methotrexate
Print| Trade Name(s): Methotrexate; Jylamvo; Otrexup; Rasuvo; Trexall; Xatmep | |
| Group 1: Antineoplastic Hazardous | AHFS Class: Antineoplastic Agents; Disease-modifying Antirheumatic Drugs |
| Formweb: methotrexate | |
| Info Links: Chemotherapy Extravasation Policy | |
Administration:
Multiple Dosage Forms - High Risk Injectables/Low Risk Other Dosage Forms
Non-Injectable Dosage Forms:
| Activity | Gloves (ASTM D6978) | Gown (chemo rated) | Mask (N95) | Notes |
| Administration |  |
if chance of splash or vomiting |
if aerosols or powders present | |
| Cleaning | |  Clean area with PD Sani-Cloth Wipes |
Injection:
| Activity | Gloves (ASTM D6978) | Gown (chemo rated) | Mask (N95) | Eyes/Face | CSTD | Decontaminate/Clean |
| Administration |  |
|
if risk of spills or splashes |  if risk of spills or splashes |  | Use approved USP 800 cleaner (Surface-Safe 2 step wipes, Oxivir Tb wipes, or PeridoxRTU) to clean area and equipment after use and between drugs. |
| Cleaning | |  if risk of spills or splashes | if risk of spills or splashes | Use approved USP 800 cleaner (Surface-Safe 2 step wipes, Oxivir Tb wipes, or PeridoxRTU) to clean area and equipment after use and between drugs. |
Patient Care Activities:
AN- PPE During Handling of Bodily Fluids, contaminated materials (LH)
Handling of bodily fluids and/or contaminated materials
| Drug Form | Glove | Gown | Eye | Mask (N95/PAPR) | Shoe |
| All forms | |  | If splashing possible |
Extravasation:
For injectable formulations:
Inflammitants
These medications are generally described as causing mild to moderate inflammation when extravasation occurs. Due to some references not using this classification, the only drugs listed in this section are ones which were unclassified by some resources, yet classified by others as imflammitant.
Reference: Hemonc.org
Disposal:
Antineoplastic Agents (LH)
Receiving and Storage:
AN-Receiving & Storage (LH)
| Form | Receipt Packaging | Environment | Glove | Storage |
| Intact tablet/capsule from UD package | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms of AN may be stored with normal inventory. Refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Non-intact, repackaged tablet or capsule | N/A | N/A | | Segregated area, negative pressure room, externally ventilated, minimum 12 ACH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Oral liquid drug or feeding tube | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms of AN may be stored with normal inventory. Refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Powder for oral liquid | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Segregated area, negative pressure room, externally ventilated, minimum 12 ACH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Topical drug | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms of AN may be stored with normal inventory. Refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Powder, solution for inhalation | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms of AN may be stored with normal inventory. Refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Vial; ampule; pre-filled syringe | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms may be stored with normal inventory. AN requiring manipulation must be segregated area, negative pressure room, externally ventilated, minimum 12 ACPH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Intravenous solution | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms may be stored with normal inventory. AN requiring manipulation must be segregated area, negative pressure room, externally ventilated, minimum 12 ACPH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Irrigation solution | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms may be stored with normal inventory. AN requiring manipulation must be segregated area, negative pressure room, externally ventilated, minimum 12 ACPH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
Spill Containment | Notes/Instructions | PPE Required |
 | Wear N95 or PAPR mask if you see powders present | |
Preparation:
Injectable (AN), or any bulk powder of any group (LH)
| Glove | Gown | Eye | Mask | Shoe | Head Cover | Hood/Cabinet | CSTD | Notes/Instructions |
(outer layer should be sterile) |
(outer layer should be chemo rated) |
|  |  |
| | Any secondary layers of PPE should be removed/discarded prior to exiting the C-PEC |
Orals AN (LH)
| Glove | Gown | Eye | Mask (N95/PAPR) | Shoe |
| |
If not in controlled environment |
If not in controlled environment |  |
*Drug may not be placed in automated repackaging or counting device.
