VALCHLOR mechlorethamine hydrochloride .012 g/60g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Alkylating Drug class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Mechlorethamine gel is used to treat early stage mycosis fungoides-type cutaneous T-cell lymphoma (CTCL; a cancer of the immune system that begins with skin rashes) in people who have received previous skin treatment. Mechlorethamine gel is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells.
Read the full MedlinePlus article ↗- Valchlor is treating a type of skin lymphoma called mycosis fungoides-type cutaneous T-cell lymphoma. It's a cancer that involves abnormal immune cells collecting in the skin. The...
- What is Valchlor actually treating on my skin?
- The most common side effect is skin irritation — redness, swelling, itching, or blistering right where you apply the gel. Some people also develop skin darkening or a bacterial ski...
- What side effects should I expect, and when should I call my doctor?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Mechlorethamine Hydrochloride — tap one for details:
Mechlorethamine Hydrochloride may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII A1A1I8X02B
A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII YS08XHA860
Racementhol is a cooling compound made from mint plant oils or synthesized in the lab. It's used in medicines as a flavoring and cooling agent to mask bitter tastes and soothe the mouth and throat.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $98.43 | $5,905.94 / 60 g |
| Medicare drug plans payPart D · Q2 2026 | $102.77 | $6,166.15 / 60 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Valchlor .012 g/60gthis 69639-0120-01 | Helsinn | 1 tube | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7872050 ↗ | Method of use | U-1427 | Jul 8, 2029 |
| US 8501819 ↗ | Method of use | U-1427 | Mar 7, 2026 |
| US 8450375 ↗ | Drug product | — | Mar 7, 2026 |
| US 8501818 ↗ | Drug product | — | Mar 7, 2026 |
| US 7838564 ↗ | Drug product | — | Mar 7, 2026 |
| US 9382191 ↗ | Drug product | — | Mar 7, 2026 |
Is there a generic version of VALCHLOR 0.016% GEL?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69639-0120-01 You're viewing this | 1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE | 2018-11-08 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For topical dermatological use only ( 2.1 ). Apply a thin film once daily to affected areas of the skin ( 2.1 , 2.2 ).
2.1Dosing and Dose Modification For Topical Dermatological Use Only Apply a thin film of VALCHLOR gel once daily to affected areas of the skin. Stop treatment with VALCHLOR for any grade of skin ulceration, blistering, or moderately-severe or severe dermatitis (i.e., marked skin redness with edema) [ see Warnings and Precautions ( 5.3 ) ]. Upon improvement, treatment with VALCHLOR can be restarted at a reduced frequency of once every 3 days.
If reintroduction of treatment is tolerated for at least one week, the frequency of application can be increased to every other day for at least one week and then to once daily application if tolerated.
2.2Application Instructions VALCHLOR is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Patients must wash hands thoroughly with soap and water after handling or applying VALCHLOR.
Caregivers must wear disposable nitrile gloves when applying VALCHLOR to patients and wash hands thoroughly with soap and water after removal of gloves. If there is accidental skin exposure to VALCHLOR, caregivers must immediately wash exposed areas thoroughly with soap and water for at least 15 minutes and remove contaminated clothing [ see Warnings and Precautions ( 5.2 ) ]. Patients or caregivers should follow these instructions when applying VALCHLOR: Apply immediately or within 30 minutes after removal from the refrigerator.
Return VALCHLOR to the refrigerator immediately after each use. Apply to completely dry skin at least 4 hours before or 30 minutes after showering or washing. Allow treated areas to dry for 5 to 10 minutes after application before covering with clothing.
