Valchlor 0.016% Gel 60gm
It is used to treat a type of lymphoma that affects the skin.
Drug Class
Antineoplastic Agent
Pharmacologic Class
Alkylating Agent
Pregnancy Category
Category D
FDA Approved
Aug 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Valchlor gel contains a medicine called mechlorethamine, which is a type of chemotherapy. When applied to the skin, it helps to slow down or stop the growth of abnormal skin cells that cause Mycosis Fungoides-type Cutaneous T-Cell Lymphoma (MF-CTCL). It works by damaging the DNA of these cancer cells, preventing them from multiplying.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Handle this medication with care, and consult your doctor or pharmacist for guidance on proper handling.
Wash your hands before and after application, unless the treated area is on your hand, in which case you should not wash your hand after application.
Caregivers should wear special gloves when applying this medication and wash their hands afterward.
Preparation and Application
Remove the medication from the refrigerator and apply it immediately or within 30 minutes.
Return the medication to the refrigerator after each use.
Apply a thin layer to clean, dry skin, avoiding healthy skin.
Allow the skin to dry for at least 5 minutes before covering with clothing.
Precautions and Timing
Wait at least 30 minutes after bathing or showering before applying this medication.
Avoid bathing, showering, or swimming for 4 hours after application.
Keep away from fire, flames, or smoking until the gel has dried.
If using a moisturizer, do not apply it within 2 hours before or 2 hours after using this medication.
Avoid using coverings (bandages, dressings, makeup) unless instructed to do so by your doctor.
Continuing Treatment
Use this medication as directed, even if your symptoms improve.
Storage and Disposal
Store this medication in a refrigerator, keeping it away from food and drink.
Return the medication to its original box and refrigerate after each use.
Protect the medication from heat and open flames.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Handle this medication with care, and consult your doctor or pharmacist for guidance on proper handling.
Wash your hands before and after application, unless the treated area is on your hand, in which case you should not wash your hand after application.
Caregivers should wear special gloves when applying this medication and wash their hands afterward.
Preparation and Application
Remove the medication from the refrigerator and apply it immediately or within 30 minutes.
Return the medication to the refrigerator after each use.
Apply a thin layer to clean, dry skin, avoiding healthy skin.
Allow the skin to dry for at least 5 minutes before covering with clothing.
Precautions and Timing
Wait at least 30 minutes after bathing or showering before applying this medication.
Avoid bathing, showering, or swimming for 4 hours after application.
Keep away from fire, flames, or smoking until the gel has dried.
If using a moisturizer, do not apply it within 2 hours before or 2 hours after using this medication.
Avoid using coverings (bandages, dressings, makeup) unless instructed to do so by your doctor.
Continuing Treatment
Use this medication as directed, even if your symptoms improve.
Storage and Disposal
Store this medication in a refrigerator, keeping it away from food and drink.
Return the medication to its original box and refrigerate after each use.
Protect the medication from heat and open flames.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or extra doses.
Lifestyle & Tips
- Apply the gel exactly as prescribed by your doctor, usually once daily.
- Wear disposable gloves when applying the gel to protect your hands and prevent transfer to other areas or people.
- Apply a thin film to affected skin areas only. Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Wash hands thoroughly with soap and water immediately after applying the gel, even if gloves were worn.
- Allow the gel to dry for 5-10 minutes before covering the treated area with clothing.
- Avoid showering or bathing for at least 4 hours after application.
- Store the gel in the refrigerator (2°C to 8°C or 36°F to 46°F). Do not freeze.
- Keep out of reach of children and pets.
- Protect treated skin from excessive sun exposure, as skin may be more sensitive.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film of Valchlor 0.016% Gel once daily to affected skin areas.
Condition-Specific Dosing:
mycosisFungoidesCTCL:
Apply a thin film once daily to affected skin areas. Treatment should be continued for at least 12 months, or until a 50% reduction in disease burden is achieved, or until progression of disease, or until intolerable toxicity.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment is necessary due to minimal systemic absorption.
Moderate:
No dosage adjustment is necessary due to minimal systemic absorption.
Severe:
No dosage adjustment is necessary due to minimal systemic absorption.
Dialysis:
No specific recommendations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No dosage adjustment is necessary due to minimal systemic absorption.
Moderate:
No dosage adjustment is necessary due to minimal systemic absorption.
Severe:
No dosage adjustment is necessary due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Mechlorethamine is an alkylating agent that inhibits rapidly proliferating cells. It forms highly reactive carbonium ion intermediates that react with nucleophilic centers on DNA, leading to cross-linking of DNA strands, inhibition of DNA replication, and ultimately cell death. This cytotoxic action is non-specific to the cell cycle.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; plasma concentrations of mechlorethamine and its metabolites were below the limit of quantification (0.1 ng/mL) in most patients.