Transport:
Transport of AN
| Form | Prep Instructions | Pneumatic Tube |
| Intact tablet/capsule from UD package | Sealed plastic bag, single pair of gloves, cautionary labeling |  |
| Non-intact, repackaged tablet or capsule | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Oral liquid drug or feeding tube | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Topical drug | Sealed plastic bag, single pair of gloves, cautionary labeling |  |
| Powder, solution for inhalation | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Vial; ampule; pre-filled syringe | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Intravenous solution | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Irrigation solution | Sealed plastic bag, single pair of gloves, cautionary labeling | |
Assessment of Risk:
| Dosage Form | Risk of Exposure | Packaging | Pharmacy Manipulation | Nurse Manipulation |
| Injectable | May occur when compounding and administration | Not eligible for AoR | Not eligible for AoR | Not eligible for AoR |
| Oral Solid | May occur when counting, repackaging, manipulating, and during administration purchasing in UD minimizes risks | Unit dose | Purchased in UD when available When not available, pharmacy will UD using HD designated packaging equipment. If manipulation is needed, it will be done while utilizing recommended PPE and engineering controls in pharmacy Dispensed in intact UD packaging | Nurse will not manipulate or touch the medication |
Black Box Warning:
Embryo-Fetal, Bone Marrow, Liver, Lung, and Kidney Toxicity Risk
PPE:
PPE Guidelines
| |  | | |  | | |
| Chemotherapy rated/tested (tested to ASTM D6978-05 (2013), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) | Disposable
| Should be worn in situations where eye, mouth, or nasal splashing is possible (i.e., during a bladder instillation of a hazardous drug) | Goggles protect the eyes, but not the face, against spraying. | Certified N95 | Powered air purifying respirator | required for compounding sterile and nonsterile hazardous drugs | required for compounding sterile and nonsterile hazardous drugs |
| Powder-free | Shown to resist permeation by hazardous drugs
| N95 offers no protection against gases and vapors. | For events such as large spills when an IV bag breaks or a line disconnects and leaks, or where there is known or suspected airborne exposure to vapors or gases | Double booties required for HD preparation areas, top layer is doffed before exiting the HD buffer room. | |||
| Inspect for visible defects | Must close in the back (no open front) | Surgical masks do NOT provide respiratory protection from drug exposure | Hazardous drugs with potential to vaporize at room temperature: • Carmustine • Cisplatin •Cyclophosphamide • Etoposide • 5-Fluorouracil • lfosfamide • Thiotepa | ||||
| Double gloving is recommended for all activities involving hazardous drugs except for handling intact, unit-dose oral agents, when one pair of chemotherapy-tested gloves is acceptable | Long sleeves with closed cuffs that are elastic or knit | ||||||
| When wearing double gloves, tuck the cuff of the inner glove under the gown sleeve and the cuff of the outer glove over the gown sleeve. | No seams or closures that could allow hazardous drugs to pass through | ||||||
| During medication manipulation/compounding the outer layer should be sterile | In preparation areas gowns should be changed every 2-3 hours or immediately after a spill or splash | ||||||
Change gloves every 30 minutes unless permeation testing has noted shorter time limits
| Gowns worn in hazardous drug handling areas must NOT be worn to other areas |
Sequence for Donning & Doffing PPE
References: Oncology Nursing Society, NIOSH
Mechanism of Action:
Methotrexate anti-tumor activity is a result of the inhibition of folic acid reductase, leading to inhibition of DNA synthesis and inhibition of cellular replication. The mechanism involved in its activity against rheumatoid arthritis is not known.
Reference: Drug Bank
Exposure Risk:
- Toxic if swallowed.
- Causes skin irritation.
- Causes serious eye irritation.
- May damage fertility or the unborn child.
Reference: SDS - Cayman Chemical
Safety Data Sheet(s):
Approved on November 22, 2024