Emollients (moisturizers) may be applied to the treated areas 2 hours before or 2 hours after application. Do not use occlusive dressings on areas of the skin where VALCHLOR was applied. Avoid fire, flame, and smoking until VALCHLOR has dried [ see Warnings and Precautions ( 5.6 ) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS The active ingredient in VALCHLOR is mechlorethamine. Each tube of VALCHLOR contains 60g of 0.016% w/w mechlorethamine clear gel (equivalent to 0.02% mechlorethamine HCl). Gel: 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) in 60g tubes ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine. Severe hypersensitivity to mechlorethamine ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Mucosal or eye injury: VALCHLOR exposure to mucous membranes, especially of the eyes, can cause mucosal injury which may be severe. Eye injury may lead to blindness. Immediately irrigate for at least 15 minutes followed by immediate medical consultation ( 5.1 ).
Secondary exposure to VALCHLOR: individuals other than the patient must avoid skin contact with VALCHLOR ( 2.2 , 5.2 ). Dermatitis: Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. Stop treatment or reduce dose frequency ( 2.1 , 5.3 ).
Non-melanoma skin cancer: Monitor patients during and after treatment ( 5.4 ). Embryo-fetal toxicity: May cause fetal harm ( 5.5 ). Flammable gel: VALCHLOR is an alcohol-based gel.
Avoid fire, flame, and smoking until the gel has dried ( 2.2 , 5.6 ).
5.1Mucosal or Eye Injury Exposure of the eyes to mechlorethamine causes pain, burns, inflammation, photophobia, and blurred vision. Blindness and severe irreversible anterior eye injury may occur. Advise patients that if eye exposure occurs, (1) immediately irrigate for at least 15 minutes with copious amounts of water, normal saline, or a balanced salt ophthalmic irrigating solution and (2) obtain immediate medical care (including ophthalmologic consultation).
Exposure of mucous membranes such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, which may be severe. Should mucosal contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, followed by immediate medical consultation.
5.2Secondary Exposure to VALCHLOR Avoid direct skin contact with VALCHLOR in individuals other than the patient. Risks of secondary exposure include dermatitis, mucosal injury, and secondary cancers. Follow recommended application instructions to prevent secondary exposure [ see Dosage and Administration ( 2.2 ) ].
5.3Dermatitis The most common adverse reaction was dermatitis, which occurred in 56% of the patients [ see Adverse Reactions ( 6.1 ) ]. Dermatitis was moderately severe or severe in 23% of patients. Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections.
The face, genitalia, anus, and intertriginous skin are at increased risk of dermatitis. Follow dose modification instructions for dermatitis [ see Dosage and Administration ( 2.1 ) ].
5.4Non-Melanoma Skin Cancer Four percent (4%, 11/255) of patients developed a non-melanoma skin cancer during the clinical trial or during one year of post-treatment follow-up: 2% (3/128) of patients receiving VALCHLOR, and 6% (8/127) of patients receiving the mechlorethamine ointment comparator. Some of these non-melanoma skin cancers occurred in patients who had received prior therapies known to cause non-melanoma skin cancer. Monitor patients for non-melanoma skin cancers during and after treatment with VALCHLOR.
Non-melanoma skin cancer may occur on any area of the skin, including untreated areas.
5.5Embryo-fetal Toxicity Based on case reports in humans, findings in animal reproduction studies, its mechanism of action, and genotoxicity findings, mechlorethamine may cause fetal harm. There are case reports of children born with malformations in pregnant women systemically administered mechlorethamine. Mechlorethamine was teratogenic and embryo-lethal after a single subcutaneous administration to animals.
Advise women to avoid becoming pregnant while using VALCHLOR. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [ see Use in Specific Populations ( 8.1 ) ].
