrawal of dose, discard vial(s) including any unused portion.

Further information

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