Tmax:
Not applicable for systemic absorption due to minimal levels.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable due to minimal systemic absorption.
ProteinBinding:
Not applicable due to minimal systemic absorption.
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable for systemic elimination due to minimal systemic absorption.
Clearance:
Not applicable for systemic clearance due to minimal systemic absorption.
ExcretionRoute:
Not applicable for systemic excretion due to minimal systemic absorption.
Unchanged:
Not applicable for systemic unchanged excretion due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Clinical response may take several weeks to months.
PeakEffect:
Not precisely defined for topical effect; clinical response typically observed over months.
DurationOfAction:
Duration of therapeutic effect is maintained with continued daily application.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Blisters or sores
- Redness
- Swelling
- Signs of skin infection, including oozing, heat, swelling, redness, or pain
- Skin ulcers
- A skin lump or growth
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
- Itching
- Change in skin color
These are not all the possible side effects that may occur. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Blisters or sores
- Redness
- Swelling
- Signs of skin infection, including oozing, heat, swelling, redness, or pain
- Skin ulcers
- A skin lump or growth
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
- Itching
- Change in skin color
These are not all the possible side effects that may occur. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation, redness, itching, or burning that does not improve or worsens.
- Blistering, peeling, or ulceration of the skin at the application site.
- Signs of infection at the application site (e.g., pus, increased pain, fever).
- Any new skin lesions or changes in existing ones, as there is a theoretical risk of secondary malignancies with long-term use of alkylating agents.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are breastfeeding, as you should not breastfeed while taking this medication.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, consult with your doctor to confirm it is safe to:
Start taking a new medication
Stop taking a medication
* Change the dosage of any medication
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are breastfeeding, as you should not breastfeed while taking this medication.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, consult with your doctor to confirm it is safe to:
Start taking a new medication
Stop taking a medication
* Change the dosage of any medication
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When handling this drug, exercise caution to avoid getting it in your eyes, as it can cause severe eye problems, including eye pain, burns, swelling, blurred vision, and potentially even blindness or long-lasting eye injury. To prevent eye exposure, avoid touching your eyes while using this medication. If accidental eye exposure occurs, immediately flush your eyes with water for at least 15 minutes and contact your doctor.
Before using any other medications or products on your skin, consult with your doctor. This includes soaps and other topical agents. To minimize the risk of transferring the medication to others, ensure that the treated skin area does not come into contact with another person's skin while the gel is in use. Cover the treated area with clothing to prevent accidental transfer. If someone else inadvertently comes into contact with the gel, they should wash the affected skin area with soap and water for at least 15 minutes and remove any contaminated clothing.
Using this medication may increase your risk of developing other skin cancers. It is crucial to discuss this risk with your doctor and undergo regular skin checks. Notify your doctor immediately if you notice any new or changing skin lesions, such as warts, sores, reddish bumps that bleed or do not heal, or changes in the color or size of a mole.
This medication is flammable, so it is essential to avoid using it near open flames or while smoking.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This drug may affect fertility, potentially leading to difficulty becoming pregnant or fathering a child. It is unclear whether fertility will return to normal if this occurs.
Additionally, this medication may harm an unborn baby. If you are a woman of childbearing potential, you must use a barrier method of birth control, such as a condom or spermicide, to prevent pregnancy while taking this drug. If you become pregnant, contact your doctor immediately.
Similarly, if your sexual partner may become pregnant, you must use a barrier method of birth control, such as a condom or spermicide, while taking this medication to prevent pregnancy. If your partner becomes pregnant, notify the doctor right away.
When handling this drug, exercise caution to avoid getting it in your eyes, as it can cause severe eye problems, including eye pain, burns, swelling, blurred vision, and potentially even blindness or long-lasting eye injury. To prevent eye exposure, avoid touching your eyes while using this medication. If accidental eye exposure occurs, immediately flush your eyes with water for at least 15 minutes and contact your doctor.
Before using any other medications or products on your skin, consult with your doctor. This includes soaps and other topical agents. To minimize the risk of transferring the medication to others, ensure that the treated skin area does not come into contact with another person's skin while the gel is in use. Cover the treated area with clothing to prevent accidental transfer. If someone else inadvertently comes into contact with the gel, they should wash the affected skin area with soap and water for at least 15 minutes and remove any contaminated clothing.
Using this medication may increase your risk of developing other skin cancers. It is crucial to discuss this risk with your doctor and undergo regular skin checks. Notify your doctor immediately if you notice any new or changing skin lesions, such as warts, sores, reddish bumps that bleed or do not heal, or changes in the color or size of a mole.