5.6Flammable Gel Alcohol-based products, including VALCHLOR, are flammable. Follow recommended application instructions [ see Dosage and Administration ( 2.2 ) ].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information: Mucosal or eye injury [ see Warnings and Precautions ( 5.1 ) ] Secondary exposure to VALCHLOR [ see Warnings and Precautions ( 5.2 ) ] Dermatitis [ see Warnings and Precautions ( 5.3 ) ] Non-melanoma skin cancer [ see Warnings and Precautions ( 5.4 ) ] The most common adverse reactions (≥5%) are dermatitis, pruritus, bacterial skin infection, skin ulceration or blistering, and hyperpigmentation ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Helsinn Therapeutics (U.S.), Inc., at 1-855-482-5245 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a randomized, observer-blinded, controlled trial, VALCHLOR 0.016% (equivalent to 0.02% mechlorethamine HCl) was compared to an Aquaphor ® -based mechlorethamine HCl 0.02% ointment (Comparator) [ see Clinical Studies ( 14 ) ].
The maximum duration of treatment was 12 months. Sixty-three percent (63%) of patients in the VALCHLOR arm and 67% in the comparator arm completed 12 months of treatment. The body system associated with the most frequent adverse reactions was skin and subcutaneous tissue disorders.
The most common adverse reactions (occurring in at least 5% of the patients) are shown in Table 1 . Table 1. Most Commonly Reported (≥5%) Cutaneous Adverse Reactions VALCHLOR N=128 % of patients Comparator N=127 % of patients Any Grade Moderately-Severe or Severe Any Grade Moderately-Severe or Severe Dermatitis 56 23 58 17 Pruritus 20 4 16 2 Bacterial skin infection 11 2 9 2 Skin ulceration or blistering 6 3 5 2 Skin hyperpigmentation 5 0 7 0 In the clinical trial, moderately-severe to severe skin-related adverse events were managed with treatment reduction, suspension, or discontinuation.
Discontinuations due to adverse reactions occurred in 22% of patients treated with VALCHLOR and 18% of patients treated with the comparator. Sixty-seven percent (67%) of the discontinuations for adverse reactions occurred within the first 90 days of treatment. Temporary treatment suspension occurred in 34% of patients treated with VALCHLOR and 20% of patients treated with the comparator.
Reductions in dosing frequency occurred in 23% of patients treated with VALCHLOR and 12% of patients treated with the comparator. Reductions in hemoglobin, neutrophil count, or platelet count occurred in 13% of patients treated with VALCHLOR and 17% treated with Comparator.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug interaction studies have been performed with VALCHLOR. Systemic exposure has not been observed with topical administration of VALCHLOR; therefore, systemic drug interactions are not likely.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 ).
8.1Pregnancy Risk Summary Based on case reports in humans, findings in animal reproduction studies, its mechanism of action, and genotoxicity findings, mechlorethamine may cause fetal harm. Available published case reports in pregnant women receiving intravenous mechlorethamine demonstrate that mechlorethamine can cause major birth defects when a pregnant woman is systemically exposed. In animal reproduction studies, subcutaneous administration of mechlorethamine to pregnant rats and ferrets during organogenesis resulted in embryo‐fetal mortality, alterations to growth, and structural abnormalities.
Based on limited available data with VALCHLOR use in pregnant women, if VALCHLOR is used during pregnancy or if the patient becomes pregnant while taking this drug, patient should be advised of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data The limited available data with VALCHLOR use in pregnant women does not show evidence of congenital malformation in newborns. Cases of newborns with congenital malformations have been reported in women who received systemic mechlorethamine during pregnancy.
Animal Data Mechlorethamine caused fetal malformations in the rat and ferret when given as single subcutaneous injections of 1 mg/kg. Other findings in animals included embryo lethality and growth retardation when administered as a single subcutaneous injection.
8.2Lactation Risk Summary There are no data on the presence of mechlorethamine or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Because of the potential for topical or systemic exposure to VALCHLOR through exposure to the mother's skin and the potential for serious adverse reactions in the breastfed child from mechlorethamine, advise patients not to breastfeed during treatment with VALCHLOR.
8.3Females and Males of Reproductive Potential Contraception Females Advise female patients of reproductive potential to use effective contraception during treatment with VALCHLOR. A barrier method of contraception should be used to avoid direct exposure of reproductive organs to VALCHLOR. Males Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with VALCHLOR [ see Nonclinical Toxicology ( 13.1 ) ].
