finasteride

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Trade Name(s): Finasteride; Proscar; Propecia
Group 3: Reproductive Hazard AHFS Class: 5-alpha-Reductase Inhibitors; Cell Stimulants and Proliferants
Preparation:
Oral - 2&3
ActivityGloves
GownEye/FaceMaskNotes/Instructions
Dispensing prepackaged formulations



  • PPE not required if dispensed in manufacturer packaging with no counting or manipulation needed.
Counting/Repackaging tablets and capsulesGloves SingleGown
Recommended if pregnant, breast feeding, or trying to conceive

Mask
If risk of dust inhalation
  • Do not split, crush, open, or otherwise manipulate tablets or capsules.
  • Manually prepack and count in designated HD area with dedicated equipment.
  • Do not use Automated Repackaging equipment.
  • Only the minimum number of tablets or capsules necessary to accomplish the task should be emptied from the bottle onto the counting tray.
  • Reasonable efforts should be made to minimize the production of powder/dust and aerosolization of any particulate as well as residual dust present in the tray.
  • Deactivate, decontaminate, clean and disinfect area and equipment after use and between hazardous drugs.
Repackaging oral liquidsGloves DoubleGownFace Shield
If risk of spill or splash		Mask
If risk of inhalation
  • Repackage in designated area with dedicated equipment
  • Deactivate, decontaminate, clean, and disinfect area and equipment after use and between hazardous drugs.
Administration:
Oral - 2&3
Formulation

Gloves

Gown

Eye/Face

Mask

Notes/Instructions
Tablet or capsule - from unit dose package

Gloves Single

or

Gloves Double

Recommended if pregnant, breast feeding, or trying to conceive.




  • Do not crush, cut, open or manipulate hazardous drugs.
Liquid - oral or feeding tube

Gloves Single

or

Gloves Double

Recommended if pregnant, breast feeding, or trying to conceive.

Gown

Recommended if pregnant, breast feeding, or trying to conceive.

Face Shield

If potential for splash, vomit or spit up.


  • Eye and face protection is recommended for patients who are unruly, predisposed to spitting out, have difficulty swallowing or if the formulation is hard to swallow.

Reference: NIOSH 2016, USP <800>

Receiving and Storage:
Storage & Handling
Type of InstanceGloves
GownMaskEye/FaceNotes/Instructions
Receiving undamaged HD shipping containerGloves Single
  • Hazardous drugs should be received in impervious plastic to segregate them from other drugs and to allow for safety in the receiving process.
  • HDs must be delivered to the HD storage area immediately after unpacking.
Receiving damaged HD shipping containerGloves Double
Gown
If container must be opened		Mask
If container must be opened		Goggles
If container must be opened
  • If possible, do not open the container. Instead, segregate the container in a segregated area and mark "hazardous." Alert other staff and contact the supplier for direction. If the container is to be returned, leave in the segregated area until the return is complete.
  • If the damaged HD container must be opened, don the appropriate PPE and transport the container to the designated HD area. Remove undamaged items, cleaning the outside of each with alcohol or hydrogen peroxide. Enclose the damaged HD item(s) in a hazardous plastic bag, seal in a small shipping box marked "hazardous," and place in a segregated area. Clean the designated HD area where the container was handled. Contact the supplier for direction.
  • If the supplier declines return, dispose of as hazardous waste.
  • If the damaged HD in the shipping container constitutes a large volume spill, report to the USP 800 Specialist.
Spill CleanupGloves DoubleGownMask
Large volume		Goggles
Large volume		Spill Kit
  • Clear the area of the spill and restrict access, if necessary.
  • Small Volume Spills: Powder or liquid spills of 5 grams/ml or less. Clean spill using a cloth, towel or wipe dampened with alcohol or hydrogen peroxide. Do not spray cleaning product directly on to surface or spill.
  • Large Volume Spills: Powder or liquid spills of 5 grams/ml or more. Use a Chemo Spill Kit and the cleaning agents included, following the instructions in the kit. Contain liquid spills by covering with absorbent sheets. If the spill is a powder, use a cloth, towel or wipe dampened with alcohol or hydrogen peroxide. Report large volume spills to the USP 800 specialist.
  • Dispose of all contaminated materials in the appropriate hazardous drug waste container.
  • After removing PPE, wash hands, arms, and face.

