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Is mechlorethamine available in the US?

2 min read

In 2018, the manufacturer of the injectable mechlorethamine (brand name Mustargen) voluntarily discontinued it in the U.S., but a topical gel formulation (Valchlor) remains available for certain skin cancers. This distinction is critical for patients and healthcare providers determining if mechlorethamine is available in the US.

Quick Summary

The injectable form of mechlorethamine, Mustargen, is no longer sold in the US, but the topical gel version, Valchlor, is still available via specialty pharmacies for specific types of cutaneous T-cell lymphoma.

Key Points

  • Injectable Discontinued: The injectable version of mechlorethamine, sold as Mustargen, was discontinued in the US by its manufacturer in 2018 due to low demand.

  • Topical Gel Available: A topical gel formulation of mechlorethamine, branded as Valchlor, remains available in the US.

  • Specific Indication: Valchlor gel is specifically approved for treating early-stage mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).

  • Specialty Pharmacy Distribution: Valchlor is not sold in traditional pharmacies and must be obtained through a specialty pharmacy.

  • Safety Precautions: The topical gel requires specific handling, application, and storage protocols, and contact with sensitive areas like eyes or the mouth must be avoided.

  • Consult a Doctor: A healthcare professional should be consulted for proper use of Valchlor or to identify alternatives for conditions previously treated with injectable mechlorethamine.

In This Article

Mechlorethamine, also known as nitrogen mustard, is a chemotherapy drug with a varied history of availability in the United States. While the injectable form is no longer available, a topical gel formulation is still used for a specific type of cancer. Understanding this difference is crucial for patients and medical professionals.

The Discontinuation of Injectable Mechlorethamine (Mustargen)

The injectable version of mechlorethamine, marketed as Mustargen, was used for decades to treat various cancers, including Hodgkin's and non-Hodgkin's lymphomas, and certain leukemias. However, due to the development of newer treatments and declining demand, the manufacturer discontinued Mustargen in 2018. This decision was based on low market demand, not safety concerns. Resources like MedlinePlus and the Veterans Affairs Health Library no longer provide updated information on this discontinued formulation.

The Availability of Topical Mechlorethamine Gel (Valchlor)

Despite the injectable form's discontinuation, mechlorethamine is still available in the US as a topical gel called Valchlor. Approved by the FDA in 2013, Valchlor is specifically indicated for treating early-stage mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in patients who have already received other skin therapies. Valchlor is applied directly to the skin to target localized lesions and has minimal systemic absorption, which helps reduce widespread chemotherapy side effects. It is exclusively available through specialty pharmacies.

How Mechlorethamine Works

As an alkylating agent, mechlorethamine damages cancer cell DNA, preventing growth and division. The topical gel delivers this effect directly to affected skin cells in MF-CTCL.

Differences Between the Discontinued Injectable (Mustargen) and Available Topical (Valchlor)

Feature Mustargen (Injectable) Valchlor (Topical Gel)
Availability in US Discontinued since 2018 Currently available
Indication Hodgkin's lymphoma, non-Hodgkin's lymphoma, leukemia, etc. Early-stage mycosis fungoides-type CTCL
Formulation Intravenous or intracavitary injection Topical gel applied to the skin
Availability Route Was available through standard pharmacy channels Available only through specialty pharmacies
Side Effects Systemic: nausea, vomiting, bone marrow suppression, hair loss Localized: skin irritation, dermatitis, itching, blistering
Systemic Absorption Designed for systemic absorption Minimally absorbed systemically

Important Considerations for Topical Mechlorethamine (Valchlor)

Safe handling and application of Valchlor are crucial. Caregivers should use disposable nitrile gloves, and hands must be washed thoroughly after use. The gel is flammable and should not be used near heat or open flames until dry. It is applied once daily to dry skin, waiting at least 30 minutes after washing before applying and at least 4 hours after applying before washing the treated area. Valchlor requires refrigeration. It is for external use only; contact with eyes, nose, or mouth necessitates immediate rinsing and medical attention.

Alternatives for Systemic Treatment

For conditions previously treated with injectable mechlorethamine, alternative systemic chemotherapy drugs like cyclophosphamide or chlorambucil are available. An oncologist can determine the best current treatment plan for a specific condition.

Conclusion: Navigating Mechlorethamine's Availability

So, is mechlorethamine available in the US? Yes, but only as the topical gel Valchlor for early-stage mycosis fungoides-type CTCL. The injectable form, Mustargen, is discontinued. Patients and healthcare providers should consult with a qualified professional for guidance on Valchlor use or alternative treatments.

Frequently Asked Questions

No, the injectable formulation of mechlorethamine, branded as Mustargen, was voluntarily discontinued by its manufacturer in 2018 due to low commercial demand.

The manufacturer, Recordati Rare Diseases, discontinued injectable mechlorethamine (Mustargen) because of low demand, not because of safety issues or lack of efficacy.

Valchlor is a topical gel formulation used for a specific type of skin lymphoma, while Mustargen was a systemic injectable formulation used for a broader range of cancers. Mustargen has been discontinued in the US, but Valchlor is still available.

Valchlor is only available through a specialty pharmacy, not a local one. Your healthcare provider will need to prescribe it and fill out a form for shipment to your home.

Valchlor is used to treat early-stage mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL), a type of skin cancer.

Yes, for conditions like Hodgkin's lymphoma, other chemotherapy agents have replaced injectable mechlorethamine. Your oncologist can discuss currently available systemic treatment options.

No, Valchlor is only FDA-approved for early-stage mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL). It should only be used under the guidance of a qualified healthcare professional.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.