A barrier method of contraception should be used to avoid direct exposure of reproductive organs to VALCHLOR. Infertility Based on animal data, mechlorethamine may impair fertility in males and females [ see Nonclinical Toxicology ( 13.1 ) ]. The reversibility of the effect on fertility is unknown.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use A total of 79 patients age 65 and older (31% of the clinical trial population) were treated with either VALCHLOR or the comparator in the clinical trial. Forty-four percent (44%) of patients age 65 or older treated with VALCHLOR achieved a CAILS response compared to 66% of patients below the age of 65. Seventy percent (70%) of patients age 65 and older experienced cutaneous adverse reactions and 38% discontinued treatment due to adverse reactions, compared to 58% and 14% in patients below the age of 65, respectively.
Similar differences in discontinuation rates between age subgroups were observed in the comparator group.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on case reports in humans, findings in animal reproduction studies, its mechanism of action, and genotoxicity findings, mechlorethamine may cause fetal harm. Available published case reports in pregnant women receiving intravenous mechlorethamine demonstrate that mechlorethamine can cause major birth defects when a pregnant woman is systemically exposed. In animal reproduction studies, subcutaneous administration of mechlorethamine to pregnant rats and ferrets during organogenesis resulted in embryo‐fetal mortality, alterations to growth, and structural abnormalities.
Based on limited available data with VALCHLOR use in pregnant women, if VALCHLOR is used during pregnancy or if the patient becomes pregnant while taking this drug, patient should be advised of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data The limited available data with VALCHLOR use in pregnant women does not show evidence of congenital malformation in newborns. Cases of newborns with congenital malformations have been reported in women who received systemic mechlorethamine during pregnancy.
Animal Data Mechlorethamine caused fetal malformations in the rat and ferret when given as single subcutaneous injections of 1 mg/kg. Other findings in animals included embryo lethality and growth retardation when administered as a single subcutaneous injection.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use A total of 79 patients age 65 and older (31% of the clinical trial population) were treated with either VALCHLOR or the comparator in the clinical trial. Forty-four percent (44%) of patients age 65 or older treated with VALCHLOR achieved a CAILS response compared to 66% of patients below the age of 65. Seventy percent (70%) of patients age 65 and older experienced cutaneous adverse reactions and 38% discontinued treatment due to adverse reactions, compared to 58% and 14% in patients below the age of 65, respectively.
Similar differences in discontinuation rates between age subgroups were observed in the comparator group.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Mechlorethamine, also known as nitrogen mustard, is an alkylating agent which inhibits rapidly proliferating cells.
12.3Pharmacokinetics Systemic exposure was undetectable after topical administration of VALCHLOR to patients. Blood samples were analyzed from 16 and 15 patients following treatment with VALCHLOR (mechlorethamine gel 0.016%) and an identical formulation consisting of mechlorethamine 0.032% w/w, respectively. For patients who received mechlorethamine 0.016%, samples were collected to measure mechlorethamine concentrations prior to dosing, on day 1, and at the first month visit.
Following the topical administration of mechlorethamine 0.016%, there were no detectable plasma mechlorethamine concentrations observed in any of the patients. Patients who received mechlorethamine 0.032% had no measurable concentrations of mechlorethamine or half-mustard after 2, 4, or 6 months of treatment.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Mechlorethamine, also known as nitrogen mustard, is an alkylating agent which inhibits rapidly proliferating cells.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING VALCHLOR is supplied in 60g tubes of 0.016% w/w mechlorethamine as a clear gel [NDC 69639-120-01]. Prior to dispensing, store in the freezer at -13°F to 5°F (-25°C to -15°C). Advise patients that refrigerated storage is required once dispensed. VALCHLOR is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
📦 Storage and Handling ▾
Prior to dispensing, store in the freezer at -13°F to 5°F (-25°C to -15°C). Advise patients that refrigerated storage is required once dispensed. VALCHLOR is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
📋 Description ▾
11 DESCRIPTION VALCHLOR is a topical product that contains mechlorethamine HCl, an alkylating drug. Mechlorethamine HCl is a white to off white solid that is very soluble in water and methanol, partially soluble in acetone, and generally not soluble in organic solvents. Mechlorethamine HCl is designated chemically as 2-chloro- N -(2-chloroethyl)- N -methylethanamine hydrochloride.