Reference: USP <800>

Disposal:
Disposals - All
Hazardous PharmaceuticalTrace ChemoBiohazardous and Sharps
Black BinYellow BinRed Bin
1.  Non-returnable hazardous, chemo and EPA regulated drugs.
(Patient specific prescriptions, partially used blister packs, containers with more than 3% medication remaining)

2. Empty bottles or packaging of P-Listed drugs.
(Warfarin, nicotine, epinephrine, nitroglycerin, physostigmine)

3. PPE with visible contamination from hazardous drug.

1. Waste contaminated through contact with chemotherapeutic agents.

(Empty vials, IV bags, syringes and tubing)


2. PPE worn while handling hazardous drugs with NO visible contamination.

(Gowns, gloves and masks)


3. Used CSTD devices.

1. All sharps capable of cutting or piercing the skin.
(Needles/syringes, broken ampules, lancets)

2. Items contaminated with blood or other potentially infectious materials.
(Tubing, bags or dressings containing blood, contaminated waste from isolation patients)


Transport:
Transporting
Dosage FormShip to Institution or PharmacyShip to Locations Outside of ODOC
Tablets and CapsulesGloves Single
  • Transport in appropriate resealable clear plastic bag with "Hazardous Drug" labeling or sticker.
  • Place bagged HD in a small shipping box labeled "Hazardous" and seal.
  • Place sealed box inside larger shipping container or box and seal.
Gloves Single
  • Transport in appropriate resealable clear plastic bag with "Hazardous Drug" labeling or sticker.
  • Place bagged HD in a small shipping box labeled "Hazardous" and seal.
  • Place sealed box inside larger shipping container or box and seal.
  • Include storage, disposal, and HazD category information.
Liquid, Topical, and TransdermalGloves Double
  • Transport in appropriate resealable clear plastic bag with "Hazardous Drug" labeling or sticker.
  • Place bagged HD in a small shipping box labeled "Hazardous" and seal.
  • Place sealed box inside larger shipping container or box and seal.
Gloves Double
  • Transport in appropriate resealable clear plastic bag with "Hazardous Drug" labeling or sticker.
  • Place bagged HD in a small shipping box labeled "Hazardous" and seal.
  • Place sealed box inside larger shipping container or box and seal.
  • Include storage, disposal, and HazD category information.

PPE:
PPE Standards
PPEStandards
Shoe Covers
Shoe Covers


  • To avoid spreading HD contamination and exposing other healthcare workers, shoe covers worn in HD handling areas must not be worn to other areas.

Gown

Gowns

  • Gowns must be changed per the manufacturer's information for permeation of the gown. If no permeation information is available, change them every 2-3 hours or immediately after a spill or splash.
  • Gowns are not reusable and must be disposed of after use.
  • Must close in the back (no open front)
  • Gowns worn in hazardous drug handling areas must NOT be worn to other areas
Gloves Single
Gloves
  • Must be worn when handling all HDs
  • Inspect for physical defects before use.
  • Gloves should be changed every 30 minutes (unless otherwise recommended by the manufacturer) and immediately when torn, punctured, or contaminated.
  • Gloves must be changed in between patients when administering different HDs.
  • Wash hands with soap and water after removing.
Face Shield
Face Shields
  • Face shields should be worn in situations where eye, mouth, or nasal splashing is possible
  • Face shields can be worn with goggles to provide a full range of protection against splashes to the face and eyes.
Goggles
Goggles
  • Goggles must be used when eye protection is needed. Eye glasses, safety glasses and face shields do not provide adequate eye protection.
  • Must be worn when there is a risk for spills or splashes of HDs or HD waste materials.
Mask
N95 Masks
  • Personnel who are unpacking HDs that are not contained in plastic should wear an N95 mask until the drug can be identified.
  • Surgical masks do not provide respiratory protection from HD exposure and must not be used.
  • N95 respirators offer no protection against gases and vapors and little protection against direct liquid splashes.
  • Follow all requirements in the Occupational Safety and Health Administration (OSHA) respiratory protection standard (29 CFR 1910.134).
Removal and Disposal
  • All PPE worn when handling HDs is considered contaminated.
  • Remove gloves first, grasping the outside of the glove with the opposite gloved hand.
  • Hold the removed glove in the gloved hand. Slide the fingers of the ungloved hand under the remained glove at wrist. Peel second glove over the first glove.
  • If wearing double glove, remove the outer gloves one at a time, turning them carefully inside out to avoid touching the outside. Leave inner gloves on.
  • The face shield, if worn, should be removed next, while avoiding contact with the front. 
  • Remove the gown, using care to pull it away from the body, not pulling it over the head, to avoid transfer of contamination to clothes and skin. Turn the gown inside out, fold it tightly, and discard it.
  • Remove the mask (if worn), avoiding touching the face-piece. 
  • Remove inner gloves (if double gloved) and discard in the disposal container. 
  • Immediately wash hands with soap and water. .
  • PPE must be placed in an appropriate waste container and further disposed of per local, state, and federal regulations.

