Drug Detail:Folotyn (Pralatrexate [ pral-a-trex-ate ])
Generic Name: PRALATREXATE 20mg in 1mL
Dosage Form: injection
Drug Class: Antimetabolites
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
- Severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2 by MDRD): Reduce the FOLOTYN dose to 15 mg/m2 [see Use in Specific Populations (8.6)].
- End stage renal disease (ESRD: eGFR less than 15 mL/min/1.73 m2 by MDRD) with or without dialysis: Avoid administration. If the potential benefit of administration justifies the potential risk, monitor renal function and reduce the FOLOTYN dose based on adverse reactions [see Warnings and Precautions (5.6), Use in Specific Populations (8.6)].
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.
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)
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
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.