The molecular weight is 192.52 and the melting point is 108-111°C. The empirical formula is C 5 H 11 Cl 2 N•HCl, and the structural formula is: CH 3 N(CH 2 CH 2 Cl) 2 •HCl. Each tube of VALCHLOR contains 60g of a gel containing 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) in a base of the following inactive ingredients: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerin, lactic acid, hydroxypropylcellulose, sodium chloride, menthol, edetate disodium, butylated hydroxytoluene.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Medication Guide ) Advise patients of the following and provide a copy of the Medication Guide. Instructions for Patients and Caregivers for Application of VALCHLOR : Apply a thin film of VALCHLOR once daily to affected areas of the skin [ see Dosage and Administration ( 2.1 ) ]. Patients must wash hands thoroughly with soap and water after handling or applying VALCHLOR.
Caregivers must wear disposable nitrile gloves when applying VALCHLOR to patients and wash hands thoroughly with soap and water after removal of gloves. If there is accidental skin exposure to VALCHLOR, caregivers must immediately wash exposed areas thoroughly with soap and water and remove contaminated clothing [ see Dosage and Administration ( 2.2 ) ]. Patients and caregivers should follow these instructions when applying VALCHLOR [ see Dosage and Administration ( 2.2 ) ]: Apply immediately or within 30 minutes after removal from the refrigerator.
Return VALCHLOR to the refrigerator immediately after each use. Apply VALCHLOR to completely dry skin at least 4 hours before or 30 minutes after showering or washing. Allow treated areas to dry for 5 to 10 minutes after application before covering with clothing.
Emollients (moisturizers) may be applied to the treated areas 2 hours before or 2 hours after application of VALCHLOR. Occlusive (air or water-tight) dressings should not be used on areas of the skin where VALCHLOR was applied. Instructions for Patients and Caregivers for Storage of VALCHLOR Store VALCHLOR refrigerated at temperatures between 36°F - 46°F (2°C - 8°C).
Advise patients that adherence to the recommended storage condition will ensure VALCHLOR will work as expected. Patients should consult a pharmacist prior to using VALCHLOR that has been left at room temperature for longer than one hour per day. Unused product should be discarded after 90 days [ see How Supplied/Storage and Handling ( 16 ) ].
With clean hands, replace tube in the original box, then place in the refrigerator. Keep VALCHLOR in its original box out of the reach of children and avoid contact with food when storing in the refrigerator. Unused VALCHLOR, empty tubes, and used application gloves should be discarded in household trash in a manner that prevents accidental application or ingestion by others, including children and pets.
Mucosal or Eye Injury Exposure of the eyes to mechlorethamine causes pain, burns, inflammation, photophobia, and blurred vision. Blindness and severe irreversible eye injury may occur. Should eye contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, normal saline, or a balanced salt ophthalmic irrigating solution, followed by immediate ophthalmologic consultation [ see Warnings and Precautions ( 5.1 ) ].
Exposure of mucous membranes such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, which may be severe. Should mucosal contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, followed by immediate medical consultation [ see Warnings and Precautions ( 5.1 ) ]. Secondary Exposure to VALCHLOR Avoid direct skin contact with VALCHLOR in individuals other than the patient.
Risks of secondary exposure include dermatitis, mucosal injury, and secondary cancers. Caregivers who help apply VALCHLOR to patients must wear disposable nitrile gloves when handling VALCHLOR. If secondary exposure occurs to eyes, mouth, or nose, immediately irrigate the exposed area for at least 15 minutes with copious amounts of water.