This medication is flammable, so it is essential to avoid using it near open flames or while smoking.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This drug may affect fertility, potentially leading to difficulty becoming pregnant or fathering a child. It is unclear whether fertility will return to normal if this occurs.
Additionally, this medication may harm an unborn baby. If you are a woman of childbearing potential, you must use a barrier method of birth control, such as a condom or spermicide, to prevent pregnancy while taking this drug. If you become pregnant, contact your doctor immediately.
Similarly, if your sexual partner may become pregnant, you must use a barrier method of birth control, such as a condom or spermicide, while taking this medication to prevent pregnancy. If your partner becomes pregnant, notify the doctor right away.
Overdose Information
Overdose Symptoms:
- Excessive local skin irritation, redness, blistering, or ulceration.
What to Do:
Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. For excessive local skin reactions, discontinue use temporarily and manage symptoms with supportive care (e.g., emollients, topical corticosteroids). If severe, seek medical attention. For accidental ingestion or significant exposure, call a poison control center (1-800-222-1222) or seek emergency medical care.
Drug Interactions
Monitoring
Baseline Monitoring
Skin examination (extent and severity of CTCL lesions)
Rationale: To establish baseline disease burden and identify areas for treatment.
Timing: Prior to initiation of therapy.
Complete blood count (CBC)
Rationale: Although systemic absorption is minimal, baseline hematologic status is prudent for any antineoplastic agent.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin examination (for local skin reactions)
Frequency: Regularly, especially during the first few weeks of treatment, then as clinically indicated.
Target: Minimize severity of reactions (e.g., erythema, pruritus, dermatitis, ulceration).
Action Threshold: Moderate to severe skin reactions may require temporary interruption or discontinuation of therapy. Use of topical corticosteroids or emollients may be considered.
Assessment of disease response
Frequency: Every 3-6 months or as clinically indicated.
Target: Reduction in disease burden (e.g., 50% reduction in mSWAT score).
Action Threshold: Lack of response or disease progression may warrant re-evaluation of treatment.
Symptom Monitoring
- Skin irritation (redness, itching, burning, dryness, peeling)
- Skin rash or dermatitis
- Skin ulceration or blistering
- Pain at application site
- Signs of allergic reaction (rare, but possible)
Special Patient Groups
Pregnancy
Valchlor is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Valchlor and for 1 week after the last dose.
Trimester-Specific Risks:
First Trimester:
Highest risk of major birth defects due to organogenesis.
Second Trimester:
Potential for fetal toxicity and growth restriction.
Third Trimester:
Potential for fetal toxicity and adverse effects on development.
Lactation
It is not known whether mechlorethamine is excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants from Valchlor, advise women not to breastfeed during treatment with Valchlor and for 1 week after the last dose.
Infant Risk:
High risk (L5) due to potential for serious adverse reactions, although systemic absorption is minimal, caution is warranted with cytotoxic agents.
Pediatric Use
Safety and effectiveness of Valchlor in pediatric patients have not been established. Use is not recommended.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (65 years and older) and younger adult patients in clinical trials. However, elderly patients may be more susceptible to skin irritation, and careful monitoring is advised.
Clinical Information
Clinical Pearls
- Valchlor is a unique topical formulation of an alkylating agent specifically approved for MF-CTCL.
- Emphasize proper application technique (gloves, thin film, hand washing) to minimize exposure to caregivers and other body areas.
- Skin irritation (dermatitis, pruritus, erythema) is a common side effect. Patients should be educated on managing these reactions, which may include temporary interruption of therapy, use of emollients, or topical corticosteroids.
- The gel should be stored in the refrigerator and not frozen.
- Clinical response can be slow, often taking several months to become apparent. Patients should be encouraged to adhere to the treatment regimen.
- Regular skin checks by the patient and clinician are crucial to monitor for both treatment response and adverse skin reactions.
Alternative Therapies
- Topical corticosteroids (e.g., clobetasol)
- Topical retinoids (e.g., bexarotene gel)
- Phototherapy (e.g., narrowband UVB, PUVA)
- Radiation therapy (e.g., total skin electron beam, localized radiation)
- Systemic therapies (e.g., methotrexate, interferon alfa, histone deacetylase inhibitors like vorinostat or romidepsin, biologics like mogamulizumab, brentuximab vedotin)
- Other topical chemotherapies (e.g., carmustine topical solution - though less common now)
Cost & Coverage
Average Cost:
Highly variable, typically >$10,000 per 60gm tube
Insurance Coverage:
Specialty Tier (requires prior authorization, may have step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.