Reference: USP <800>

Additional Information:

ODOC Formweb

Assessment of Risk:

AoR

Exposure Risk:

  • Harmful if swallowed. 
  • May damage fertility or the unborn child. 
  • Causes damage to organs {testes, oral} through prolonged or repeated exposure. 
  • Very toxic to aquatic life with long lasting effects.

Reference: SDS - Cayman Chemical

Supplemental Information:

Only met the NIOSH criteria as a developmental and/or reproductive hazard

Mechanism of Action:

Finasteride acts as a competitive and specific inhibitor of Type II 5α-reductase, a nuclear-bound steroid intracellular enzyme primarily located in the prostatic stromal cell that converts the androgen testosterone into the more active metabolite, 5α-dihydrotestosterone (DHT).1 DHT is considered to be the primary androgen playing a role in the development and enlargement of the prostate gland. It serves as the hormonal mediator for the hyperplasia upon accumulation within the prostate gland.7 DHT displays a higher affinity towards androgen receptors in the prostate gland compared to testosterone10 and by acting on the androgen receptors, DHT modulates genes that are responsible for cell proliferation.9 Responsible for the production of DHT together with type I 5α-reductase, the type II 5α-reductase isozyme is primarily found in the prostate, seminal vesicles, epididymides, and hair follicles as well as liver.11 Although finasteride is 100-fold more selective for type II 5α-reductase than for the type I isoenzyme,3 chronic treatment with this drug may have some effect on type I 5α-reductase, which is predominantly expressed in sebaceous glands of most regions of skin, including the scalp, and liver. It is proposed that the type I 5α-reductase and type II 5α-reductase is responsible for the production of one-third and two-thirds of circulating DHT, respectively. 

The mechanism of action of Finasteride is based on its preferential inhibition of Type II 5α-reductase through the formation of a stable complex with the enzyme in vitro and in vivo.Label Finasteride works selectively, where it preferentially displays a 100-fold selectivity for the human Type II 5α-reductase over type I enzyme.11 Inhibition of Type II 5α-reductase blocks the peripheral conversion of testosterone to DHT, resulting in significant decreases in serum and tissue DHT concentrations, minimal to moderate increase in serum testosterone concentrations, and substantial increases in prostatic testosterone concentrations. As DHT appears to be the principal androgen responsible for stimulation of prostatic growth, a decrease in DHT concentrations will result in a decrease in prostatic volume (approximately 20-30% after 6-24 months of continued therapy). It is suggested that increased levels of DHT can lead to potentiated transcription of prostaglandin D2, which promotes the proliferation of prostate cancer cells.4 In men with androgenic alopecia, the mechanism of action has not been fully determined, but finasteride has shown to decrease scalp DHT concentration to the levels found in the hairy scalp, reduce serum DHT, increase hair regrowth, and slow hair loss. Another study suggests that finasteride may work to reduce bleeding of prostatic origin by inhibiting vascular endothelial growth factor (VEGF) in the prostate, leading to atrophy and programmed cell death.3This may bestow the drug therapeutic benefits in patients idiopathic prostatic bleeding, bleeding during anticoagulation, or bleeding after instrumentation.3

Reference: Drug Bank

Safety Data Sheet(s):
Source References:

DrugBank

NIH DailyMed

NIH PubChem

FDA Medication Guides

FDA Specific Drug Information

NIOSH Documents:

Approved on January 8, 2024