Thoroughly wash affected areas of the skin with soap and water [ see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.2 ) ]. Dermatitis If patients experience skin irritation after applying VALCHLOR, such as redness, swelling, inflammation, itchiness, blisters, ulceration, or secondary skin infections, instruct patients to discuss with their physician options for changes in the…
💬 Medication Guide ▾
MEDICATION GUIDE VALCHLOR ® (val-klor) (mechlorethamine) gel Important information: VALCHLOR is for use on skin only. Do not get VALCHLOR near or in your eyes, mouth, or nose. What is the most important information I should know about VALCHLOR?
Keep VALCHLOR away from your eyes, mouth, and nose. If VALCHLOR gets in your eyes it can cause eye pain, burning, swelling, redness, sensitivity to light, and blurred vision. It may also cause blindness and permanent injury to your eyes.
If VALCHLOR gets in your eyes, rinse your eyes right away for at least 15 minutes with a large amount of water, normal saline, or an eye wash solution. If VALCHLOR gets in your mouth or nose it can cause pain, redness, and ulcers. Rinse the affected area right away for at least 15 minutes with a large amount of water.
Get medical help right away if VALCHLOR gets in your eyes, mouth, or nose. Talk with your healthcare provider before using VALCHLOR about how to get medical help. What is VALCHLOR?
VALCHLOR is a prescription medicine used on the skin (topical) to treat people with Stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma who have received previous skin treatment. It is not known if VALCHLOR is safe and effective in children. Do not use VALCHLOR if you are severely allergic to mechlorethamine.
Tell your healthcare provider if you have had an allergic reaction to mechlorethamine. Before using VALCHLOR, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant. VALCHLOR may harm your unborn baby.
Avoid becoming pregnant during treatment with VALCHLOR. Tell your healthcare provider right away if you become pregnant while using VALCHLOR. -Females who are able to become pregnant should use a barrier method of birth control, such as a male condom or spermicide, during treatment with VALCHLOR. -Males with female partners who are able to become pregnant should use a barrier method of birth control, such as a male condom or spermicide, during treatment with VALCHLOR. are breastfeeding or plan to breastfeed. It is not known if VALCHLOR passes into your breast milk.
Do not breastfeed during treatment with VALCHLOR. Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use VALCHLOR?
Use VALCHLOR exactly as your healthcare provider tells you. Caregivers must wear disposable nitrile gloves when applying VALCHLOR. Wash your hands with soap and water after touching or applying VALCHLOR.
Safely throw away used disposable nitrile gloves in household trash. Apply VALCHLOR right away or within 30 minutes after you take it out of the refrigerator. Return VALCHLOR to the refrigerator right after each use.
Apply a thin layer of VALCHLOR 1 time each day (or as instructed by your healthcare providers) to completely dry affected areas of the skin at least 4 hours before or 30 minutes after showering or washing. Let the treated areas dry for 5 to 10 minutes after applying VALCHLOR before covering with clothing. Moisturizers may be applied to the treated areas 2 hours before or 2 hours after applying VALCHLOR.
You should not use air or water-tight bandages on areas of the skin treated with VALCHLOR. What should I avoid while using VALCHLOR? VALCHLOR is flammable.
Avoid fire, flame, and smoking until VALCHLOR has dried. What are the possible side effects of VALCHLOR? See " What is the most important information I should know about VALCHLOR?" VALCHLOR can cause serious side effects, including: Risk of Secondary Exposure to VALCHLOR.
You may have a risk of inflammation of your skin (dermatitis), injury to your eyes, mouth, or nose, and certain types of cancers. Caregivers who accidentally come into contact with VALCHLOR must wash the affected area with soap and water right away for at least 15 minutes and remove any contaminated clothing. Get medical help right away if VALCHLOR gets in yo…